REGULUS THERAPEUTICS INC. The interim unaudited condensed financial statements and this Management's Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with the financial statements and notes thereto for the year endedDecember 31, 2019 and the related Management's Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K for the year endedDecember 31, 2019 , or Annual Report, filed with theSecurities and Exchange Commission onMarch 12, 2020 . Past operating results are not necessarily indicative of results that may occur in future periods. FORWARD-LOOKING STATEMENTS This quarterly report on Form 10-Q contains "forward-looking statements" within the meaning of federal securities laws made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth below under Part II, Item 1A, "Risk Factors" in this quarterly report on Form 10-Q. Except as required by law, we assume no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise. These statements, which represent our current expectations or beliefs concerning various future events, may contain words such as "may," "will," "expect," "anticipate," "intend," "plan," "believe," "estimate" or other words indicating future results, though not all forward-looking statements necessarily contain these identifying words. Such statements may include, but are not limited to, statements concerning the following: •the initiation, cost, timing, progress and results of, and our expected ability to undertake certain activities and accomplish certain goals with respect to our research and development activities, preclinical studies and clinical trials; •our ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations, and/or warnings in the label of an approved product candidate; •our ability to obtain funding for our operations; •our plans to research, develop and commercialize our product candidates; •the potential election of any strategic collaboration partner to pursue development and commercialization of any programs or product candidates that are subject to a collaboration with such partner; •our ability to attract collaborators with relevant development, regulatory and commercialization expertise; •future activities to be undertaken by our strategic collaboration partners, collaborators and other third parties; •our ability to obtain and maintain intellectual property protection for our product candidates; •the size and growth potential of the markets for our product candidates, and our ability to serve those markets; •our ability to successfully commercialize, and our expectations regarding future therapeutic and commercial potential with respect to our product candidates; •the rate and degree of market acceptance of our product candidates; •our ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; •regulatory developments inthe United States and foreign countries; •the performance of our third-party suppliers and manufacturers; •the success of competing therapies that are or may become available; •the loss of key scientific or management personnel; •our ability to successfully secure and deploy capital; •our ability to satisfy our debt obligations; •the accuracy of our estimates regarding future expenses, future revenues, capital requirements and need for additional financing; •the potential impact of the COVID-19 pandemic on our business; and •the risks and other forward-looking statements described under the caption "Risk Factors" under Part II, Item 1A of this quarterly report on Form 10-Q. In addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this report, and while we believe such information 20 -------------------------------------------------------------------------------- forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements. OVERVIEW We are a clinical-stage biopharmaceutical company focused on discovering and developing first-in-class drugs targeting microRNAs to treat diseases with significant unmet medical need. We were formed in 2007 when Alnylam Pharmaceuticals, Inc. ("Alnylam") and Ionis Pharmaceuticals, Inc. ("Ionis") contributed significant intellectual property, know-how and financial and human capital to pursue the development of drugs targeting microRNAs pursuant to a license and collaboration agreement. Our most advanced product candidates are RG-012 and RGLS4326. RG-012 is an anti-miR targeting miR-21 for the treatment of Alport syndrome, a life-threatening kidney disease with no approved therapy available. InNovember 2018 , we and Sanofi agreed to transition further development activities of our miR-21 programs, including our RG-012 program. As a result, Sanofi became responsible for all costs incurred in the development of RG-012 and any other miR-21 programs. The transition activities were completed in the second quarter of 2019. RGLS4326 is an anti-miR targeting miR-17 for the treatment of autosomal dominant polycystic kidney disease ("ADPKD"). In addition to these clinical programs, we continue to develop a pipeline of preclinical drug product candidates. microRNAs are naturally occurring ribonucleic acid ("RNA") molecules that play a critical role in regulating key biological pathways. Scientific research has shown that an imbalance, or dysregulation, of microRNAs is directly linked to many diseases. Furthermore, many different infectious pathogens interact and bind to host microRNA to survive. To date, over 500 microRNAs have been identified in humans, each of which can bind to multiple messenger RNAs that control key aspects of cell biology. Since many diseases are multi-factorial, involving multiple targets and pathways, the ability to modulate multiple pathways by targeting a single microRNA provides a new therapeutic approach for treating complex diseases. RNA plays an essential role in the process used by cells to encode and translate genetic information from deoxyribonucleic acid, or DNA, to proteins. RNA is comprised of subunits called nucleotides and is synthesized from a DNA template by a process known as transcription. Transcription generates different types of RNA, including messenger RNAs that carry the information for proteins in the sequence of their nucleotides. In contrast, microRNAs are RNAs that do not code for proteins but rather are responsible for regulating gene expression by modulating the translation and decay of target messenger RNAs. By interacting with many messenger RNAs, a single microRNA can regulate the expression of multiple genes involved in the normal function of a biological pathway. Many pathogens, including viruses, bacteria and parasites, also use host microRNAs to regulate the cellular environment for survival. In some instances, the host microRNAs are essential for the replication and/or survival of the pathogen. For example, miR-122 is a microRNA expressed in human hepatocytes and is a key factor for the replication of the hepatitis C virus ("HCV"). We believe that microRNA therapeutics have the potential to become a new and major class of drugs with broad therapeutic application for the following reasons: •microRNAs play a critical role in regulating biological pathways by controlling the translation of many target genes; •microRNA therapeutics regulate disease pathways which may result in more effective treatment of complex multi-factorial diseases; •many human pathogens, including viruses, bacteria and parasites, use microRNAs (host and pathogen encoded) to enable their replication and suppression of host immune responses; and •microRNA therapeutics may be synergistic with other therapies because of their different mechanism of action. We have assembled significant expertise in the microRNA field, including expertise in microRNA biology and oligonucleotide chemistry, a broad intellectual property estate, relationships with key opinion leaders and a disciplined drug discovery and development process. We are using our microRNA expertise to develop chemically modified, single-stranded oligonucleotides that we call anti-miRs to modulate microRNAs and address underlying disease. We believe microRNAs may play a critical role in complex disease and that targeting them with anti-miRs may become a source of a new and major class of drugs with broad therapeutic application, much like small molecules, biologics and monoclonal antibodies. We believe that microRNA biomarkers may be used to select optimal patient segments in clinical trials and to monitor disease progression or relapse. We believe these microRNA biomarkers can be applied toward drugs that we develop and drugs developed by other companies with which we partner or collaborate. 21 -------------------------------------------------------------------------------- Since our inception throughJune 30, 2020 , we have received$342.5 million from the sale of our equity and convertible debt securities,$91.8 million from our strategic collaborations, principally from upfront payments, research funding and preclinical and clinical milestones, and$19.8 million in net proceeds from our Term Loan. As ofJune 30, 2020 , we had cash and cash equivalents of$23.4 million . Development Stage Pipeline
We currently have two programs in clinical development.
RG-012: InMay 2017 , we completed a Phase 1 multiple-ascending dose ("MAD") clinical trial in 24 healthy volunteers (six-week repeat dosing) to determine safety, tolerability and pharmacokinetics ("PK") of RG-012 prior to chronic dosing in patients. In Phase 1 clinical trials to date, RG-012 was well-tolerated, and there were no serious adverse events ("SAEs") reported. In the third quarter of 2017, we initiated HERA, a Phase 2 randomized (1:1), double-blinded, placebo-controlled clinical trial evaluating the safety and efficacy of RG-012 in 40 Alport syndrome patients. In parallel, a renal biopsy study was also initiated in the third quarter of 2017 to evaluate RG-012 renal tissue PK, target engagement and downstream effects on genomic disease biomarkers. Kidney tissue concentrations were achieved in biopsy patients that would be predictive of therapeutic benefit based on animal disease models. In addition, modulation of the target, miR-21, was observed. InDecember 2017 , we concluded our global ATHENA natural history of disease study. RG-012 has received orphan designation in boththe United States andEurope . InNovember 2018 , we and Sanofi agreed to transition further development activities of our miR-21 programs, including our RG-012 program to Sanofi. As a result, Sanofi became responsible for all costs incurred in the development of these miR-21 programs. The transition activities, including the transfer of the investigational new drug application ("IND"), were completed in the second quarter of 2019. While Sanofi is currently enrolling patients into a Phase 2 clinical trial, with sites inthe United States ,Europe , andAustralia , we believe new site initiation and patient enrollment has been, and will continue to be, impacted by the COVID-19 pandemic. RGLS4326: RGLS4326 is a novel oligonucleotide designed to inhibit miR-17 using a unique chemistry designed to preferentially deliver to the kidney. Preclinical studies with RGLS4326 have demonstrated a reduction in kidney cyst formation, improved kidney weight/body weight ratio, decreased cyst cell proliferation and preserved kidney function in mouse models of ADPKD. InMarch 2018 , we completed dose escalation of a Phase 1 single ascending dose ("SAD") clinical trial in healthy volunteers and found RGLS4326 was well tolerated and no SAEs were reported. InApril 2018 , we initiated a Phase 1 randomized, double-blind, placebo-controlled, MAD clinical trial in healthy volunteers designed to characterize the safety, tolerability, PK and pharmacodynamics of multiple doses of RGLS4326. InJuly 2018 , we voluntarily paused this study due to unexpected observations in our 27-week mouse chronic toxicity study, which was designed to support the Phase 2 proof-of-concept clinical trial in ADPKD previously planned to start in mid-2019. The observations in the mouse chronic toxicity study were unexpected, given the favorable safety profile of RGLS4326 in previous 7-week non-GLP and GLP toxicity studies in mouse and non-human primates required for Phase 1 testing, which had no significant findings across similar dose levels and frequencies. InSeptember 2018 , we initiated a new mouse chronic toxicity study with several changes believed to address the unexpected findings in the earlier terminated chronic mouse toxicity study. InJanuary 2019 , we submitted a comprehensive data package for RGLS4326 to theU.S. Food and Drug Administration ("FDA") that included the results from the planned 13-week interim analysis of the ongoing repeat mouse chronic toxicity study, as well as results from additional investigations, analytical testing, additional data from the previously terminated mouse chronic toxicity study, data from the completed Phase 1 SAD study and data from the first cohort of the Phase 1 MAD study to support our plan to resume the Phase 1 MAD study. InJuly 2019 , FDA notified us of additional nonclinical data requirements and placed the IND on a partial clinical hold, formalizing the specific requirements to re-initiate the MAD study and further proceed into studies of extended duration. The additional data requirements were outlined in two parts. In order to resume the MAD study, FDA requested the final reports from the chronic toxicity studies in both mice and non-human primates and satisfactory related analyses to ensure subjects can be safely dosed. InNovember 2019 , we submitted a complete response to the partial clinical hold in order to be able to resume the MAD study and inDecember 2019 , FDA lifted the partial clinical hold on the MAD study. We recommenced the MAD study inFebruary 2020 and have completed all dosing. Top-line results showed that RGLS4326 is well-tolerated with no serious adverse events reported. Preliminary results suggest plasma exposure is dose proportional. The Phase 1b short-term dosing study in patients with ADPKD is planned to be an open-label study evaluating RGLS4326 for safety, PK, and changes in levels of polycystin 1 (PC1) and polycystin 2 (PC2). Patients with ADPKD, due to the mutation in the polycystic kidney disease gene, have been reported to have low levels of PC1 and PC2. This study is designed to evaluate whether different dose levels of RGLS4326 can increase levels of PC1 and PC2 in ADPKD patients. The study is on track to be initiated in the second half of this year, with results from the first cohort of patients available after completion of six weeks of dosing. Additional non-clinical studies initiated last year in mice and non-human primates to further 22 -------------------------------------------------------------------------------- characterize the PK properties of RGLS4326 have also been recently completed. The RGLS4326 IND is currently on a partial clinical hold for treatment of extended duration beyond the current Phase 1b study until the second set of requirements outlined by FDA have been satisfactorily addressed. Information from the Phase 1 clinical studies, together with information from the recently completed additional nonclinical studies, will be used to address the second set of requirements to support studies of extended duration. InJuly 2020 , the FDA granted orphan drug designation to RGLS4326.
Preclinical Pipeline
A major focus of our preclinical research has historically targeted dysregulated microRNAs implicated in diseases of high unmet medical need where we know we can effectively deliver to the target tissue or organ, such as the liver and kidney. We also have early discovery programs investigating additional microRNA targets for infectious diseases, immunology and indications for which there is microRNA dysregulation or in disease settings where the host microRNAs are essential for the replication and/or survival of the pathogen.
We currently have multiple programs in various stages of preclinical development.
Glioblastoma multiforme program: InJanuary 2019 , we announced RGLS5579 as a clinical candidate in our glioblastoma multiforme ("GBM") program. RGLS5579, which targets microRNA-10b, demonstrated statistically significant improvements in survival as both a monotherapy as well as in combination with temozolamide ("TMZ") in an orthotopic GBM animal model. In combination with TMZ, the addition of a single dose of anti-mir-10b, delivered intracranially, led to a more than two-fold improvement in survival compared to TMZ alone. These, and additional survival data on RGLS5579, were presented inNovember 2018 at theSociety for Neuro-Oncology Meeting inNew Orleans, Louisiana . We plan to seek a partner to further advance development of RGLS5579. Hepatitis B virus program: We have determined that advancing our preclinical programs targeting the Hepatitis B virus ("HBV") represents an attractive opportunity in our pipeline for investment, affecting an estimated 250 million people worldwide. We have identified several microRNA targets that serve as host factors for the virus. Our lead compound directed to one of the host microRNAs has demonstrated sub-nanomolar potency against HBV DNA replication and more than 95% reduction in Hepatitis B surface antigen in in vitro studies. Additionally, we have demonstrated reduction of both HBV DNA and surface antigen in an in vivo efficacy model. We believe that targeting a host factor in the liver represents a unique mechanism of action for treatment of the virus compared to other programs in development and holds the potential for achieving a functional cure. We have nominated a development candidate and plan to commence IND-enabling activities. Non-Alcoholic Steatohepatitis program: Across multiple animal models of non-alcoholic steatohepatitis ("NASH"), our lead candidate has demonstrated improvement in key endpoints, including NAFLD Activity Score (NAS), liver transaminases, hyperglycemia, and disease-related gene expression. In the diet-induced NASH mouse model (Amylin model) after two to four weekly doses, early onset of improvement across multiple disease parameters including liver triglycerides and blood levels of transaminases was observed. After nine weeks of treatment, there was evidence of sustained benefit with significant improvement of liver fibrosis and hyperglycemia compared to control-treated animals. We believe that targeting dysregulated microRNA in a complex disease like NASH may offer a unique mechanism of action from other programs in development. We plan to seek a partner to further advance its development. FINANCIAL OPERATIONS OVERVIEW Revenue Our revenues generally consist of upfront payments for licenses or options to obtain licenses in the future, milestone payments and payments for other research services under collaboration agreements. In the future, we may generate revenue from a combination of license fees and other upfront payments, payments for research and development services, milestone payments, product sales and royalties in connection with strategic collaborations. 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, if at all, 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 collaboration partners. If our current or future collaboration partners do not elect or otherwise agree to fund our development costs pursuant to our current or future strategic collaboration agreements, or we or our strategic collaboration partner fails to develop product candidates in a timely manner or obtain regulatory approval for them, our ability to generate future revenues, and our results of operations and financial position would be adversely affected. 23 -------------------------------------------------------------------------------- Research and development expenses Research and development expenses consist of costs associated with our research activities, including our drug discovery efforts and the development of our therapeutic programs. Our research and development expenses include: •employee-related expenses, including salaries, benefits, travel and stock-based compensation expense; •external research and development expenses incurred under arrangements with third parties, such as contract research organizations, or CROs, contract manufacturing organizations, or CMOs, other clinical trial related vendors, consultants and our scientific advisors; •license fees; and •facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities, amortization of leasehold improvements and equipment, and laboratory and other supplies. We expense research and development costs as incurred. We account for nonrefundable advance payments for goods and services that will be used in future research and development activities as expenses when the service has been performed or when the goods have been received. Certain of the raw materials used in the process of manufacturing drug product are capitalized upon their acquisition and expensed upon usage, as we have determined these materials have alternative future use. To date, we have conducted research on many different microRNAs with the goal of understanding how they function and identifying those that might be targets for therapeutic modulation. At any given time we are working on multiple targets, primarily within our therapeutic areas of focus. Our organization is structured to allow the rapid deployment and shifting of resources to focus on the most promising targets based on our ongoing research. As a result, in the early phase of our development programs, our research and development costs are not tied to any specific target. However, we are currently spending the vast majority of our research and development resources on our lead development programs. Since our inception, we have spent a total of approximately$368.5 million in research and development expenses throughJune 30, 2020 . The process of conducting clinical trials and preclinical studies necessary to obtain regulatory approval is costly and time consuming. We, or our strategic collaboration partners, may never succeed in achieving marketing approval for any of our product candidates. The probability of success for each product candidate may be affected by numerous factors, including preclinical data, clinical data, competition, manufacturing capability and commercial viability. Successful development of future product candidates is highly uncertain and may not result in approved products. Completion dates and completion costs can vary significantly for each future product candidate and are difficult to predict. We anticipate we will make determinations as to which programs to pursue and how much funding to direct to each program on an ongoing basis in response to our ability to maintain or enter into new collaborations with respect to each program or potential product candidate, the scientific and clinical success of each future product candidate, as well as ongoing assessments as to each future product candidate's commercial potential. We will need to raise additional capital and may seek additional collaborations in the future in order to advance our various programs. General and administrative expenses General and administrative expenses consist primarily of salaries and related benefits, including stock-based compensation, related to our executive, finance, legal, business development and support functions. Other general and administrative expenses include allocated facility-related costs not otherwise included in research and development expenses and professional fees for auditing, tax and legal services, some of which are incurred as a result of being a publicly-traded company. Other income (expense), net Other income (expense) consists primarily of interest income and expense and various income or expense items of a non-recurring nature. We earn interest income from interest-bearing accounts and money market funds for cash and cash equivalents and marketable securities, such as interest-bearing bonds, for our short-term investments. Interest expense is primarily attributable to interest charges associated with borrowings under our secured Term Loan. CRITICAL ACCOUNTING POLICIES AND ESTIMATES 24 -------------------------------------------------------------------------------- There have been no significant changes to our critical accounting policies sinceDecember 31, 2019 . For a description of critical accounting policies that affect our significant judgments and estimates used in the preparation of our financial statements, refer to Item 7 in Management's Discussion and Analysis of Financial Condition and Results of Operations and Note 1 to our financial statements contained in our Annual Report and Note 1 to our condensed financial statements contained in this quarterly report on Form 10-Q. RESULTS OF OPERATIONS Comparison of the three and six months endedJune 30, 2020 and 2019 The following table summarizes our results of operations for the three and six months endedJune 30, 2020 and 2019 (in thousands): Three months ended Six months ended June 30, June 30, 2020 2019 2020 2019 Revenue under collaborations $ - $
18
4,242 1,836 7,360 7,819
General and administrative expenses 2,254 2,850 4,676 6,383
Interest and other expenses, net (451) (347) (862) (869)
Revenue under collaborations
Our revenues are generated from ongoing collaborations, and generally consist of
upfront payments for licenses or options to obtain licenses in the future,
milestone payments and payments for other research services. Revenue under our
collaboration with Sanofi was zero and less than $0.1 million for the three and
six months ended June 30, 2020 , respectively. Revenue under our collaboration
with Sanofi was less than $0.1 million and $6.8 million for the three and six
months ended June 30, 2019 , respectively, which was attributable to recognition
of the Upfront Amendment Payments under the 2018 Sanofi Amendment as revenue
during the three months ended March 31, 2019 .
Research and development expenses
The following tables summarize the components of our research and development
expenses for the periods indicated, together with year-over-year changes
(dollars in thousands):
Increase (decrease)
Three months Three months
ended June 30, ended June 30,
2020 % of total 2019 % of total $ %
Research and development
Personnel and internal expenses $ 1,355 32 % $ 1,152 63 % $ 203 18 %
Third-party and outsourced
expenses 2,610 62 % 822 45 % 1,788 218 %
Non-cash stock-based compensation 159 4 % (294) (16) % 453 (154) %
Depreciation 118 2 % 156 8 % (38) (24) %
Total research and development
expenses $ 4,242 100 % $ 1,836 100 % $ 2,406 131 %
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Increase (decrease)
Six months ended Six months ended
June 30, 2020 % of total June 30, 2019 % of total $ %
Research and development
Personnel and internal expenses $ 2,648 36 % $ 3,947 51 % $ (1,299) (33) %
Third-party and outsourced
expenses 4,159 58 % 3,341 43 % 818 24 %
Non-cash stock-based compensation 316 4 % 194 2 % 122 63 %
Depreciation 237 2 % 337 4 % (100) (30) %
Total research and development
expenses $ 7,360 100 % $ 7,819 100 % $ (459) (6) %
Research and development expenses were $4.2 million and $7.4 million for the
three and six months ended June 30, 2020 , compared to $1.8 million and $7.8
million for the three and six months ended June 30, 2019 . The aggregate increase
for the three months ended June 30, 2020 , as compared to the three months ended
June 30, 2019 , was driven by a $1.8 million increase in external development
expenses, primarily attributable to the fact that the FDA lifted the partial
clinical hold on the MAD study in December 2019 and we recommenced the MAD study
in February 2020 , with the final dosing of the final cohort completing in July
2020 . The aggregate decrease for the six months ended June 30, 2020 , as compared
to the six months ended June 30, 2019 , was driven by a $1.3 million reduction in
personnel and internal expenses, primarily attributable to continued cost
reduction efforts subsequent to our corporate restructurings, partially offset
by an increase of $0.8 million in external development expenses, attributable to
recommencement and completion of the final cohort of the MAD study.
General and administrative expenses
General and administrative expenses were $2.3 million and $4.7 million for the
three and six months ended June 30, 2020 , compared to $2.9 million and $6.4
million for the three and six months ended June 30, 2019 . These amounts reflect
personnel-related and ongoing general business operating costs. The decreases
for the three and six months ended June 30, 2020 , as compared to the three and
six months ended June 30, 2019 , are primarily attributable to continued cost
reduction efforts subsequent our corporate restructurings.
Interest and other expenses, net
Net interest and other expenses were $0.5 million and $0.9 million for the three
and six months ended June 30, 2020 , respectively, compared to $0.3 million and
$0.9 million for the three and six months ended June 30, 2019 , respectively.
These amounts are primarily related to interest charges associated with our
outstanding Term Loan.
LIQUIDITY AND CAPITAL RESOURCES
Since our inception through June 30, 2020 , we have received $342.5 million from
the sale of our equity and convertible debt securities, $91.8 million from our
collaborations, principally from upfront payments, research funding and
preclinical and clinical milestones, and $19.8 million in net proceeds from our
Term Loan. As of June 30, 2020 , we had cash and cash equivalents of $23.4
million .
The accompanying financial statements have been prepared on a basis which
assumes we are a going concern, and does not include any adjustments to reflect
the possible future effects on the recoverability and classification of assets
or the amounts and classifications of liabilities that may result from any
uncertainty related to our ability to continue as a going concern.
If we are unable to maintain sufficient financial resources, our business,
financial condition and results of operations will be materially and adversely
affected. There can be no assurance that we will be able to obtain the needed
financing on acceptable terms or at all. Additionally, equity or debt financings
may have a dilutive effect on the holdings of our existing stockholders. These
factors raise substantial doubt about our ability to continue as a going
concern.
Our future capital requirements are difficult to forecast and will depend on
many factors, including:
•whether and when we achieve any milestones under our collaboration and license
agreement with Sanofi;
•the terms and timing of any other strategic collaboration, licensing and other
arrangements that we may establish;
•the initiation, progress, timing and completion of preclinical studies and
clinical trials for our development programs and product candidates, and
associated costs;
•the number and characteristics of product candidates that we pursue;
26
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•the outcome, timing and cost of regulatory approvals;
•delays that may be caused by changing regulatory requirements;
•the cost and timing of hiring new employees to support our continued growth;
•the costs involved in filing and prosecuting patent applications and enforcing
and defending patent claims;
•the costs and timing of procuring clinical and commercial supplies of our
product candidates;
•the costs and timing of establishing sales, marketing and distribution
capabilities, and the pricing and reimbursement for any products for which we
may receive regulatory approval;
•the extent to which we acquire or invest in businesses, products or
technologies;
•the extent to which our PPP Loan is forgiven; and
•payments under our Term Loan.
The following table shows a summary of our cash flows for the six months ended
Six months ended
June 30,
2020 2019
(unaudited)
Net cash (used in) provided by:
Operating activities $ (11,228) $ (10,124)
Investing activities - 274
Financing activities 526 15,486
Total $ (10,702) $ 5,636
Operating activities
Net cash used in operating activities was $11.2 million for the six months ended
June 30, 2020 , compared to $10.1 million for the six months ended June 30, 2019 .
The increase in net cash used in operating activities was primarily attributable
to a net loss of $12.9 million for the six months ended June 30, 2020 , compared
to a net loss of $8.3 million for the six months ended June 30, 2019 , and
adjustments for non-cash charges, including stock-based compensation, of $1.8
million for the six months ended June 30, 2020 , compared to adjustments for
non-cash charges, including stock-based compensation, of $3.9 million for the
six months ended June 30, 2019 . This net increase was partially offset by
changes in operating assets and liabilities resulting in net cash provided by
operating activities of $0.5 million for the six months ended June 30, 2020 ,
compared to net cash used in operating activities of $5.8 million for the six
months ended June 30, 2019 .
Investing activities
Net cash provided by investing activities was zero for the six months ended June
30, 2020 . Net cash provided by investing activities was $0.3 million for the six
months ended June 30, 2019 , attributable to the sale of property and equipment.
Financing activities
Net cash used in financing activities was $0.5 million for the six months ended
June 30, 2020 , compared to net cash provided by financing activities of $15.5
million for the six months ended June 30, 2019 . Net cash provided by financing
activities for the six months ended June 30, 2019 was primarily attributable to
proceeds from the issuance of our common stock, partially offset by the
remittance of principal amortization payments under our Term Loan.
CONTRACTUAL OBLIGATIONS AND COMMITMENTS
As of June 30, 2020 , there have been no material changes, outside of the
ordinary course of business, in our outstanding contractual obligations from
those disclosed within the contractual obligations table under "Management's
Discussion and Analysis of Financial Condition and Results of Operations", as
contained in our Annual Report, with the exception of the PPP Loan received in
April 2020 (refer to note 5 for information regarding the PPP Loan).
OFF-BALANCE SHEET ARRANGEMENTS
As of June 30, 2020 , we did not have any off-balance sheet arrangements.
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