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Regulus Therapeutics (RGLS)

Regulus Therapeutics Inc. is a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs. Regulus has leveraged its oligonucleotide drug discovery and development expertise to develop a pipeline complemented by a rich intellectual property estate in the microRNA field. Regulus maintains its corporate headquarters in La Jolla, CA.

RGLS stock data

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

12 May 22
11 Aug 22
31 Dec 22
Quarter (USD) Mar 22 Dec 21 Sep 21 Jun 21
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD) Dec 21 Dec 20 Dec 19 Dec 18
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Cash burn rate (est.) Burn method: Change in cash Burn method: Operating income Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 53.96M 53.96M 53.96M 53.96M 53.96M 53.96M
Cash burn (monthly) 2.16M (no burn) 2.24M 2.43M 2.13M 2.07M
Cash used (since last report) 9.42M n/a 9.77M 10.59M 9.28M 9.02M
Cash remaining 44.54M n/a 44.19M 43.38M 44.68M 44.95M
Runway (months of cash) 20.6 n/a 19.7 17.9 21.0 21.8

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
9 Jun 22 Simeonidis Simos Stock Option Common Stock Grant Acquire A No No 0.27 90,000 24.3K 90,000
9 Jun 22 Rosen Hugh Stock Option Common Stock Grant Acquire A No No 0.27 90,000 24.3K 90,000
9 Jun 22 Papadopoulos Stelios Stock Option Common Stock Grant Acquire A No No 0.27 90,000 24.3K 90,000
9 Jun 22 Rastetter William H Stock Option Common Stock Grant Acquire A Yes No 0.27 90,000 24.3K 90,000
9 Jun 22 Nunn Jason Raleigh Stock Option Common Stock Grant Acquire A No No 0.27 90,000 24.3K 90,000
13F holders Current Prev Q Change
Total holders 41 44 -6.8%
Opened positions 3 10 -70.0%
Closed positions 6 11 -45.5%
Increased positions 15 9 +66.7%
Reduced positions 5 8 -37.5%
13F shares Current Prev Q Change
Total value 23.73M 15.19M +56.2%
Total shares 84.91M 58.28M +45.7%
Total puts 0 0
Total calls 56.1K 96.8K -42.0%
Total put/call ratio
Largest owners Shares Value Change
FHI Federated Hermes 29.05M $8.66M NEW
Growth Equity Opportunities V 14.58M $5.65M 0.0%
NEA Management 14.45M $4.31M +124.0%
Biotechnology Value Fund L P 9.66M $0 0.0%
DAFNA Capital Management 5.56M $1.66M 0.0%
Vanguard 3.68M $1.1M +21.4%
Victory Capital Management 2.23M $664K -0.0%
Sarissa Capital Management 1.85M $552K 0.0%
Ikarian Capital 1.29M $384K +4.9%
Geode Capital Management 649.07K $193K +10.2%
Largest transactions Shares Bought/sold Change
FHI Federated Hermes 29.05M +29.05M NEW
NEA Management 14.45M +8M +124.0%
Empery Asset Management 0 -5.07M EXIT
Asymmetry Capital Management 0 -2.73M EXIT
EcoR1 Capital 0 -2.54M EXIT
Altium Capital Management 0 -1.33M EXIT
Vanguard 3.68M +648.12K +21.4%
Renaissance Technologies 133.4K +111.1K +498.2%
Susquehanna International 65.83K +65.83K NEW
Ikarian Capital 1.29M +60.71K +4.9%

Financial report summary

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Risks
  • RISKS RELATED TO THE DISCOVERY AND DEVELOPMENT OF PRODUCT CANDIDATES
  • The approach we are taking to discover and develop drugs is novel and may never lead to marketable products.
  • We may not be successful in our efforts to identify or discover potential product candidates.
  • Preclinical and clinical studies of our product candidates may not be successful. If we are unable to generate successful results from our preclinical and clinical studies of our product candidates, or experience significant delays in doing so, our business may be materially harmed.
  • If clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do not otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.*
  • Any of our product candidates may cause adverse effects ("AEs") or have other properties that could delay or prevent their regulatory approval or limit the scope of any approved label or market acceptance.
  • Even if we complete the necessary preclinical studies and clinical trials, we cannot predict whether or when we will obtain regulatory approval to commercialize a product candidate and we cannot, therefore, predict the timing of any revenue from a future product.
  • Even if we obtain regulatory approval for a product candidate, we will still face extensive regulatory requirements and our products may face future development and regulatory difficulties.
  • We may use our financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater likelihood of success.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • Payments under the instruments governing our indebtedness may reduce our working capital. In addition, a default under our loan and security agreement could cause a material adverse effect on our financial position.*
  • We have never generated any revenue from product sales and may never be profitable.
  • RISKS RELATED TO OUR RELIANCE ON THIRD PARTIES
  • We rely on third parties to conduct some aspects of our compound formulation, research and preclinical studies, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such formulation, research or testing.
  • We rely on third-party manufacturers to produce our preclinical and clinical product candidates, and we intend to rely on third parties to produce future clinical supplies of product candidates that we advance into clinical trials and commercial supplies of any approved product candidates.
  • We rely on limited sources of supply for the drug substance of product candidates and any disruption in the chain of supply may cause a delay in developing and commercializing these product candidates.
  • Manufacturing issues may arise that could increase product and regulatory approval costs or delay commercialization.
  • We rely on third parties to conduct, supervise and monitor our clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business.
  • RISKS RELATED TO OUR INTELLECTUAL PROPERTY
  • If we are unable to obtain or protect intellectual property rights related to our future products and product candidates, we may not be able to compete effectively in our markets.
  • Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.
  • If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
  • We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming and unsuccessful.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
  • RISKS RELATED TO COMMERCIALIZATION OF PRODUCT CANDIDATES
  • The commercial success of our programs that are part of our collaboration agreements with Sanofi or others will depend in large part on the development and marketing efforts of our collaboration partners. If our collaboration partners are unable or unwilling to perform in accordance with the terms of our agreements, our potential to generate future revenue from these programs would be significantly reduced and our business would be materially and adversely harmed.
  • We face significant competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively.
  • The commercial success of our product candidates will depend upon the acceptance of these product candidates by the medical community, including physicians, patients and healthcare payors.*
  • If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product candidates, we may be unable to generate any revenues.
  • If we obtain approval to commercialize any approved products outside of the United States, a variety of risks associated with international operations could materially adversely affect our business.
  • Coverage and adequate reimbursement may not be available for our product candidates, which could make it difficult for us to sell products profitably.
  • RISKS RELATED TO OUR BUSINESS OPERATIONS AND INDUSTRY
  • Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
  • We may need to expand our organization and may experience difficulties in managing this growth, which could disrupt our operations.*
  • Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
  • We may undertake internal restructuring activities that could result in disruptions to our business or otherwise materially harm our results of operations or financial condition.
  • Certain current and future relationships with customers and third party payors as well as certain of our business operations may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, health information privacy and information security laws and other privacy and information security laws. If we are unable to comply, or have not fully complied or are perceived to have not fully complied, with such laws, we could face significant penalties, including criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.*
  • We face potential product liability, and, if successful claims are brought against us, we may incur substantial liability and costs.
  • We are subject to stringent and evolving U.S. and foreign laws, regulations, rules, contractual obligations, policies and other obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions, litigation, fines and penalties, a disruption of our business operations; reputational harm, loss of revenue or profits, and other adverse business consequences.*
  • Changes in funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal functions on which the operation of our business may rely, which could negatively impact our business.
  • Our business could be adversely affected by the effects of health pandemics or epidemics, including the ongoing COVID-19 pandemic, in regions where we or third parties on which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other business operations, or materially affect our operations globally, including at our headquarters in San Diego and at our clinical trial sites, as well as the business or operations of our collaborators, manufacturers, CROs or other third parties with whom we conduct business.*
  • RISKS RELATED TO OUR COMMON STOCK
  • The market price of our common stock may be highly volatile.
  • We may be unable to comply with the applicable continued listing requirements of The Nasdaq Capital Market.*
  • The requirements of being a publicly traded company may strain our resources and divert management’s attention.
  • Sales of a substantial number of shares of our common stock in the public market by our existing stockholders could cause our stock price to fall.
  • Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.*
  • Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.*
  • We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.
  • Provisions in our amended and restated certificate of incorporation and bylaws, as well as provisions of Delaware law, could make it more difficult for a third party to acquire us or increase the cost of acquiring us, even if doing so would benefit our stockholders or remove our current management.
Management Discussion
  • 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 was zero for the three months ended March 31, 2022 and 2021.
  • Research and development expenses were $3.7 million for the three months ended March 31, 2022, compared to $3.3 million for the three months ended March 31, 2021. These amounts reflect the internal and external costs associated with advancing our clinical and preclinical pipeline. The aggregate increase for the three months ended March 31, 2022, as compared to the three months ended March 31, 2021, was primarily attributable to an increase in external research and development expenses, which were primarily driven by an increase in spend on IND-related activities (most notably, third-party drug manufacturing) for our RGLS8429 product candidate.
  • General and administrative expenses were $2.9 million for the three months ended March 31, 2022, compared to $2.5 million for the three months ended March 31, 2021. The increase for the three months ended March 31, 2022, as compared to the three months ended March 31, 2021, was attributable to a general increase in personnel-related and ongoing general business operating costs.

Content analysis

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H.S. junior Avg
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