RGLS Regulus Therapeutics Inc.

0.48
+0.02  (+4%)
Previous Close 0.46
Open 0.48
52 Week Low 0.4222
52 Week High 1.74
Market Cap $17,243,000
Shares 35,922,916
Float 32,398,585
Enterprise Value $8,467,999
Volume 165,599
Av. Daily Volume 2,205,061
Stock charts supplied by TradingView

Drug Pipeline

Drug Stage Notes
RGLS4326
Autosomal dominant polycystic kidney disease (ADPKD)
Phase 1
Phase 1
Phase 1 trial completion of dosing announced July 22, 2020. Well-tolerated with no serious adverse events reported. Phase 1b trial planned.
RG-012 - HERA
Alport Syndrome
Phase 2
Phase 2
Phase 2 enrollment has been paused due to financial conditions - noted July 5, 2018.

Latest News

  1. LA JOLLA, Calif., Sept. 11, 2020 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs ("Regulus"), today announced that Jay Hagan, President and Chief Executive Officer of Regulus, will present at the H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15, 2020 at 11:00 AM EDT.

    A live webcast of the presentation will be available through the investor relations section of the Company's website at www.regulusrx.com.

    About Regulus

    Regulus Therapeutics Inc. (NASDAQ:RGLS) 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. 

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the completion of preclinical and clinical activities concerning the RGLS4326 program, the sufficiency of the data resulting from the ongoing or planned preclinical studies required to recommence clinical studies for extended duration dosing and the timing of preclinical and clinical activities.  Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Regulus' current expectations and involve assumptions that may never materialize or may prove to be incorrect.  Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and in the endeavor of building a business around such drugs, and feedback from the FDA. In addition, while Regulus expects the COVID-19 pandemic to adversely affect its business operations and financial results, the extent of the impact on Regulus' ability to achieve its preclinical and clinical development objectives and the value of and market for its common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S. and in other countries, and the effectiveness of actions taken globally to contain and treat the disease.   These and other risks are described in additional detail in Regulus' filings with the Securities and Exchange Commission.  All forward-looking statements contained in this press release speak only as of the date on which they were made. Regulus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/regulus-therapeutics-to-present-at-the-hc-wainwright-22nd-annual-virtual-global-investment-conference-301128135.html

    SOURCE Regulus Therapeutics Inc.

    View Full Article Hide Full Article
  2. LA JOLLA, Calif., Sept. 3, 2020 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs ("Regulus"), today announced that Jay Hagan, President and Chief Executive Officer of Regulus, will present at the Wells Fargo Virtual Healthcare Conference on Wednesday, September 9, 2020 at 10:40 AM EDT.

    A live webcast of the presentation will be available through the investor relations section of the Company's website at www.regulusrx.com.

    About Regulus

    Regulus Therapeutics Inc. (NASDAQ:RGLS) 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. 

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the completion of preclinical and clinical activities concerning the RGLS4326 program, the sufficiency of the data resulting from the ongoing or planned preclinical studies required to recommence clinical studies for extended duration dosing and the timing of preclinical and clinical activities.  Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Regulus' current expectations and involve assumptions that may never materialize or may prove to be incorrect.  Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and in the endeavor of building a business around such drugs, and feedback from the FDA. In addition, while Regulus expects the COVID-19 pandemic to adversely affect its business operations and financial results, the extent of the impact on Regulus' ability to achieve its preclinical and clinical development objectives and the value of and market for its common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S. and in other countries, and the effectiveness of actions taken globally to contain and treat the disease.   These and other risks are described in additional detail in Regulus' filings with the Securities and Exchange Commission.  All forward-looking statements contained in this press release speak only as of the date on which they were made. Regulus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/regulus-therapeutics-to-present-at-the-2020-wells-fargo-virtual-healthcare-conference-301123689.html

    SOURCE Regulus Therapeutics Inc.

    View Full Article Hide Full Article
  3. LA JOLLA, Calif., Aug. 31, 2020 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs, today announced that pursuant to an amendment of its term loan agreement with Oxford LLC, the Company is eligible for up to an additional seven months of interest only payments in the event the Company pays down $10 million in loan principal before April 30, 2021 (the "Principal Paydown Event") utilizing proceeds from the sale of materials to, and potential milestones received from, Sanofi as described below.  In the event the Principal Paydown Event does not occur by April 30, 2021, the Company will make principal and accrued interest payments…

    LA JOLLA, Calif., Aug. 31, 2020 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs, today announced that pursuant to an amendment of its term loan agreement with Oxford LLC, the Company is eligible for up to an additional seven months of interest only payments in the event the Company pays down $10 million in loan principal before April 30, 2021 (the "Principal Paydown Event") utilizing proceeds from the sale of materials to, and potential milestones received from, Sanofi as described below.  In the event the Principal Paydown Event does not occur by April 30, 2021, the Company will make principal and accrued interest payments, in arrears, commencing May 1, 2021, in accordance with the previously amended terms.  If the Principal Paydown Event occurs after April 30, 2021 but on or before July 31, 2021, then the Company will recommence an extended interest only payment period through December 31, 2021.  In the event the Company receives the additional interest only period, principal and accrued interest payments will recommence on January 1, 2022.

    Concurrently with the Oxford amendment described above, the Company also entered into an amendment with Sanofi concerning the receipt of potential milestones from Sanofi for its development of miR-21 programs.  The Company has also sold additional compound-related materials to Sanofi in exchange for $1 million.  Under the terms of the amendment with Sanofi, and in lieu of the previous $10 million enrollment milestone, the Company is eligible to receive an additional $4 million upon the completion of transfer and verification of the materials sold to Sanofi and an additional $5 million milestone upon achievement of the enrollment milestone.  In the event the enrollment milestone occurs first, the Company will receive the entire $9 million for both milestones.  In addition, the Company is eligible to receive $25.0 million upon the achievement of an additional development milestone related to Sanofi's development of miR-21 compounds.

    "We are pleased to enter into these two amended agreements with our partner, Sanofi, and with our lender, Oxford," stated Jay Hagan, CEO of Regulus. "Their creative support in this restructuring provides Regulus the opportunity to pay down debt principal with Oxford from the proceeds received from Sanofi while potentially extending our interest-only period through the end of 2021."

    About Regulus

    Regulus Therapeutics Inc. (NASDAQ:RGLS) 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. 

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the achievement of milestone payments from is collaboration partners and paydown of its debt with Oxford LLC.  Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Regulus' current expectations and involve assumptions that may never materialize or may prove to be incorrect.  Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and in the endeavor of building a business around such drugs. In addition, while Regulus expects the COVID-19 pandemic to adversely affect its business operations and financial results, the extent of the impact on Regulus' ability to achieve its preclinical and clinical development objectives and the value of and market for its common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S. and in other countries, and the effectiveness of actions taken globally to contain and treat the disease.   These and other risks are described in additional detail in Regulus' filings with the Securities and Exchange Commission.  All forward-looking statements contained in this press release speak only as of the date on which they were made. Regulus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/regulus-therapeutics-announces-restructuring-of-sanofi-and-oxford-loan-agreements-301120681.html

    SOURCE Regulus Therapeutics Inc.

    View Full Article Hide Full Article
  4. Dr. Menzel brings significant leadership in the global healthcare sector

    Stoke Therapeutics, Inc., (NASDAQ:STOK), a biotechnology company pioneering a new way to treat the underlying cause of genetic diseases by precisely upregulating protein expression, today announced the appointment of Garry E. Menzel, Ph.D., to both its Board of Directors and Compensation Committee.

    "Garry brings more than 25 years of executive management experience in the global healthcare sector, including senior leadership roles at TCR2 Therapeutics, DaVita Healthcare, and Regulus Therapeutics. His training as a scientist along with his deep financial and operational expertise in life sciences will make him an important resource for the Stoke team, especially now…

    Dr. Menzel brings significant leadership in the global healthcare sector

    Stoke Therapeutics, Inc., (NASDAQ:STOK), a biotechnology company pioneering a new way to treat the underlying cause of genetic diseases by precisely upregulating protein expression, today announced the appointment of Garry E. Menzel, Ph.D., to both its Board of Directors and Compensation Committee.

    "Garry brings more than 25 years of executive management experience in the global healthcare sector, including senior leadership roles at TCR2 Therapeutics, DaVita Healthcare, and Regulus Therapeutics. His training as a scientist along with his deep financial and operational expertise in life sciences will make him an important resource for the Stoke team, especially now that we are a clinical stage company following the start of our Phase 1/2a clinical trial in Dravet syndrome and as we work to expand the pipeline using our TANGO platform," said Edward M. Kaye, M.D., Chief Executive Officer of Stoke Therapeutics.

    "As a long-serving board member of the Epilepsy Foundation, I have learned how challenging epilepsy can be, particularly for people who are living with severe genetic epilepsies like Dravet syndrome and their families," said Dr. Menzel. "The pace of discovery and innovation in this space is gathering momentum and patients are in dire need of creative therapies such as those being developed by Stoke. I look forward to working with Ed and his team to further their efforts not only with Dravet syndrome but also expanding use of TANGO to other severe genetic diseases."

    Dr. Menzel currently serves as President and Chief Executive Officer of TCR2 Therapeutics Inc. (NASDAQ:TCRR), a clinical stage oncology company with three novel immunotherapies for solid tumors and hematological malignancies. He is a co-founder of Black Diamond Therapeutics, Inc. (NASDAQ:BDTX), a clinical stage oncology company, where he continues to serve on the Board of Directors. Dr. Menzel previously served as Chief Financial Officer of DaVita Healthcare Partners (NYSE:DVA), which at the time operated one of the largest networks of kidney dialysis centers and primary care physician practices in the United States. Prior to that, Dr. Menzel served as Chief Operating Officer at microRNA therapy company Regulus Therapeutics, Inc. (NASDAQ:RGLS). He began his career in the banking industry, starting as a consultant at Bain & Company and subsequently held global leadership roles running the biotechnology practices at Goldman Sachs and Credit Suisse where he advised on more than $100 billion in strategic transactions.

    Outside of his corporate board positions, Dr. Menzel serves on the National Board of the Epilepsy Foundation, and previously served on the Board of Directors of the Institute for Systems Biology and the Board of Directors of the University of California, San Francisco (UCSF) School of Pharmacy. Dr. Menzel holds a Ph.D. in Biochemistry and Molecular Biology from St. John's College, University of Cambridge, a Master of Business Administration from Stanford University and a Bachelor of Science in Biochemistry from the Imperial College of Science and Technology.

    About Stoke Therapeutics

    Stoke Therapeutics, Inc. (NASDAQ:STOK), is a biotechnology company pioneering a new way to treat the underlying causes of severe genetic diseases by precisely upregulating protein expression to restore target proteins to near normal levels. Stoke aims to develop the first precision medicine platform to target the underlying cause of a broad spectrum of genetic diseases in which the patient has one healthy copy of a gene and one mutated copy that fails to produce a protein essential to health. These diseases, in which loss of approximately 50% of normal protein expression causes disease, are called autosomal dominant haploinsufficiencies. The company's lead investigational new medicine is STK-001, a proprietary antisense oligonucleotide (ASO) that has the potential to be the first disease-modifying therapy to address the genetic cause of Dravet syndrome, a severe and progressive genetic epilepsy. Stoke is headquartered in Bedford, Massachusetts with offices in Cambridge, Massachusetts. For more information, visit https://www.stoketherapeutics.com/ or follow the company on Twitter at @StokeTx.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking" statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: our expectation about timing and execution of anticipated milestones and timing thereof; the expansion of our pipeline and the use of the TANGO platform to other genetic diseases and our ability to use study data to advance the development of STK-001; the ability of STK-001 to treat the underlying causes of Dravet syndrome; and the ability of TANGO to design medicines to increase protein production and the expected benefits thereof. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "potential," "possible," "will," "would," and other words and terms of similar meaning. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our ability to develop, obtain regulatory approval for and commercialize STK-001 and future product candidates; the timing and results of preclinical studies and clinical trials; the risk that positive results in a clinical trial may not be replicated in subsequent trials or success in early stage clinical trials may not be predictive of results in later stage clinical trials; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials; regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events; failure to protect and enforce our intellectual property, and other proprietary rights; failure to successfully execute or realize the anticipated benefits of our strategic and growth initiatives; risks relating to technology failures or breaches; our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks associated with current and potential delays, work stoppages, or supply chain disruptions caused by the coronavirus pandemic; risks associated with current and potential future healthcare reforms; risks relating to attracting and retaining key personnel; failure to comply with legal and regulatory requirements; risks relating to access to capital and credit markets; environmental risks; risks relating to the use of social media for our business; and the other risks and uncertainties that are described in the Risk Factors section of our most recent annual or quarterly report and in other reports we have filed with the U.S. Securities and Exchange Commission. These statements are based on our current beliefs and expectations and speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements.

    View Full Article Hide Full Article
  5. LA JOLLA, Calif., Aug. 13, 2020 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today reported financial results for the second  quarter ended June 30, 2020 and provided a corporate update. 

    "We are pleased with the progress of our ADPKD program and the completion of dosing of the MAD clinical study for RGLS4326 in healthy volunteers," said Jay Hagan, CEO of Regulus. "We plan to initiate a Phase 1b study in patients with ADPKD to evaluate short-term treatment of RGLS4326 for safety, tolerability, pharmacokinetics, and changes in biomarkers of the disease.  We have also recently completed additional non-clinical studies needed to address some of the FDA requirements to support studies of extended duration."

    Second Quarter 2020 Corporate Highlights and Recent Updates

    Appointment of Chief Scientific Officer: In August, Dr. Denis Drygin joined Regulus as its Chief Scientific Officer.

    Program Updates

    • RGLS4326 for Autosomal Dominant Polycystic Kidney Disease: In July 2020, the Company completed dosing in the MAD clinical study for RGLS4326 in healthy volunteers. The Phase 1 MAD study is a randomized, double blind, placebo-controlled clinical trial evaluating three different dose levels of RGLS4326 for safety, tolerability, and pharmacokinetic properties. Top-line results showed that RGLS4326 is well-tolerated with no serious adverse events reported. Preliminary results suggest plasma exposure is dose proportional. In July 2020, the FDA granted Orphan Drug Designation to RGLS4326 for ADPKD.

    The Company plans to initiate a Phase 1b open-label, short-term multiple dose study in patients with ADPKD in the second half of 2020. The study will evaluate RGLS4326 for safety, pharmacokinetics, and changes in levels of polycystin 1 (PC1) and polycystin 2 (PC2). Patients with ADPKD, due to the mutation in the PKD 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. 

    • Advancement of Hepatitis B virus (HBV) Program: The Company has identified several microRNA targets that serve as host factors for the hepatitis B virus (HBV). Our lead compound directed to one of the host microRNAs has demonstrated 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 HBV DNA, surface antigen and pgRNA 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.
    • Additional Research Updates: Cell therapies have been approved to treat a variety of hematological malignancies. Targeting solid tumors, however, has proven challenging for cell therapies due to the immune-suppressive effect of the tumor microenvironment (TME). The Company believes that ex vivo modulation of microRNA may enable cell therapy approaches to overcome the effects of the TME and address other challenges faced by cell therapies. The Company has demonstrated that targeting microRNA ex vivo can improve certain characteristics of engineered cells including an improved in vitro expansion, effector function, cytokine production, as well as resistance to exhaustion induced by tonic signaling. The Company is pursuing multiple applications of microRNA technology in a variety of cell therapies.

    Second Quarter 2020 Financial Results

    Cash Position: As of June 30, 2020, Regulus had $23.4 million in cash and cash equivalents.

    Research and Development (R&D) Expenses: Research and development expenses were $4.2 million and $7.4 million for the three and six months ended June 30, 2020, respectively, compared to $1.8 million and $7.8 million for the three and six months ended June 30, 2019, respectively. The aggregate increase for the three months ended June 30, 2020, as compared to the three months ended June 30, 2019, was driven by an increase in external development expenses, primarily attributable to the FDA lifting the partial clinical hold on the MAD study in December 2019 and completion of the dosing for the Phase 1 of the MAD study 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 reduction in personnel and internal expenses, partially offset by an increase in external development expenses attributable to recommencement and completion of the dosing of  the MAD study in July 2020.

    General and Administrative (G&A) Expenses: General and administrative expenses were $2.3 million and $4.7 million for the three and six months ended June 30, 2020, respectively, compared to $2.9 million and $6.4 million for the three and six months ended June 30, 2019, respectively. 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 to our corporate restructurings.

    Revenue: Revenue was zero and less than $0.1 million for the three and six months ended June 30, 2020, respectively, compared to less than $0.1 million and $6.8 million for the three and six months ended June 30, 2019, respectively. Revenue recognized for the six months ended June 30, 2019 was attributable to the upfront payments received under the 2018 Sanofi Amendment related to the transfer of the RG-012 program to Sanofi.

    Net Loss: Net loss was $6.9 million, or $0.23 per share (basic and diluted), and $12.9 million, or $0.48 per share (basic and diluted), for the three and six months ended June 30, 2020, respectively, compared to $5.0 million, or $0.30 per share (basic and diluted), and $8.3 million, or $0.61 per share (basic and diluted), for the same periods in 2019.

    About ADPKD

    ADPKD, caused by the mutations in the PKD1 or PKD2 genes, is among the most common human monogenic disorders and a leading cause of end-stage renal disease. The disease is characterized by the development of multiple fluid filled cysts primarily in the kidneys, and to a lesser extent in the liver and other organs. Excessive kidney cyst cell proliferation, a central pathological feature, ultimately leads to end-stage renal disease in approximately 50% of ADPKD patients by age 60.

    About RGLS4326

    RGLS4326 is a novel oligonucleotide designed to inhibit miR-17 and designed to preferentially target the kidney. Preclinical studies with RGLS4326 have demonstrated direct regulation of Pkd1 and Pkd2, reduction of cyst growth in human in vitro ADPKD models, and attenuation of cyst proliferation and improvement of kidney function in mouse models of ADPKD.  The Company recently completed the multiple ascending dose study of RGLS4326 in healthy volunteers. Administration of RGLS4326 was well-tolerated with no serious adverse events reported.  The Company is initiating a Phase 1b study in patients with ADPKD to evaluate short-term treatment of RGLS4326 for safety, tolerability, pharmacokinetics, and changes in biomarkers of the disease.  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.

    About Regulus

    Regulus Therapeutics Inc. (NASDAQ:RGLS) 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. 

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the completion of preclinical and clinical activities concerning the RGLS4326 program, the sufficiency of the data resulting from the ongoing or planned preclinical studies required to recommence clinical studies for extended duration dosing and the timing of preclinical and clinical activities.  Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Regulus' current expectations and involve assumptions that may never materialize or may prove to be incorrect.  Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and in the endeavor of building a business around such drugs, and feedback from the FDA. In addition, while Regulus expects the COVID-19 pandemic to adversely affect its business operations and financial results, the extent of the impact on Regulus' ability to achieve its preclinical and clinical development objectives and the value of and market for its common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S. and in other countries, and the effectiveness of actions taken globally to contain and treat the disease. These and other risks are described in additional detail in Regulus' filings with the Securities and Exchange Commission.  All forward-looking statements contained in this press release speak only as of the date on which they were made. Regulus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Regulus Therapeutics Inc.

    Selected Financial Information

    Condensed Statement of Operations

    (In thousands, except share and per share data)







    Three months ended

    June 30,



    Six months ended

    June 30,





    2020



    2019



    2020



    2019







    Revenues:

























    Revenue under strategic alliances                              



    $

    -



    $

    18



    $

    6



    $

    6,796

    Operating expenses:

















    Research and development



    4,242



    1,836



    7,360



    7,819

    General and administrative



    2,254



    2,850



    4,676



    6,383

    Total operating expenses



    6,496



    4,686



    12,036



    14,202

    Loss from operations



    (6,496)



    (4,668)



    (12,030)



    (7,406)

    Other expense, net



    (451)



    (347)



    (862)



    (869)

    Loss before income taxes



    (6,947)



    (5,015)



    (12,892)



    (8,275)

    Income tax expense (benefit)





    -





    (1)



    8



    (1)

    Net loss



    $

    (6,947)



    $

    (5,016)



    $

    (12,884)



    $

    (8,276)



























    Net loss per share, basic and diluted



    $

    (0.23)



    $

    (0.30)



    $

    (0.48)



    $

    (0.61)

    Weighted average shares used to compute basic and diluted net loss per 

         share:





    29,801,974





    16,705,587





    26,933,173





    13,560,183

     





    June 30,

    2020



    December 31,

    2019





     (Unaudited)

    Cash and cash equivalents



    $

    23,419



    $

    34,121

    Total assets



    29,782



    42,081

    Term loan, less debt issuance costs



    14,642



    14,631

    Stockholders' equity





    8,584





    20,015

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/regulus-therapeutics-reports-second-quarter-2020-financial-results-and-recent-updates-301112071.html

    SOURCE Regulus Therapeutics Inc.

    View Full Article Hide Full Article
View All Regulus Therapeutics Inc. News