On August 13, 2020 Caladrius Biosciences, Inc. (Nasdaq: CLBS) ("Caladrius" or the "Company"), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse, not manage, disease, reported financial results for the three and six months ended June 30, 2020 (Press release, Caladrius Biosciences, AUG 13, 2020, View Source [SID1234563595]).

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Product Development and Financing Highlights

CLBS119 clinical trial targeting the repair of COVID-19 induced lung damage to be initiated in 3Q 2020

Caladrius is committed to helping patients and communities combat the public health crisis of COVID-19 by leveraging its proprietary CD34+ cell technology to potentially repair COVID-19 induced lung damage. Experience to date indicates that a large portion of COVID-19 survivors who required ventilatory support will suffer long-term, debilitating lung damage.1 Scientists learned in the aftermath of the first SARS epidemic that the coronavirus targets cells that express CD34.2 Depletion of that cell population generally is thought to be connected to the lung’s inability to repair itself.2 Early reports from the COVID-19 pandemic indicate that the endothelial cells that line the microvasculature of the lung are targeted by the virus and that the destruction of the lung microcirculation may be a critical factor in the inability of the lung to repair itself even after the virus has been eliminated.3 Clinical trials and preclinical models have shown that CD34+ cells act in a restorative and regenerative capacity in multiple organs, including models of severe lung inflammation.4 Research has also shown that a deficiency in vascular CD34+ cells can result in a predisposition to injury in the lungs.5 Based on this accumulated evidence, Caladrius is excited to launch the pilot study of CLBS119 to evaluate its autologous CD34+ cell therapy for the repair of COVID-19 induced lung damage in patients who have suffered respiratory failure. The trial is planned to initiate by late August with the first patient expected to be treated in September.

CLBS12 development in Japan continues to yield promising results

The Company’s open-label, registration-eligible study in Japan of CLBS12, its SAKIGAKE-designated product candidate for the treatment of critical limb ischemia ("CLI"), a disease with no currently available approved therapy6 and a higher mortality rate than all cancers except that of lung cancer,7 has shown positive results to date. The Buerger’s Disease cohort has concluded with 4 out of 7 (57%) patients achieving a positive outcome, an outstandingly positive result for these patients who normally see continued progression leading to amputation. Despite the global impact of COVID-19, which has caused the deceleration of clinical trial enrollment globally, the Company remains encouraged by the patient pre-screening pipeline that has been identified and targets to complete trial enrollment by the end of 2020 and report top line data for the full study in late 2021 or early 2022. Based on the data from the concluded Buerger’s Disease cohort and the data to date in the no-option CLI cohort, the Company maintains its expectation of the study’s ultimate success.

CLBS16 to be studied in Phase 2b trial for the treatment of coronary microvascular dysfunction

Caladrius recently completed and announced the results of its ESCaPE-CMD Phase 2 study of CLBS16 for the treatment of coronary microvascular dysfunction ("CMD"), a disease that continues to be underdiagnosed and potentially afflicts millions annually – a vast majority of whom are female – with no current treatment options. Data from the Phase 2 trial showed highly statistically significant improvement in coronary flow reserve correlating with symptom relief for patients with CMD after a single intracoronary injection of CLBS16. The Company is committed to raising awareness of this growing women’s health crisis as it initiates a rigorous Phase 2b clinical trial of CLBS16 with the first patient expected to be enrolled by late 2020. The double-blind, randomized, placebo-controlled trial will evaluate the efficacy and safety of delivering autologous CD34+ cells (CLBS16) in subjects with coronary microvascular dysfunction and without obstructive coronary artery disease.

CLBS14 remains poised to enter a single confirmatory phase 3 clinical trial

The Company’s Phase 3 protocol for its RMAT-designated product candidate, CLBS14, for the treatment of no-option refractory angina ("NORDA") remains ready to initiate pending sufficient funding to run the program to completion. Based on an abundance of very strong data from previous Phase 1, 2, and 3 studies, Caladrius remains confident in the potential for clinical success once the program is executed.

Caladrius secures almost $30 million in new capital year-to-date and extends cash runway through the end of 2021

In April 2020, Caladrius generated $10.9 million in non-dilutive funding through the sale of a portion of its qualified New Jersey net operating losses. Throughout the remainder of the second quarter, the Company executed two registered direct offerings priced at the market under Nasdaq rules raising an additional aggregate $9.3 million. In July 2020, Caladrius raised $2.0 million in a private placement priced at the market under Nasdaq rules. In addition, Caladrius opportunistically raised $8.3 million through its Common Stock At-the-Market Sales Agreement with H.C. Wainwright & Co. year-to-date.

"Despite COVID-19’s unprecedented global impact, we continue to deliver on a number of key initiatives that we believe position the Company for success in the quarters ahead," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius. "To date in 2020, we successfully raised enough capital to extend our cash runway through the end of 2021, continued activities in support of our existing and newly initiated clinical programs and strengthened our Board with the previously announced addition of Dr. Michael Davidson."

"We are excited about what lies ahead through the balance of 2020 and into 2021 with a number of key milestones expected, including the commencement of our pilot study of CLBS119 in COVID-19 induced lung damage, the completion of enrollment in our Phase 2 study of CLBS12 for critical limb ischemia and the initiation of our Phase 2b study of CLBS16 in coronary microvascular dysfunction," concluded Dr. Mazzo.

Second Quarter 2020 Financial Highlights

Research and development expenses for the second quarter of 2020 were $1.8 million, a 39% decrease compared with $3.0 million for the second quarter of 2019. Research and development in both periods focused on the advancement of our ischemic repair platform. More specifically, R&D expense comprised (i) costs associated with investigational new drug application and planning for commencement of a pilot study of CLBS119, (ii) execution expenses for our ongoing registration-eligible study for CLBS12 in critical limb ischemia in Japan, and (iii) expenses for both the completion of our ESCaPE-CMD clinical study for CLBS16 in coronary microvascular dysfunction and planning for the follow on Phase 2b study.

General and administrative expenses for the second quarter of 2020 were $2.5 million, compared with $2.4 million for the second quarter of 2019.

Overall, net income was $6.6 million for the second quarter of 2020, which included a $10.9 million income tax benefit from the sale of qualified New Jersey net operating losses, compared to a net loss of $5.1 million for the second quarter of 2019.

Balance Sheet Highlights

As of June 30, 2020, Caladrius had cash, cash equivalents and marketable securities of $34.9 million. Based on existing programs and projections, the Company remains confident that its current cash balances will fund its operations through 2021.

Conference Call

Caladrius management will host a conference call for investors beginning at 4:30 p.m. ET on Thursday, August 13, 2020 to discuss the financial results, provide a business update and answer questions.

Shareholders and other interested parties may participate in the conference call by dialing 866-595-8403 (domestic) or 706-758-9979 (international) and referencing conference ID number 2093833. The conference call will also be webcast live under the Investors section on the Company’s website at www.caladrius.com.

For those unable to participate in the live conference call, a replay will be accessible approximately two hours after its completion through August 20, 2020, by dialing 855-859-2056 (domestic) or 404-537-3406 (international) and referencing conference ID number 2093833. A webcast audio recording of the call will also be archived for 90 days under the Investors section of the Company’s website at www.caladrius.com.

On August 13, 2020 Myriad Genetics, Inc. (NASDAQ: MYGN, "Myriad" or the "Company"), a global leader in molecular diagnostics and precision medicine, reported the appointment of Paul J. Diaz as President and Chief Executive Officer, effective August 13, 2020 (Press release, Myriad Genetics, AUG 13, 2020, View Source [SID1234563594]). He will also serve on the Company’s Board of Directors. Mr. Diaz brings to Myriad Genetics more than three decades of executive leadership and business transformation experience in healthcare across a variety of healthcare segments.

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"Paul is an exceptional leader and executive with extraordinary passion, vision, experience, and operational skills," said S. Louise Phanstiel, Chair of Myriad’s Board of Directors. "His focus on building high performing teams, and instilling a culture that empowers people to deliver high quality patient care, distinctive customer service and innovation, will be important to supporting Myriad’s mission and growth. We are excited to have Paul assume the leadership of Myriad Genetics and chart the course to realize the Company’s full potential. We look forward to officially introducing Paul during our fourth quarter earnings call. Myriad is dedicated to providing vital information to physicians, patients and their families that enables them to make better decisions about their health and treatment planning. Paul’s personal dedication, throughout his career, to patients and their care will be critical in advancing Myriad’s vision of being a trusted advisor transforming patients’ lives worldwide with pioneering molecular diagnostics."

"I am very excited to join the talented management team and Board of Directors of Myriad Genetics, an organization dedicated to helping patients and physicians identify the risk of developing disease and accurately diagnosing disease and disease progression," commented Paul. "Our goal is to empower patients, as consumers, and their physicians and our payer partners with the information and data to help guide their treatment decisions, to improve clinical outcomes and lower healthcare costs. I am equally excited about Myriad’s potential for innovation and growth. The Company has a tremendous opportunity to transform its business, and strategically position itself for sustainable, profitable growth. We will look to leverage the company’s culture of innovation and revitalize our approach to the commercializing of its products and customer service levels."

Mr. Diaz served as the President and Chief Executive Officer and Executive Director and Director of Kindred Healthcare, Inc. for over ten years, where he led the growth, revitalization and diversification of the business that positioned Kindred as the largest provider of post-acute health care services in the United States. Most recently, Mr. Diaz was a Partner at Cressey & Company LP, a private equity firm focusing on healthcare services and HCIT companies. Mr. Diaz is an experienced director and operating executive, having served as an executive and board member of multiple public and private companies. He currently serves on the board of DaVita, Inc. (NYSE: DVA) and is a member of the Board of Trustees of Johns Hopkins Medicine. Mr. Diaz graduated from The American University with a B.S. in Business Administration and with a J.D. from The Georgetown University Law Center.

Heidrick & Struggles led the search process for Myriad.

On August 13, 2020 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported its financial results for the second quarter ended June 30, 2020 (Press release, CohBar, AUG 13, 2020, View Source [SID1234563593]).

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"Today, we announced positive preliminary preclinical results in ARDS as a first step in our new COVID-19 ARDS program," said Steven Engle, CohBar’s Chief Executive Officer. "Recently, we resumed our Phase 1b study in NASH and obesity and we presented new positive results from our antifibrotic peptide program at the American Thoracic Society’s Virtual Conference. We were pleased to report that CohBar was added to the Russell 2000 and raised $4.5 million during the quarter from our at-the-market facility. With these new programs and results, our confidence continues to grow in CohBar’s vision of developing new therapeutics from mitochondrially encoded peptides to treat multiple chronic diseases and extend healthy lifespan."

Second Quarter 2020 and Recent Highlights

Resumed CB4211 clinical study for NASH and Obesity: In July, the company announced that it had resumed screening and enrollment in the Phase 1b stage of its Phase 1a/1b clinical trial of CB4211, its lead candidate for treating nonalcoholic steatohepatitis (NASH) and obesity, following a temporary pause in response to the COVID-19 pandemic. NASH has been estimated to affect as many as 12% of adults in the U.S., and there is currently no approved treatment for the disease.

Generated preliminary preclinical data in new program targeting COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS) and ARDS: Today, the company announced new preliminary results in the evaluation of its CB5064 analogs in an ARDS model, which showed reduced levels of fluid accumulation, cytokine secretion, and neutrophil infiltration. In May, the company chose a new disease target for its apelin agonists program: COVID-19 associated ARDS. The company expects the apelin agonists to also affect ARDS in general, which impacts approximately three million patients globally. CohBar previously presented data at the 2019 ADA Conference showing the beneficial effects of this novel family of peptides on glucose tolerance, insulin sensitivity, and weight loss in an obese mouse model of type 2 diabetes.

Presented new antifibrotic results at the American Thoracic Society: In August, the company presented new efficacy results in a poster presentation at the American Thoracic Society 2020 International Conference. Antifibrotic and anti-inflammatory effects were demonstrated for MBT2 (CB5138-1) in vitro in human cells and in vivo in prophylactic and therapeutic preclinical models of idiopathic pulmonary fibrosis (IPF). IPF is a chronic, progressive, debilitating, and usually fatal interstitial lung disease that affects approximately 100,000 people in the U.S.

Gained research coverage of CohBar: In May, Wall Street firm Brookline Capital Markets initiated coverage on CohBar.

Met with pharmaceutical companies at BIO 2020: In June, the company presented and hosted meetings at the BIO 2020 Conference with top pharmaceutical and biotechnology companies. In a panel on aging, CohBar’s CEO spoke on the "Redefining What it Means to Get Old: New Breakthroughs in Aging Biology."

Raised $4.5M in new capital: In June, the company sold 2,350,067 shares of common stock at an average price of $1.925 per share under an at-the-market offering program. The company received aggregate gross proceeds of approximately $4.5 million, before commissions and other estimated offering expenses totaling approximately $0.2 million.

CohBar added to the Russell Indexes: On June 26, the company joined the Russell 2000 and 3000 Indexes. The Russell 2000 Index serves as a leading benchmark for small-cap stocks in the United States.

Continued investment community outreach: In July, the company presented its new COVID-19 ARDS program at the Sachs Novel Coronavirus Investment Forum.

Conducted Annual General Meeting: In June, the company held its Annual General Meeting and provided a review and update on its progress and plans. The slides are available on the company’s website at www.cohbar.com.
Founders Update

During the second quarter and subsequent period, CohBar’s founders, Dr. Pinchas Cohen, Dean of the USC Leonard Davis School of Gerontology, and Dr. Nir Barzilai, Director of the Institute for Aging Research at Albert Einstein College of Medicine, continued to present on the study of mitochondrial science, aging and age-related diseases.

Dr. Cohen chaired the University of Southern California Public Health Policy Advisory Committee that oversaw returning to campus after the COVID-19 related shutdown. He also published a commentary linking this topic to aging research titled "COVID-19: The Importance of GeroScience in Promising Research Directions." During this period, under Dr. Cohen’s leadership, USC was awarded a USC-Buck Nathan Shock Center of Excellence in the Biology of Aging, joining a nation-wide network of seven other centers, including the one at Einstein, led by Dr. Barzilai. Dr. Cohen also published two papers on the importance of mitochondrial peptides on healthy aging and longevity. These papers are "The mitochondrial derived peptide humanin is a regulator of lifespan and healthspan" and "Peptides derived from small mitochondrial open reading frames: Genomic, biological, and therapeutic implications."

Dr. Barzilai’s book Age Later has been published by St. Martin’s Press and is available on Amazon. It describes the background of mitochondrial derived peptides and the founding of CohBar. Also, Dr. Barzilai gave talks that recognized CohBar in the Longevity Technology and Longevity Leadership meetings. He also participated in a new TEDx and was mentioned in Bloomberg, The New York Times, Wired, Wall Street Journal, among others.

Second Quarter 2020 Financial Highlights

Cash and Investments: CohBar had cash, cash equivalents and investments of $12.3 million as of June 30, 2020, compared to $12.6 million as of December 31, 2019. The cash burn for the quarter ended June 30, 2020, was approximately $2.5 million.

R&D Expenses: Research and development expenses were $1.5 million for the three months ended June 30, 2020, compared to $1.4 million in the prior year quarter. The increase in research and development expenses was primarily due to higher consulting costs.

G&A Expenses: General and administrative expenses were $1.4 million for the three months ended June 30, 2020, compared to $1.5 million in the prior year quarter. The decrease in general and administrative expenses was primarily due to lower recruiting and travel expenses.

Net Loss: For the three months ended June 30, 2020, net loss, which included $1.8 million of non-cash expenses, was $4.1 million, or $0.09 per basic and diluted share. For the three months ended June 30, 2019, net loss, which included $0.8 million of non-cash expenses, was $3.1 million, or $0.07 per basic and diluted share.
Second Quarter Investor Call and Slide Presentation:

Date: August 13, 2020
Time: 5:00 p.m. ET (2:00 p.m. PT)

Conference Audio

Dial-in U.S. and Canada: (877) 451-6152
Dial-in International: (201) 389-0879
Conference ID No.: 13707178
Slide Presentation

Go to www.webex.com, click on the ‘Join a Meeting’ button and enter meeting number 145 324 6260 and Password CWBR, or
Go to www.cohbar.com and click on Q2 2020 Shareholder Presentation at the top of homepage.
For individuals participating in the Investor Call and Slide Presentation, please call into the conference audio and log into Webex approximately 10 minutes prior to its start.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on August 13, 2020, through 11:59 p.m. Eastern Time on September 3, 2020. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 13707178. The audio recording along with the slide presentation will also be available at www.cohbar.com during the same period.

On August 13, 2020 Myriad Genetics, Inc. (NASDAQ: MYGN, "Myriad" or the "Company"), a global leader in molecular diagnostics and precision medicine, reported financial results for its fiscal fourth-quarter 2020 and provided an update on recent business activity (Press release, Myriad Genetics, AUG 13, 2020, View Source [SID1234563592]).

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"Following the substantial decline in test volumes at the end of Q3 and beginning of Q4 due to COVID-19 social distancing policies we saw a significant recovery in test volume trends throughout the quarter, with volumes in late June increasing to approximately 75% of the pre-pandemic level," said R. Bryan Riggsbee, interim president and CEO and CFO, Myriad Genetics. "As we look forward to fiscal year 2021, we are prepared to manage the business within whatever constraints that the COVID-19 pandemic imposes, and as such we will be investing in new capabilities such as telemedicine and direct-to-patient sample collection initiatives that will support the increase in test volumes above the Q4 levels towards pre-pandemic levels as quickly as possible. While we cannot predict the course of the pandemic or its full effect on our business we plan execute on several key business during fiscal year 2021 which should allow us to exit the year with growing momentum."

4Q20 Financial Highlights:

While test volumes were detrimentally impacted by the global pandemic, the company saw a significant recovery in overall test volume in the quarter. Averaged across our tests, volumes ended the quarter at approximately 75 percent of their pre-pandemic level.
Generated revenue of $93.2 million in the fiscal fourth-quarter 2020 and reduced total on-GAAP expenses by approximately $41 million from the prior quarter.
Total cash and cash equivalents and marketable securities increased sequentially in the fiscal fourth-quarter to $254.8 million.
Recent Business Highlights:

Received a final local coverage determination (LCD) for pharmacogenomic (PGx) testing by Palmetto GBA and CGS Administrators, LLC, two of the administrative contractors for the Centers for Medicare & Medicaid Services. The new LCD expands coverage for patients to all healthcare providers licensed and qualified to diagnose the condition and prescribe relevant medications (either independently or in an arrangement).
Published a new study for riskScore in the Journal of the American Medical Association Network Open demonstrating the ability of Myriad’s polygenic risk score to modify breast cancer risk stratification in women diagnosed with pathogenic mutations in common breast cancer genes.
Announced a new collaboration with OptraHEALTH to implement a cognitive ChatBOT named Gene which provides genetic and financial assistance information to prospective patients with the ability to answer over 500,000 health related questions.
Launched our proprietary AMPLIFY technology which increases maternal fetal fraction an average of 2.3 times and further increases the already market-leading accuracy of our Prequel non-invasive prenatal screening test.
Published a new study in Genetics in Medicine comprising over 93,000 patients which showed the challenges associated with ethnicity-based guidelines for carrier screening used by both the American College of Medical Genetics and the American College of Gynecology. In the study, following ethnicity-based guidelines from ACOG and ACMG would have resulted in 77 percent of carriers of severe genetic disease being missed.
Launched a new radiographic progression (RP) enhancement tool for the Vectra test report that is personalized based on the age, gender and adiposity of the patient. The new test report will provide individual risk of a patient’s risk of RP within one year.
Received favorable coverage decisions for Prolaris from four new commercial health plans including one of the top five national providers of health insurance. In aggregate the new health plans represent 26 million covered lives.
Received U.S. Food and Drug Administration (FDA) approval for the myChoice CDx test for use as a companion diagnostic by healthcare professionals to identify advanced ovarian cancer patients with positive homologous recombination deficiency status, who are eligible or may become eligible, for first-line maintenance treatment with Lynparza (olaparib) in combination with bevacizumab.
Financial Guidance
Given the continued unpredictability pertaining to the COVID-19 pandemic and the impact it has had on both customer behavior and our ability to market our tests to physician customers, the company continues to see a wide range of possible financial outcomes for fiscal year 2021. As a result, the company has decided to not provide fiscal year 2021 financial guidance.

Conference Call and Webcast
A conference call will be held today, Thursday, August 13, 2020, at 4:30 p.m. EDT to discuss Myriad’s financial results for the fiscal fourth-quarter and business developments. The dial-in number for domestic callers is 1-800-381-7839. International callers may dial 1-212-239-2905. All callers will be asked to reference reservation number 21966478. An archived replay of the call will be available for seven days by dialing (800) 633-8284 and entering the reservation number above. The conference call along with a slide presentation will be available through a live webcast at www.myriad.com.

On August 13, 2020 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), reported financial results for the second quarter ended June 30, 2020 and provided a corporate update (Press release, Regulus, AUG 13, 2020, View Source [SID1234563591]).

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"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.