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APOLLO ENDOSURGERY, INC. REPORTS THIRD QUARTER 2020 RESULTS

On November 5, 2020 Apollo Endosurgery, Inc. ("Apollo") (Nasdaq: APEN), a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, reported financial results for the third quarter ended September 30, 2020 (Press release, Apollo Endosurgery, NOV 5, 2020, View Source [SID1234570065]).
Third Quarter 2020 and Recent Highlights
•Total Endoscopy revenue increased 21% compared to the third quarter of 2019 to $12.5 million
•U.S. Endoscopy revenue increased 37% compared to the third quarter of 2019 to $6.6 million
•Gross margin increased to 55% compared to 48% in the third quarter of 2019
•Net loss improved by 70% to $2.6 million compared to $8.7 million for the third quarter of 2019
•Ended the quarter with $38.2 million in cash, cash equivalents and restricted cash
"The third quarter rebound in elective procedures in our direct markets was both quicker and stronger than our early expectations," stated Todd Newton, Apollo’s Chief Executive Officer. "We also took steps in the third quarter to lower our annual operating expenses and improve our liquidity position. As a result, we believe our liquidity provides sufficient runway through 2021 and through the COVID-19 pandemic, completion of the MERIT trial, and launch of X-Tack."
Third Quarter Results
Worldwide Endoscopy product sales were $12.5 million for the third quarter of 2020, an increase of 21% compared to the third quarter of 2019 as the easing of public health interventions due to the COVID-19 pandemic generated a resurgence in elective procedures that use our Endoscopy products.
Geographically, U.S. Endoscopy sales increased 37% to $6.6 million for the third quarter of 2020 and OUS Endoscopy sales increased 7% to $5.9 million.
By product group, U.S. ESS product sales increased 28% to $4.7 million for the third quarter of 2020 compared to the same period in 2019, while OUS ESS sales remained unchanged at $2.9 million. U.S. IGB product sales increased 70% to $1.9 million for the third quarter of 2020, while OUS IGB product sales increased 15% to $3.0 million.
Total revenue for the third quarter of 2020 was $12.8 million, an increase of 14% from $11.3 million in the prior year third quarter. Excluding $0.1 million and $0.8 million of transition service revenue in the third quarter of 2020 and 2019, respectively, related to the Surgical product line which was divested in December of 2018, total revenue increased 21%.
Gross margin increased to 55% for the third quarter of 2020 from 48% in the third quarter of 2019 primarily due to benefits from completed gross margin improvement projects and the higher mix of IGB product sales and direct market sales as a percentage of total revenue.
Total operating expenses decreased $3.7 million, or 30%, for the third quarter of 2020 due to the liquidity preservation program implemented in the second quarter of 2020 in response to the COVID-19 pandemic.
Net loss for the third quarter of 2020 was $2.6 million compared to $8.7 million for the third quarter of 2019, an improvement of 70%.
Cash, cash equivalents and restricted cash were $38.2 million as of September 30, 2020.
Conference Call
Apollo will host a conference call on November 5, 2020 at 3:30 p.m. Central Time / 4:30 p.m. Eastern Time to discuss operating results for the third quarter ended September 30, 2020. To join the conference call by telephone, please dial +1-785-424-1667. A live webcast of the conference call will be made available on the "Events and Presentations" section of our Investor Relations website: ir.apolloendo.com.
A replay of the webcast will be made available on Apollo’s website, www.apolloendo.com following the event.

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Regulus Therapeutics Reports Third Quarter 2020 Financial Results and Recent Updates

On November 5, 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 third quarter ended September 30, 2020 and provided a corporate update (Press release, Regulus, NOV 5, 2020, View Source [SID1234570064]).

"We are pleased with the progress on our ADPKD program with the recent announcement of dosing of the first patient in the Phase 1b clinical trial of RGLS4326 in patients with ADPKD", stated Jay Hagan, CEO of Regulus. "Next year is shaping up to be an important one for Regulus, with data from the first cohort anticipated by end of Q1 2021. We also achieved $10 million in milestones from our collaboration with Sanofi enabling us to reduce our outstanding debt to $4.7 million and extend the interest-only period through the end of 2021."

Third Quarter 2020 Corporate Highlights and Recent Updates

Amendment of Sanofi Collaboration Agreement and Achievement of Milestones: In August 2020, the Company entered into an amendment with Sanofi concerning the receipt of potential milestones from Sanofi for its development of miR-21 programs. Under the terms of the amendment with Sanofi, the Company was eligible to receive $4 million upon the completion of transfer and verification of certain materials valued at an additional $1 million sold to Sanofi. In addition to this payment of $5 million received, the Company achieved a $5 million interim enrollment milestone and is eligible to receive an additional $25 million upon the successful achievement of a development milestone related to the Phase 2 HERA study.

Term Loan Amendments and Reduction in Principal: In August 2020, and concurrently with the Sanofi amendment, the Company amended its term loan agreement with Oxford LLC, under which 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. In September and October 2020, the Company made payments totaling $5 million to Oxford and plans to make an additional $5 million payment to Oxford before the end of 2020, thus triggering the additional interest only period. These payments will reduce the remaining principal due under the term loan to approximately $4.7 million. Remaining principal and accrued interest payments will commence on January 1, 2022.

Program Updates

RGLS4326 for ADPKD: In October 2020, the Company dosed the first patient in a Phase 1b clinical study for RGLS4326 in patients with ADPKD. The Phase 1b is an adaptive design, open-label, multiple dose study in up to three cohorts of patients with ADPKD and will evaluate administration of RGLS4326 for safety, pharmacokinetics, and changes in levels of polycystin 1 (PC1) and polycystin 2 (PC2). Patients with ADPKD, due to a mutation in the PKD genes, have been reported to have low levels of PC1 and PC2, the proteins encoded by the PKD1 and PKD2 genes, respectively. This study is designed to assess whether different dose levels of RGLS4326 can increase levels of PC1 and PC2 in ADPKD patients. The first cohort is planned to enroll up to nine patients who will receive RGLS4326 every two weeks over a six week period. The Company anticipates availability of results from the first cohort by the end of Q1 2021.
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. The Company believes 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. The Company has nominated a development candidate and plans 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 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.
Third Quarter 2020 Financial Results

Cash Position: As of September 30, 2020, Regulus had $17.8 million in cash and cash equivalents.

Revenue: Revenue was $5.0 million for the three and nine months ended September 30, 2020, respectively, compared to less than $0.1 million and $6.8 million for the three and nine months ended September 30, 2019, respectively. Revenue recognized for the three and nine months ended September 30, 2020 was attributable to the completion of transfer and verification of certain materials to Sanofi under the August 2020 amendment. Revenue recognized for the nine months ended September 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.

Research and Development (R&D) Expenses: Research and development expenses were $4.0 million and $11.4 million for the three and nine months ended September 30, 2020, respectively, compared to $2.4 million and $10.3 million for the three and nine months ended September 30, 2019, respectively. The aggregate increase for the three months ended September 30, 2020, as compared to the three months ended September 30, 2019, was driven by an increase in external development expenses, primarily attributable to FDA lifting the partial hold on the MAD study in December 2019 and completion of the dosing for the Phase 1 of the MAD study in July 2020, as well as start-up activities leading up to the first patient dosing in our RGLS4326 Phase 1b study in October 2020. The aggregate increase for the nine months ended September 30, 2020, as compared to the nine months ended September 30, 2019, was driven by an increase in external development expenses, attributable to RGLS4326 MAD and Phase 1b study activities, partially offset by a reduction in personnel and internal expenses.

General and Administrative (G&A) Expenses: General and administrative expenses were $2.1 million and $6.7 million for the three and nine months ended September 30, 2020, compared to $2.6 million and $9.0 million for the three and nine months ended September 30, 2019. These amounts reflect personnel-related and ongoing general business operating costs. The decreases for the three and nine months ended September 30, 2020, as compared to the three and nine months ended September 30, 2019, are primarily attributable to continued cost reduction efforts subsequent to our corporate restructurings.

Net Loss: Net loss was $1.5 million, or $0.04 per share (basic and diluted), and $14.4 million, or $0.47 per share (basic and diluted), for the three and nine months ended September 30, 2020, respectively, compared to $5.4 million, or $0.26 per share (basic and diluted), and $13.7 million, or $0.86 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 RGLS4326 IND is currently on a Partial Clinical Hold for treatment of extended duration by FDA until the second set of requirements outlined by the agency 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. RGLS4326 received orphan drug designation from FDA in July 2020.

Kezar Life Sciences Reports Third-Quarter 2020 Financial Results and Provides Business Updates

On November 5, 2020 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, reported its third-quarter 2020 financial results and corporate highlights (Press release, Kezar Life Sciences, NOV 5, 2020, View Source [SID1234570063]).

"The third quarter of 2020 saw continued momentum for Kezar, punctuated by the U.S. FDA granting Orphan Drug Designations for our lead candidate KZR-616 for the treatment of polymyositis and dermatomyositis," said John Fowler, Kezar’s Co-Founder and Chief Executive Officer. "In addition, our presentations at a number of medical and scientific meetings this fall highlight the compelling therapeutic potential of our two highly novel programs in immunoproteasome inhibition and the protein secretion pathway. With each step forward, our conviction deepens that Kezar’s novel small molecule approaches in autoimmunity and oncology could have profound impacts on a wide array of diseases with high unmet need."

Clinical Highlights & Updates

KZR-616: Selective Immunoproteasome Inhibitor

KZR-616 is currently being evaluated for the treatment of severe autoimmune diseases.

In October 2020, Orphan Drug Designations (ODD) were granted for KZR-616 in both dermatomyositis (DM) and polymyositis (PM) by the U.S. Food and Drug Administration (FDA). Both orphan diseases are autoimmune inflammatory myopathies that are chronic and debilitating diseases characterized by marked morbidity and mortality. The estimated prevalence of DM and PM in the United States is up to 71,000 and 51,000, respectively. Orphan Drug Designation can provide certain benefits for the development of KZR-616, including a period of marketing exclusivity for the first marketing application, if approved for the designated indication, certain tax credits and waiver of certain administrative fees.
The MISSION Phase 2 trial in patients with active, proliferative lupus nephritis (LN) opened for enrollment under a new protocol in August 2020. The primary efficacy endpoint for the trial is the number of patients achieving a renal response measured by a 50% or greater reduction in urine protein to creatinine ratio (UPCR) at six months.
Interim data are expected in late 2021, and topline data are expected in the first half of 2022. To allow for responding patients to continue treatment with KZR-616, a 12-month extension study will also be made available.
Updated results from the MISSION Phase 1b portion were presented at the American College of Rheumatology Annual Meeting (ACR Convergence 2020) in November 2020. These results indicate that KZR-616 60mg administrated subcutaneously weekly is well-positioned for development as a long-term treatment option in autoimmune disease.
The PRESIDIO Phase 2 trial of KZR-616 in polymyositis (PM) and dermatomyositis (DM) continues to enroll. A 12-month open-label extension study has been initiated for patients completing the placebo-controlled trial.
Topline data are expected in the first half of 2022.
Pre-clinical results of KZR-616 in a murine model of polymyositis were presented during ACR Convergence 2020. The results provide a rationale for targeting selective immunoproteasome inhibition for the treatment of polymyositis.
KZR-261: Protein Secretion Program

KZR-261, a first-in-class protein secretion inhibitor, targets the Sec61 translocon and has demonstrated broad anti-tumor activity in preclinical models of both solid and hematologic malignancies. Additional preclinical data further detailing the ability of novel small molecule Sec61 inhibitors to target multiple checkpoint proteins on various cell populations, thereby offering the potential of combination therapy in a single compound, are being presented during the 8th Annual Meeting of the International Cytokine & Interferon Society (Cytokines 2020) and the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November 2020.
An Investigational New Drug (IND) application for KZR-261 is on-track for a planned submission in the first quarter of 2021. The Phase 1 clinical trial will evaluate dose escalation and safety and tolerability in patients with solid tumors to begin shortly after IND acceptance.
Third-Quarter 2020 Financial Results

Cash, cash equivalents and marketable securities totaled $150.0 million as of September 30, 2020, compared to $78.2 million as of December 31, 2019. The increase in cash, cash equivalents and marketable securities was primarily attributable to the net proceeds from Kezar’s underwritten public offerings in February and June 2020, net of cash used by the Company in operations to advance its clinical stage programs and preclinical research and development.
Research and development expenses for the third quarter of 2020 increased by $1.2 million to $8.3 million, compared to $7.1 million in the third quarter of 2019. This increase was primarily related to advancing both the KZR-616 clinical program in multiple indications and the protein secretion preclinical program.
General and administrative expenses for the third quarter of 2020 increased by $0.7 million to $3.3 million, compared to $2.6 million in the third quarter of 2019. The increase was primarily due to an increase in personnel expenses, including non-cash stock-based compensation, legal and professional fees.
Net loss for the third quarter of 2020 was $11.3 million, or $0.23 per basic and diluted common share, compared to a net loss of $9.1 million, or $0.48 per basic and diluted common share, for the third quarter of 2019.
Total shares of common stock outstanding were 46.3 million as of September 30, 2020. Additionally, there were outstanding pre-funded warrants to purchase 3.8 million shares of common stock at an exercise price of $0.001 per share and outstanding options to purchase 4.5 million shares of common stock at a weighted average exercise price of $6.12 per share as of September 30, 2020.
About KZR-616

KZR-616 is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Data generated from Phase 1a and 1b clinical trials provide evidence that KZR-616 exhibits a favorable safety and tolerability profile for development in severe, chronic autoimmune diseases. Phase 2 trials are underway in severe autoimmune diseases.

About KZR-261

KZR-261, a novel, first-in-class protein secretion inhibitor, is the first clinical candidate to be nominated from Kezar’s research and discovery efforts targeting protein secretion pathways. KZR-261 is a broad-spectrum anti-tumor agent that acts through direct interaction and inhibition of Sec61 activity. The compound was discovered by Kezar through a robust medicinal chemistry campaign in which several scaffolds were progressed through the company’s proprietary platform evaluating Sec61 modulation. As a result, Kezar has established a broad library of protein secretion inhibitors. KZR-261 has demonstrated several encouraging properties that lead to its potential to be an anti-cancer agent for the treatment of solid and hematologic malignancies. IND-enabling activities are currently underway, and an IND submission in solid tumors is expected to be filed in the first quarter of 2021.

Calithera Biosciences Reports Third Quarter 2020 Financial Results and Recent Highlights

On November 5, 2020 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel, small-molecule drugs for the treatment of cancer and other life-threatening diseases, reported its financial results for the third quarter ended September 30, 2020 (Press release, Calithera Biosciences, NOV 5, 2020, View Source [SID1234570062]).

"To date, 2020 has been a significant year for Calithera as we’ve made remarkable progress to advance our clinical development efforts across our pipeline and work toward reporting our first pivotal trial results with our lead candidate glutaminase inhibitor telaglenastat, while continuing to strengthen our cash position," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "We look forward to reporting top-line results from our pivotal CANTATA trial evaluating telaglenastat in renal cell carcinoma in late fourth quarter of 2020 or early first quarter 2021. We also announced recently the initiation of the first clinical trial to evaluate our novel arginase inhibitor in cystic fibrosis, and the initiation of our first clinical trial evaluating telaglenastat in people with non-small cell lung cancer whose tumors have KEAP1 or NRF2 genetic mutations."

Third Quarter 2020 and Other Recent Program Highlights

Progress continues toward top-line data readout of pivotal Phase 3 CANTATA randomized trial of telaglenastat and cabozantinib in advanced renal cell carcinoma (RCC). The CANTATA trial is a global, randomized, double-blind clinical trial of telaglenastat combined with cabozantinib, in patients with advanced or metastatic RCC who have received one or two prior treatments. The trial enrolled 444 patients at multiple centers globally. The primary endpoint is progression-free survival (PFS). Calithera expects to report top-line efficacy and safety data from the trial in late fourth quarter of 2020 or early first quarter 2021.
KEAPSAKE randomized trial evaluating telaglenastat in non-small cell lung cancer (NSCLC) patients with a KEAP1 or NRF2 genetic mutation enrolled first patient in September. Mutations in the KEAP1/NRF2 pathway, which occur in an estimated 20 percent of NSCLC patients, are associated with aggressive tumor growth and poor outcomes for patients. The double-blind KEAPSAKE trial will enroll approximately 120 patients with stage IV non-squamous NSCLC with tumors that have the KEAP1 or NRF2 mutation. Patients will be randomized to receive telaglenastat or placebo, in combination with pembrolizumab, carboplatin and pemetrexed. The study will evaluate the safety and investigator-assessed PFS of telaglenastat plus this standard-of-care chemo-immunotherapy regimen. Calithera anticipates sharing interim data from the KEAPSAKE trial in 2021.
ENTRATA Phase 2 study of telaglenastat with everolimus in RCC survival analysis completed. The ENTRATA trial was a randomized, double-blind, trial designed to evaluate the safety and efficacy of telaglenastat in combination with everolimus versus placebo with everolimus in patients with advanced clear cell RCC who have been treated with at least two prior lines of systemic therapy, including at least one prior VEGFR-targeted tyrosine kinase inhibitor. The trial enrolled 69 patients. The primary endpoint was PFS per investigator assessment with a predetermined threshold of p≤0.2 one-sided. Top-line results were reported in June 2019. Telaglenastat, when added to everolimus, doubled the median PFS in heavily pretreated patients with advanced RCC to 3.8 months as compared to 1.9 months for everolimus alone, and reduced the risk of disease progression or death by 36% (HR=0.64, p=0.079 one-sided). Although the study was not powered for survival, it was evaluated as a secondary endpoint, and is now mature enough to be reported. Based on the data cutoff of September 30, 2020, the median overall survival is 14.4 months vs. 9.7 months in the telaglenastat and control arms, respectively (HR=0.80, p=0.24 one-sided).
Pfizer clinical collaboration investigating the CDK4/6 inhibitor IBRANCE with telaglenastat expanded to evaluate the combination in pancreatic cancer patients. In July 2019, Calithera initiated a Phase 1/2 trial of the combination of telaglenastat plus Ibrance in patients with solid tumors including expansion cohorts in KRAS-mutated colorectal cancer and KRAS-mutated non-small cell lung cancer. In November, Calithera announced the expansion of this collaboration to include an additional cohort of patients with pancreatic ductal adenocarcinoma (PDAC) whose tumors harbor mutations in both KRAS and CDKN2A.
CB-280 arginase inhibitor program advanced. In October, Calithera presented a trial in progress poster at the North American Cystic Fibrosis 2020 Virtual Conference. The presentation included preclinical study results which suggest CB-280 significantly improved lung function and reduced Pseudomonas aeruginosa colony-forming units in pre-clinical models. Arginase inhibition with CB-280 resulted in improved central airway resistance in CFTR knockout mice, and decreased lung infection in wild type and DeltaF508-CFTR-expressing mice infected with Pseudomonas aeruginosa. Enrollment in the Ph1b study is ongoing and Calithera expects to share interim data in 2021. In November, Calithera was awarded up to $2.4M from the Cystic Fibrosis Foundation to support clinical development of CB-280.
INCB001158 program continued progress. INCB001158, an internally discovered molecule, is being evaluated in multiple clinical trials for the treatment of patients with solid tumors both as a monotherapy, in combination with anti-PD-1 immunotherapy, and in multiple chemotherapy regimens. While Calithera remains committed to and confident in the INCB001158 development program, Calithera decided to opt out of co-development obligations with Incyte in order to focus resources on internal development programs.
Preclinical data presented from CB-668 IL4I1 program. CB-668 is an investigational first-in-class, potent, orally administered IL4I1 inhibitor as a novel immuno-oncology approach to cancer. New preclinical data for CB-668 will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Virtual Meeting November 11-14, 2020.
Selected Third Quarter 2020 Financial Results

Cash, cash equivalents and investments totaled $137.7 million at September 30, 2020.

Research and development expenses were $18.2 million for the three months ended September 30, 2020, compared to $17.2 million for the same period in the prior year. The increase of $1.0 million was due to a $1.9 million increase in the telaglenastat program and a $1.5 million increase in the CB-280 program, partially offset by a $1.0 million decrease in the INCB001158 program and a decrease of $1.4 million in early stage research.

General and administrative expenses were $4.7 million for the three months ended September 30, 2020, compared with $3.9 million for the same period in the prior year. The increase of $0.8 million was primarily related to an increase in higher personnel-related and facility costs.

Interest and other income, net was $0.2 million for the three months ended September 30, 2020, compared to $0.8 million for the same period in the prior year, mainly as a result of lower interest rates.

Net loss for the three months ended September 30, 2020 was $22.7 million, or $0.32 per share.

Conference Call Information

Calithera will host an update conference call today, Thursday, November 5, at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time. The call may be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 and referring to conference ID 6869011. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at View Source The webcast will be recorded and available for replay on Calithera’s website for 30 days.

FIBROGEN REPORTS THIRD QUARTER 2020 FINANCIAL RESULTS

On November 5, 2020 FibroGen, Inc. (NASDAQ:FGEN) reported financial results for the third quarter of 2020 and provided an update on the company’s recent developments (Press release, FibroGen, NOV 5, 2020, View Source [SID1234570061]).

"I am pleased with our progress with roxadustat across a number of fronts; including engagement with the FDA, commercial preparations in the U.S., and our impressive sales results in China." said Enrique Conterno, Chief Executive Officer, FibroGen. "As the world navigates the effects of the COVID-19 pandemic, we continue to advance our roxadustat and pamrevlumab clinical programs."

Key Events in Recent Months and Other Developments

Roxadustat

FibroGen and its partners presented 42 abstracts, including 10 oral presentations and 2 late-breaker poster presentations, at the recent American Society of Nephrology (ASN) Kidney Week 2020 Reimagined conference:
• Two late-breaking abstracts explored the cardiovascular outcomes of patients with anemia of chronic kidney disease (CKD) treated with roxadustat, including associations between achieved hemoglobin levels and risk of Major Adverse Cardiovascular Events (MACE) and MACE+.
• New analyses showed the efficacy of roxadustat across the continuum of patients with anemia of CKD – both on dialysis and not on dialysis – including different dialysis modalities, iron repletion status, and comorbidities.
• Presentations addressed the safety profile of roxadustat related to neoplasms, hypertension, and ophthalmological effects.
• Additional presentations explored the increased risk of red blood cell transfusion at lower hemoglobin levels and the impact of roxadustat on rates of hospitalization due to heart failure.
U.S. NDA for roxadustat for the treatment of anemia of chronic kidney disease, in dialysis-dependent and non-dialysis-dependent patients, is under review with a Prescription Drug User Fee Act (PDUFA) date of December 20, 2020.
Marketing authorization application (MAA) for roxadustat for the treatment of anemia in adult patients with CKD, both on dialysis and not on dialysis, is under review by the European Medicines Agency (EMA).
Japan sNDA for roxadustat for the treatment of anemia of CKD in non-dialysis-dependent patients is under review by the Pharmaceuticals and Medical Devices Agency (PMDA).
Continued enrollment of the Phase 3 roxadustat clinical trial in anemia associated with myelodysplastic syndromes (MDS) and Phase 2 roxadustat clinical trial in chemotherapy-induced anemia (CIA).
Pamrevlumab

Initiated LELANTOS, a Phase 3 trial of pamrevlumab in patients with non-ambulatory Duchenne muscular dystrophy (DMD).
Continued enrollment of the ZEPHYRUS Phase 3 clinical trial of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF).
Continued enrollment of the LAPIS Phase 3 clinical trial of pamrevlumab in patients with locally advanced unresectable pancreatic cancer (LAPC).
Upcoming Events

Plan to initiate ZEPHYRUS-2, a Phase 3 trial of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF) as COVID-19 conditions improve.
Plan to initiate LELANTOS-2, a Phase 3 trial of pamrevlumab in patients with ambulatory Duchenne muscular dystrophy (DMD) by year-end.
Corporate and Financial

Total revenue for the third quarter of 2020 was $44.0 million, as compared to $33.2 million for the third quarter of 2019. The current quarter revenue consisted of $22.7 million in net roxadustat sales in China, $20.7 million in development revenue, $2.3 million for sales of bulk drug product, and a net reduction of $1.7 million for certain adjustments.
Net income for the third quarter of 2020 was $33.0 million, or $0.36 net income per basic and $0.35 per diluted share, compared to a net loss of $49.4 million, or $0.57 net loss per basic and diluted share one year ago.
Amended China Agreement with AstraZeneca in July 2020 such that both parties are optimally aligned to maximize the economic value of the roxadustat franchise, with more predictable economics and profitability for FibroGen. As a result, we reversed approximately $84.4 million of co-promotion expenses as a reduction to selling, general and administrative expenses in the third quarter of 2020.
At September 30, 2020, FibroGen had $719.3 million in cash, cash equivalents, restricted time deposits, investments, and receivables.
Based on our latest forecast, we now estimate our year-end 2020 balance for cash, cash equivalents, restricted time deposits, investments, and receivables to be in the range of $770 to $780 million.
Appointed Percy Carter, MBA, PhD, to the newly-created position of Chief Scientific Officer.
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Thursday, November 5, 2020, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (877) 658-9081 (U.S. and Canada) or 1 (602) 563-8732 (international), reference the FibroGen third quarter 2020 financial results conference call, and use passcode 5994243. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and use passcode 5994243.

About Roxadustat
Roxadustat is a first-in-class, oral small molecule HIF-PH inhibitor that promotes erythropoiesis through increased endogenous production of erythropoietin; improved iron absorption, transport, and mobilization; and downregulation of hepcidin, which helps to overcome the negative impact of inflammation on hemoglobin synthesis and red blood cell production. Roxadustat is approved in China for the treatment of anemia of adult patients with CKD, both on dialysis and not on dialysis. In Japan, roxadustat is approved for the treatment of anemia of CKD patients on dialysis, and a supplemental NDA for the treatment of anemia of CKD patients not on dialysis is under regulatory review. The roxadustat NDA for the treatment of anemia of CKD in patients both on dialysis and not on dialysis is under review by the U.S. Food and Drug Administration with a Prescription Drug User Fee Act date of December 20, 2020. The Marketing Authorization Application for roxadustat for the treatment of anemia of CKD in patients both on dialysis and not on dialysis was filed by our partner Astellas and accepted by the European Medicines Agency for review on May 21, 2020. Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and chemotherapy-induced anemia (CIA).

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa. AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in the U.S., China, and other markets in the Americas and in Australia/New Zealand, as well as Southeast Asia.

About Pamrevlumab
Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and locally advanced unresectable pancreatic cancer (LAPC), and Duchenne muscular dystrophy (DMD); and in Phase 2 clinical development for the treatment of coronavirus (COVID-19). For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.