On August 5, 2021 Keros Therapeutics, Inc. ("Keros" or the "Company") (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need, reported financial results for the quarter ended June 30, 2021 (Press release, Keros Therapeutics, AUG 5, 2021, View Source [SID1234585976]).

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"We have made substantial progress over the past quarter, including announcing our preliminary results from our Phase 2 clinical trial of KER-050," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer. "We continue to make notable progress advancing our pipeline, and remain focused on the execution of our near-term development plans. In that regard, we remain on track to initiate several clinical trials for KER-050, KER-047 and KER-012 over the balance of 2021."

Recent Corporate Highlights:

Executive leadership changes: In August 2021, the Company announced that Simon Cooper, M.B.B.S., has been appointed to serve as the Company’s Chief Medical Officer, effective as of August 2, 2021. Dr. Cooper succeeded Claudia Ordonez, M.D., who departed from the Chief Medical Officer position effective July 30, 2021. Dr. Ordonez will provide consulting services to the Company until September 15, 2021.
Issuance of Keros foundational U.S. patent: In May 2021, the United States Patent and Trademark Office issued U.S. Patent No. 11,013,785, which is a composition of matter patent directed to novel therapeutic proteins, including KER-050, that contains 20 claims and expires in November 2037.
Recent Program Highlights:

KER-050 for the treatment of ineffective hematopoiesis to address cytopenias
In June 2021, Keros announced preliminary results from Cohorts 1 and 2 (0.75 mg/kg and 1.5 mg/kg) of Part 1 of its Phase 2 clinical trial evaluating KER-050 in patients with myelodysplastic syndromes. Following Safety Review Committee recommendation, dosing for Cohort 3 of the trial was initiated at 2.5 mg/kg of KER-050, to be administered once every four weeks for 12 weeks.
The Company expects to report additional Part 1 data and initiate Part 2 of the trial by the end of 2021.
Second Quarter 2021 Financial Results

Keros reported a net loss of $15.6 million in the second quarter of 2021 as compared to a net loss of $10.8 million in the second quarter of 2020. The increase in net loss for the second quarter was largely due to increased research and development efforts as well as additional infrastructure expenses
to support our operations as a publicly traded company.

Research and development expenses were $10.0 million for the second quarter of 2021 as compared to $7.3 million for the same period in 2020. The increase of $2.7 million was primarily due to additional research and development efforts, manufacturing activities, and personnel expenses to support the advancement of our pipeline.

General and administrative expenses were $5.7 million for the second quarter of 2021 as compared to $3.7 million for the same period in 2020. The increase of $2.0 million was primarily due to increase in personnel expenses and other external expenses to support Keros’ organizational growth.

Keros’ cash and cash equivalents as of June 30, 2021 was $237.1 million compared to $265.9 million as of December 31, 2020. Keros expects that the cash and cash equivalents it had on hand at June 30, 2021 will fund its operating expenses and capital expenditure requirements into the fourth quarter of 2023.

On August 5, 2021 Novavax, Inc. (NASDAQ: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, reported its financial results and operational highlights for the second quarter ended June 30, 2021 (Press release, Novavax, AUG 5, 2021, View Source [SID1234586007]).

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"We are highly encouraged by the filing of regulatory submissions in multiple markets, made in partnership with Serum Institute of India. We view these submissions as the first of many filings to come, which will allow NVX-CoV2373 to be made available at a global scale," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "Our clinical successes over the second quarter reaffirm our confidence in NVX-CoV2373’s differentiated efficacy profile. We continue to see the circulation of new variants and inequitable access to vaccine globally, demanding that we bring our COVID-19 vaccine to market as swiftly as possible."

Second Quarter 2021 and Recent Highlights

COVID-19 Vaccine Clinical and Non-Clinical Development

Reported final analysis from PREVENT-19 U.S. and Mexico Phase 3 trial
Achieved primary efficacy endpoint with overall efficacy of 90.4% against mild, moderate, and severe disease
Demonstrated 100% protection against moderate and severe disease
Demonstrated 91.0% efficacy among high-risk populations
Demonstrated 92.6% efficacy against Variants of Concern/Variants of Interest (VoC/VoI) and 100% efficacy against variants not considered VoC/VoI
Completed enrollment of pediatric expansion of PREVENT-19 Phase 3 trial
Enrolled 2,248 adolescents aged 12-17 across up to 75 sites in the U.S.
Blinded crossover expected to begin in August 2021 to ensure all participants have access to active vaccine
Published results from late-stage South Africa Phase 2b and UK Phase 3 trials in The New England Journal of Medicine
Completed UK Phase 3 crossover arms and initiated crossover studies in PREVENT-19 and South Africa Phase 2b trials to ensure all participants have access to active vaccine
Advanced clinical development of booster studies of NVX-CoV2373
Reported 6-month booster data from U.S. and Australia Phase 2 trial
Wild-type neutralizing antibodies increased more than 4-fold versus primary vaccination series
Cross-reactive functional antibodies to the Delta (B.1.617.2) variant strain detected after primary vaccination series and increased more than 6-fold following boosting
Analysis of sera from primary series immunization showed cross-reactive functional antibodies to the Alpha (B.1.1.7), Beta (B.1.351), and Delta (B.1.617.2) variant strains, all of which increased 6- to 10-fold with a booster dose
Participated in two UK Vaccines Taskforce-supported studies evaluating heterologous vaccination (Com-COV2) and heterologous boosting (CoV-Boost)
COVID-19 Vaccine Regulatory Pathway

Filed regulatory submissions in partnership with Serum Institute of India Pvt. Ltd. (SII) for emergency use authorization in multiple markets
Submitted regulatory filings with the Drugs Controller General of India (DCGI) and regulatory agencies in Indonesia and the Philippines
Expect to file for Emergency Use Listing with the World Health Organization in August 2021
Expect to complete regulatory filing with the UK Medicines and Healthcare products Regulatory Agency (MHRA) in the third quarter of 2021
Expect to complete additional regulatory filings in other markets within weeks of MHRA filing, including with the European Medicines Agency (EMA), Australian Therapeutic Goods Administration, Health Canada, and New Zealand Medsafe
Expect to submit for emergency use authorization to the U.S. Food and Drug Administration in the fourth quarter of 2021
COVID-19 Vaccine Manufacturing and Supply

Collaborated with partners globally to progress toward anticipated manufacturing capacity
On track to achieve capacity of 100 million doses per month by the end of the third quarter of 2021 and 150 million doses per month by the end of the fourth quarter 2021
Initiated technology transfer at National Research Council of Canada Biologics Manufacturing Centre to produce NVX-CoV2373
Expanded agreements globally to ensure equitable access to low-, middle-, and high-income countries
Entered into advance purchase agreement with Gavi, the Vaccine Alliance, to provide 1.1 billion doses to the COVAX Facility
Novavax to manufacture and distribute 350 million doses
SII to manufacture and distribute the remaining balance of the 1.1 billion doses to low- and middle-income countries
Finalized terms of advance purchase agreement with European Commission to supply up to 100 million doses with the option for an additional 100 million doses through 2023
Delivery of doses to begin following anticipated regulatory approval from EMA
NanoFluTM / NVX-CoV2373 Combination Vaccine (qNIV/CoV2373)

Announced preclinical data for qNIV/CoV2373 and expect to initiate Phase 1 clinical trial in Australia later this year
qNIV/CoV2373 induced strong functional antibodies, high levels of anti-S IgG, and neutralizing antibody titers
Preclinical data manuscript submitted for publication to a peer-reviewed journal and posted via the preprint server on bioRxiv.org
Announced data from sub-study in UK Phase 3 trial, supporting co-administration of NVX-CoV2373 with influenza vaccination
431 participants received approved seasonal influenza vaccine, while half of those participants were co-vaccinated with NVX-CoV2373
Co-administration did not negatively impact influenza immune response for any of the four influenza strains in the quadrivalent influenza vaccine
Confirmed efficacy trend of 87.5% against COVID-19
Data manuscript submitted for publication to a peer-reviewed journal and posted via the preprint server on medRxiv.org
Malaria Vaccine / Matrix-M Adjuvant Collaboration

Ongoing clinical development for R21, the University of Oxford’s malaria vaccine candidate formulated with Matrix-M adjuvant, in collaboration with SII
Phase 3 licensure trial underway in 4,800 participants, aged 5-36 months
Phase 2b clinical trial results demonstrated 77% efficacy and were published in Preprints with The Lancet
Financial Results for the Three Months Ended June 30, 2021

Novavax reported a net loss of $352 million, or $4.75 per share, for the second quarter of 2021, compared to a net loss of $18 million, or $0.30 per share, for the second quarter of 2020.

Novavax revenue in the second quarter of 2021 was $298 million, compared to $36 million in the same period in 2020. This increase was due to increased development activities relating to NVX-CoV2373 for services performed under the U.S. government and Coalition for Epidemic Preparedness Innovations agreements.

Research and development expenses increased to $571 million in the second quarter of 2021, compared to $35 million in the same period in 2020. The increase was primarily due to the development of NVX-CoV2373.

General and administrative expenses increased to $73 million in the second quarter of 2021, compared to $18 million for the same period in 2020. The increase was primarily due to increased employee-related costs, stock-based compensation expenses, and professional fees supporting our NVX-CoV2373 program.

As of June 30, 2021, Novavax had $2.1 billion in cash, cash equivalents and restricted cash, compared to $806 million as of December 31, 2020. Net cash provided by operating activities for the first six months of 2021 was $807 million, compared to $93 million for the same period in 2020. The increase in cash provided was primarily due to $1.1 billion in payments under advance purchase agreements recorded as deferred revenue and the timing of payments to third parties.

Through utilization of At-the-Market (ATM) offerings during the first six months of 2021, Novavax raised net proceeds of $565 million.

Conference Call

Novavax will host its quarterly conference call today at 4:30 p.m. ET. The dial-in numbers for the conference call are (866) 652-5200 (Domestic) or (412) 317-6060 (International). Participants will be prompted to request to join the Novavax, Inc. call. A replay of the conference call will be available starting at 7:30 p.m. ET on August 5, 2021 until 7:30 p.m. ET on November 12, 2021. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412) 317-0088 (International) and use passcode 10158313.

A webcast of the conference call can also be accessed on the Novavax website at novavax.com/events. A replay of the webcast will be available on the Novavax website until November 12, 2021.

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’ patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that blocked the binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response in Phase 1/2 clinical testing.

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall; and the PREVENT-19 trial in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 55% efficacy overall in HIV-negative participants and 48.6% efficacy against a newly emerging escape variant first described in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

About NanoFlu

NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax’ patented saponin-based Matrix-M adjuvant.

About Matrix-M Adjuvant

Novavax’ patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

On August 5, 2021 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal ("GI") diseases in areas of high unmet need, reported financial results for the second quarter ended June 30, 2021 (Press release, Synthetic Biologics, AUG 5, 2021, View Source [SID1234586031]).

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Recent Developments:

Announced completion of patient dosing and observation in the Phase 1, open label, single-ascending dose ("SAD") clinical trial of SYN-020 intestinal alkaline phosphatase ("IAP")
Continuing enrollment in the Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant ("HCT") recipients
Current cash position of approximately $74.3 million
Current cash runway expected to provide funding to complete Phase 1b/2a clinical trial of SYN-004, clinical trials of SYN-020 through proof-of-concept, and other key milestones into 2023
Anticipated Milestones:

Expect to commence second Phase 1 multiple-ascending dose ("MAD") clinical trial of SYN-020 during Q3 2021; topline data anticipated during Q2 2022
Topline data readout from the first antibiotic cohort of the SYN-004 Phase 1b/2a clinical trial is expected during Q4 2021
"During the second quarter, we remained focused on the advancement of our portfolio of gastrointestinal and microbiome-focused clinical programs," said Steven A. Shallcross, Chief Executive Officer of Synthetic Biologics. "We were pleased to complete patient dosing and observation in the Phase 1 SAD clinical trial of SYN-020 intestinal alkaline phosphatase with preliminary results demonstrating that SYN-020 maintained a favorable safety profile, was well tolerated at all dose levels, and no adverse events were attributed to SYN-020. Looking ahead, we intend to commence a second Phase 1 MAD clinical trial of SYN-020 in healthy adult volunteers during the third quarter of 2021 with topline results expected during the second quarter of 2022. Both the Phase 1 SAD and MAD studies are designed to support the advancement of SYN-020 in multiple potential therapeutic indications, including celiac disease, nonalcoholic fatty liver disease ("NAFLD"), radiation enteritis, and age-related metabolic and inflammatory diseases."

Mr. Shallcross continued, "Patient screening and enrollment in the SYN-004 Phase 1b/2a clinical trial in allogeneic HCT recipients remains ongoing at the Washington University School of Medicine in St. Louis ("Washington University"). At this time, enrollment is proceeding as expected and we anticipate announcing topline results from this first of three antibiotic cohorts during the fourth quarter of 2021. We believe SYN-004 has the potential to significantly improve outcomes for allogeneic HCT recipients by preventing downstream complications often caused by disruption of the gut microbiome by intravenous ("IV") beta-lactam antibiotics following conditioning therapy. We are very excited about the potential for our portfolio of clinical development programs to be long-term value drivers for our Company and look forward to sharing important updates as they become available."

Clinical Development and Operational Update

Announced completion of patient dosing and observation in the Phase 1, open label, single-ascending dose clinical trial of SYN-020
The Phase 1 SAD study enrolled 24 healthy adult volunteers into four cohorts with SYN-020 given orally as single doses ranging from 5 mg to 150 mg.
Analyses of preliminary data demonstrated that SYN-020 maintained a favorable safety profile, was well tolerated at all dose levels, and no adverse events were attributed to the study drug. No serious adverse events were reported.
A second Phase 1 clinical trial evaluating multiple-ascending doses of SYN-020 in healthy volunteers is expected to commence during the third quarter of 2021. Topline data are anticipated during the second quarter of 2022, pandemic conditions permitting.
Both studies are intended to support the development of SYN-020 in multiple potential clinical indications including celiac disease, NAFLD, radiation enteritis, as well as indications supported by the Company’s collaboration with Massachusetts General Hospital.
Enrollment in the Company’s Phase 1b/2a clinical trial of SYN-004 in allogeneic HCT recipients for the prevention of acute graft-versus-host-disease ("aGVHD") remains ongoing
The Phase 1b/2a clinical trial comprises a single center, randomized, double-blind, placebo-controlled clinical trial of oral SYN-004 in up to 36 evaluable adult allogeneic HCT recipients.
The goal of this clinical trial is to evaluate the safety, tolerability, and potential absorption into the systemic circulation (if any) of oral SYN-004 administered to allogeneic HCT recipients who receive an IV beta-lactam antibiotic to treat fever.
Study participants will be enrolled into three sequential cohorts and administered a different study-assigned IV beta-lactam antibiotic. Eight participants in each cohort will receive SYN-004 and four will receive placebo.
Safety and pharmacokinetic data for each cohort will be reviewed by an independent Data and Safety Monitoring Committee ("DSMC"), which will make a recommendation on whether to proceed to the next IV beta-lactam antibiotic.
A topline data readout for the first antibiotic cohort is anticipated during the fourth quarter of 2021, pandemic conditions permitting.
Received notification from the NYSE American that the Company had regained compliance with all of the continued listing standards set forth in Part 10, Section 1003 of the NYSE American Company Guide (the "Company Guide") relating to the Exchange’s continued listing requirements.
Quarter Ended June 30, 2021 Financial Results

General and administrative expenses decreased by 2% to approximately $1.26 million for the three months ended June 30, 2021, from approximately $1.29 million for the three months ended June 30, 2020. This decrease is primarily due to lower legal costs and vacation expense offset by higher insurance costs, audit fees and registration fees. The charge related to stock-based compensation expense was $83,000 for the three months ended June 30, 2021, compared to $67,000 for the three months ended June 30, 2020.

Research and development expenses increased by 21% to approximately $1.9 million for the three months ended June 30, 2021, from approximately $1.6 million for the three months ended June 30, 2020. This increase is primarily the result of increased clinical trial expenses as we began dosing patients in the Phase 1b/2a clinical trial of SYN-004 and Phase 1 SAD clinical trial of SYN-020 during the three months ended June 30, 2021, offset by lower indirect program costs for the three months ended June 30, 2021, including salary and related expense reductions, a decrease in manufacturing costs for SYN-020 and market research. In addition, as a result of the global COVID-19 pandemic, our clinical development partner (Washington University) reduced their operating capacity during 2020 to include only essential activities as part of their pandemic response, which delayed the start of our clinical trial until 2021. We anticipate research and development expense to increase as our ongoing clinical trials continue to enroll patients. The charge related to stock-based compensation expense was $19,000 for the three months ended June 30, 2021, compared to $19,000 related to stock-based compensation expense for the three months ended June 30, 2020.

Other income was $2,000 for the three months ended June 30, 2021, compared to other income of $6,000 for the three months ended June 30, 2020. Other income for the three months ended June 30, 2021 and 2020 is primarily comprised of interest income.

Cash and cash equivalents as of June 30, 2021 totaled $74.3 million, an increase of $68.1 million from December 31, 2020.

Conference Call

Synthetic Biologics will hold a conference call today, Thursday, August 5, 2021, at 4:30 p.m. (EST). The dial-in information for the call is as follows, U.S. toll free: 1-888-347-5280 or International: +1 412-902-4280. Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at View Source." target="_blank" title="View Source." rel="nofollow">View Source An archive of the call will be available for replay at the same URL, View Source , for 90 days after the call.

On August 5, 2021 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) ("Aurinia" or the "Company") reported its financial results for the second quarter ended June 30, 2021 (Press release, Aurinia Pharmaceuticals, AUG 5, 2021, View Source [SID1234586047]). Amounts, unless specified otherwise, are expressed in U.S. dollars.

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"Aurinia continues to make progress toward transforming the treatment of lupus nephritis (LN) by improving access to treatment and providing disease education and care for the long underserved LN patient community," said Peter Greenleaf, President and Chief Executive Officer of Aurinia. "Our second quarter results demonstrate our momentum as COVID-related restrictions are loosened in parts of the United States with a significant increase in both revenue and patient start forms. We are confident that with this year-to-date performance and a strong balance sheet, that we are well-poised for growth as we continue our work to expand the treatment of LN and seek new opportunities that could address the needs of patients with serious autoimmune disorders."

Mr. Greenleaf further stated, "As we continue to expand patient access to LUPKYNIS across the United States, we anticipate that annual net revenue for LUPKYNIS will be in the range of $40 to $50 million for 2021, setting Aurinia up for a very strong 2022 as we recognize the benefit of patients continuing on therapy and hopefully achieving reductions in their proteinuria."

Recent Highlights

Second Quarter 2021 U.S. Commercial Activities

415 PSFs during the second quarter with over 800 PSFs received year-to-date;
As of June 30, 2021, a total of 45 LUPKYNIS-specific policies had been published by insurers representing approximately 110 million covered lives in the U.S.; and
Converted over 50% of PSFs to patients on therapy by the end of the second quarter.
Recent Operational Developments

On May 10, 2021, The Lancet, an international, peer-reviewed medical journal, published the results of the Company’s Phase 3 AURORA-1 study evaluating LUPKYNIS (voclosporin) in adults with LN.
On May 20, 2021, the Company announced that the interim analysis of the AURORA-2 continuation study showed that subjects in the LUPKYNIS treatment arm sustained meaningful reductions in proteinuria, with no change in mean estimated glomerular filtration rate (eGFR) at 104 weeks of treatment.
Effective June 14, 2021, the Company appointed Dr. Brinda Balakrishnan, M.D., Ph.D., to the Company’s Board of Directors. Dr. Balakrishnan is Group Vice President, Corporate and Business Development of BioMarin Pharmaceutical Inc.
On June 25, 2021, Aurinia’s licensing partner, Otsuka Pharmaceutical Co., Ltd., filed an initial marketing authorization application (MAA) with the European Medicines Agency (EMA) seeking approval for the use of voclosporin for the treatment of adult patients with active LN in the European Union, as well as Norway, Iceland and Liechtenstein. Upon approval the Company would be eligible for up to an additional $30 million in approval related milestones, low double-digit royalties on sales, and additional revenues for the supply of product to Otsuka under a cost-plus arrangement.
Upcoming Milestones

Aurinia anticipates reporting top-line results from the ongoing AURORA-2 two-year continuation study of voclosporin for the treatment of LN by the end of 2021.
Financial Liquidity at June 30, 2021

As of June 30, 2021, Aurinia had cash and cash equivalents and investments of $323.7 million compared to $422.7 million at December 31, 2020. The decrease was primarily related to the commercial infrastructure spend to support the launch of LUPKYNIS, payments for inventory and an upfront payment made as part of a collaborative agreement with Lonza to build a dedicated manufacturing capability (or monoplant).

Net cash used in operating activities was $91.5 million for the six months ended June 30, 2021 compared to $44.6 million for the six months ended June 30, 2020. The increase was primarily due to the commercial infrastructure spend to support the launch of LUPKYNIS, payments for inventory and a one-time payment to a related party upon achievement of specific milestones. In the prior year, the Company was still in the development phase of LUPKYNIS and as a result, did not incur any material related selling expenses.

The Company believes that it has sufficient financial resources to fund its current plans, which include funding commercial activities, including FDA related post approval commitments, manufacturing and packaging of commercial drug supply, conducting planned research and development (R&D) programs, and operating activities into at least 2023.

Financial Results for the Quarter Ended June 30, 2021

For the quarter ended June 30, 2021, Aurinia recorded a net loss of $47.0 million or $0.37 net loss per common share, as compared to a net loss of $26.5 million or $0.24 net loss per common share for the quarter ended June 30, 2020. For the six months ended June 30, 2021, Aurinia recorded a net loss of $97.4 million or $0.76 net loss per common share as compared to a net loss of $52.5 million or $0.47 net loss per common share.

Total revenue was $6.6 million and $29 thousand for the quarters ended June 30, 2021 and June 30, 2020, respectively. Total revenue was $7.5 million and $59 thousand for the six months ended June 30, 2021 and June 30, 2020, respectively. The increase for both periods was primarily the result of the commercial sales of LUPKYNIS following FDA approval in January 2021.

Cost of sales were $308 thousand and nil for the quarters ended June 30, 2021 and June 30, 2020, respectively. Cost of sales were $356 thousand and nil for the six months ended June 30, 2021 and June 30, 2020, respectively. The increase for both periods was primarily the result of commercial sales of LUPKYNIS. Gross margin for the three and six months ended June 30, 2021 was approximately 95%.

Selling, general and administrative (SG&A) expenses were $43.8 million and $15.4 million for the quarters ended June 30, 2021 and June 30, 2020, respectively. For the six months ended June 30, 2021 and June 30, 2020, SG&A expenses were $83.1 million and $26.5 million, respectively. The increase for both periods was primarily due to the expansion of the commercial infrastructure, administrative functions and patient assistance programs to support the launch of LUPKYNIS. SG&A share-based compensation expense for the three and six months ended June 30, 2021 was $6.5 million and $13.2 million, respectively.

R&D expenses were $10.1 million and $11.1 million for the quarters ended June 30, 2021 and June 30, 2020, respectively. For the six months ended June 30, 2021 and June 30, 2020, R&D expenses were $19.9 million and $24.9 million, respectively. The decrease for both periods was primarily due to lower contract research organization expenses and other third-party clinical trial expenses following the approval of LUPKYNIS, including a reduction in new drug application preparation costs, capitalization of supply costs following approval, and termination of the dry eye trial during the fourth quarter of 2020. R&D share-based compensation expense for the three and six months ended June 30, 2021 was $1.1 million and $2.2 million, respectively.

This press release is intended to be read in conjunction with the Company’s unaudited condensed consolidated financial statements and Management’s Discussion and Analysis for the quarter ended June 30, 2021 in the Company’s Quarterly Report on Form 10-Q, which is accessible on Aurinia’s website at www.auriniapharma.com, on SEDAR at www.sedar.com or on EDGAR at www.sec.gov/edgar.

Conference Call Details

Aurinia will host a conference call and webcast to discuss the quarter ended June 30, 2021 financial results today, Thursday, August 5, 2021 at 4:30 p.m. EDT. The audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. In order to participate in the conference call, please dial +1-877-407-9170 (Toll-free U.S. & Canada). An audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.

About Lupus Nephritis

LN is a serious progression of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals have already developed LN at the time of SLE diagnosis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure. Black and Asian individuals with SLE are four times more likely to develop LN and individuals with Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

On August 5, 2021 BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio or the Company), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, reported its financial results for the second quarter ended June 30, 2021 and provided an update on the Company’s operations (Press release, BridgeBio, AUG 5, 2021, View Source [SID1234585797]).

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"We measure success by the number of meaningful medicines we are able to develop and deliver to patients. By that metric, our most significant accomplishment of the quarter was the approval of TRUSELTIQ (infigratinib) for patients with cholangiocarcinoma – our second FDA approval as a company and our first for a cancer treatment. All drug approvals are a team effort that extends far beyond BridgeBio. We thank the patient community, physicians, scientists and advocates for their commitment and drive. They made this approval possible," said BridgeBio founder and CEO Neil Kumar, Ph.D.

Major milestones anticipated in the next 12 months for BridgeBio’s four core value drivers:

Acoramidis (AG10) – Transthyretin (TTR) stabilizer for transthyretin amyloid cardiomyopathy (ATTR-CM): Topline results from Part A of the ATTRibute-CM trial are expected in late 2021 and from Part B in 2023. The primary endpoint at Part A is the change from baseline in a 6-minute walk distance (6MWD) in trial participants receiving acoramidis or placebo after 12 months. In a previous Phase 3 study in ATTR-CM patients, participants receiving the current standard of care treatment demonstrated a decline in 6MWD of approximately 25 meters (m) from an average baseline of 351m at 12 months.1 From a comparable average 6MWD baseline in the ATTRibute-CM study, the Company is seeking to more potently halt the observed decline in acoramidis-treated participants. As a reminder, healthy elderly adults typically decline only 7m in 12 months.2 If the change from baseline in 6MWD in Part A is highly statistically significant (p < 0.01), BridgeBio expects to submit an application for regulatory approval of acoramidis in 2022 to the FDA.
Encaleret – Calcium-sensing receptor (CaSR) inhibitor for ADH1: Received Fast Track designation from the FDA. Early results from an ongoing Phase 2 proof-of-concept study shared at the Endocrine Society’s 2021 Annual Meeting (ENDO) in March 2021 showed normalization of blood calcium and urine calcium in 6 of 6 (100%) ADH1 participants. Additional data from the ongoing study are expected in the second half of 2021. If the development program is successful, encaleret could be the first approved therapy for ADH1, a condition caused by gain of function variants in the CaSR gene estimated to be carried by 12,000 individuals in the United States alone.
Low-dose infigratinib – FGFR1-3 inhibitor for achondroplasia: Initial data from the ongoing Phase 2 dose ranging study are expected in the first half of 2022. Achondroplasia is the most common form of genetic short stature and one of the most common genetic diseases, with a prevalence of greater than 55,000 cases in the United States and European Union. Low-dose infigratinib is the only known product candidate in clinical development for achondroplasia that is designed to target the disease at its genetic source and the only orally administered product candidate in clinical-stage development.
BBP-631 – AAV5 gene therapy candidate for congenital adrenal hyperplasia (CAH): Received Fast Track designation from the FDA in May 2021. Investigational New Drug (IND) application cleared by the FDA and site activation for initiation of a first-in-human Phase 1/2 study is ongoing, with initial data anticipated in mid-2022. CAH is one of the most prevalent genetic diseases potentially addressable with AAV gene therapy, with more than 75,000 cases estimated in the United States and European Union. The disease is caused by deleterious mutations in the gene encoding an enzyme called 21-hydroxylase, leading to lack of endogenous cortisol production. BridgeBio’s AAV5 gene therapy candidate is designed to provide a functional copy of the 21-hydroxylase-encoding gene (CYP21A2) and potentially address many aspects of the disease course.
Recent pipeline progress and corporate updates:

FDA approval received for TRUSELTIQ (infigratinib) under the accelerated approval program for the treatment of patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (CCA) with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement as detected by an FDA-approved test. TRUSELTIQ is an orally administered, ATP-competitive, tyrosine kinase inhibitor of FGFR. In the pivotal trial of patients with advanced, unresectable CCA, an aggressive malignancy with poor prognosis, TRUSELTIQ led to cases of tumor shrinkage. BridgeBio is eligible to receive upfront, regulatory and commercial milestone payments totaling up to approximately $2.45 billion USD through its strategic collaboration with Helsinn Group to co-develop and commercialize infigratinib in certain oncology indications.
Fast Track designation received from the FDA for BBP-812, BridgeBio’s AAV9 gene therapy candidate for Canavan disease. IND cleared by the FDA and site activation for initiation of a first-in-human Phase 1/2 study is ongoing. Canavan disease is an extremely rare genetic condition starting in infancy with an incidence of approximately one in 100,000 births worldwide.
Fast Track designation received from the FDA for infigratinib, an FGFR inhibitor, for the treatment of urothelial carcinoma (urinary tract and bladder cancer).
New Drug Application (NDA) acceptance from the Israeli Ministry of Health for NULIBRY (fosdenopterin) for injection to treat patients with molybdenum cofactor deficiency (MoCD) Type A. The FDA approved NULIBRY as the first therapy to reduce the risk of mortality in patients with MoCD Type A in February 2021. MoCD Type A is an ultra-rare, life-threatening genetic disorder that progresses rapidly, results in severe and largely irreversible neurological injury, and has a high infant mortality rate.
First-in-human Phase 1 trial of BBP-711, a glycolate oxidase (GO) inhibitor to treat patients with hyperoxaluria, initiated in May 2021.
Research collaborations initiated with MUSC Foundation for Research Development, Stanford University and the University of Pittsburgh to identify and advance therapies for genetic diseases and cancers for a total of 23 partnerships among BridgeBio and leading academic and research institutions to date.
Non-exclusive, co-funded clinical collaboration initiated with Bristol Myers Squibb to study BBP-398, a potentially best-in-class SHP2 inhibitor, in combination with OPDIVO (nivolumab) in patients with advanced solid tumors with KRAS mutations.
BridgeBio Pharma R&D Day: BridgeBio will hold a virtual R&D Day on Tuesday, October 12, 2021, from 8:30 am ET – 11:30 am ET. The event will be webcast and registration information can be found here.
Second Quarter 2021 Financial Results:

Cash, Cash Equivalents and Marketable Securities

Cash, cash equivalents and marketable securities, excluding restricted cash, totaled $898.4 million as of June 30, 2021, compared to $607.1 million as of December 31, 2020. The net increase in balance of $291.3 million is attributed to $731.4 million in net proceeds received from the issuance of our 2.25% Convertible Senior Notes due 2029 (the 2029 Notes) in January 2021 and $30.2 million in upfront payment and reimbursements received in connection with our License and Collaboration Agreement with Helsinn Healthcare S.A. and Helsinn Therapeutics (U.S.), Inc. (collectively, Helsinn) , which became effective in April 2021, and $25.0 million in net proceeds from our Amended Loan and Security Agreement with Hercules Capital, Inc. in April 2021 (the Amended Hercules Term Loan). The cash receipts were partially offset by a $61.3 million payment related to capped call options and a $50.0 million payment to repurchase shares of BridgeBio common stock, both in relation to the issuance of our 2029 Notes. In connection with our acquisition of Eidos Therapeutics, Inc. (Eidos) in January 2021, we paid $63.6 million in direct transaction costs and $21.3 million to Eidos stockholders who elected cash settlement. The remaining change of $299.1 million primarily related to payments of interest and operating costs and expenses.

Cash, cash equivalents and marketable securities, excluding restricted cash, decreased by $102.9 million compared to our balance as of March 31, 2021, which was $1,001.3 million. The decrease in cash is mainly due to cash used primarily related to our operating costs and expenses and partially offset by the payments received from Helsinn and proceeds from the Amended Hercules Term Loan as also discussed above.

Revenues

Total revenues for the three and six months ended June 30, 2021 were $54.0 million and $54.5 million, respectively. Our revenues mainly include upfront and milestone payments arising from the License and Collaboration Agreement with Helsinn and the License Agreement between our affiliate Navire Pharma, Inc. and LianBio.

Operating Costs and Expenses

Operating costs and expenses for the three and six months ended June 30, 2021 were $148.0 million and $316.0 million, respectively, as compared to $124.6 million and $227.1 million for the same periods in the prior year. The increases in operating costs and expenses of $23.4 million and $88.9 million, respectively, during the periods were attributable to the increase in personnel costs resulting from an increase in the number of employees to support the progression in our research and development programs, including our increasing research pipelines, as well as an increase in stock-based compensation related to the achievement of various performance-based milestone compensation arrangements tied to regulatory and development milestones. Stock-based compensation for the three and six months ended June 30, 2021 was $32.0 million and $66.9 million, respectively, as compared to $18.4 million and $28.6 million for the same periods in the prior year. Amounts for the three and six months ended June 30, 2021 reflect the reduction in operating costs and expenses arising from cost sharing recognized under our License and Collaboration Agreement with Helsinn.

Our research and development expenses have not been significantly impacted by the global COVID-19 pandemic for the periods presented. While we experienced some delays in certain of our clinical enrollment and trial commencement activities, we continue to adapt in this unprecedented time to enable alternative site, telehealth and home visits, at-home drug delivery, as well as mitigation strategies with our contract manufacturing organizations. The longer-term impact, if any, of COVID-19 on our operating costs and expenses is currently unknown.