On August 10, 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 second quarter ended June 30, 2020 (Press release, Calithera Biosciences, AUG 10, 2020, View Source [SID1234563325]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continued our positive momentum from 2019 into the first half of 2020, further strengthening our cash position and advancing our key clinical development programs," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "Recently, we announced the initiation of the first clinical trial to evaluate our novel arginase inhibitor in cystic fibrosis, and we have also made significant progress toward 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. We look forward to top-line results from our pivotal CANTATA trial in renal cell carcinoma in late fourth quarter of 2020 or early first quarter 2021."

Second Quarter 2020 and Other Recent Program Highlights

CANTATA randomized trial of telaglenastat and cabozantinib in advanced renal cell carcinoma (RCC). The pivotal 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 CANTATA trial enrolled 444 patients at multiple centers globally. The primary endpoint is progression-free survival (PFS). In light of delays associated with COVID-19, and pending further developments in the ongoing pandemic, 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 in non-small cell lung cancer (NSCLC) patients with a KEAP1 or NRF2 genetic mutation. Mutations in the KEAP1/NRF2 pathway, which occur in an estimated 20 percent of NSCLC patients, are associated with aggressive tumor growth. Recently presented clinical data demonstrate that activation of this pathway, either through the loss of KEAP1 function or activation of NRF2, are associated with poor clinical outcomes among patients with NSCLC receiving front-line standard-of-care chemoimmunotherapy. Pre-clinical models have shown that activation of the KEAP1/NRF2 pathway makes tumors dependent on glutaminase activity for growth and survival, making these tumors exquisitely sensitive to inhibition of glutaminase activity by telaglenastat. The double-blind telaglenastat trial, which is open for enrollment, 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 these standard-of-care chemoimmunotherapies. Given the previously reported challenges associated with opening new clinical studies during the current stage of the COVID-19 pandemic, Calithera expects to enroll the first patient in the third quarter of 2020, pending further developments in the COVID-19 situation. Calithera plans to present interim data from this trial in 2021.

Pfizer clinical collaboration with the CDK4/6 inhibitor IBRANCE, and the dual-mechanism poly (ADP-ribose) polymerase (PARP) inhibitor TALZENNA, each in combination with telaglenastat. In March 2019, Calithera initiated a Phase 1/2 trial of the combination of telaglenastat plus Talzenna in patients with solid tumors including expansion cohorts in RCC and triple-negative breast cancer. Dose escalation has been successfully completed. Following preliminary dose expansion, the company is no longer developing this combination. In July 2019, the company 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. Dose escalation has been completed and dose expansion cohorts are enrolling following a temporary pause due to the COVID-19 situation.

CB-280 arginase inhibitor program. In July 2020, Calithera initiated a Phase 1b clinical trial in adult patients with cystic fibrosis and chronic airway infection. The randomized, double blind, placebo-controlled, dose escalation trial will evaluate multiple ascending doses of CB-280, dosed orally twice daily for 14 days, compared to placebo in up to 32 adult CF patients to determine a safe dose range for CB-280. The study follows the completion of a Phase 1 trial that evaluated the safety, tolerability and pharmacokinetic profile of CB-280 in healthy volunteers.

INCB001158 program. 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. INCB001158 is being developed as part of a collaboration and license agreement with Incyte.

Selected Second Quarter 2020 Financial Results

Cash, cash equivalents and investments totaled $154.1 million at June 30, 2020. In April 2020, Calithera completed an underwritten public offering of 5,750,000 shares of common stock, resulting in net proceeds of approximately $33.5 million after deducting underwriting fees and offering expenses.

Research and development expenses were $15.7 million for the three months ended June 30, 2020, compared to $20.9 million for the same period in the prior year. The decrease of $5.3 million was due to a $2.4 million decrease in the telaglenastat program, a $1.9 million decrease in the INCB001158 program and a decrease of $1.2 million for investment in early stage research programs, offset by a $0.2 million increase in the CB-280 program.

General and administrative expenses were $5.1 million for the three months ended June 30, 2020, compared with $4.0 million for the same period in the prior year. The increase of $1.1 million was primarily related to a $0.9 million increase in higher personnel-related and facility costs and $0.2 million higher professional services costs mainly for legal and consulting services.

Interest and other income, net was $0.4 million for the three months ended June 30, 2020, compared to $0.8 million for the same period in the prior year.

Net loss for the three months ended June 30, 2020 was $20.4 million, or $0.29 per share.

Conference Call Information

Calithera will host an update conference call today, Monday, August 10, 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 4562868. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days.

On August 10, 2020 Omeros Corporation (Nasdaq: OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers, reported recent highlights and developments as well as financial results for the second quarter ended June 30, 2020, which include (Press release, Omeros, AUG 10, 2020, View Source [SID1234563324]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

●Revenues for the second quarter of 2020 were $13.5 million, compared to $26.8 million in the second quarter of 2019 and $23.5 million in the first quarter of 2020. The decreases reflect the impact of the postponement of cataract procedures by ASCs and hospitals due to COVID-19. Cataract surgery resumed beginning in the second half of May 2020, and by the end of June 2020, the run rate of weekly OMIDRIA sales approximated levels seen prior to the pandemic.

●Net loss in the second quarter of 2020 was $33.3 million, or $0.61 per share. This compares to a net loss of $14.5 million, or $0.29 per share, in the second quarter of 2019. Net loss in the second quarter of 2020 included non-cash expenses of $6.9 million, or $0.13 per share.

●Six COVID-19 patients in Italy with acute respiratory distress syndrome (ARDS) were treated with narsoplimab under a compassionate use program. All patients, who initially required mechanical ventilation, recovered, survived and were discharged from the hospital. Narsoplimab treatment was associated with rapid and sustained improvement across all assessed markers of endothelial/cellular damage and/or inflammation.

●Omeros completed submission to FDA of the chemistry, manufacturing and controls (CMC) information for the Company’s rolling Biologic License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

●Omeros submitted a clinical trial application to European regulators and an investigational new drug application to the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for OMS906, the company’s MASP-3 inhibitor.

"The data from COVID-19 patients treated with narsoplimab clearly support the growing body of scientific literature pointing to the central role of MASP-2 and the lectin pathway in COVID-19-related lung injury," said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. "Narsoplimab represents the first time that a lectin pathway inhibitor has been used to treat COVID-19 and, in addition to complement inhibition, brings what appears to be a unique benefit – anticoagulant effects, which may also prove to be very important in the treatment of this disease and other endothelial injury syndromes. Discussions with U.S. government agencies are underway with the objective of expanding the availability of narsoplimab to COVID-19 patients. We are also rapidly advancing toward regulatory approval for narsoplimab in the treatment of transplant-associated TMA. We have recently completed submission of the remaining CMC portion of our rolling BLA. We are targeting this quarter for the completion of the BLA, and preparations for anticipated commercial launch are proceeding well. We also reached a key milestone in our OMS906 program, with the on-schedule submission of the clinical trial application. In addition, we filed an IND to FDA to increase the likelihood of initiating enrollment next month. I am immensely proud of our team – they’ve continued to adapt to the challenges imposed by COVID-19, advancing our clinical and development programs and improving the lives of patients."

Second Quarter and Recent Developments

●In response to a request from physicians in Bergamo, Italy, Omeros implemented a compassionate use program for narsoplimab to treat six COVID-19 patients with ARDS requiring continuous positive airway pressure (CPAP) or intubation prior to treatment. All narsoplimab-treated patients recovered and survived. Narsoplimab was associated with rapid and sustained reduction of circulating endothelial cell counts and concurrent reduction of serum levels of IL-6, IL-8, LDH, D-dimer and AST. Narsoplimab was well tolerated and no adverse drug reactions were reported. A retrospective comparison of two control groups with similar entry criteria and baseline characteristics showed significantly higher mortality rates, at 32 percent and 53 percent, than the narsoplimab-treated group. A manuscript detailing the results of the study has been accepted for publication in the peer-reviewed journal Immunobiology.

Endothelial damage, which can play an early and central pathogenic role in ARDS and thrombosis, activates the lectin pathway of complement. Mannan-binding lectin-associated serine protease-2 (MASP-2), the lectin pathway’s effector enzyme and the target for narsoplimab, binds the nucleocapsid protein of severe acute respiratory syndrome-associated coronavirus-2 (SARS-CoV-2) – the virus responsible for COVID-19 – resulting in complement activation and lung injury.

Discussions are progressing between Omeros and offices in the Department of Health and Human Services, including the Biomedical Advanced Research and Development Authority (BARDA), along with the National Institutes of Health Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program regarding potential funding to accelerate large-scale manufacturing to enable broader availability of narsoplimab for COVID-19 patients and for other COVID-19-related programmatic activities.

●Recent developments regarding narsoplimab, Omeros’ lead human monoclonal antibody targeting MASP-2 in Phase 3 clinical programs for the treatment of HSCT-TMA, Immunoglobulin A (IgA) nephropathy, and atypical hemolytic uremic syndrome (aHUS), include the following:

oIn preparation for the anticipated commercial launch of narsoplimab, Omeros is working closely with the transplant community, patient advocacy groups and payers.

oResuts from the pivotal trial of narsoplimab in the treatment of HSCT-TMA will be presented at the virtual annual meeting of the European Society of Bone Marrow Transplant (EBMT) in August by Dr. Rafael Duarte, chair of the 2020 EBMT meeting.

oProfessor Alessandro Rambaldi of the University of Milan and the Director of the Department of Hematology and Oncology at the Papa Giovanni XXIII Hospital presented results from the HSCT-TMA pivotal trial at the 25th Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in June.

oAn article authored by a group from the University of Leicester led by Dr. Jonathan Barratt PhD, FCRP, Professor of Renal Medicine, has been published in the peer-reviewed journal Drugs of the Future. The manuscript describes the beneficial effects of narsoplimab in IgA vasculitis-associated nephritis, a rapidly progressive glomerulonephritis.

oAn article titled "Inhibition of the lectin pathway of the complement system as a novel approach in the management of IgA vasculitis associated nephritis" was published in Nephron.

oA manuscript presenting Omeros’ IgA nephropathy Phase 2 clinical data and authored by the company’s IgA nephropathy Academic Leadership Committee, which is comprised of international thought leaders in IgA nephropathy, has been accepted for publication by the peer-reviewed journal Kidney International Reports.

●Recent developments regarding OMIDRIA include the following:

oData from a study demonstrating the effect of OMIDRIA on reducing instances of postoperative cystoid macular edema, breakthrough iritis and pain as well as the need for postoperative topical steroids was presented at the virtual American Society of Cornea and Refractive Surgery Congress in May.

●Updates regarding Omeros’ other development programs and platforms include the following:
oOmeros submitted a clinical trial application in June to European regulators as well as an investigational new drug application to FDA in July to initiate a Phase 1 clinical trial for OMS906, the company’s MASP-3 inhibitor and currently expects to begin enrollment in the Phase 1 trial in September.

Financial Results

For the second quarter of 2020, revenues, all related to sales of OMIDRIA, were $13.5 million, down from $26.8 million for the same period in 2019 and $23.5 million for the first quarter of 2020. The decrease in the current quarter is due to ambulatory centers (ASCs) and hospitals postponing nearly all cataract surgeries from mid-March until mid-May due to the COVID-19 pandemic. Cataract surgeries resumed beginning in the second half of May 2020 and by the end of June 2020, the run rate of weekly OMIDRIA sales approximated levels seen prior to the pandemic.

Total costs and expenses for the first quarter of 2020 were $41.2 million compared to $36.1 million for the same period in 2019. The increase reflects incremental narsoplimab manufacturing costs together with increased costs supporting the preparation of our rolling BLA for HSCT-TMA in the U.S. Selling, general and administrative expenses were $16.9 million for both the second quarter of 2020 and the corresponding period in 2019.
For the three months ended June 30, 2020, Omeros reported a net loss of $33.3 million, or $0.61 per share, compared to a net loss of $14.5 million, or $0.29 per share, for the same period in 2019. Net loss in the second quarter of 2020 included non-cash expenses of $6.9 million, or $0.13 per share, while net loss in the second quarter of 2019 included non-cash expenses of $6.3 million, or $0.13 per share.

As of June 30, 2020, Omeros had $16.1 million of cash, cash equivalents and short-term investments available for operations and accounts receivable of $15.8 million.

On August 10, 2020 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported financial results and business highlights for the second quarter of 2020 (Press release, CASI Pharmaceuticals, AUG 10, 2020, View Source [SID1234563323]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "One of the positive developments with respect to EVOMELA this quarter was the successful transition to a new manufacturer for the commercial supply in China. This was a key accomplishment as we expect it to significantly reduce our cost of revenue. Despite the impact of COVID19 and manufacturer change in the second quarter, we expect EVOMELA revenue to reach at least $10 million for the full year 2020. We also expect significant improvement in our margins for EVOMELA for the second half of 2020."

Dr. He continued, "The current Phase 1 trials for CNCT19, a CD19 CAR-T therapy, conducted by our development partner, Juventas, are well underway. Juventas expects to complete trials in B-NHL and B-ALL and initiate registration trials in the first quarter 2021, followed by NDA filing in China in early 2022. As Juventas’ exclusive commercial partner, we expect that with a locally developed and manufactured CD19 CAR-T, we will be able to offer a much lower price point than imported therapies and thus be able to make this important cell-based therapy available to significantly more patients in China."

"With regard to CID-103, our anti-CD38 monoclonal antibody, we recently submitted our IMPD application with MHRA, the British health authority, to initiate our Phase 1 clinical study in the UK. Clinical centers in the EU continue to be impacted by COVID-19; however, we expect to initiate our study in the first quarter 2021 assuming the centers open back up for clinical trial activities."

"And finally, we were pleased to report our recent closing of an underwritten public offering for gross proceeds of $43.7 million. This successful financing attracted a number of new, fundamentally-driven, long-term oriented, healthcare-dedicated investors to the CASI story, as well as continued investment by our management. We look forward to continuing to expand our U.S. investor base, and importantly, positioning CASI to accelerate long-term value creation for our shareholders."

Second Quarter 2020 Financial Results

·Revenues consisted primarily of product sales of EVOMELA that launched in August of 2019. Revenues were $2.7 million for the three months ended June 30, 2020. The decrease in the second quarter revenue figures, compared to those in the first quarter was primarily due to a manufacturer change and the effects caused by the global COVID-19 pandemic. We have since received shipment of EVOMELA from the new, lower-cost supplier and expect the product to be released into our distribution chain this month. We expect our revenue from EVOMELA will resume its original projected course in the second half of 2020.

·Costs of revenues were $2.5 million for the quarter ended June 30, 2020. Costs of revenues have been impacted by a previous supply arrangement which has since been replaced by a current lower-cost supplier. We expect that the unit cost of inventories of EVOMELA will be considerably lower in the second half of 2020.

Research and development expenses for the second quarter ended June 30, 2020 were $1.9 million, compared with $3.0 million for the same period in 2019. The decrease in R&D expenses is primarily due to reduced regulatory costs associated with our ANDAs and lower costs associated with preclinical development activities, offset by an increase in R&D expenses incurred related to the development of CID-103.

· General and administrative expenses for the second quarter of 2020 were $4.1 million, compared with $7.0 million for the same period in 2019. The decrease in G&A expenses was primarily because the 2019 period included costs related to sales and marketing efforts to prepare for the August 2019 launch of EVOMELA, as well as lower professional fees and travel costs incurred during the 2020 period.

·Selling and marketing expenses for the second quarter 2020 were $1.6 million. The increase is due to selling costs related to commercial sales of EVOMELA that began in August of 2019.

·Acquired in-process R&D expenses for the three months ended June 30, 2020 were $0 million, compared with $5.8 million for the same period in 2019, relating to the acquisition of the Black Belt license in April 2019.

·Net loss for the second quarter of 2020 was $8.5 million compared to $15.3 million for the same period in 2019.

·As of June 30, 2020, the Company had cash and cash equivalents of $44.9 million compared to $53.9 million as of March 31, 2020. As reported, the Company consummated an underwritten public offering in July 2020 generating gross proceeds of approximately $43.7 million.

Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, can be found at www.casipharmaceuticals.com.

Conference Call

The Company will host a conference call reviewing the second quarter highlights today at 4:30 p.m. ET. The conference call can be accessed by dialing (833) 647-4459 (U.S.), (800) 870-0181 (China), (400) 682-8629 (China, domestic), 800933597 (Hong Kong) to listen to the live conference call. The conference ID number for the live call is 5223239. Participants dialing in via International Toll-Free Service (ITFS) numbers will be required to provide the following passcode to join the conference call: 8336474459, 6025859887.

This call will be recorded and available for replay by dialing (800) 585-8367 (U.S.) or (404)-537-3406 (international) and enter 5223239 to access the replay.

On August 10, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported financial results for the second quarter ended June 30, 2020 and provided an update on its recent corporate activities and outlook (Press release, Halozyme, AUG 10, 2020, View Source [SID1234563322]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The second quarter marked the achievement of multiple key milestones for Halozyme including two FDA approvals and one EMA approval for partnered drugs bringing the total number of FDA-approved products utilizing our ENHANZE drug delivery technology to five," said Dr. Helen Torley, president and chief executive officer. "In addition, we are delighted to report that in the second quarter we delivered our first profitable quarter of expected sustainable profitability with earnings per share of $0.19. We see this as an important first step in our transformation to a high growth, high margin business delivering sustainable revenue growth and profitability over the long term. The events of the quarter were highlighted by our partner Janssen receiving approvals in both the U.S. and the EU for the subcutaneous form of DARZALEX utilizing ENHANZE, which is branded as DARZALEX FASPROTM in the U.S. We earned $25 million in total milestone payments from Janssen during the quarter, upon the first commercial sales in both markets. In late June, our partner Roche received FDA approval for Phesgo, a fixed-dose combination of two monoclonal antibodies, Perjeta and Herceptin, utilizing our ENHANZE technology for the treatment of patients with HER2-positive breast cancer. In addition to providing important new treatment options for patients, each of these newly-approved drugs represents the subcutaneous form of a growing, blockbuster franchise, and we expect their adoption to be an important driver of our growth and profitability in the coming years."

"I want to again express my gratitude to the Halozyme team, our partners and suppliers for their tireless work as we all navigate challenges posed by the COVID-19 pandemic," continued Dr. Torley. "Based on the latest information from our partners, I am pleased to report that we are maintaining our financial outlook for the full year 2020. It is possible that our partners’ timelines may change as a result of future changes related to COVID-19. We will continue to monitor this closely and provide updates as appropriate."

Second Quarter 2020 and Recent Highlights Include:

On June 29, the Company announced that Roche received FDA approval for Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf), a fixed-dose combination of Perjeta and Herceptin for subcutaneous injection utilizing ENHANZE technology for the treatment of patients with HER2-positive breast cancer. Phesgo can be administered in approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose. This is compared to approximately 150 minutes for a sequential infusion of a loading dose of Perjeta and Herceptin using the standard intravenous (IV) formulations, and between 60-150 minutes for subsequent maintenance infusions of the two medicines. Phesgo can be administered by a healthcare professional in a treatment center or at a patient’s home.
On June 13, the Company announced that findings from Janssen’s phase 3 ANDROMEDA (AMY3001) study evaluating subcutaneous daratumumab utilizing ENHANZE in light-chain Amyloidosis were presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 25th Annual Congress. Janssen reported that the study met the primary endpoint of percentage of patients with hematologic complete response.
On June 4, the Company announced that Janssen received European marketing authorization for the subcutaneous formulation of DARZALEX (daratumumab) utilizing ENHANZE for the treatment of adult patients with multiple myeloma in all currently approved DARZALEX intravenous (IV) formulation indications in frontline and relapsed / refractory settings. Subsequent launch of the product and first commercial sale in Europe resulted in a $10 million milestone payment in the quarter.
In June 2020, Bristol Myers Squibb initiated a Phase 1/2 study of ipilimumab in combination with nivolumab in multiple tumor types utilizing ENHANZE technology.
On May 1, the Company announced that Janssen received U.S. FDA approval of DARZALEX FASPROTM (daratumumab hyaluronidase human- fihj) in four regimens across five indications in multiple myeloma patients, including newly diagnosed, transplant-ineligible patients as well as relapsed or refractory patients. As a fixed-dose formulation, DARZALEX FASPROTM can be administered subcutaneously over three to five minutes, significantly less time than IV DARZALEX, which requires multi-hour infusions. Subsequent launch of the product and first commercial sale resulted in a $15 million milestone in the quarter.
Second Quarter 2020 Financial Highlights

Revenue for the second quarter was $55.2 million compared to $39.1 million for the second quarter of 2019. The year-over-year increase was primarily driven by $32.3 million in collaboration payments from Janssen and Bristol Myers Squibb in the current period. Revenue for the quarter included $15.8 million in royalties, which compared to $18.1 million in the prior year period.
Research and development expenses for the second quarter were $9.0 million, compared to $33.9 million for the second quarter of 2019. The decrease in expenses was due to a decrease in clinical trial activities-related costs as a result of the Company halting its oncology drug development efforts in November 2019.
Selling, general and administrative expenses for the second quarter were $11.0 million, compared to $17.3 million for the second quarter of 2019. The decrease was due to lower compensation and commercial-related expenses related to the corporate restructuring announced in November 2019.
The Company reported the first quarter of what it expects will be sustainable profitability. Net income for the second quarter was $25.8 million, or $0.19 per share, compared to a net loss in the second quarter of 2019 of $14.6 million, or $0.10 per share.
Cash, cash equivalents and marketable securities were $385.4 million at June 30, 2020, compared to $421.3 million at December 31, 2019.
Financial Outlook for 2020

The Company continues to monitor the impact of the COVID-19 pandemic on its business and receives updates from its partners and suppliers on how their businesses are affected. Based on this information and Halozyme’s planned expenditures for the year, the Company’s 2020 financial guidance remains unchanged. For 2020 Halozyme continues to expect:

Revenues of $230 million to $245 million, representing growth of 17% to 25%;
Earnings per share on a GAAP basis of $0.60 to $0.75.
The Company remains committed to capital return and plans to repurchase an additional number of shares, up to an additional $96 million worth, during the remainder of 2020. The amount and timing of shares repurchased during 2020 will be subject to a variety of factors including market conditions, other business considerations and applicable legal requirements.

Webcast and Conference Call

Halozyme will webcast its Quarterly Update Conference Call for the second quarter of 2020 today, Monday, August 10, 2020 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme’s corporate website and a replay will be available following the close of the call. To register for this conference call, please use this link: View Source To access the webcast and additional documents related to the call, please visit halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. A telephone replay will be available for two weeks after the call by dialing (800) 585-8367 (domestic callers) or (416) 621-4642 (international callers) using replay ID number 6277618.

On August 10, 2020 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported corporate updates and financial results for the second quarter and six months ended June 30, 2020 (Press release, CymaBay Therapeutics, AUG 10, 2020, View Source [SID1234563321]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Specifically, in the second quarter and through early August 2020, CymaBay achieved significant progress in its ongoing efforts to review its strategic options, one of which included completing a scientific investigation and working with the FDA to lift the clinical holds on the seladelpar INDs in nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC), the three liver diseases in which CymaBay had terminated clinical studies late last year.

Sujal Shah, President and CEO of CymaBay, stated, "We are thrilled with the significant progress made to date in our efforts to conduct a review of strategic options, one of which was to pursue the reinstatement of our seladelpar program. Specifically, in May, we convened a panel of expert liver pathologists and hepatologists that unanimously concluded after a thorough, independent investigation, that there was no clinical, biochemical, or histological evidence of seladelpar-induced liver injury for patients enrolled in our Phase 2b NASH study. We discussed the panel’s findings and related information with the FDA and submitted complete responses to the agency, and in July, the FDA notified us that all clinical holds on seladelpar were lifted. In addition to this favorable outcome, we evaluated and announced last week positive topline results from our ENHANCE study of seladelpar in PBC which, despite being terminated early, provided sufficient data which appear to support seladelpar’s efficacy and tolerability in this patient population. After receiving notification from the FDA, and reviewing the latest clinical data from the ENHANCE study, we stopped our review of strategic options having decided to focus on reinstating the clinical development program for seladelpar in PBC and to continue to evaluate seladelpar for other indications. We have also been very successfully at minimizing our operating expenses through the first half of the year and expect our cash to fund our current operating plan into 2022."

Recent Corporate Highlights

In May 2020, a panel of eight of the world’s foremost expert liver pathologists and hepatologists, whose collective experience relevant to CymaBay’s investigation includes drug-induced liver injury, NASH and cholestatic liver diseases, completed a four-day independent review analyzing findings from CymaBay’s NASH Phase 2b study, and the results of independent pathologist’s reviews of the study biopsies, which included a blinded unpaired review and a paired review blinded to chronologic order of the biopsies. The panel unanimously supported lifting the clinical hold for seladelpar and re-initiation of clinical development pending approval by the FDA. In June 2020, CymaBay discussed the data and the panel’s conclusions with the FDA and submitted complete responses to the agency. In July 2020, the FDA lifted clinical holds on seladelpar in all indications with open INDs (NASH, PBC and PSC).

In August 2020, CymaBay announced positive topline results from ENHANCE for seladelpar in patients with PBC. Topline data for patients through 3 and 6 months demonstrated anti-cholestatic, anti-inflammatory, and anti-pruritic activity. Notably, 78.2% of patients on seladelpar 10 mg versus 12.5% on placebo achieved the primary composite outcome after only 3 months (p<0.0001). In addition, 27.3% of patients on seladelpar 10 mg versus zero on placebo experienced normalization of ALP by 3 months (p<0.0001). Treatment with seladelpar 10 mg also resulted in a statistically significant improvement in pruritus (p<0.05) for patients with moderate-to-severe itch versus placebo. Overall, seladelpar appeared to be safe and well-tolerated in this study.

CymaBay intends to reinitiate the long-term study, a Phase 3 study and other NDA-enabling studies to confirm the potential of seladelpar to be a best-in-class treatment for patients with PBC and to further evaluate suitable strategies to advance seladelpar in other indications.

CymaBay held $168.9 million in cash, cash equivalents and short-term investments as of June 30, 2020 and had no outstanding debt. Cash and investments are deemed sufficient to fund CymaBay’s current operating plan into 2022.

Due to the ongoing effects of the global coronavirus pandemic, CymaBay continues to conduct its operations remotely for all employees, which has allowed business activities to continue as seamlessly as possible. To date, these developments have not had a significant impact on CymaBay’s financial condition or its ability to execute its business plan. CymaBay will continue to closely monitor pandemic developments and their associated risks to the business, including plans to restart clinical development of seladelpar, and will continue to take actions available to mitigate them where possible. Further, all CymaBay’s actions will be guided by a commitment to taking all steps possible to ensure the health and safety of its employees as well as patients enrolled in its clinical studies.
Second Quarter and Six Months Ended June 30, 2020 Financial Results

Research and development expenses for the three months ended June 30, 2020 were $7.9 million, compared to $21.1 million for the three months ended June 30, 2019. Research and development expenses for the six months ended June 30, 2020 were $17.5 million, compared to $39.7 million for the six months ended June 30, 2019. Research and development expense in the three and six months of 2020 was significantly lower than the corresponding periods in 2019 primarily due to declining clinical trial activities related to the Phase 3 PBC, Phase 2b NASH, and Phase 2 PSC clinical trials, and other studies, as efforts continued to shut down these studies which were early-terminated as a result of the FDA’s clinical holds that were placed on the seladelpar program in the fourth quarter of 2019.

General and administrative expenses for the three months ended June 30, 2020 were $3.4 million, compared to $4.5 million for the three months ended June 30, 2019. General and administrative expenses for the six months ended June 30, 2020 were $7.7 million, compared to $10.2 million for the six months ended June 30, 2019. General and administrative expenses in the three and six months of 2020 were lower than the corresponding periods in 2019 due to lower employee compensation and other administrative expenses incurred as a result of a December 2019 reduction-in-force and restructuring effort that was undertaken to reduce costs in response to the FDA’s clinical holds on the seladelpar program.

Net loss for the three months ended June 30, 2020 was $10.7 million, or ($0.16) per diluted share, compared to a net loss of $24.0 million, or ($0.35) per diluted share in the three months ended June 30, 2019. Net loss for the six months ended June 30, 2020 was $23.8 million, or ($0.35) per diluted share, compared to a net loss of $47.1 million, or ($0.72) per diluted share in the six months ended June 30, 2019. Net loss was lower in the three and six months of 2020 compared to the corresponding periods in 2019 primarily due to a decrease in operating expenses, including clinical trial and labor related expenses, as a result of the early-termination of our seladelpar studies and our cost reduction efforts undertaken in response to the FDA’s clinical holds that were placed on the seladelpar program in the fourth quarter of 2019.
Conference Call Details

CymaBay will host a conference call today at 4:30 p.m. ET to discuss second quarter 2020 financial results and provide a corporate update. To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13706143. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source