On August 10, 2020 Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company, reported the second quarter 2020 financial results and provided a general business update (Press release, Tocagen, AUG 10, 2020, View Source [SID1234563327]).

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"We are very happy to have concluded the reverse merger on June 15th and in that process, brought on a very well-respected group of investors, including Alger, BVF Partners, Franklin Templeton and OrbiMed to support Forte as we continue to grow the company. Our lead program, FB-401, developed in collaboration with the National Institute of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID), has shown great potential in the initial Phase 1/2a study in mild, moderate and severe atopic dermatitis patients, including adults and children as young as 3 years old." said Paul Wagner, Ph.D., CEO of Forte Biosciences "We look forward to further validating FB-401’s potential with the randomized trial in mild to moderate atopic dermatitis patients, including adults and children 2 years of age and older, which will be initiating shortly. There is a particular need for safe and effective atopic dermatitis therapies for children."

Second Quarter 2020 Financial Results

Merger

On June 15, 2020, Forte merged with Tocagen, a publicly traded biotechnology company, with Forte being the surviving entity. As part of the merger, each share of Forte common stock outstanding was converted into the right to receive 3.1624 shares of Tocagen common stock following a 15:1 reverse split of Tocagen’s common stock. Post-merger and post-reverse split, Forte had approximately 10.8 million shares of common stock outstanding, with prior Forte stockholders collectively owning approximately 84.7% of the combined company and prior Tocagen stockholders owning approximately 15.3%. Forte’s common stock is traded on the Nasdaq Capital Market under the ticker symbol "FBRX." Prior to the Merger, Forte was a privately-held company incorporated in Delaware.

Financing

During the second quarter of 2020, Forte raised $24 million in equity financing associated with the merger that closed on June 15, including a $4.6 million financing that closed on June 16. Forte Biosciences ended the quarter with approximately $28 million in cash which the company believes is sufficient to fund operations for at least the next 12 months. Forte had 11.2 million shares of common stock outstanding as of June 30, 2020.

Operating Results

Research and development expenses were $1.9 million and $3.3 million for the three and six months ended June 30, 2020, respectively, compared to $0.3 million and $1.2 million for the comparable periods in 2019. The increases in 2020 were primarily due to increased outsourced contract manufacturing costs and clinical development costs as we gear up to commence Phase 2 clinical trials for FB-401.

General and administrative expenses were $0.8 million and $1.4 million for the three and six months ended June 30, 2020, respectively, compared to $0.3 million and $0.6 million for the comparable periods in 2019. The increases in 2020 were primarily due to professional fees for legal, auditing, tax and business consulting services, and personnel expenses as we transitioned to being a public company.

In connection with the Merger, we recognized a charge of $32.1 million for acquired in-process research and development related to the reverse merger with Tocagen.

Additional detail on our financial results for the second quarter 2020 can be found in our Form 10-Q as filed today with the SEC. You can also find more information in the investor relations section of our website at www.fortebiorx.com.

Conference Call and Webcast Information

The Forte management will host a conference call and webcast today at 4:30 PM Eastern Time. Participants may access the call by dialing 877-300-8521 (Domestic) or 412-317-6026 (International), the conference ID number is: 10147071. The call will also be webcast and can be accessed from the investor relations section of Forte’s website at View Source or View Source A replay of the call will also be available through August 17th.

On August 10, 2020 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, reported financial results for the second quarter ended June 30, 2020. As previously announced, in lieu of a financial results and business update call, Akebia management plans to host a conference call and webcast in early September to report top-line data from PRO2TECT, the second of its two global Phase 3 cardiovascular outcomes programs (Press release, Akebia, AUG 10, 2020, View Source [SID1234563326]). The two PRO2TECT studies evaluated the efficacy and safety of vadadustat, the Company’s investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of anemia due to chronic kidney disease (CKD) in adult patients not on dialysis.

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"We had an incredible quarter in terms of advancing our vadadustat clinical development program, bringing us that much closer to achieving our purpose to better the life of each person impacted by kidney disease. We reported exciting, positive top-line data from our global Phase 3 INNO2VATE program highlighting vadadustat’s potential as a new oral standard of care for treating anemia due to CKD in adult patients on dialysis, and topped off the quarter with the first regulatory approval of vadadustat in Japan," said John P. Butler, President and Chief Executive Officer of Akebia Therapeutics. "The next chapter of Akebia’s growth story is starting to unfold and as previously announced, we plan to share top-line data from PRO2TECT in early September."

Recent Business Highlights

In August, the Company announced database lock for PRO2TECT and plans to report top-line data from PRO2TECT in early September. This announcement follows Akebia’s earlier update provided in May that it had achieved the target number of major adverse cardiovascular events (MACE) for the PRO2TECT studies.

In July, the Company announced an investigator-sponsored research study by The University of Texas Health Science Center at Houston (UTHealth) in Houston, Texas, evaluating the use of vadadustat as a potential therapy to prevent and lessen the severity of acute respiratory distress syndrome (ARDS), a complication of COVID-19 infection.

In June, Mitsubishi Tanabe Pharma Corporation (MTPC), Akebia’s collaboration partner in Japan for vadadustat, obtained the first regulatory approval of vadadustat (Japan trade name: VAFSEO), as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients, by the Ministry of Health, Labour and Welfare in Japan.

In May, the Company reported positive top-line data from INNO2VATE, the first of its two global Phase 3 cardiovascular outcomes programs, which evaluated the efficacy and safety of vadadustat versus darbepoetin alfa for the treatment of anemia due to CKD in adult patients on dialysis. Vadadustat showed consistency across both efficacy and all MACE components, achieving the primary efficacy and safety endpoints, as well as the key secondary efficacy endpoint, of the studies. Please refer to Akebia’s INNO2VATE Data Announcement for the top-line data.

In May, the Company completed a public offering of its common stock raising net proceeds of $142.4 million.

In May, the Company announced that its collaboration partner, Japan Tobacco, Inc., filed a supplemental New Drug Application with the Pharmaceuticals and Medical Devices Agency (PMDA) seeking an additional indication for Riona (generic name in Japan: ferric citrate hydrate) to treat adult patients with iron deficiency anemia (IDA) in Japan.

Second Quarter Financial Results

Revenues: Total revenue was $90.1 million for the second quarter of 2020 compared to $100.8 million for the second quarter of 2019. The decline versus the prior year period was driven by lower collaboration revenue consistent with the Company completing the INNO2VATE studies and nearing completion of the PRO2TECT studies.

Collaboration revenue was $59.4 million for the second quarter of 2020 compared to $71.7 million in the second quarter of 2019.

Net product revenue for Auryxia (ferric citrate) was $30.7 million for the second quarter of 2020 compared with $29.1 million in the second quarter of 2019, an increase of 5.5 percent.

COGS: Cost of goods sold increased $136.9 million compared to the prior year period primarily due to a non-cash impairment charge of $115.5 million related to Auryxia, and higher non-cash inventory write-downs, which included $12.4 million largely related to a manufacturing quality issue related to Auryxia identified in the second quarter of 2020.

R&D Expenses: Research and development expenses were $52.8 million for the second quarter of 2020 compared to $85.7 million for the second quarter of 2019. The decline versus the prior year period was primarily driven by a decrease in costs consistent with the Company completing the INNO2VATE studies and nearing completion of the PRO2TECT studies.

SG&A Expenses: Selling, general and administrative expenses were $35.5 million for the second quarter of 2020 compared to $36.1 million for the second quarter of 2019.

Net Loss: Net loss was $175.8 million for the second quarter of 2020 compared to $58.2 million for the second quarter of 2019. The increase in net loss compared to the prior year period was due primarily to the non-cash impairment charge and higher non-cash inventory write-downs.

Cash Position: Cash, cash equivalents and available-for-sale securities as of June 30, 2020 were $295.3 million. The increase in the Company’s cash position is primarily attributable to net proceeds of $142.4 million from Akebia’s public offering of common stock, which was completed in May 2020. The Company believes that its cash runway extends beyond the expected U.S. launch of vadadustat.

"The non-cash impairment charge reflects the change in value of the Auryxia intangible asset on our balance sheet, primarily driven by the compounding impact of the 2018 decision by the Centers for Medicare and Medicaid Services (CMS) rescinding Medicare Part D coverage of Auryxia for its IDA indication and imposing a prior authorization requirement for the hyperphosphatemia indication," stated David A. Spellman, Chief Financial Officer of Akebia Therapeutics. "While we are frustrated and disappointed that a resolution has not been reached on this matter for the benefit of patients, we remain optimistic about Auryxia’s growth prospects."

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]).

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"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]):

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●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]).

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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.