On August 9, 2021 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported its financial results for the second quarter of 2021 and provided a corporate update (Press release, Gossamer Bio, AUG 9, 2021, View Source [SID1234586133]).

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"I am tremendously proud of the dedication and perseverance the Gossamer team has shown this year, pressing forward with the execution of two Phase 2 studies for our lead clinical programs, seralutinib and GB004, in the face of operational challenges presented by the pandemic," said Faheem Hasnain, Co-Founder, Chairman and Chief Executive Officer of Gossamer. "We are also very happy to share data from the first extended clinical experience of seralutinib, the first such data from an inhaled kinase inhibitor in patients with PAH. Though the pandemic limited the number of patients who were able to continue onto the OLE, these patient experiences provide additional evidence supporting the potential of seralutinib to improve the lives of PAH patients."

Clinical-Stage Product Candidate Updates

Seralutinib (GB002): Inhaled PDGFR, CSF1R and C-KIT Inhibitor for PAH

While the conduct of the Phase 1b study of seralutinib in patients with Functional Class II and III PAH was interrupted by the COVID-19 pandemic, two of the eight patients that completed the two-week Phase 1b study were also able to complete the optional 6-month open-label extension period.
Both patients entered and completed the extension study on three classes of background therapy, including oral prostacyclins.
No serious adverse events were reported, and no safety concerns identified with longer term treatment over a six-month period at a twice daily 90mg dose.
In both patients, decreases in NT-proBNP, a biomarker for right heart strain, and increases in six-minute walk distance, a potential registrational endpoint for PAH, were observed.
Enrollment is ongoing in the TORREY Study, a Phase 2 clinical trial in patients with PAH whose disease has progressed despite standard-of-care therapy. The primary endpoint is change in pulmonary vascular resistance (PVR) from baseline at week 24. Topline data from the TORREY study are expected in the first half of 2022, subject to developments in the ongoing COVID-19 pandemic.
Additional exploratory biomarker data from the completed seralutinib two-week Phase 1b in eight PAH patients will be presented via ePoster at the Virtual European Respiratory Society (ERS) International Congress 2021 being held virtually from September 5 – 8, 2021. Abstract content will be available online at the ERS website, starting on August 23, 2021, two weeks prior to the beginning of the virtual ERS Congress. ePoster details:
ePoster Title: Evidence of Target Engagement and Pathway Modulation: Biomarker Analysis of the Phase 1b Inhaled Seralutinib Study
Session Date: Sunday, September 5, 2021
Session Time: 1:15pm CEST / 7:15am EDT / 4:15am PDT
GB004: Oral, Gut-Targeted HIF-1α Stabilizer for Inflammatory Bowel Disease (IBD)

Enrollment is ongoing in the SHIFT-UC Study, a Phase 2 clinical trial in patients with active UC despite treatment with 5-ASAs. The primary endpoint is proportion of patients with clinical remission at week 12. Topline data from the SHIFT-UC study are expected in the first half of 2022, subject to developments in the ongoing COVID-19 pandemic.
Additional post-hoc analysis of clinical data from the completed GB004 Phase 1b in patients with active UC will be presented at the United European Gastroenterology (UEG) Virtual Week 2021 being held virtually from October 3 – 5, 2021. Presentation details:
Abstract Title: Assessment of Composite Endpoints Comprising Symptomatic, Histologic, Endoscopic, and Molecular Improvement in a Phase 1b Study of GB004, a Gut-Targeted, Hypoxia-Inducible Factor (HIF)-1α Stabilizer, in Mild-to-Moderate Ulcerative Colitis
Presenting Author: Silvio Danese, MD, PhD
Abstract Number: OP124
Session Title: IBD Clinical Trials III
Session Date: Monday, October 4, 2021
Session Time: 3:00pm CEST / 9:00am EDT / 6:00am PDT
GB1275: Oral CD11b Modulator for Solid Tumor Oncology Indications

Gossamer will discontinue clinical development of its immuno-oncology product candidate, GB1275, which is currently in a Phase 1/2 clinical trial in solid tumor indications as a monotherapy and in combination with either pembrolizumab or chemotherapy.
Financial Results for the Quarter Ended June 30, 2021

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of June 30, 2021, were $405.9 million. The Company expects the combination of current cash, cash equivalents and marketable securities, and access to its debt facility will be sufficient to fund its operating and capital expenditures into the second half of 2023.
Research and Development (R&D) Expenses: For the quarter ended June 30, 2021, R&D expenses were $44.3 million, compared to R&D expenses of $38.7 million for the same period in 2020.
General and Administrative (G&A) Expenses: For the quarter ended June 30, 2021, G&A expenses were $11.3 million, compared to $11.7 million for the same period in 2020.
Net Loss: Net loss for the quarter ended June 30, 2021, was $59.8 million, or $0.80 per share, compared to a net loss of $66.9 million, or $1.00 per share, for the same period in 2020.
Conference Call and Webcast

Gossamer’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Monday, August 9, to discuss its second quarter 2021 financial results, provide a corporate update, and present the seralutinib Phase 1b open-label extension data.

The live audio webcast may be accessed through the "Events / Presentations" page in the "Investors" section of the Company’s website at www.gossamerbio.com. Alternatively, the conference call may be accessed through the following:

On August 9, 2021 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that the pivotal Phase III POLARIX trial investigating Polivy (polatuzumab vedotin) in combination with Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) versus Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) met its primary endpoint by demonstrating significantly improved and clinically meaningful progression-free survival in people with previously untreated diffuse large B-cell lymphoma (DLBCL) (Press release, Genentech, AUG 9, 2021, View Source [SID1234586150]). Safety outcomes were consistent with those seen in previous trials.

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"Since 40% of people with DLBCL relapse after initial therapy, achieving meaningful treatment effects in the front-line setting has the potential to be transformative," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "This Polivy regimen is the first in two decades to improve progression-free survival in DLBCL compared to the standard of care, and we look forward to sharing these results with health authorities to bring this important potential new treatment option to patients as soon as possible."

Today’s POLARIX results will be presented at an upcoming medical meeting and submitted to health authorities as part of Genentech’s commitment to transforming the treatment of DLBCL by providing options tailored to patient and healthcare professional needs. Genentech would like to thank all investigators, academic partners and people with DLBCL who participated in the study.

Currently, Polivy is used as an off-the-shelf, fixed-duration treatment option in the relapsed or refractory (R/R) DLBCL setting, and is approved in combination with bendamustine and Rituxan for the treatment of R/R DLBCL in more than 60 countries worldwide, including in the EU and in the U.S. Genentech continues to explore areas of unmet need where Polivy has the potential to deliver benefit, with ongoing studies investigating combinations of Polivy with the CD20xCD3 T cell-engaging bispecific antibodies mosunetuzumab and glofitamab, with Venclexta (venetoclax), which is being developed by AbbVie and Genentech, and with Rituxan in combination with gemcitabine and oxaliplatin in the Phase III POLARGO study.

About the POLARIX study

POLARIX [NCT03274492] is an international Phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety and pharmacokinetics of Polivy (polatuzumab vedotin) plus Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) versus Rituxan, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) in people with previously untreated diffuse large B-cell lymphoma (DLBCL). Eight-hundred and seventy-nine patients were randomized 1:1 to receive either Polivy plus R-CHP plus a vincristine placebo for six cycles, followed by Rituxan for two cycles; or R-CHOP plus a Polivy placebo for six cycles, followed by two cycles of Rituxan. The primary outcome measure is progression-free survival as assessed by the investigator using the Lugano Response Criteria for malignant lymphoma. POLARIX is being conducted in collaboration with The Lymphoma Study Association (LYSA) and The Lymphoma Academic Research Organisation (LYSARC).

About Polivy (polatuzumab vedotin-piiq)

Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B cells, an immune cell impacted in some types of non-Hodgkin’s lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells. Polivy is being developed by Genentech using Seagen ADC technology and is currently being investigated for the treatment of several types of NHL.

About DLBCL

DLBCL is the most common form of non-Hodgkin’s lymphoma (NHL), accounting for about one in three cases of NHL. DLBCL is an aggressive (fast-growing) type of NHL. While it is generally responsive to treatment in the frontline, as many as 40% of patients will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short. Approximately 150,000 people worldwide are estimated to be diagnosed with DLBCL each year.

Polivy U.S. Indication

Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat diffuse large B-cell lymphoma in adults who have progressed after at least two prior therapies.

The accelerated approval of Polivy is based on a type of response rate. There are ongoing studies to confirm the clinical benefit of Polivy.

Important Safety Information

Possible serious side effects

Everyone reacts differently to Polivy therapy, so it’s important to know what the side effects are. Some people who have been treated with Polivy have experienced serious to fatal side effects. A patient’s doctor may stop or adjust a patient’s treatment if any serious side effects occur. Patients must contact their healthcare team if there are any signs of these side effects.

Nerve problems in arms and legs: This may happen as early as after the first dose and may worsen with every dose. If a patient already has nerve pain, Polivy may make it worse. The patient’s doctor will monitor for signs and symptoms, such as changes in sense of touch, numbness or tingling in hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to walking patterns
Infusion-related reactions: A patient may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of the infusion
Infections: Patients should contact their healthcare team, if they experience a fever of 100.4°F or higher, chills, cough, or pain during urination. Also, a patient’s doctor may give medication before giving Polivy, which may prevent some infections, and monitor blood counts throughout treatment with Polivy. Treatment with Polivy can cause severe low blood cell counts
Rare and serious brain infections: A patient’s doctor will monitor the patient closely for signs and symptoms of these types of infections. Patients should contact their doctor if they experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes
Tumor lysis syndrome: Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy
Potential harm to liver: Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of the skin or the white part of the eyes. Patients may be at higher risk if they already have liver problems or are taking other medication
Side effects seen most often

The most common side effects during treatment were

Low blood cell counts (platelets, red blood cells, white blood cells)
Nerve problems in arms and legs
Tiredness or lack of energy
Diarrhea
Nausea
Fever
Decreased appetite
Infections
Polivy may not be for everyone. A patient should talk to their doctor if they are

Pregnant or may be pregnant: Data have shown that Polivy may harm an unborn baby
Planning to become pregnant: Women should avoid getting pregnant while taking Polivy. Women should use effective contraception during treatment and for at least 3 months after their last Polivy treatment. Men taking Polivy should use effective contraception during treatment and for at least 5 months after their last Polivy treatment
Breastfeeding: Women should not breastfeed while taking Polivy and for at least 2 months after the last dose
These may not be all the side effects. Patients should talk to their healthcare provider for more information about the benefits and risks of Polivy treatment.

Report side effects to the FDA at (800) FDA-1088 or View Source Report side effects to Genentech at (888) 835-2555.

Please visit View Source for the full Prescribing Information for additional Important Safety Information.

About Genentech in Hematology

For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we’re investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. For more information visit View Source

On August 9, 2021 ChemoCentryx, Inc., (Nasdaq: CCXI), reported financial results for the second quarter ended June 30, 2021 and provided an overview of recent corporate highlights (Press release, ChemoCentryx, AUG 9, 2021, View Source [SID1234586178]).

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"We appreciate the recent opportunity to provide the U.S. FDA with supplementary data and analyses to our NDA, which the Agency deemed to be a major amendment," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "We are looking forward to decisions later this year on regulatory submissions for avacopan in ANCA-associated vasculitis in the U.S. and abroad. Meanwhile, we are further developing our pipeline, as evidenced by the launch of a Phase I study with our novel orally-administered immune checkpoint inhibitor CCX559, which we hope will be part of a new era of precise cancer treatment. Further clinical work in other high need areas, such as the initiation of a Phase III trial of avacopan in patients with severe Hidradenitis Suppurativa, constitute important next steps in building the CCXI pipeline to benefit patients most in need."

Key Second Quarter 2021 Highlights and Recent Developments

In July the Company announced the filing of additional information to its NDA submission, which the FDA deemed to be a major amendment. The PDUFA review period for avacopan in the treatment of ANCA-associated vasculitis was extended, with a new PDUFA goal date of October 7, 2021. The Company’s filing followed the May 6 meeting of the FDA’s Arthritis Advisory Committee.
In Q2, the Company initiated Phase I clinical development of CCX559, a novel, orally-administered, PD-1/PD-L1 checkpoint inhibitor. CCX559 was featured in an abstract at the April 2021 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). As a next generation therapy, small molecule inhibitors may have advantageous properties compared to approved monoclonal antibodies, such as better penetration into solid tumors, reduced immunogenicity, lack of Fc-mediated side effects, and the convenience of oral administration.
The Company plans to meet with the FDA to discuss the Phase III development of avacopan in patients with Hurley Stage 3 (severe) Hidradenitis Suppurativa (HS) with the goal of initiating a Phase III clinical trial in those patients. In the Phase II AURORA trial, avacopan demonstrated a statistically significant higher response than placebo in a pre-specified subgroup of Hurley Stage 3 patients, which will further guide clinical development.
The Company plans to initiate clinical development of avacopan in patients with lupus nephritis in the first half of 2022.
The Company also plans to schedule a meeting later this year with the FDA to discuss evidence of clinical benefit from the ACCOLADE trial of avacopan in the very rare disorder C3 Glomerulopathy (C3G). There are no FDA approved therapies for this rare disorder. In the ACCOLADE trial, avacopan demonstrated statistically significant improvement in renal function as measured by pre-specified secondary endpoints of eGFR and also improvement in the pre-specified endpoint of C3G Histology Index (HI) Disease Chronicity score, compared to placebo over 26 weeks of blinded treatment, while not attaining a statistically significant improvement in the primary endpoint of the C3G HI Disease Activity Score. Avacopan was well tolerated in C3G patients.
The Company ended Q2 with cash, cash equivalents and investments of $402.6 million at June 30, 2021.
Second Quarter 2021 Financial Results

Revenue was $1.8 million for the second quarter of 2021, compared to $49.4 million for the same period in 2020. The decrease in revenue from 2020 to 2021 was principally attributable to the acceleration of revenue recognition in 2020 associated with the decision to discontinue development of CCX140 in Focal Segmental Glomerulosclerosis (FSGS).

Research and development expenses were $20.9 million for the second quarter of 2021, compared to $18.8 million for the same period in 2020. The increase from 2020 to 2021 was primarily attributable to the manufacture of commercial drug supply in anticipation of the launch of avacopan for the treatment of ANCA vasculitis and higher research and drug discovery expenses, including those associated with the development of CCX559, the Company’s orally-available small molecule checkpoint (PD-1/PD-L1) inhibitor. These increases were partially offset by lower Phase II related expenses due to the completion of the avacopan AURORA Phase IIb clinical trial in patients with HS and the discontinuation of further clinical development of CCX140 in FSGS in 2020.

General and administrative expenses were $19.7 million for the second quarter of 2021, compared to $10.3 million for the same period in 2020. The increase from 2020 to 2021 was primarily due to higher employee-related expenses, including those associated with the Company’s commercialization planning efforts, and higher professional fees.

Net loss for the second quarter of 2021 was $39.2 million, compared to net income of $20.3 million for the same period in 2020.

Total shares outstanding at June 30, 2021 were approximately 69.9 million shares.

Cash, cash equivalents and investments totaled $402.6 million at June 30, 2021.

Conference Call and Webcast

The Company will host a conference call and webcast today, August 9, 2021 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial (877) 303-8028 (Domestic) or (760) 536-5167 (International). The conference ID number is 2164528. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the call.

On August 9, 2021 Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, reported preliminary, unaudited revenue for the month of July 2021 (Press release, Biofrontera, AUG 9, 2021, View Source [SID1234586103]).

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The Company’s preliminary, unaudited revenue from product sales in July 2021 amounted to approximately EUR 1,570 thousand, compared to EUR 1,523 thousand in July 2020, an increase of 3%.

Preliminary revenues from product sales in the US were around EUR 1,026 thousand compared to EUR 795 thousand in July 2020, an increase of 29%. In Germany, revenues from product sales amounted to approximately EUR 357 thousand, compared to EUR 572 thousand in July 2020, a decrease of 38%. In this context, the relatively high comparative sales in July 2020 in Germany resulted from catch-up effects due to the weak previous months caused by the pandemic. In the rest of Europe, the Company generated product sales of around EUR 187 thousand, compared to EUR 156 thousand in July 2020, a plus of 20%.

Due to the pandemic, the monthly and year-to-date sales development is also compared with sales in 2019 for increased transparency. As such, an increase of 9% in July 2021 for total product sales was achieved in all markets compared to July 2019. In the USA, product sales increased by about 15% compared to July 2019. In July 2021, sales were up by around 6% in Germany while sales revenue in the remaining European markets decreased by approximately 11% compared to July 2019.

Compared to 2019, product sales in all markets were down by around 3% compared to sales in the period January to July 2021. Year-to-date sales in 2021 increased by around 23% in Germany and by 22% in the rest of the European market compared to the same period in 2019. Revenue in the US market was down 13%, mainly due to weak sales in January, February, and the first half of March this year due to the pandemic, as well as the lack of or lower sales of Aktipak and Xepi compared to the period January to July 2019.

On August 9, 2021, Amgen Inc. (the "Company") reported that it issued and sold $1,250,000,000 aggregate principal amount of its 1.650% Senior Notes due 2028 (the "2028 Notes"), $1,250,000,000 aggregate principal amount of its 2.000% Senior Notes due 2032 (the "2032 Notes"), $1,150,000,000 aggregate principal amount of its 2.800% Senior Notes due 2041 (the "2041 Notes") and $1,350,000,000 aggregate principal amount of 3.000% Senior Notes due 2052 (the "2052 Notes" and, together with the 2028 Notes, the 2032 Notes and the 2041 Notes, the "Notes") (Filing, 8-K, Amgen, AUG 9, 2021, View Source [SID1234586118]). The Notes are registered under an effective Registration Statement on Form S-3 (Registration No. 333-236351) (the "Registration Statement"), filed on February 10, 2020, and were issued pursuant to an indenture, dated as of May 22, 2014 (the "Indenture"), between the Company and The Bank of New York Mellon Trust Company, N.A., as trustee, and an officer’s certificate, dated as of August 9, 2021 (the "Officer’s Certificate"), setting forth the terms of the Notes. Net proceeds to the Company from the offering were approximately $4,942,167,000, after deducting underwriters’ discounts and estimated offering expenses payable by the Company.

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The relevant terms of the Notes are set forth in the Indenture, included as Exhibit 4.1 of the Company’s Current Report on Form 8-K, filed on May 22, 2014, and incorporated herein by reference, and the Officer’s Certificate (including the forms of the Notes) attached hereto as Exhibit 4.2 and incorporated herein by reference.

The 2028 Notes will pay interest at the rate of 1.650% per annum, the 2032 Notes will pay interest at the rate of 2.000% per annum, the 2041 Notes will pay interest at the rate of 2.800% per annum and the 2052 Notes will pay interest at the rate of 3.000% per annum, which, in the case of the 2028 notes and the 2041 notes, shall be payable in cash semi-annually in arrears on February 15 and August 15 of each year, beginning on February 15, 2022, and in the case of the 2032 notes and the 2052 notes, shall be payable in cash semi-annually in arrears on January 15 and August 15 of each year, beginning on January 15, 2022. The 2028 Notes will mature on August 15, 2028, the 2032 Notes will mature on January 15, 2032, the 2041 Notes will mature on August 15, 2041 and the 2052 Notes will mature on January 15, 2052.

In the event of a change in control triggering event, as defined in the Officer’s Certificate, the holders of the Notes may require the Company to purchase for cash all or a portion of their Notes at a purchase price equal to 101% of the principal amount of Notes, plus accrued and unpaid interest, if any. The descriptions of the Indenture, the Officer’s Certificate and the Notes in this report are summaries and are qualified in their entirety by the terms of the Indenture, the Officer’s Certificate and the Notes, respectively.

The Notes will rank equal in right of payment to all of the Company’s other existing and future senior unsecured indebtedness, senior in right of payment to all of the Company’s existing and future subordinated indebtedness, effectively subordinated in right of payment to all of the Company’s subsidiaries’ obligations (including secured and unsecured obligations) and subordinated in right of payment to the Company’s secured obligations, to the extent of the assets securing such obligations.