On November 10, 2020 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 third quarter of 2020 and provided a corporate update (Press release, Gossamer Bio, NOV 10, 2020, View Source [SID1234570489]).

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"We are very excited about the continued advancement of our pipeline with the start of two robust Phase 2 clinical trials for GB002 and GB004 and the planned dose expansion cohort for GB1275," said Sheila Gujrathi, M.D., Co-Founder and Chief Executive Officer of Gossamer. "We believe that these clinical programs hold tremendous potential to benefit high unmet need patient populations."

Clinical-Stage Product Candidate Updates

GB002: Inhaled PDGFR Inhibitor for Pulmonary Arterial Hypertension (PAH)

GB002 is currently being evaluated in an ongoing Phase 1b trial in PAH. Gossamer will discuss the initial results from this ongoing trial at as part of a GB002-focused investor webinar in December 2020.
Sites activated in the TORREY Study, a 24-week Phase 2 clinical trial in functional class II and III PAH patients. Gossamer expects to begin enrollment for this trial in the fourth quarter of 2020. 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.
GB004: Oral HIF-1α Stabilizer for Inflammatory Bowel Disease

Several patients dosed in the SHIFT-UC Study, a Phase 2 clinical trial in UC patients. 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.
Data presented from completed Phase 1b study in patients with active mild-to-moderate ulcerative colitis (UC) at UEG Week Virtual 2020. These posters and presentations are available at www.gossamerbio.com, on the "Posters and Publications" page.
GB1275: Oral CD11b Modulator for Oncology Indications

Two GB1275 posters are being presented at the 35th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2020), being held virtually from November 9 – 14. This includes clinical and biomarker data from the ongoing GB1275 Phase 1/2 clinical trial, KEYNOTE-A36, in advanced solid tumors and corresponding presentations from Johanna Bendell, M.D. and Wells Messersmith, M.D.
Poster Title: Preliminary results from KEYNOTE-A36, a study of GB1275, a first-in-class oral CD11b modulator, alone and with pembrolizumab or chemotherapy in specified advanced solid tumors
Poster / Abstract Number: 388
Presenting Author: Johanna Bendell, M.D.
Link: View Source

Poster Title: Combining transcriptomic- and tissue-based immune biomarkers to evaluate GB1275, a CD11b modulator, as a single agent or with pembrolizumab in patients with advanced solid tumors
Poster / Abstract Number: 389
Presenting Author: Wells Messersmith, M.D.
Link: View Source

Encouraging biological activity, particularly at GB1275 doses greater than or equal to 800 mg BID, was seen in tumor types that are known to be less responsive to checkpoint inhibitors. This activity supports the mechanism of action of GB1275 in modulating myeloid cell biology in the tumor microenvironment, with potential to enhance anti-tumor response when it is combined with a checkpoint inhibitor.

Prolonged stable disease has been observed in seven patients, in both the monotherapy and combination dose groups. Five of seven patients with observed prolonged stable disease received doses of 800mg BID or higher of GB1275.

One microsatellite stable-colorectal cancer patient receiving oral GB1275 800 mg twice daily, in combination with pembrolizumab, achieved a partial response. The patient had received five lines of therapy prior to trial enrollment and is continuing on study treatment.

Clinical safety data to date suggest that GB1275 alone and combined with pembrolizumab (up to 1200 mg twice daily) is generally well tolerated, and the maximum tolerated dose of GB1275 has not been reached.
GB001: Oral DP2 Antagonist for Moderate-to-Severe Asthma

Engaging with global regulatory authorities regarding the forward clinical development path of an oral DP2 antagonist in moderate-to-severe asthma to inform potential partnerships or strategic alternatives.
Financial Results for the Quarter Ended September 30, 2020

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of September 30, 2020, were $555.4 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 September 30, 2020, R&D expenses were $41.8 million, compared to R&D expenses of $40.1 million for the same period in 2019.
General and Administrative (G&A) Expenses: For the quarter ended September 30, 2020, G&A expenses were $11.4 million, compared to $9.8 million for the same period in 2019.
Net Loss: Net loss for the quarter ended September 30, 2020, was $57.8 million, or $0.80 or share, compared to a net loss of $48.5 million, or $0.80 per share, for the same period in 2019. The increase was primarily attributable to an increase in interest expense of $4.0 million and a decrease in investment income of $1.7 million.
Conference Call and Webcast

Gossamer’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Tuesday, November 10, to discuss its third quarter 2020 financial results and provide a corporate update.

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:

A replay of the audio webcast will be available for 30 days on the "Investors" section of the Company’s website, www.gossamerbio.com.

On November 10, 2020 Five Prime Therapeutics, Inc. (NASDAQ: FPRX) ), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, reported positive topline results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial (Press release, Five Prime Therapeutics, NOV 10, 2020, View Source [SID1234570488]). The trial compared mFOLFOX6 chemotherapy in combination with bemarituzumab (bema, FPA144), a first-in-class targeted therapy, in patients with fibroblast growth factor receptor 2b-positive (FGFR2b+), non HER2 positive (non HER2+) front-line advanced gastric or gastroesophageal junction (GEJ) cancer.

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"These results bring us one step closer to the first potential targeted therapy for advanced gastric cancer in over a decade," said Helen Collins, M.D., Five Prime’s Executive Vice President and Chief Medical Officer. "Benefit was observed in patients whose tumors overexpressed FGFR2b, even without evidence of amplification, and that may broaden the therapeutic potential of bemarituzumab in more cancer types. We are excited about the results of the FIGHT trial and the opportunity to advance the development of bemarituzumab, the first and only investigational treatment targeting FGFR2b+. Five Prime is grateful to the patients and investigators who participated in our clinical trials, and we look forward to discussing next steps with health authorities worldwide."

All three efficacy endpoints in the FIGHT trial – PFS, OS and ORR – achieved pre-specified statistical significance at a 2-sided alpha of 0.20. The incidence of all grade adverse events was comparable in the treatment and control arms of the study (100% vs 98.7%, respectively) as were serious adverse events (31.6% vs 36.4%) and deaths due to adverse events (6.6% vs 5.2%). Adverse events ≥ Grade 3 were reported more frequently in the treatment arm than in the placebo arm (82.9% vs 74.0%). Corneal and stomatitis adverse events were reported more frequently in the bemarituzumab arm, and more patients discontinued bemarituzumab (34.2%) compared to placebo (5.2%) due to an adverse event. Importantly, no adverse events of retinal detachment or hyperphosphatemia were reported in the bemarituzumab arm. Despite the higher frequency of discontinuation of bemarituzumab compared to placebo, all efficacy endpoints favored bemarituzumab. Overall, the Phase 2 FIGHT trial results validate the importance of the novel target, FGFR2b, which is overexpressed in approximately 30 percent of HER2- gastric cancers worldwide.

The company will complete a full evaluation of the available FIGHT Phase 2 data and work with investigators to share the results at an upcoming medical conference.

"We have known for some time that FGFR is a viable target in gastric cancer and many other malignancies," said Zev A. Wainberg, M.D., Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center. "This is the first data to signal that a targeted therapy directed to FGFR2b may reduce the risk of disease progression and improve overall survival in gastric cancer. This study result showing bemarituzumab’s potential benefit is an important and exciting development."

Five Prime and Roche Tissue Diagnostics (formerly Ventana Medical Systems) have also found that FGFR2b is overexpressed in numerous other cancers, including squamous non-small cell lung cancer, triple negative breast cancer, ovarian cancer, pancreatic cancer and intrahepatic cholangiocarcinoma. This represents additional potential areas for development of bemarituzumab beyond gastric and GEJ cancer.

Conference Call Information

Five Prime will host a conference call and live audio webcast today at 4:30pm (EST) / 1:30 (PST) to discuss topline results from the Phase 2 FIGHT trial. To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 9977806. To access the live webcast please visit View Source

An archived copy of the webcast will be available on Five Prime’s website beginning approximately two hours after the conference call. Five Prime will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.

About the FIGHT Trial

The FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment (FIGHT) trial (NCT03694522) was designed to evaluate the efficacy and safety of bemarituzumab in combination with modified FOLFOX6 (mFOLFOX6; leucovorin calcium, fluorouracil, and oxaliplatin) vs. mFOLFOX6 plus placebo in the front-line setting of patients with newly diagnosed FGFR2b positive, locally advanced or metastatic gastric and GEJ cancer.

Patients’ tumors were identified to be FGFR2b+ by immunohistochemistry and by FGFR2 gene amplification using a blood-based circulating tumor DNA assay. Testing was performed at a central laboratory.

The trial enrolled 155 patients in 15 countries across Asia, the European Union, and the United States. Today’s announcement contains the initial top-line results from the primary analysis based on a prespecified number of events.

About FGFR2b

The fibroblast growth factor (FGF)/fibroblast growth factor receptor (FGFR) pathway is implicated in the development and growth of cancer cells. FGFR2b is a form of FGFR found in epithelial cells, such as those in the stomach and skin. Data from the FIGHT trial suggests that approximately 30% of patients with non HER2+ gastroesophageal cancers overexpress FGFR2b.1 Five Prime and Roche Tissue Diagnostics have also found that FGFR2b is overexpressed in numerous other cancers, including squamous non-small cell lung cancer (NSCLC), triple negative breast (TNBC), ovarian, pancreatic and intrahepatic cholangiocarcinoma.

About Bemarituzumab

Bemarituzumab (anti-FGFR2b, FPA144) is a first-in-class targeted antibody that blocks fibroblast growth factors (FGFs) from binding and activating FGFR2b, inhibiting several downstream pathways. Blocking FGFR2b activation is thought to slow cancer progression. Bemarituzumab is being developed in gastric and GEJ cancer as a targeted therapy for tumors that overexpress FGFR2b.

Five Prime granted an exclusive license to Zai Lab to develop and commercialize bemarituzumab in Greater China, and Zai Lab collaborated with Five Prime on the Phase 2 FIGHT trial in Greater China.

About Gastric Cancer and GEJ Cancer

Gastric cancer, also known as stomach cancer, is the third most common cause of cancer death worldwide and, excluding non-melanoma skin cancer, the fifth most common cancer worldwide, with over 1,000,000 new cases diagnosed each year.2 In countries where routine screening is not readily available, up to 90 percent of patients are diagnosed with advanced disease that is inoperable.3 For HER2- patients, frontline therapy available today is the same systemic chemotherapy available since the 1990s.3,4

On November 10, 2020 Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, reported financial results for the third quarter 2020 (Press release, Equillium, NOV 10, 2020, View Source [SID1234570487]).

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"We continue to make significant progress towards our goal of bringing itolizumab to patients suffering from a range of severe immuno-inflammatory disorders," said Bruce Steel, chief executive officer of Equillium. "We are well positioned to continue advancing our core trials including the Phase 1b EQUATE trial in acute graft-versus-host disease (aGVHD) where we recently reported positive response rates across the first three dose cohorts, as well as our Phase 1b EQUIP and EQUALISE trials in uncontrolled asthma and lupus nephritis, respectively. In parallel, we are poised to initiate the global Phase 3 EQUINOX trial of itolizumab in hospitalized COVID-19 patients during this quarter. We look forward to sharing additional updates at our upcoming Analyst Day in December."

Business Highlights:

Reported 100% overall response rate in cohort 3 and 80% overall response rate across all cohorts to date from the EQUATE Phase 1b study of itolizumab in the first-line treatment of severe aGVHD patients
Received US Food and Drug Administration clearance to initiate global EQUINOX Phase 3 randomized, placebo-controlled trial of itolizumab in hospitalized COVID-19 patients
Presented pre-clinical data demonstrating that modulation of the CD6-ALCAM pathway with itolizumab improves kidney and skin pathology in systemic lupus erythematosus (SLE) at the 2020 American College of Rheumatology (ACR) Virtual Convergence
Presented new data and insights on the CD6-ALCAM pathway in uncontrolled asthma at the European Respiratory Society International Congress 2020
Strengthened the balance sheet by raising a total of $53.0 million in net proceeds from financings in the third quarter 2020, resulting in $90.5 million in cash and investments at the end of the quarter
Upcoming Catalysts:

Initiate EQUINOX Phase 3 trial in Q4 2020, initial data expected mid-year 2021
Report topline data from the EQUATE Phase 1b open label dose escalation study in first-line treatment of patients with aGVHD in the first half of 2021
Continue to advance the EQUALISE and EQUIP Phase 1b trials
Host company-sponsored virtual Analyst Day on December 4, 2020
Third Quarter 2020 Financial Results

Research and development (R&D) expenses. Total R&D expenses for the three months ended September 30, 2020 were $4.2 million, compared with $4.2 million for the same period in 2019. Although total R&D expenses remained flat compared to the prior period, significant changes included a reduction of R&D expenses due to an R&D tax benefit realized by Equillium’s Australian subsidiary as well as lower travel expenses offset by an increase in employee compensation and benefits primarily related to increased headcount as well as an increase in clinical expense primarily related to startup costs associated with the EQUINOX COVID-19 Phase 3 trial.

General and administrative (G&A) expenses. Total G&A expenses for the three months ended September 30, 2020 were $2.3 million, compared with $2.1 million for the same period in 2019. The increase in G&A expenses was primarily due to a $0.2 million increase in corporate consulting expenses.

Net loss. Net loss for the three months ended September 30, 2020 was $6.6 million, or $(0.31) per basic and diluted share, compared with a net loss of $6.0 million, or $(0.35) per basic and diluted share for the same period in 2019.

Cash, cash equivalents and short-term investments. Equillium held cash, cash equivalents and short-term investments totaling $90.5 million at September 30, 2020, compared to $53.1 million at December 31, 2019. The increase in cash was driven by $53.8 million in total net proceeds raised from equity financings in 2020 through September 30.

Cash used in operations. Equillium used $4.9 million of cash in its operations during the three months ended September 30, 2020, compared to $5.1 million in the prior quarter ended June 30, 2020. Over the nine-month period ended September 30, 2020, Equillium has used approximately $16.4 million of cash in its operations.

About Itolizumab

Itolizumab is a clinical-stage, first-in-class monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Itolizumab is currently being evaluated in multiple clinical trials in patients with severe diseases, including aGVHD, lupus nephritis, uncontrolled asthma, and will soon be evaluated in a clinical trial of patients with COVID-19. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited. Itolizumab is marketed in India under the trade name "ALZUMAb-L" for the treatment of chronic plaque psoriasis and has received emergency use approval in India to treat cytokine release syndrome in COVID-19 patients with moderate to severe acute respiratory distress syndrome.

On November 10, 2020 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that management will participate in four upcoming virtual investor conferences (Press release, Zymeworks, NOV 10, 2020, View Source [SID1234570486]).

Stifel’s 2020 Virtual Healthcare Conference is scheduled for November 16-18, 2020. Zymeworks is presenting on Tuesday, November 17, 2020 at 4:40 p.m. ET.

Jefferies’ Virtual London Healthcare Conference is scheduled for November 17-19, 2020. Zymeworks is presenting on Wednesday, November 18, 2020 at 11:25 a.m. ET (4:25 p.m. GMT).

Wolfe’s 2020 Virtual Healthcare Conference is scheduled for November 18-19, 2020. Zymeworks is presenting on Thursday, November 19, 2020 at 2:20 p.m. ET.

SVB Leerink’s Oncology Day is scheduled for November 19, 2020. Zymeworks will be participating in conference; there is no public presentation.

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Interested parties can access a live webcast of the presentations via a link from Zymeworks’ website at View Source, which will also host recorded replays available afterwards.

On November 10, 2020 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that it has commenced an underwritten public offering of 4,000,000 shares of its common stock (Press release, ORIC Pharmaceuticals, NOV 10, 2020, View Source [SID1234570485]). All of the shares in the proposed offering will be sold by ORIC. In addition, ORIC expects to grant the underwriters a 30-day option to purchase an additional 600,000 shares of its common stock in the offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the offering.

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J.P. Morgan Securities LLC, Citigroup, Jefferies LLC and Guggenheim Securities are acting as joint book-running managers for the proposed offering. Oppenheimer & Co. Inc. is acting as lead manager for the proposed offering.

The proposed offering will be made only by means of a preliminary prospectus, copies of which may be obtained, when available, from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected]; Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at (800) 831-9146; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, NY 10017, by telephone at (212) 518-9658 or by email at [email protected].

A registration statement relating to the securities has been filed with the Securities and Exchange Commission (SEC) but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release does not constitute an offer to sell or a solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.