On November 10, 2020 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for the quarter ended September 30, 2020 (Press release, MEI Pharma, NOV 10, 2020, View Source [SID1234570483]).

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"As we move through fiscal year 2021, we are well-positioned and well-capitalized to achieve our goals across our pipeline. Importantly, we remain focused on advancing zandelisib toward commercialization with our partner Kyowa Kirin and establishing its potential as an important treatment option in multiple lines of treatment across various B-cell malignancies," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "Our immediate focus is the completion of enrollment in the TIDAL study evaluating patients with follicular lymphoma, a study intended to support our accelerated approval strategy with FDA. TIDAL enrollment is expected to be completed in the first quarter of 2021 subject, of course, to developments in the global COVID-19 pandemic."

Dr. Gold continued: "Beyond TIDAL we are broadening our development activity for zandelisib, including the addition of a marginal zone arm to TIDAL to support an opportunity for potential expansion of our accelerated approval strategy if successful, the initiation of a Phase 3 study in second line follicular and marginal zone lymphomas sometime in mid-2021, and plans to support select investigator-initiated trials, initially in first-line DLBCL. Additionally, we are continuing ex-U.S. development efforts led by Kyowa Kirin, including the start of the Japan Phase 2 study to support marketing authorization in Japan. Finally, we will continue to advance the clinical development of our other wholly owned programs, voruciclib and ME-344."

First Quarter Fiscal Year 2021 Corporate Highlights

In September 2020, MEI announced the appointment of Brian T. Powl as senior vice president, marketing, a new role reporting to David Urso, chief operating officer and general counsel. Mr. Powl joined MEI from Celgene Corporation where he served as vice president, global commercial CAR T lead.
First Quarter Fiscal Year 2021 Financial Results

As of September 30, 2020, MEI had $176.1 million in cash, cash equivalents, and short-term investments with no outstanding debt. Additionally, MEI had a receivable of $20.4 million from the Japanese taxing authorities that was withheld from the $100 million paid by Kyowa Kirin Co. under the terms of the April 2020 global license, development and commercialization agreement. This receivable was received in October 2020.
For the quarter ended September 30, 2020, cash used in operations was $9.1 million compared to $14.1 million for 2019.
Research and development expenses were $13.0 million for the quarter ended September 30, 2020, compared to $9.0 million for 2019. The increase was primarily related to increased development costs associated with zandelisib, including increased activity in the TIDAL study and start-up costs related to the Phase 3 study, as well as increased personnel costs to support clinical trial activities.
General and administrative expenses were $5.9 million for the quarter ended September 30, 2020, compared to $4.1 million for 2019. The increase primarily relates to personnel costs and general corporate expenses incurred during the quarter ended September 30, 2020.
MEI recognized revenues of $3.8 million for the quarter ended September 30, 2020, compared to $1.2 million for the quarter ended September 30, 2019. The increase in revenue primarily related to the license agreement with Kyowa Kirin and included the recognition of fees allocated to research and development obligations, including a portion of Kyowa Kirin’s share of zandelisib costs which were $4.9 million for the quarter ended September 30, 2020. Revenue also includes recognition of fees allocated to performance obligations in accordance with the Helsinn License Agreement.
Net loss was $2.1 million, or $0.02 per share, for the quarter ended September 30, 2020, compared to net loss of $3.0 million, or $0.04 per share for 2019. The Company had 112,522,001 shares of common stock outstanding as of September 30, 2020, compared with 73,654,927 shares as of September 30, 2019.
The adjusted net loss for the quarter ended September 30, 2020, excluding non-cash expenses related to changes in the fair value of the warrants issued in connection with the May 2018 financing (a non-GAAP measure), was $15.3 million, compared to an adjusted net loss of $12.3 million for 2019.

On November 10, 2020 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported financial results for the third quarter ended September 30, 2020 (Press release, Tracon Pharmaceuticals, NOV 10, 2020, View Source [SID1234570482]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

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"We made great progress during the quarter by securing capital from dedicated healthcare funds that extends our runway past expected ENVASARC registration trial interim data and into 2022. We expect to enroll patients at multiple sites in the ENVASARC trial this year and also expect our partners to submit envafolimab for approval in China before the end of the year," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We are focused on enrolling the ENVASARC trial expeditiously so we may deliver interim data in 2021, final data in 2022, and assuming positive clinical data and regulatory approval, potentially commercialize envafolimab in 2023 and thereby address a high unmet need within sarcoma."

Recent Corporate Highlights

Envafolimab

In September, TRACON highlighted data from the registration trial of envafolimab in MSI-H/dMMR cancer that showed a 32% confirmed objective response rate (ORR) in patients (n=41) with MSI-H/dMMR colorectal cancer (CRC) who failed a fluoropyrimidine, oxaliplatin and irinotecan, and had at least two on-study tumor assessments. Twelve-month duration of response (DOR) was 75% and 12-month overall survival (OS) was 65%. The ORR in the overall population (n=103) was 43%, 12-month DOR was 92% and 12-month OS was 75%. Envafolimab demonstrated good tolerability and safety and there continued to be no infusion-related reactions. The 32% ORR is nearly identical to the 28% ORR reported for Opdivo and 33% ORR reported for Keytruda in separate trials of MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan.
TRC102

In October, TRACON announced orphan drug designation from the U.S. FDA for TRC102 in malignant glioma, including glioblastoma. TRC102 is a small molecule inhibitor of DNA base inhibitor repair being studied in Phase 1 and Phase 2 trials sponsored by the National Cancer Institute.
Corporate

In August, TRACON announced financings of approximately $10.0 million in the aggregate with multiple healthcare focused institutional investors through private placements of its common stock and pre-funded warrants. The financings were completed at market price, and TRACON expects that the net proceeds will extend its cash runway into 2022.
Expected Key Upcoming Milestones

Enroll patients at multiple sites into the ENVASARC registration trial during the fourth quarter of 2020.

Submission of envafolimab for approval in MSI-H/dMMR CRC to the National Medicinal Products Administration (NMPA) in China by our corporate partners 3D Medicines and Alphamab Oncology.

Independent Data Monitoring Committee review of ENVASARC safety data in 1H 2021.

FDA decision on orphan drug designation for envafolimab in sarcoma in 1H 2021.

Interim ENVASARC efficacy and safety data in mid-2021.

Third Quarter 2020 Financial Results

Cash and cash equivalents were $26.5 million at September 30, 2020, compared to $16.4 million at December 31, 2019. We expect our current cash and cash equivalents to fund operations into the first quarter of 2022.

Research and development expenses for the third quarter of 2020 were $1.8 million, compared to $3.1 million for the third quarter of 2019.

General and administrative expenses for the third quarter of 2020 were $2.1 million, compared to $2.0 million for the third quarter of 2019.

Net loss for the third quarter of 2020 was $4.0 million, compared to $5.2 million for the third quarter of 2019.
Conference Call Details

Tuesday, November 10, at 4:30 PM Eastern Time / 1:30 PM Pacific Time
Domestic: 855-779-9066
International: 631-485-4859
Conference ID: 7399456
A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Envafolimab

Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in registration trials. Envafolimab is currently dosing in a Phase 2 registration trial as a single agent in MSI-H/dMMR advanced solid tumor patients and a Phase 3 registration trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, 3D Medicines and Alphamab Oncology. In the Phase 2 registration trial, the confirmed ORR in MSI-H/dMMR CRC patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 32%, which was similar to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan and the 33% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of KEYNOTE-164.

About TRC102

TRC102 (methoxyamine) is a novel, small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA) and has orphan drug designation from the US FDA in malignant glioma, including glioblastoma.

About TRC253

TRC253 is a Phase 3 ready novel, orally bioavailable small molecule drug that is a potent, high affinity competitive inhibitor of the androgen receptor (AR) and AR mutations, including the F877L mutation. The AR F877L mutation results in an alteration in the AR ligand binding domain that confers resistance to therapies for prostate cancer. Therapies targeting the AR have demonstrated clinical efficacy by extending time to disease progression, and in some cases, the survival of patients with metastatic castration-resistant prostate cancer. However, resistance to these agents is often observed and several molecular mechanisms of resistance have been identified, including gene amplification, overexpression, alternative splicing, and point mutation of the AR. TRC253 recently completed a Phase 1/2 clinical trial in prostate cancer conducted by TRACON. TRACON believes TRC253 can be developed and commercialized successfully in China and is actively seeking a strategic collaboration.

About TJ004309

TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJ004309 is currently being studied in a Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.

On November 10, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), a component of the National Institutes of Health, for joint development of CA-4948, a first-in-class small molecule IRAK4 kinase inhibitor, as an anti-cancer agent under the NCI Experimental Therapeutics Program (NExT) (Press release, Curis, NOV 10, 2020, View Source [SID1234570481]).

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Under the CRADA, Curis will collaborate with the NCI Cancer Therapy Evaluation Program to conduct non-clinical and clinical studies of Curis’s proprietary compound CA-4948, an IRAK-4 kinase inhibitor that acts as a Toll-like Receptor (TLR) suppressor, as an anti-cancer agent.

"In addition to expanding the reach of this important clinical program, we believe this CRADA will provide powerful validation of our target-specific approach to developing impactful novel therapeutics for patients suffering from devastating cancers," said James Dentzer, President and Chief Executive Officer of Curis. We look forward to working closely alongside the team at the NCI and utilizing their tremendous expertise and resources as we advance CA-4948 through the clinical process."

About CA-4948

CA-4948 is a small molecule inhibitor of IRAK4, which is currently being tested in a Phase 1 dose escalating clinical trial in patients with non-Hodgkin lymphomas, including those with Myeloid Differentiation Primary Response 88 ("MYD88"), alterations. CA-4948 is also being investigated in a separate Phase 1 trial for acute myeloid leukemia and myelodysplastic syndromes. The Company is planning a combination study of CA-4948 and ibrutinib, a BTK inhibitor, in non-Hodgkin lymphomas with planned enrollment commencing in the fourth quarter of 2020.

On November 10, 2020 GlycoMimetics, Inc. (Nasdaq: GLYC), reported that CEO Rachel King plans to present an overview of the company at the upcoming Stifel 2020 Virtual Healthcare Conference on Tuesday, November 17 and the Jefferies Virtual London Healthcare Conference on Thursday, November 19 (Press release, GlycoMimetics, NOV 10, 2020, View Source [SID1234570480]). Both presentations will be available on the Company’s website, under the Investors tab. Details are as follows:

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Stifel 2020 Virtual Healthcare Conference
November 16-18, 2020
GlycoMimetics presentation: Tuesday, November 17, 8:00 a.m. (EST)

Jefferies Virtual London Healthcare Conference
November 17-19, 2020
GlycoMimetics presentation: Thursday, November 19, 6:45 – 7:15 (BST)

On November 10, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its financial results for the third quarter ended September 30, 2020 (Press release, Curis, NOV 10, 2020, View Source [SID1234570479]).

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"We have continued to advance our clinical programs towards important catalysts at the end of this year and into 2021, which we expect to be another important year of data for Curis," said James Dentzer, President and Chief Executive Officer of Curis. "We have been pleased with the enrollment progress of our first-in-class IRAK4 inhibitor, CA-4948, in a Phase 1 study in patients with non-Hodgkin’s lymphoma (NHL), and we look forward to providing an update at ASH (Free ASH Whitepaper). We began a second Phase 1 study for patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS) and we are pleased to announce today a CRADA with the NCI for further development of CA-4948 as an anti-cancer agent. We also look forward to initiating our Phase 1 combination study evaluating CA-4948 and the BTK inhibitor, ibrutinib, in patients with NHL, including those with MYD88 altered disease."

Mr. Dentzer continued, "We also initiated patient dosing during the third quarter in our VISTA program, CI-8993, in the Phase 1a/1b study for patients with relapsed / refractory solid tumors. We are excited about our rapid progress from IND approval to patient dosing in this study and look forward to providing more updates over the coming quarters."

Third Quarter 2020 and Recent Operational Highlights

Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene collaboration):

Curis is evaluating CA-4948 in an ongoing Phase 1 dose-escalation study for the treatment of patients with R/R NHL, including patients with diffuse large B-cell lymphoma (DLBCL), Waldenström’s macroglobulinemia (WM) and oncogenic MYD88 mutations. An update of safety and efficacy data from the trial will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which is being held virtually from December 5-8, 2020.
Curis continues to enroll patients in a second open-label Phase 1 dose-escalation study of CA-4948 in patients with R/R AML and high-risk MDS, including patients with spliceosome mutations that drive expression of the long isoform of IRAK4 (IRAK4-L). The primary objective of the study is to determine the maximum tolerated dose and recommended Phase 2 dose of CA-4948 based on safety and tolerability, dose-limiting toxicities (DLTs), and pharmacokinetic and pharmacodynamic findings. A minimum of three patients will be enrolled at each dose level, starting with 200 mg BID, which was determined to be safe, capable of achieving relevant levels of drug exposure, and demonstrated signs of biologic activity and clinical efficacy in a separate, ongoing Phase 1 study. Initial data from the study will be presented in a Trial in Progress poster at ASH (Free ASH Whitepaper).
Today, Curis announced that it entered into a CRADA with the NCI’s Experimental Therapeutics Program for the development of CA-4948. Under the agreement, the NCI and Curis will collaborate on the non-clinical and clinical development of Curis’s proprietary compound CA-4948, an IRAK-4 kinase inhibitor that acts as a Toll-like Receptor (TLR) suppressor as an anti-cancer agent.
Curis expects to initiate a Phase 1 study evaluating CA-4948 in combination with ibrutinib, a BTK inhibitor. In preclinical models, CA-4948 has demonstrated anti-cancer activity that is highly synergistic with BTK inhibition. The Company will present a Trial in Progress poster at ASH (Free ASH Whitepaper).
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext collaboration):

Curis initiated patient dosing in Q3 in a Phase 1a/1b study of CI-8993 in patients with relapsed / refractory solid tumors.
Curis will present a Trial in Progress poster on CI-8993 at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting, which is being held virtually from November 9-14, 2020.
Corporate:

As of November 3, 2020, extended cash runway through the second quarter of 2021, as a result of aggregate proceeds of approximately $10.0M since June 30, 2020 from the Company’s at-the-market sales agreement with JonesTrading and stock purchase agreement with Aspire Capital.
Upcoming 2020 Planned Milestones

Declare the recommended Phase 2 dose for CA-4948 in the ongoing lymphoma Phase 1 study and report updated efficacy data from the study later this quarter.
Report initial data later this quarter from the Phase 1 study of CA-4948 in patients with AML/MDS, including patients with spliceosome mutations that encode oncogenic IRAK4-L.
Continue enrollment in Phase 1a/1b dose escalation study of CI-8993 in patients with relapsed / refractory solid tumors.
Initiate Phase 1 study of CA-4948 in combination with ibrutinib.
Third Quarter 2020 Financial Results

For the third quarter of 2020, Curis reported a net loss of $6.0 million, or $0.11 per share on both a basic and diluted basis, as compared to a net loss of $6.4 million, or $0.19 per share on both a basic and diluted basis, for the same period in 2019. Curis reported a net loss of $22.4 million, or $0.52 per share on both a basic and diluted basis, for the nine months ended September 30, 2020 as compared to a net loss of $23.5 million, or $0.71 per share on both a basic and diluted basis for the same period in 2019.

Revenues for the third quarter of 2020 were $2.7 million, as compared to $2.9 million for the same period in 2019. Revenues for the nine months ended September 30, 2020 were $7.8 million, as compared to $6.7 million for the same period in 2019. Revenues for all periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.

Operating expenses for the third quarter of 2020 were $7.5 million, as compared to $8.2 million for the same period in 2019. Operating expenses for the nine months ended September 30, 2020 were $26.4 million, as compared to $23.7 million for the same period in 2019, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were stable at $0.1 million for the third quarter of 2020, as compared to $0.1 million for the same period in 2019. Cost of royalty revenues for the nine months ended September 30, 2020 were $0.4 million, as compared to $0.3 million for the same period in 2019.

Research and Development Expenses. Research and development expenses were $4.7 million for the third quarter of 2020, as compared to $5.1 million for the same period in 2019. The decrease in research and development expenses for the quarter is primarily attributable to reduced clinical trial costs related to CA-170 and fimepinostat. Research and development expenses were $17.5 million for the nine months ended September 30, 2020, as compared to $14.8 million for the same period in 2019.

General and Administrative Expenses (G&A). General and administrative expenses were $2.6 million for the third quarter of 2020, as compared to $2.9 million for the same period in 2019. The decrease was driven primarily by lower personnel and stock-based compensation costs partially offset by higher legal, professional and consulting services costs. General and administrative expenses were $8.6 million for the nine months ended September 30, 2020, as compared to $8.6 million for the same period in 2019.

Other expense, net. Net other expense was $1.3 million for the third quarter of 2020, as compared to $1.1 million for the same period in 2019. Net other expense for the third quarter 2020 primarily consisted of imputed interest expense related to future royalty payments. Net other expense was $3.8 million for the nine months ended September 30, 2020, as compared to $6.5 million for the same period in 2019.

As of September 30, 2020, Curis’ cash, cash equivalents, marketable securities and investments totaled $23.6 million and there were approximately 56.7 million shares of common stock outstanding. Curis expects that its existing cash, cash equivalents and investments should enable it to maintain its planned operations through the second quarter of 2021.

Conference Call Information

Curis management will host a conference call today, November 10, 2020, at 4:30 p.m. ET, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.