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.

On November 10, 2020 HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company whose mission is to advance precision medicine, reported its financial results for the quarter ended September 30, 2020 (Press release, HTG Molecular Diagnostics, NOV 10, 2020, View Source [SID1234570484]).

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Recent Business Highlights

Released HTG EdgeSeq Reveal version 3.0, adding additional software functionalities, including analytic capabilities for use with HTG’s entire RUO profiling assay menu and new RUO oncology applications. HTG EdgeSeq Reveal, originally launched in January 2019, is a web-based biostatistical analysis software suite designed to accelerate customer research by streamlining statistical analysis of samples processed with HTG’s RUO profiling assays.

Entered into a 10-year Commercialization and Distribution Agreement (Master Agreement) with QIAGEN Manchester Limited (QIAGEN), providing the foundation for HTG and QIAGEN to combine their technological and commercial strengths with the goal to offer pharmaceutical companies global development, distribution and commercialization capabilities for companion diagnostic assays developed on the HTG EdgeSeq platform.
"As the impact of COVID-19 placed continued pressure on our core oncology business, including planned studies and laboratory operations of our customers in the third quarter of 2020, we continued to make strategic shifts in our business into areas less impacted by the pandemic," said John Lubniewski, President and CEO of HTG. "We also believe strategic adjustments made over the past several months to lessen the impact of COVID-19 on our business are working. These efforts have focused on customer diversification to include a larger number of smaller and mid-sized biopharma customers and academic medical centers who have shown signs of returning to work more quickly than our larger customers. We are also targeting the large immune response market, which is often a new call point with our current customer base. Immune response target markets include, but are not limited to, autoimmune disorder and infectious disease. The ultimate impact of COVID-19 remains uncertain, but we are seeing positive trends in non-oncology opportunities and believe direct revenue from our core oncology business will begin to recover to pre-COVID levels in the first half of next year."

Mr. Lubniewski continued, "Our product development team continued to perform on our key milestones during the quarter. We have produced our first white paper on technical feasibility for our approximately 20,000 gene whole transcriptome (WTTx) HTG EdgeSeq panel, and we believe we remain on track to delivering upcoming development and commercialization milestones as well. We have positioned ourselves through careful cost savings, strategic initiatives and a continued focus on strengthening our technology to meet demand and to grow when we and our customers are able to return to normal operations."

Third Quarter 2020 Financial Highlights:

Total revenue for the quarter ended September 30, 2020 was $1.8 million, compared with $5.4 million for the same period in 2019. The decrease in revenue is a result of the impact of the COVID-19 pandemic requiring the closure of customer facilities or continuing to limit the ability of our customers to operate at pre-pandemic levels.

Product and product-related services revenue was $1.7 million for the quarter ended September 30, 2020, compared with $4.3 million for the same period in 2019. Throughout the pandemic, HTG’s ability to ship instruments and consumables to customer facilities and the ability of its customers to prepare and ship samples to HTG’s VERI/O laboratory for processing has been limited. In addition to the impacts of the COVID-19 pandemic, this decrease reflects a decline in lower margin subcontracted laboratory services revenue when compared with the third quarter of 2019.

Collaborative development services revenue for the quarter ended September 30, 2020 was $0.1 million compared with $1.1 million for the same period in 2019, reflecting the completion of remaining procedures under existing arrangements and ongoing sales efforts to identify and contract new programs in this area.

Net loss from operations for the quarter ended September 30, 2020 was $5.2 million, compared with $4.6 million for the third quarter of 2019. Net loss per share was $(0.07) for the third quarter of 2020 compared with $(0.15) for the third quarter of 2019.

Cash, cash equivalents and short-term available-for-sale securities totaled $30.5 million as of September 30, 2020, with current liabilities of approximately $6.0 million and non-current liabilities of $14.5 million.

Conference Call and Webcast:

HTG will host a conference call for the investment community today beginning at 4:30 p.m. Eastern Time. Conference call and webcast details are as follows:

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.