On November 6, 2017 XOMA Corporation (Nasdaq:XOMA), a pioneer in the discovery, development and licensing of therapeutic antibodies, reported its third quarter 2017 financial results and recent business highlights (Press release, Xoma, NOV 6, 2017, View Source [SID1234521612]).

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“We made significant progress on multiple fronts executing our new business strategy, and in doing so we completely transformed the Company. The highlight events were clearly the license agreements we secured for both gevokizumab and our IL-1 beta intellectual property portfolio with Novartis. Our strategy was further reinforced with new license agreements for use of our proprietary phage display libraries for antibody discovery. We also received milestone payments from our extensive portfolio of partner-funded programs,” stated Jim Neal, Chief Executive Officer of XOMA. “These third quarter transactions have resulted in a completely revamped balance sheet and multiple years of projected cash runway. With more than two dozen partner-funded programs that have the potential to generate substantial additional milestone and royalty payments, we are very well positioned to deliver sustained growth in the years ahead and create long-term value for shareholders.”

Recent Business Highlights

XOMA made important progress positioning the Company for long-term strategic success:

Licensing the global commercial rights to gevokizumab, a novel anti-IL-1 beta allosteric monoclonal antibody, to Novartis. In a separate agreement, XOMA granted Novartis a license to its intellectual property covering the use of IL-1 beta targeting antibodies in the treatment of cardiovascular disease. Under these agreements, XOMA received $31 million in cash payments, including a $5 million equity investment. The Company is eligible to receive up to $438 million in development, regulatory and commercial milestones plus tiered high-single to mid-double-digit royalties on net sales of gevokizumab. XOMA is also eligible to receive low-single-digit royalties on canakinumab sales in cardiovascular indications, rising to mid-single-digit royalties under certain circumstances. In addition to the upfront payments, Novartis also settled XOMA’s €12 million debt to Servier, and extended the maturity date on the Company’s debt to Novartis from September 2020 to September 2022.
Entering into new non-exclusive license agreements with three separate companies, Tizona Therapeutics, Inc., Torch Biosciences, Inc., and LakePharma, for use of XOMA’s proprietary phage display libraries for antibody discovery. Under these agreements, the Company is eligible to receive development and regulatory milestone payments plus single-digit royalties on net sales of products.
Earning a $3 million milestone payment related to the clinical advancement of an anti-botulism product candidate the Company licensed to Nanotherapeutics, Inc., in 2015. In September 2017, XOMA received an initial cash payment of $250,000 related to the milestone. The remaining amounts of the milestone payment will be received in monthly payments over the next eleven months. If the product candidate advances from its current stage of development to production and stockpiling by governmental agencies, XOMA is eligible to receive a 15 percent royalty on net sales.
Continuing implementation of the Company’s previously announced aggressive corporate cost reduction plan.
Financial Results

XOMA recorded total revenues of $36.2 million for the third quarter of 2017, compared to $0.6 million for the third quarter of 2016. The increase in revenues for the third quarter of 2017 was due primarily to upfront payments received relating to the Company’s license agreements with Novartis in August 2017.

Research and development (R&D) expenses were $0.3 million for the third quarter of 2017, compared to $8.7 million for the third quarter of 2016. The decrease in R&D expenses for the third quarter of 2017 was due primarily to reductions of $3.5 million in salaries and related expenses, $1.8 million in external manufacturing activities, $1.2 million in the allocation of facilities and information technology costs, $0.9 million in clinical trial costs, and $0.4 million in consulting costs. The decrease in external manufacturing costs included a one-time adjustment of $0.7 million to reverse the cost of a batch of drug material that did not meet quality standards. The significant reduction in R&D spending year-over-year is a result of the execution of the Company’s corporate strategy of leveraging its extensive portfolio of partnered programs and licensed technologies.

General and administrative (G&A) expenses were $7.3 million for the third quarter of 2017, compared to $4.1 million for the third quarter of 2016. G&A expenses for the three months ended September 30, 2017, included increases of $1.9 million in consulting services primarily related to the Company’s license agreements with Novartis, $1.0 million in the allocation of facilities and information technology costs due to a greater proportion of general and administrative personnel after the Company’s restructuring activities, and $1.0 million in stock compensation cost, partially offset by a $0.6 million decrease in salaries and benefits.

Net income for the third quarter of 2017 was $26.3 million, compared to net loss of $12.5 million for the third quarter of 2016. The significant net income for the third quarter of 2017 was due primarily to the increase in total revenues previously discussed.

On September 30, 2017, XOMA had cash and cash equivalents of $47.7 million. The Company ended December 31, 2016, with cash and cash equivalents of $25.7 million. The Company’s current cash and cash equivalents are expected to be sufficient to fund its operations for multiple years.

On November 6, 2017 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company developing new gene and cell-based immunotherapies for cancer, reported its financial results for the third quarter ended Sept. 30, 2017, and provided an update on plans to initiate a pivotal trial in brain cancer, progress with its chimeric antigen receptor (CAR) T cell Phase 1 trials and expectations for a Phase 1 trial in solid tumors to be conducted at the National Cancer Institute (NCI) (Press release, Ziopharm, NOV 6, 2017, View Source [SID1234521613]).

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“At ZIOPHARM, we remain focused on fully realizing the potential of immunotherapy by focusing on cost, complexity, and control to overcome the barriers of price and manufacturing,” said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM Oncology.

Dr. Cooper continued, “With the Sleeping Beauty system, we are genetically modifying T cells with chimeric antigen receptors and T-cell receptors to target hematologic cancers and solid tumors with rapid and cost-efficient manufacturing in a matter of days, not weeks. Based on preclinical and clinical data we have generated over the last two years, which we are excited to share at ASH (Free ASH Whitepaper) 2017, we will undertake clinical trials in the coming year manufacturing T-cell therapies in less than two days under point-of-care.”

He added, “We also are excited about initiating pivotal and combination trials as we develop Ad-RTS-hIL-12 plus veledimex to treat brain cancer. Our demonstrated ability to safely control interleukin-12 to stimulate an immune anti-tumor response in the brain under control of the RheoSwitch has shown a survival benefit compared to historical controls in patients who have failed multiple lines of therapy, all of which energizes us to bring this much needed therapeutic option to patients as soon as possible.”

Program Updates

Ad-RTS-hIL-12 plus veledimex for gliomas

ZIOPHARM is advancing Ad-RTS-hIL-12 plus veledimex as a gene therapy to treat patients with recurrent glioblastoma (rGBM). Ad-RTS-hIL-12 is an adenoviral vector administered via a single injection into the tumor and engineered to express human IL-12, a powerful cytokine that has demonstrated a targeted, anti-tumor immune response. The expression of hIL-12 is controlled and modulated with the RheoSwitch Therapeutic System (RTS) by the small molecule veledimex, an activator ligand which crosses the blood-brain barrier.

Initiation of Pivotal Trial in rGBM to Begin by End of 2017 – ZIOPHARM will initiate a pivotal trial for Ad-RTS-hIL-12 plus veledimex for the treatment of rGBM by the end of 2017. Based on guidance from U.S. and European regulatory authorities relative to a registration trial, as well as feedback from key opinion leaders and other stakeholders, the Company has decided to move forward with a randomized control trial. The Company remains in active discussions with potential partners in further development of this asset.

Initiation of Combination Trial with Checkpoint Inhibitor in rGBM to Begin by End of 2017 – ZIOPHARM will initiate a trial of adult patients with rGBM who will receive a single dose of Ad-RTS-hIL-12 plus veledimex in combination with a checkpoint inhibitor targeting programmed cell death protein 1 (PD-1) by the end of 2017.

Announced Initiation of Phase 1 for Pediatric Tumors — Subsequent to the initiation of a Phase 1 study to evaluate the stereotactic administration of Ad-RTS-hIL-12 plus veledimex in adult patients with rGBM during the second quarter, ZIOPHARM recently began a new Phase 1 study of Ad-RTS-hIL-12 with veledimex for the treatment of pediatric brain tumors and is recruiting patients.

Announced Four Presentation Abstracts at the 2017 Annual Meeting of the Society for Neuro-Oncology – The Company will provide an update to survival of patients and associated correlative studies from the Phase 1 trial during the 22nd Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO). The meeting will be held Nov. 16 – 19 in San Francisco.

At the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June, the Company reported encouraging results from its multi-center Phase 1 trial evaluating Ad-RTS-hIL-12 plus veledimex following craniotomy. The median overall survival (mOS) for patients receiving 20 mg of veledimex was 12.5 months, which compared favorably to historical controls. Additional data from this trial also shows three lines of evidence supporting potential efficacy:

Patients who received low-dose systemic corticosteroids for post-operative management have a much better survival rate than those who received higher doses of corticosteroids, as the latter presumably interferes with immune activation; and
mOS appears directly correlated to an increased ratio of CD8+/FOXP3+ (effector/suppressor) T cells measured in peripheral blood which is consistent with IL-12-mediated cellular immune activation; and
Biopsies of three patients many weeks after completion of veledimex showed infiltration of CD8+ T cells which is attributed to the effects of IL-12, as well as evidence of the imaging phenomenon known as pseudo-progression.
Advancing CAR T Therapies to Point-of-Care

ZIOPHARM is developing novel adoptive cell-based therapies, including chimeric antigen receptor (CAR) T-cell therapies, with a unique focus on developing scalable, efficient technologies to overcome the high costs that come with manufacturing using virus to genetically program T cells.

Announced Abstracts Accepted for Presentation at the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting – In investigator-led studies conducted at MD Anderson Cancer Center, ZIOPHARM has used DNA plasmids from first- and second-generation Sleeping Beauty (SB) system to express CAR in clinical trials to render T cells specific for CD19. The first-generation trials yielded safety and efficacy data from treating patients with non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL). The ongoing second-generation trial, which was designed to refine the CAR and manufacturing processes, infuses CD19-specific CAR+ T cells in patients with advanced lymphoid malignancies after lymphodepleting chemotherapy. With this second-generation trial, the Company is testing the revised CAR design, shortening the manufacturing process to two weeks, and establishing continued safety of SB-modified T cells in patients.

These two trials support the Company’s plans to undertake the very rapid production of T cells under technology referred to as “point-of-care” (P-O-C). The Company expects to stop enrollment in the second-generation study in 2018 when it initiates the third-generation study to leverage SB to manufacture CAR+ T cells co-expressing a membrane-bound version of the cytokine interleukin (IL)-15, or mbIL15, in less than two days.

Posters to be presented at the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH) (Free ASH Whitepaper) include:

Updates on patients enrolled in the first- and second-generation trials featuring response, survival data, and persistence of infused CAR+ T cells;
Further preclinical in vitro and in vivo data for the P-O-C technology to generate clinical-grade CD19-specific T cells will be presented at ASH (Free ASH Whitepaper).
Update on the Company’s ongoing Phase 1 study of CD33-specific CAR+ T-cell therapy for treatment of relapsed or refractory acute myeloid leukemia, or AML.
Update on the genetic engineering of regulatory T cells for the treatment of graft-versus-host-disease.
T-Cell Receptors Targeting Neoantigens

The Company is developing genetically modified T-cell receptors (TCRs) using SB to treat solid tumor targets under a Cooperative Research and Development Agreement (CRADA), with the National Cancer Institute (NCI). Preparations are underway at the NCI for a clinical trial to evaluate adoptive cell transfer using the Company’s non-viral system to express tumor-specific TCRs that recognize specific immunogenic mutations, or neoantigens.

Anticipate Filing of IND under CRADA with NCI in First Quarter of 2018 – Research conducted under the CRADA is under the direction of Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NCI. The Company expects that once ongoing validation of the manufacturing process at NCI is complete, an Investigational New Drug application to open a Phase 1 trial will be filed with the U.S. Food and Drug Administration (FDA) in the first quarter of 2018.

Corporate Update

Today, the Company also announced that effective as of November 6, 2017, Dr. David Mauney will serve as the Company’s Chief Operating Officer on an interim basis, in addition to his current role as the Company’s Executive Vice President and Chief Business Officer. Effective as of the same date, Caesar J. Belbel will no longer serve as the Company’s Chief Operating Officer. He will continue to serve as the Company’s Executive Vice President, Chief Legal Officer and Secretary.

Third-Quarter 2017 Financial Results

Net loss applicable to the common shareholders for the third quarter of 2017 was $17.6 million, or $(0.13) per share, compared to a net loss of $14.4 million, or $(0.11) per share, for the third quarter of 2016. The increase is primarily due to an increase in operating expenses of $2.2 million and an increase of $1.3 million related to the value of preferred stock dividends.

Research and development expenses were $11.1 million for the third quarter of 2017, compared to $9.0 million for the third quarter of 2016. The increase in research and development expenses for the three months ended September 30, 2017 is primarily due to expanded development in our gene and cell therapy programs.

General and administrative expenses were $3.6 million for the third quarter of 2017, compared to $3.5 million for the third quarter of 2016.

The Company ended the quarter with unrestricted cash resources of approximately $84.4 million.

As part of our strategic co-development activities at MD Anderson Cancer Center, a prepayment of approximately $29.4 million remains for programs to be conducted by the Company at MD Anderson Cancer Center under the current Research and Development Agreement.

The Company believes its current resources will be sufficient to fund its currently planned operations into the fourth quarter of 2018.
Conference Call and Slide Webcast

ZIOPHARM will host a conference call and webcast slide presentation today, Nov. 6, at 4:30 p.m. ET. The call can be accessed by dialing 1-844-309-0618 (U.S. and Canada) or 1-661-378-9465 (international). The passcode for the conference call is 8769629. To access the slides and live audio webcast, or the subsequent archived recording, visit the “Investors & Media” section of the ZIOPHARM website at www.ziopharm.com. The webcast will be recorded and available for replay on the Company’s website for two weeks.

On November 6, 2017 RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary drugs for gastrointestinal and inflammatory diseases and cancer, reported that it will report its third quarter 2017 financial results on Monday, November 13, 2017 (Press release, RedHill Biopharma, NOV 6, 2017, View Source [SID1234521588]).

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The Company will host a conference call on Monday, November 13, 2017, at 9:00 am EST to review the financial results and business highlights.

To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-877-280-2296; International: +1-212-444-0896; and Israel: +972-3-763-0147. The access code for the call is: 2543708.

The conference call will be broadcasted live and available for replay on the Company’s website, View Source, for 30 days. Please access the Company’s website at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

On November 6, 2017 OncoCyte Corporation (NYSE American:OCX), a developer of novel, non-invasive blood based tests for the early detection of cancer, reported 14, 2017, after the close of the U.S. financial markets (Press release, BioTime, NOV 6, 2017, View Source [SID1234521579]). The Company will host a conference call on Tuesday, November 14, 2017, at 4:30 p.m. ET / 1:30 p.m. PT to discuss the results along with recent corporate developments.

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The dial-in number in the U.S./Canada is 888-542-1102, for international participants the number is 719-325-2356. For all callers, refer to Conference ID 1817036. To access the live webcast, go to the investor relations section on the company’s website, View Source

A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling 888-203-1112 toll-free (from U.S./Canada); international callers dial 719-457-0820. Use the Conference ID 1817036. Additionally, the archived webcast will be available View Source

On November 6, 2017 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported that it will deliver pre-clinical data on its Combination Pan-antigen Cytotoxic Therapy (ComPACT) platform on November 11, 2017, at the 32nd annual Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, Heat Biologics, NOV 6, 2017, View Source [SID1234521582]).

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The poster, Gp96-IG/costimulatory Combination Vaccine Improves T-cell Priming and Enhances Immunity, Memory, and Tumor Elimination, will be presented by Louis E. Gonzalez, Ph.D., director of research and principal scientist for Heat. He is available for discussion from 12:30 p.m. – 2 p.m. and 6:30 p.m. – 8 p.m. on Saturday, Nov. 11, 2017.

ComPACT is Heat’s next generation, T-cell Activation Platform (TCAP). It combines T-cell activation and co-stimulation in a single therapy by both delivering the gp96 heat shock protein and a T-cell co-stimulatory fusion protein (OX40L) in a single compound.