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Conatus Pharmaceuticals Reports First Quarter 2019 Financial Results and Program Updates

On May 2, 2019 Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) reported financial results for the first quarter ended March 31, 2019, and provided updates on its development programs (Press release, Conatus Pharmaceuticals, MAY 2, 2019, View Source [SID1234535611]).

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Program Updates
The company is currently conducting two double-blind, placebo-controlled Phase 2b clinical trials in collaboration with Novartis – the EmricasaN, a Caspase inhibitOR, for Evaluation (ENCORE) trials, designed to evaluate emricasan, a first-in-class pan-caspase inhibitor, in patients with liver cirrhosis caused by nonalcoholic steatohepatitis (NASH).

The ENCORE-LF (for Liver Function) clinical trial, initiated in the second quarter of 2017, has enrolled approximately 210 patients with stable decompensated NASH cirrhosis. The primary endpoint is event-free survival, which is a composite of all-cause mortality, new decompensation events, or ≥4 points progression in Model for End-stage Liver Disease (MELD) score. Enrollment was completed in the first quarter of 2019. Top-line results triggered by reaching a prespecified number of events are expected in mid-2019.

The ENCORE-PH (for Portal Hypertension) clinical trial, initiated in the fourth quarter of 2016, enrolled 263 patients with compensated or early decompensated NASH cirrhosis and severe portal hypertension. The trial’s primary endpoint was change in mean hepatic venous pressure gradient (HVPG) from baseline to Week 24 in any of three emricasan dosing groups compared with placebo. Top-line results were reported in December 2018 showing HVPG trends consistently favoring emricasan compared with placebo in the overall population but not meeting the primary endpoint. The greatest improvement was observed in patients with a baseline HVPG of 16 mmHg or higher.

Week 24 results from the ENCORE-PH clinical trial were detailed in a late-breaker oral presentation at The International Liver Congress 2019, the Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria, on April 13, 2019. The associated abstract was also selected by EASL for inclusion in the "Best of ILC" summary slide deck highlighting the most noteworthy contributions to the scientific program at this year’s meeting. A copy of the presentation is available in the Investors section of the Conatus website at www.conatuspharma.com.

Patients had the option to continue on their assigned doses of treatment or placebo in a double-blind 24-week extension period. Results following the extension period are expected in mid-2019 and will include longer term safety, liver function and clinical outcomes, but there will be no additional HVPG measurements.
During the first quarter of 2019, the company announced top-line results from a third double-blind, placebo-controlled Phase 2b clinical trial, the ENCORE-NF (for NASH Fibrosis) clinical trial in patients with biopsy-confirmed NASH and liver fibrosis. The trial’s primary endpoint was a ≥1 CRN fibrosis stage improvement with no worsening of steatohepatitis compared with placebo at week 72. The trial did not meet the primary endpoint.

The company announced in March 2019 the selection of its first internally developed product candidate, CTS-2090, an orally active inhibitor of caspase 1. Caspase 1 occupies a uniquely central position in the NLRP3 inflammasome pathway and blocks activation of the potent inflammatory cytokine IL-1β. Blocking IL-1β is a clinically validated approach to treating inflammatory diseases, with several injectable biologic products using that mechanism of action already on the market. CTS-2090 is currently in preclinical development and IND-enabling studies, with an initial clinical trial planned to begin by the first half of 2020. The company plans to pursue rare autoinflammatory diseases as initial clinical targets for CTS-2090.

Financial Results
The net loss was $4.7 million for the first quarter of 2019 compared with a net loss of $5.0 million for the first quarter of 2018.

Total revenues were $7.0 million for the first quarter of 2019 compared with $9.7 million for the first quarter of 2018. Total revenues consisted of collaboration revenues related to the Novartis agreement. The decrease in total revenues was primarily due to lower emricasan-related research and development expenses resulting in corresponding lower revenues related to the Novartis agreement.

Research and development expenses were $9.4 million for the first quarter of 2019 compared with $12.1 million for the first quarter of 2018. The decrease in research and development expenses was primarily due to lower spending related to the ENCORE-PH clinical trial and manufacturing activities, partially offset by higher spending related to the ENCORE-LF clinical trial.

General and administrative expenses were $2.6 million for the first quarter of 2019 compared with $2.7 million for the first quarter of 2018.

Cash, cash equivalents and marketable securities were $33.8 million at March 31, 2019, compared with $40.7 million at December 31, 2018, and a projected year-end 2019 balance, without including any potential milestone payments under the Novartis collaboration, of between $10 million and $15 million.

Coherus BioSciences Management to Present at Two Upcoming Investor Healthcare Conferences

On May 2, 2019 Coherus BioSciences, Inc. (Nasdaq: CHRS), reported that senior management will present at two upcoming investor healthcare conferences (Press release, Coherus Biosciences, MAY 2, 2019, View Source [SID1234535610]).

Management will deliver a company presentation at the Bank of America Merrill Lynch Global Healthcare Conference 2019 on Wednesday, May 15th at 4:35 p.m. PT taking place in Las Vegas, Nevada.
Management will deliver a company presentation at the 2019 RBC Capital Markets Global Healthcare Conference on Tuesday, May 21st at 2:35 p.m. ET taking place in New York, New York.
The audio portion of the presentations will be available on the investors page of the Coherus BioSciences website at View Source

Anixa Biosciences to Present at B. Riley FBR Institutional Investor Conference

On May 2, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, reported that it will be presenting at the 20th Annual B. Riley FBR Institutional Investor Conference to be held May 22–23, 2019, at the Beverly Hilton Hotel in Beverly Hills, CA (Press release, Anixa Biosciences, MAY 2, 2019, View Source [SID1234535609]). Dr. Amit Kumar, Chairman, President and CEO of Anixa, will be presenting, as well as meeting with investors.

Anixa’s presentation will be live webcast at 8:30 a.m. PDT/11:30 a.m. EDT on May 23, 2019. Please register at www.wsw.com/webcast/brileyfbr3/anix to view the live webcast. A recording of the presentation will be available on Anixa’s website after the conclusion of the conference. The recording will be available for 90 days.

Adaptimmune to Present Data Demonstrating that its Off-the-shelf Process Produces T-cells from Stem Cells that Respond to Cancer Targets with a SPEAR TCR at ASGCT Meeting

On May 2, 2019 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that it will present new and compelling data during an oral presentation about its off-the-shelf SPEAR T-cell program at the annual American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) meeting (Press release, Adaptimmune, MAY 2, 2019, View Source;p=RssLanding&cat=news&id=2396799 [SID1234535607]). Data indicate that T-cells can be generated from Human Induced Pluripotent Stem Cells (hiPSC) in vitro and that these T-cells respond to cancer targets via engineered SPEAR TCRs. This process will be used to investigate the ability of this off-the-shelf SPEAR T-cell product to fight cancer.

"Our three autologous SPEAR T-cell therapies are already in the clinic and have the potential to treat cancer in multiple solid tumor indications," said Rafael Amado, Adaptimmune’s President of R&D. "Beyond the promise of our current autologous therapies, this allogeneic approach – or more simply ‘off-the-shelf’ product – could offer treatment to more patients more quickly, and provide a homogeneous and unlimited source of therapeutic cells. We are thrilled with the progress we have made, both in the gene editing space with our partners at Universal Cells and with our internal T-cell differentiation program."

During an oral presentation scheduled for 11:30 AM ET today at the ASGCT (Free ASGCT Whitepaper) Annual Meeting, Dr. Jo Brewer, Adaptimmune’s Vice President of Allogeneic Research, will present progress to-date with Adaptimmune’s off‑the-shelf SPEAR T-cell program:

Adaptimmune has demonstrated hiPSC differentiation in a serum-free process without the addition of mouse stromal cells, which is designed to enable scale-up and GMP manufacture of a gene-edited off-the-shelf SPEAR T-cell product
Lentiviral transduction of T-cells derived from hiPSCs with a SPEAR TCR produces differentiated T-cells that can respond to cancer targets in vitro
The process starts with an hiPSC line, before the cells are rendered invisible to the host immune system with a series of Recombinant Adeno-Associated Virus (rAAV)-based gene-editing steps (the editing will be performed in association with Universal Cells, an Astellas Company)
The process has been shown to promote differentiation of cells from a pluripotent state (SSEA4+Oct4+TRA-160+) through various intermediate stages: CD34+CD45+ hematopoietic progenitor cells (HPC), pro-/pre-T CD7+CD5+cells, and CD4+CD8+ double positive cells towards CD3+CD8+TCR+ single positive T-cells

Zymeworks Reports 2019 First Quarter Financial Results

On May 2, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported financial results for the first quarter ended March 31, 2019 (Press release, Zymeworks, MAY 2, 2019, View Source [SID1234535590]).

"We are pleased to have advanced both of our lead assets to the next stages of clinical development; recently commencing a Phase 2 study for ZW25 and starting enrollment in the Phase 1 clinical trial for our antibody-drug conjugate, ZW49," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "Accordingly, we have also expanded our leadership team, adding experienced executives with critical competencies needed to facilitate the development and approval of our clinical-stage assets. We believe we are now well-positioned to deliver on our ambitious clinical goals throughout 2019 and beyond."

First Quarter 2019 Business Highlights and Recent Developments

Phase 2 Clinical Trial Begins for ZW25 in First-Line HER2-Expressing Metastatic Gastroesophageal Cancers
The Phase 2 trial is evaluating ZW25 in combination with standard of care (SOC) chemotherapy for the first-line treatment of HER2-positive metastatic gastroesophageal cancers. This trial is intended to support a potential first-line registrational trial and could position ZW25 as a new SOC.
Phase 1 ZW49 Clinical Study Open and Enrolling Patients
Enrollment is underway in the United States for the Phase 1 clinical trial of ZW49, Zymeworks’ novel bispecific HER2-targeted antibody-drug conjugate. The objectives of this study are to evaluate safety and early anti-tumor activity as well as establish a recommended dose for future clinical trials.
Three Experienced Development Executives Added to Management Team
Zymeworks expanded its leadership team and added key functional expertise to support the development of its maturing clinical pipeline. The newly created positions include Neil Josephson, M.D., Vice President, Clinical Research; Bruce Hart, Ph.D., Vice President, Regulatory Affairs; and Mark Hollywood, Senior Vice President, Technical and Manufacturing Operations.
Eli Lilly and Daiichi Sankyo Programs Advance Toward Clinical Testing
Zymeworks’ partner, Eli Lilly, filed an Investigational New Drug Application for its second Azymetric program, triggering a US$8.0 million payment to Zymeworks. In addition, Daiichi Sankyo recently exercised its option for a commercial license to an immuno-oncology bispecific built using Zymeworks’ Azymetric and EFECT platforms. Zymeworks will receive a US$3.5 million payment.
Financial Results for the Quarter Ended March 31, 2019

Revenue for the three months ended March 31, 2019 was $11.9 million as compared to $0.04 million in the same period of 2018. Revenue for 2019 includes an $8.0 million development milestone payment upon Lilly’s submission of an investigational new drug application, $3.5 million of recognized deferred revenue from our licensing and collaboration agreement with BeiGene, as well as $0.4 million in other research support payments. Revenue for the same period in 2018 was $0.04 million, consisting of research support payments.

For the three months ended March 31, 2019, research and development expenses were $17.5 million as compared to $13.1 million in the first three months of the prior year. The change was primarily due to an increase in clinical trial activity and associated drug manufacturing costs for ZW25, as well as an increase in other research and discovery activities as compared to the same period in 2018. Research and development expenses also included non-cash stock-based compensation expense of $1.1 million from equity classified equity awards and $0.4 million expense related to the non-cash mark-to-market revaluation of certain historical liability classified equity awards.

For the three months ended March 31, 2019, general and administrative expenses were $9.0 million as compared to $7.1 million in the first quarter of 2018. The change was primarily due to an increase in employee compensation expenses from increased head count in 2019 over 2018, including non-cash stock-based compensation, as well as other increases in professional fees associated with year-over-year corporate growth. General and administrative expenses included non-cash stock-based compensation expense of $1.5 million from equity classified equity awards and $1.3 million expense related to the non-cash mark-to-market revaluation of certain historical liability classified equity awards.

The net loss for the three months ended March 31, 2019, was $13.6 million as compared to $21.2 million in the same period of 2018. This was primarily due to increased revenue, interest income and 2018 warrant valuation expense, which was not relevant for 2019, that offset an increase in research and development expenses associated with our lead therapeutic candidates and other programs as well as general and administrative expenses.

Zymeworks expects research and development expenditures to increase over time in line with the advancement and expansion of the Company’s clinical development of its product candidates, as well as its ongoing preclinical research activities. Additionally, Zymeworks anticipates continuing to receive revenue from its existing and future strategic partnerships, including technology access fees and milestone-based payments. However, Zymeworks’ ability to receive these payments is dependent upon either Zymeworks or its collaborators successfully completing specified research and development activities.

As of March 31, 2019, Zymeworks had $180.3 million in cash and cash equivalents and short-term investments.