Atara Biotherapeutics Announces Presentations Highlighting Tab-cel® and Mesothelin-Targeted CAR T Clinical Results at American Society of Clinical Oncology (ASCO) Annual Meeting

On May 15, 2019 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported three presentations at the upcoming ASCO (Free ASCO Whitepaper) 2019 Annual Meeting, which will take place in Chicago, Illinois from May 31 to June 4, 2019 (Press release, Atara Biotherapeutics, MAY 15, 2019, View Source [SID1234536330]).

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An oral session will feature a presentation by Atara’s collaborators at Memorial Sloan Kettering Cancer Center (MSK) with additional Phase 1 clinical results for their regionally delivered autologous mesothelin-targeted chimeric antigen receptor T-cell (CAR T) immunotherapy for patients with malignant pleural mesothelioma.

Atara will also present two studies highlighting tab-cel (tabelecleucel), the Company’s product candidate in Phase 3 development for patients with Epstein-Barr virus-associated post-transplant lymphoproliferative disorder (EBV+ PTLD) as well as in earlier stage development for other EBV-associated hematologic malignancies and solid tumors.

One study describes a potential biomarker for clinical response to tab-cel in patients with Epstein-Barr virus-associated diseases. A second presentation focuses on the design of Atara’s ongoing Phase 1b/2 clinical study design of tab-cel in combination with KEYTRUDA (pembrolizumab) for patients with platinum-resistant or recurrent EBV-associated nasopharyngeal carcinoma (NPC).

Details of the presentations are as follows:

Abstract 2511: Regional delivery of mesothelin-targeted CAR T cells for pleural cancers: Safety and preliminary efficacy in combination with anti-PD-1 agent
Oral Presentation Date and Time:Tuesday, June 4, 2019, 8:36 a.m. – 8:48 a.m. CDT
Session Title: The Who, What, and Where of CAR T
Location: S406, McCormick Place, South Building, Chicago, IL
Authors:Prasad S. Adusumilli, Marjorie G Zauderer, Valerie W Rusch, Roisin E O’Cearbhaill, Amy Zhu, Daniel Ngai, Erin McGee, Navin Chintala, John Messinger, Waseem Cheema, Elizabeth F Halton, Claudia R Diamonte, John Pineda, Alain Vincent, Shanu Modi, Steve Solomon, David R Jones, Renier J Brentjens, Isabelle C Riviere, Michel W Sadelain
Affiliations:Memorial Sloan Kettering Cancer Center
Summary: Atara’s collaborators at Memorial Sloan Kettering Cancer Center (MSK) reported positive Phase 1 clinical results for their mesothelin-targeted CAR T immunotherapy for patients with solid tumors at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019. Efficacy and safety results were presented for patients with malignant pleural mesothelioma who may also have received pembrolizumab and lymphodepleting chemotherapy. Following administration of a novel mesothelin-targeted CAR T, MSK investigators observed a 72% response rate in a subset of these patients. Additional results from this study will be presented at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting.

Abstract 2532: Correlation of circulating EBV-targeted cytotoxic T lymphocyte precursors (EBV-CTLp) and clinical response following tabelecleucel (tab-cel) infusion in patients with EBV-driven disease
Poster Presentation Date and Time: Saturday, June 1, 2019, 8:00 a.m. – 11:00 a.m. CDT
Session Title: Developmental Immunotherapy and Tumor Immunobiology
Location: Poster Board 176, Hall A, McCormick Place, South Building, Chicago, IL
Authors: Blake T. Aftab, Daniel Munson, Kevin Rasor, Philippe Foubert, Donald Tsai, Wen Kai Weng, Armin Ghobadi, Koen van Besien, Yan Sun, Minoti Hiremath, Willis Navarro, Susan Prockop
Affiliations: Atara Biotherapeutics, University of Pennsylvania, Stanford University, Washington University, Cornell University, Memorial Sloan Kettering Cancer Center
Summary: Circulating EBV-CTLp were measured for patients with EBV-associated diseases following tab-cel administration. The study found a correlation between response rate and increases in EBV-CTLp and suggests EBV-CTLp levels could be used as a biomarker for clinical response to tab-cel treatment.

Abstract TPS6092: Tabelecleucel in combination with pembrolizumab (Pembro) in platinum-pretreated, recurrent/metastatic Epstein-Barr virus (EBV)-positive nasopharyngeal carcinoma (EBV+NPC)
Poster Presentation Date and Time: Saturday, June 1, 2019, 1:15 p.m. – 4:15 p.m. CDT
Session Title: Head and Neck Cancer
Location: Poster Board 79b, Hall A, McCormick Place, South Building, Chicago, IL
Authors:Lillian L. Siu, Joshua Bauml, Douglas Adkins, A. Dimitrios Colevas, Cesar Perez, Jennifer Choe, Yang Zhang, Wen Shi, Willis Navarro, Missak Haigentz Jr, Guilherme Rabinowits, David Pfister
Affiliations:Princess Margaret Cancer Centre, Perelman School of Medicine, Washington University School of Medicine, Stanford Cancer Institute, Sylvester Comprehensive Cancer Center, Duke University, Atara Biotherapeutics, Morristown Medical Center/Atlantic Health System, Miami Cancer Institute, Memorial Sloan Kettering Cancer Center
Summary: EBV-associated nasopharyngeal carcinoma (EBV+ NPC) is a solid tumor of the head and neck. Tab-cel Phase 1 EBV+ NPC clinical study results were encouraging and support ongoing development in combination with KEYTRUDA (pembrolizumab) for patients with platinum-resistant or recurrent EBV+ NPC.

Seattle Genetics to Present at RBC Capital Markets 2019 Global Healthcare Conference

On May 15, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that management will present at the RBC Capital Markets 2019 Global Healthcare Conference on Wednesday, May 22, 2019 at 8:30 a.m. Eastern Time (Press release, Seattle Genetics, MAY 15, 2019, View Source [SID1234536346]). The presentation will be webcast live and available for replay from Seattle Genetics’ website at www.seattlegenetics.com in the Investors section.

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Rakuten Medical Highlights Upcoming Presentations and Activities During the ASCO Annual Meeting, May 31 – June 4, 2019 in Chicago

On May 15, 2019 Rakuten Medical, a clinical-stage biotechnology company developing precision-targeted cancer therapies based on its proprietary photoimmunotherapy (PIT) platform, reported that it will be presenting data from its Phase 2a clinical trial focused on RM-1929 PIT in patients with locoregional, recurrent head and neck squamous cell carcinoma (rHNSCC) during the ASCO (Free ASCO Whitepaper) annual meeting, May 31 – June 4, 2019 in Chicago (Press release, Rakuten Medical, MAY 15, 2019, View Source;june-4-2019-in-chicago-300851238.html [SID1234536363]).

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In addition, study criteria and details on Rakuten Medical’s Phase 3 clinical trial of ASP-1929 PIT therapy versus physician’s choice standard-of-care for the treatment of patients with locoregional rHNSCC will also be highlighted during a poster presentation.

Details about Rakuten Medical activities throughout ASCO (Free ASCO Whitepaper) are listed below:

Poster Discussion Session

Results of a Phase 2a, multicenter, open-label, study of RM-1929 photoimmunotherapy (PIT) in patients with locoregional, recurrent head and neck squamous cell carcinoma (rHNSCC) (Abstract 6014)

Presenter:

David M. Cognetti, MD, FACS, Jefferson Center for Head and Neck Surgery at the Thomas Jefferson University Hospital, Philadelphia

Date/time:

1:15 p.m. – 4:15 p.m. CST, with discussion from 4:30 p.m. – 6 p.m. CST, Saturday, June 1, 2019

Location:

Hall A

Overview:

In this study, results are reported of a Phase 2a trial of PIT with a targeted drug, RM-1929, consisting of the EGFR-directed antibody, Cetuximab. It is conjugated to a photoactivatable dye (IRDye 700DX). Binding of the antibody-dye conjugate to cancer cells, followed by a photoactivation with non-thermal red light, induces selective and rapid necrosis of cancer cells with minimal damage to surrounding tissue.

Poster Presentation

A global Phase 3 multicenter, randomized, double-arm, open-label trial of ASP-1929 photoimmunotherapy vs. physician’s choice standard of care for the treatment of patients with locoregional, recurrent head and neck squamous cell carcinoma (rHNSCC) (Abstract TPS6094)

Presenter:

Jeannie Hou, MD, VP of Clinical Development for Rakuten Medical

Date/time:

1:15 p.m. – 4:15 p.m. CST, Saturday, June 1, 2019

Location:

Hall A

Overview:

The objective of this Phase 3 study is to evaluate the efficacy and safety of ASP-1929 (EGFR-directed antibody Cetuximab-IR700 conjugate) PIT treatment as a monotherapy in patients with locoregional rHNSCC. Patients with rHNSCC have few curative treatment options available and low response rates; therefore, new modalities that can be targeted, minimally invasive, and provide improved tumor response and control with limited side effects are needed.

Exhibit Hall

Medical Affairs Booth, Rakuten Medical

Location:

Booth #16024

Date/time:

9 a.m. – 5 p.m. CST, Saturday – Monday, June 1-3, 2019.

About Photoimmunotherapy
Photoimmunotherapy (PIT) is an investigational, anti-cancer treatment platform that is comprised of a drug and device combination that utilizes monoclonal antibodies conjugated to a dye (IRDye 700DX). Transient excitation of IRDye 700Dx with non-thermal red light (690 nm) is believed to result in anti-cancer activity, which is mediated by biophysical processes that may compromise the membrane integrity of cells. The requirement of targeted binding of antibody-IR700 conjugate to a specific antigen on the cell surface and subsequent illumination is believed to result in rapid and selective cell killing and tumor necrosis with minimal effects on surrounding normal tissue. PIT may also lead to the systemic induction of innate and adaptive immunity.

Iovance Biotherapeutics Announces Updates to Tumor Infiltrating Lymphocyte (TIL) Therapy Clinical Programs

On May 15, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported updates from ongoing clinical trials including new interim data from studies of TIL therapy LN-145 in patients with advanced cervical cancer and with TIL therapy lifileucel in advanced melanoma (Press release, Iovance Biotherapeutics, MAY 15, 2019, View Source;p=RssLanding&cat=news&id=2398790 [SID1234536387]). These data will be presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) taking place May 31 to June 4, 2019, in Chicago. In addition, the company announced that the first PD-1/PD-L1 naive patient has been dosed with TIL therapy and that it has entered into a collaboration with Genocea to evaluate the potential for an improved TIL product.

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Data from the innovaTIL-04 study in patients with recurrent, metastatic or persistent cervical cancer showed an ORR of 44 percent (1 complete response, 9 partial responses and 2 unconfirmed partial responses) and a disease control rate of 89 percent. At 3.5-month median study follow-up, 11 out of 12 patients maintained a response. The mean patient age was 47 years and study participants had experienced a mean of 2.6 prior lines of therapy. The adverse event profile was generally consistent with the underlying advanced disease and the profile of the lymphodepletion and IL-2 regimens. These data will be presented on Saturday, June 1 (Abstract #2538). As a reference, ORR for Keytruda used in second line cervical cancer patients is 14 percent.1

"As advanced cervical cancer is typically diagnosed at a relatively young age and efficacy of existing treatment options is extremely low, there is potential to significantly impact care with an option that can bring about long-term remission and complete responses," said Amir Jazaeri, M.D., innovaTIL-04 study investigator and associate professor of Gynecological Oncology and Reproductive Medicine at the MD Anderson Cancer Center. "The interim data from LN-145 present compelling evidence that TIL therapy, provided as a single administration, could improve upon current treatments."

Updated results from Cohort 2 in the ongoing innovaTIL-01 study demonstrated an ORR of 38 percent (2 complete responses, 18 partial responses and 1 unconfirmed partial response) in 55 consecutively dosed post-PD-1 patients with Stage IIIC/IV unresectable melanoma. In this study, patients were heavily pretreated, with a mean of 3.1 lines of prior therapy including anti-PD1, and had high baseline tumor burden. The disease control rate was 76 percent. At 7.4-month median follow-up, responses were maintained in the majority of patients (only 4 out of 21 responders had progressed at the time of data analysis for the abstract). These data are consistent with prior results from Cohort 2, presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2018 Annual Meeting, which demonstrated a 38 percent ORR in a subset of 47 of the 55 patients in Cohort 2. Adverse events resolved to baseline 2 weeks post TIL infusion. These data will be presented on Saturday, June 1 (Abstract #2518).

"We are pleased to be sharing our broader melanoma data and now Gen-2 cervical data at ASCO (Free ASCO Whitepaper). The data are indicative of the efficacy of TIL therapy in multiple indications. Further, we believe that TIL therapy is a platform which may offer patients with different advanced cancers a potential therapy," said Maria Fardis, Ph.D., president and chief executive officer of Iovance Biotherapeutics. "We will provide further updates, including duration of response data, at the ASCO (Free ASCO Whitepaper) meeting."

The company today also announced that first melanoma patient has been dosed in its Phase 2 IOV-COM-202 study. This represents the first instance of a patient naive to checkpoint inhibitor treatment receiving Iovance’s TIL therapy in combination with Keytruda.

"TIL therapy represents a promising approach to further advance on the gains that have been made in cancer treatment thanks to immunotherapy and combination approaches," commented Sajeve Thomas, M.D., Iovance study investigator and oncologist at the Orlando Heath UF Health Cancer Center. "We are encouraged to be part of evaluating new applications of Iovance TIL therapy with combinations and additional tumor types and look forward to the results in these areas."

IOV-COM-202 is a Phase 2 global multicenter study evaluating the safety and efficacy of Iovance autologous TIL therapy in combination with pembrolizumab in patients who have not received prior immunotherapy for treatment. The study is currently enrolling in the U.S. and Europe. Additional information on this study is available at View Source

To support efforts to improve the potency of TIL, Iovance has entered into a collaboration with Genocea to evaluate its ATLAS platform. As reported by the company at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2019 Annual Meeting, melanoma patients receiving lifileucel have a unique mutational landscape, suggesting that high mutational load solid tumors such as melanoma may benefit from treatment with a patient specific, polyclonal product such as the Iovance TIL product. The company plans to utilize the ATLAS platform to evaluate the potential for an improved TIL product.

Conference call

Management will host a conference call and live audio webcast to discuss these results on Thursday, May 16 at 8:00 a.m. EDT. To participate in the conference call, please dial 1-844-646-4465 (U.S.) or 1-615-247-0257 (international) and reference the access code 9291799. A live webcast can be accessed under "News & Events: Investor Calendar" in the Investors section of the Company’s website at www.iovance.com or at the link: View Source An archived webcast will be available in the Investors section of www.iovance.com for thirty days following the call.

Details of ASCO (Free ASCO Whitepaper) Abstracts

Abstract #2538. Amir Jazaeri et al. Safety and efficacy of adoptive cell transfer using autologous tumor infiltrating lymphocytes (LN-145) for treatment of recurrent, metastatic, or persistent cervical carcinoma. Poster display Saturday, June 1, 8:00 a.m. – 11:00 a.m. CDT.
Abstract #2518. Amod Sarnaik et al. Safety and efficacy of cryopreserved autologous tumor infiltrating lymphocyte therapy (LN-144, lifileucel) in advanced metastatic melanoma patients who progressed on multiple prior therapies including anti-PD-1. Poster display Saturday, June 1, 8:00 a.m. – 11:00 a.m. CDT; poster discussion 1:15 p.m. – 2:45 p.m. CDT.
Additional information is available at the ASCO (Free ASCO Whitepaper) website and at View Source

1View Source

DelMar Pharmaceuticals Announces Third Quarter Fiscal Year 2019 Financial Results

On May 15, 2019 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, reported its financial results for the third quarter ended March 31, 2019 (Press release, DelMar Pharmaceuticals, MAY 15, 2019, View Source [SID1234536331]). DelMar executive management will host a business update conference call for investors, analysts and other interested parties on May 23, 2019 at 4:30 p.m. Eastern Time.

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"The third quarter proved to be an important period of progress as we advanced VAL-083 in both of our Phase 2 clinical trials in GBM with encouraging early results, especially in our first line GBM trial, while continuing the evaluation of this first-in-class, small molecule’s potential to treat a range of solid tumor cancers. I am also pleased by the establishment of our formal Scientific Advisory Board led by world-renowned oncology experts," commented Saiid Zarrabian, President and Chief Executive Officer of DelMar Pharmaceuticals. "In addition, we initiated execution of our planned rights offering to provide capital to continue the advancement of our clinical trials through their estimated planned completion in mid-calendar 2020, and we executed the necessary recent reverse stock split which potentially enables us to regain compliance with Nasdaq’s listing requirements."

Key Highlights and Recent Developments

Achieved the halfway enrollment point for VAL-083’s Phase 2, open-label, first-line temozolomide-naïve, MGMT-unmethylated glioblastoma multiforme (GBM) study at Sun Yat-sen University Cancer Center (SYSUCC) with encouraging results for 11 of the initial 15 patients treated

Continued enrolling patients in VAL-083’s Phase 2, open-label, second-line, Avastin-naïve, MGMT-unmethylated, recurrent GBM study being conducted at the MD Anderson Cancer Center (MDACC)

Received approval from MDACC’s Institutional Review Board (IRB) for protocol expansion to include maintenance stage, MGMT-unmethylated GBM patients. This provides an opportunity for enrollment of a larger patient population who may benefit from VAL-083 in an earlier stage of this hard-to-treat disease

Presented data supporting VAL-083 as potential treatment for pediatric brain tumors at the Society for Neuro-Oncology Pediatric Neuro-Oncology Basic and Translational Research Conference

Established Scientific Advisory Board with inaugural members Drs. Napoleone Ferrara and John de Groot
Potentially regained compliance with Nasdaq’s minimum bid price listing requirement of $1.00 by executing a 1-for-10 reverse stock split

Launched a financing via a shareholder rights offering

On February 20, 2019, DelMar announced that its Phase 2 study evaluating VAL-083 in patients with newly diagnosed GBM achieved its halfway enrollment point. This trial, targeted to enroll up to thirty patients, is a single-arm, open-label study testing VAL-083 in combination with standard radiotherapy in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. An estimated 60% of GBM patients possess an unmethylated MGMT gene, which confers a more limited response to current standard of care treatment as well as a lower survival probability. This clinical trial was initiated in February 2017 and is being conducted at SYSUCC in Guangzhou, China in collaboration with Guangxi Wuzhou Pharmaceutical Company. As of February 15, 2019, fifteen patients have been enrolled in this study.

The Company was pleased to report that for the 15 patients enrolled as of February 15, 2019, 11 completed their prospectively planned Magnetic Resonance Imaging (MRI) scans and have had their initial assessment for tumor progression. Tumor progression is based on the trial investigator’s clinical and radiologic assessment, according to the Response Assessment in NeuroOncology (RANO) criteria. Of these 11 patients, five were assessed by the Principal Investigator as having a "Complete Response," three of whom were based on significant tumor shrinkage, and two of whom were based on their tumors continuing to remain "below measurable level" from post-surgery baseline MRI to post-cycle three MRI. Additionally, six patients were assessed as having "Stable Disease." Of the remaining four patients, one died prior to their post-cycle three MRI and three have not been on study long enough to reach their planned post-cycle three MRI. As of the February 15, 2019 data cutoff, 12 of the 15 enrolled patients were still alive. Similar to prior experience, myelosuppression has been the most common adverse event observed. Two dose-limiting toxicities have been reported (thrombocytopenia) – one at the 40 mg/m2/day dose and one at the 30 mg/m2/day dose.

Throughout the quarter, DelMar continued to enroll patients in VAL-083’s Phase 2, open-label, second-line, Avastin-naïve, MGMT-unmethylated, recurrent GBM study being conducted at the MDACC. On April 3, 2019, the Company announced that the MDACC’s IRB approved a trial protocol amendment to expand the study with the addition of up to 35 patients at a dose of 30 mg/m2. Also, the MDACC IRB approved the addition of up to 24 patients in the pre-temozolomide (TMZ) maintenance setting. The biomarker driven trial, which was originally designed as a single arm study evaluating VAL-083 in patients with MGMT-unmethylated bevacizumab (Avastin)-naïve recurrent GBM, has been expanded to include an additional maintenance-stage (adjuvant therapy) treatment group. This protocol amendment, in addition to the Company’s ongoing Phase 2 trial in newly diagnosed patients with MGMT-unmethylated GBM being conducted at SYSUCC, expands DelMar’s evaluation range of VAL-083 as a potential treatment for unmethylated GBM patients to include newly-diagnosed, maintenance-stage, and recurrent patients. Maintenance-stage GBM provides the greatest opportunity to control disease progression after radiation therapy, and represents the largest addressable GBM market opportunity for VAL-083 given patients are typically healthier and as such, are able to optimally benefit therapeutically from increased treatment cycles compared to the recurrent treatment setting. Maintenance GBM patients may be able to receive 12+ cycles of VAL-083 versus five or six cycles for recurrent GBM patients.

At the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s annual meeting in April 2019, we reported that per investigator assessment at the end of cycle two for the MDACC study:

9/35 (25.7%) patients initially receiving 40 mg/m2 exhibited Stable Disease
4/10 (40.0%) patients initially receiving 30 mg/m2 exhibited Stable Disease
Two patients have not yet reached the end of cycle 2

The Company has launched a rights offering made available to stockholders of record as of Tuesday, May 21, 2019. If fully subscribed, this financing initiative will provide DelMar with sufficient cash to fund planned operations into the middle of calendar 2020, and the estimated enrollment completion date for all three of our Phase 2 trials.

For further details on the Company’s operating and financial results, as well as more detail about its updated strategy, refer to DelMar’s Form 10-K filed with the SEC on September 24, 2018, as well as the Company’s Quarterly Report on Form 10-Q for the three and nine months ended March 31, 2019 filed with the SEC on May 14, 2019:

View Source

CONFERENCE CALL DETAILS

DelMar will host a conference call to discuss its financial results for quarter ended March 31, 2019 and provide a corporate update on May 23, 2019, at 4:30 p.m. Eastern Time. For both "listen-only" participants and those who wish to take part in the question and answer portion of the call, the telephone Dial-in Number is 1-877‑876‑9173 (toll free) with Conference ID DELMAR.

A replay of the conference call will be available on the IR Calendar of the Investors section of the Company’s website at www.delmarpharma.com and will be archived for 30 days.

SUMMARY OF FINANCIAL RESULTS FOR PERIODS ENDED MARCH 31, 2019
At March 31, 2019, the Company had cash and cash equivalents on hand of approximately $2.2 million.

For the three months ended March 31, 2019, the Company reported a net loss of $1,663,985, or $0.67 per share, compared to a net loss of $2,933,057, or $1.31 per share, for the three months ended March 31, 2018.

For the nine months ended March 31, 2019, the Company reported a net loss of $5,465,486, or $2.27 per share, compared to a net loss of $8,761,061, or $4.41 per share, for the nine months ended March 31, 2018.

The following represents selected financial information as of March 31, 2019. The Company’s financial information has been prepared in accordance with U.S. GAAP and this selected information should be read in conjunction with DelMar’s consolidated condensed interim financial statements and management’s discussion and analysis, as filed.

DelMar’s financial statements as filed with the U.S. Securities Exchange Commission can be viewed on the company’s website at: View Source

Research and development expenses decreased to $735,844 during the three months ended March 31, 2019 from $1,779,609 for the three months ended March 31, 2018. The decrease was largely attributable to a decrease in clinical development costs, intellectual property, personnel, and preclinical research during the three months ended March 31, 2019 compared to the three months ended March 31, 2018.

General and administrative expenses decreased during the three months ended March 31, 2019 to $935,530 from $1,155,038 for the three months ended March 31, 2018, largely due to a decrease in non-cash, share-based compensation expense, professional fees and travel, partially offset by higher personnel costs in the cResearch and development expenses decreased to $2,702,213 during the nine months ended March 31, 2019 from $5,856,197 for the nine months ended March 31, 2018. The decrease was largely attributable to a decrease in clinical development costs, personnel, preclinical research, intellectual property and travel costs during the nine months ended March 31, 2019 compared to the nine months ended March 31, 2018.

General and administrative expenses were $2,796,884 for the nine months ended March 31, 2019 compared to $2,911,538 for the nine months ended March 31, 2018. The decrease was largely due to lower professional fees and travel, partially offset by higher personnel and non-cash, share-based compensation expense during the nine months ended March 31, 2019 compared to the nine months ended March 31, 2018.urrent quarter compared to the prior quarter.