Ohr Pharmaceutical Reports Fiscal Second Quarter 2018 Financial Results

On May 15, 2018 Ohr Pharmaceutical, Inc. (Nasdaq:OHRP), a pharmaceutical company developing therapies for ophthalmic diseases, reported financial results for its fiscal second quarter ended March 31, 2018 (Press release, Ohr Pharmaceutical, MAY 15, 2018, View Source [SID1234526649]).

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"During the fiscal second quarter we embarked on a process to evaluate a range of strategic alternatives to maximize shareholder value," said Dr. Jason Slakter, chief executive officer of Ohr Pharmaceutical. "We engaged Roth Capital to act as our exclusive financial advisor and are encouraged by the progress we have made to date."

Financial Results for the Second Quarter ended March 31, 2018

For the quarter ended March 31, 2018, the Company reported a net loss of approximately $2.2 million, or ($0.04) per share, compared to a net loss of approximately $7.7 million, or ($0.21) per share in the same period of 2017.
For the quarter ended March 31, 2018, total operating expenses were approximately $2.2 million, consisting of $0.6 million in general and administrative expenses, $1.8 million of research and development expenses, $0.3 million in depreciation and amortization, $0.7 million in impairment of goodwill, and $1.2 million in gain on settlement of accounts payable and long term liabilities. This compares to total operating expenses of $7.7 million in the same period of 2017, consisting of $1.4 million in general and administrative expenses, $6.0 million of research and development expenses, and $0.3 million in depreciation and amortization.
At March 31, 2018, the Company had cash and cash equivalents of approximately $5.2 million, compared to cash and equivalents of approximately $12.8 million at September 30, 2017.
Financial Results for the Six Months Ended March 31, 2018

For the six months ended March 31, 2018, the Company reported a net loss of approximately $6.3 million, or ($0.11) per share, compared to a net loss of approximately $14.7 million, or ($0.43) per share in the same period of 2017.
For the six months ended March 31, 2018, total operating expenses were approximately $6.4 million, consisting of $2.1 million in general and administrative expenses, $4.2 million of research and development expenses, $0.6 million in depreciation and amortization, $0.7 million in impairment of goodwill, and $1.2 million in gain on settlement of accounts payable and long term liabilities. This compares to total operating expenses of $14.7 million in the same period of 2017, comprised of approximately $3.2 million in general and administrative expenses, $10.9 million in research and development expenses, and $0.6 million in depreciation and amortization.

Nanobiotix revenue for the 1st quarter of 2018

On May 15, 2018 NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported its unaudited revenues for the first quarter of 2018 (Press release, Nanobiotix, MAY, 15, View Source [SID1234526647]).

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Activity and result during the first quarter of 2018

There has been no revenue booked during the first quarter of 2018, which is fully in line with the Company’s
expectations. In January, Nanobiotix presented first promising data from I/II trial evaluating NBTXR3 in liver cancers, including primary (Hepatocellular, HCC) and liver metastasis from other tumors, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Annual Meeting (ASCO-GI).

The product has demonstrated a very good safety profile, with no adverse event (serious or not) related to NBTXR3
and no dose-limiting toxicity (DLT). Out of 10 patients treated, 7 were evaluable. Out of these 7 patients, 3 patients
achieved a complete response and 3 patients achieved a partial response as best overall response. These data are only first preliminary response data which will be completed with additional data. This is the third indication in the global development of NBTXR3 confirming transferability across different cancers.

Also in January, Nanobiotix partnered with the Providence Cancer Institute to run immunotherapeutic preclinical
research in pancreatic cancers. The collaboration with Providence Cancer Institute, located at the Robert W. Franz
Cancer Center in Portland, Ore., one of the world’s leading oncological research centers, will provide essential
preclinical data on the ability of NBTXR3 activated by radiotherapy to induce an antitumoral immune response.

Myriad Genetics to Present Eight Studies at the 2018 American Society of Clinical Oncology Annual Meeting

On May 15, 2018 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that it will present results from eight studies at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting to be held June 1 to 5, 2018 in Chicago, Ill (Press release, Myriad Genetics, MAY 15, 2018, View Source [SID1234526646]). Abstracts of the Company’s presentations will be available at: abstracts.asco.org on May 16 at 5:00 p.m. EDT.

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"We look forward to presenting exciting new discoveries at ASCO (Free ASCO Whitepaper) that we believe will expand the reach of personalized medicine for patients with cancer," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetics. "Importantly, our presentations will focus on new advances in predicting breast cancer recurrence and the need for chemotherapy, the role of hereditary cancer testing in preventing cancer or optimizing treatment plans, and novel companion diagnostics for helping guide medication selection for patients with breast or ovarian cancers."

A list of Myriad presentations at ASCO (Free ASCO Whitepaper) 2018 are below. Follow Myriad on Twitter via @MyriadGenetics and stay informed about symposium news and updates by using the hashtag #ASCO18.

Title Presenter Abstract Number Day/Time Myriad Product

Oral Presentation

Validation of a Combined Residual Risk Score
for Healthy Unaffected Women Presenting to Breast
Cancer (BC) Screening Centers Kathryn Dalton Presentation 1507 Sunday, June 3, 2018: 8:00-11:30 a.m. CDT. riskScore

Poster Presentations

Predicting Expected Absolute Chemotherapy
Treatment Benefit in Women with Early-Stage
Breast Cancer using a 12-Gene Expression
Assay William Gradishar Abstract 525 Saturday, June 2, 2018: 8:00-11:30 a.m. EndoPredict

In Silico Evaluation of the 12-gene molecular
score (EndoPredict) and the Recurrence Score
(Oncotype DX) as Predictors of Response to
Neo-adjuvant Chemotherapy in Estrogen
Receptor Positive (ER+), HER2 Negative
(HER2-) Breast Cancer Hatem Soliman Abstract 539

Saturday, June 2, 2018: 8:00-11:30 a.m. CDT. EndoPredict

Promoting Colorectal Cancer (CRC) Screening
after Multiplex Genetic Testing and Genetic
Counselling Gregory Idos Abstract 1582 Saturday, June 2, 2018: 1:15-4:45 p.m. CDT.

Myriad myRisk

Promoting Breast Cancer Screening after
Multiplex Genetic Panel Testing (MGPT) and
Genetic Counselling Gregory Idos Abstract 1581 Saturday, June 2, 2018: 1:15-4:45 p.m. CDT.

Myriad myRisk

Evaluation of Homologous Recombination
Deficiency (HRD) status with pathological
response to carboplatin +/- veliparib
in BrighTNess, a randomized phase 3 study in
early stage TNBC Melinda Telli Abstract 519 Saturday, June 2, 2018: 3:00-4:15 p.m. CDT. myChoice HRD

Locus-specific loss of heterozygosity (LOH) in
BRCA1/2 mutated (mBRCA) ovarian tumors
from the SOLO2 (NCT01874353) and Study 19
(NCT00753545) clinical trials Kirsten Timms Abstract 5563 Monday, June 4, 2018: 1:15-4:45 p.m. CDT.

myChoice HRD
About EndoPredict
EndoPredict is a second-generation, multigene prognostic test for patients diagnosed with ER+, HER2- early-stage breast cancer. The test provides physicians with information to devise personalized treatment plans for their patients. EndoPredict has been validated in approximately 4,000 patients with node-negative and node-positive cancer and has been used clinically in more than 20,000 patients. In contrast to first-generation multigene prognostic tests, EndoPredict detects the likelihood of late metastases (i.e., metastasis formation after more than five years) and, therefore, can guide treatment decisions regarding the need for chemotherapy, as well as extended anti-hormonal therapy. Accordingly, therapy decisions backed by EndoPredict confer a high level of diagnostic safety. For more information, please visit: www.endopredict.com.

About Myriad myRisk Hereditary Cancer
The Myriad myRisk Hereditary Cancer panel uses validated technologies and algorithms in an 850 step laboratory process to evaluate 28 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma. For more information, please visit: View Source

About riskScoreTM
riskScore is a clinically validated algorithm that predicts a women’s remaining 5-year and lifetime risk of developing breast cancer. The algorithm combines the analysis of over 80 well-studied genetic markers and the Tyrer-Cuzick model to accurately estimate breast cancer risk for woman of European descent. For more information, please visit: View Source

About myChoice HRD
Myriad’s myChoice HRD is the first homologous recombination deficiency test that can detect when a tumor has lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. High myChoice HRD scores reflective of DNA repair deficiencies are prevalent in all breast cancer subtypes, ovarian and most other major cancers. In previously published data, Myriad showed that the myChoice HRD test predicted drug response to platinum therapy in certain patients with triple-negative breast and ovarian cancers. It is estimated that 1.8 million people in the United States and Europe who are diagnosed with cancers annually may be candidates for treatment with DNA-damaging agents. For more information, please visit: View Source

Molecular Templates to Present at the UBS Global Healthcare Conference

On May 15, 2018 Molecular Templates, Inc. (Nasdaq:MTEM) ("Molecular"), a clinical-stage oncology company focused on the discovery and development of the company’s proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics for cancer, reported that its management will provide a corporate overview at the UBS Global Healthcare Conference, taking place May 21-23 at the Grand Hyatt New York hotel in New York City (Press release, Molecular Templates, MAY 15, 2018, View Source [SID1234526645]).

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Presentation Details

Date:
Time:
Location:
Webcast: Monday, May 21
8:00am Eastern Time
Ballroom IV
https://cc.talkpoint.com/ubsx001/052118a_as/?entity=70_OJGBE5X

X4 Pharmaceuticals Presents Clinical Data Demonstrating Combinability of X4P-001-IO and Opdivo® (nivolumab) in Patients with Clear Cell Renal Cell Carcinoma

On May 15, 2018 X4 Pharmaceuticals, a clinical stage biotechnology company developing novel CXCR4 antagonists to improve immune cell trafficking to treat cancer and rare disease, reported results from a pilot study of X4P-001-IO in combination with Opdivo (nivolumab) in patients with clear cell renal cell carcinoma (ccRCC) who are non-responsive to the anti-PD-1 checkpoint inhibitor Opdivo alone (Press release, X4 Pharmaceuticals, 15 15, 2018, View Source [SID1234526644]). The data were presented at the 16th Annual Meeting of the Association for Cancer Immunotherapy (CIMT) (Free CIMT Whitepaper), taking place May 15-17 in Mainz, Germany.

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Results from the nine patients with advanced ccRCC enrolled in the pilot study as of February 26, 2018 were presented at the CIMT (Free CIMT Whitepaper) meeting in a poster session on May 15th and an oral presentation on May 17th. All patients in the study were non-responsive to single agent Opdivo with either stable or progressive disease. Enrolled patients continued to receive standard bi-weekly Opdivo therapy and X4P-001-IO (400 mg, oral, once daily). Median duration of treatment with the combination was 3.7 months (range 1-10 months).

Highlights of the data presented at CIMT (Free CIMT Whitepaper) include:

X4P-001-IO in combination with Opdivo had acceptable toxicity. The most frequent adverse events were diarrhea, nasal congestion, dry eye, headache and cough. No grade 4 or 5 adverse events occurred. All Grade 3/serious adverse events were manageable with appropriate intervention.
Combination therapy with X4P-001-IO and Opdivo exhibited anti-tumor activity in some patients with advanced ccRCC who were previously non-responsive to single agent Opdivo therapy.
Four patients who had progressed on prior Opdivo monotherapy had a best response of stable disease with additional X4P-001-IO treatment.
Of the five patients who were stable on prior Opdivo monotherapy, one had a partial response with combination therapy.
"These data demonstrate that the combination with X4P-001-IO and nivolumab has the potential to augment responses in patients who previously received the anti-PD-1 checkpoint inhibitor nivolumab alone," said David F. McDermott, M.D., Beth Israel Deaconess Medical Center, Harvard Medical School and lead investigator of the study. "This preliminary data requires validation in larger studies as we continue to seek treatments to address the larger population of cancer patients who do not adequately respond to checkpoint inhibitors."

"These findings contribute to our growing understanding of combining CXCR4 antagonists with other agents such as checkpoint inhibitors," said Sudha Parasuraman, M.D., Chief Medical Officer of X4 Pharmaceuticals. "Because the mechanisms of CXCR4 antagonism and check point inhibition act at different points in the tumor immunity cycle, it is reasonable to consider the potential for synergistic activity."

About X4P-001-IO in Cancer

X4P-001-IO is an investigational selective, oral, small molecule antagonist of C-X-C receptor type 4 (CXCR4). CXCR4 is a chemokine receptor present in abundance on certain immune cells and cancer cells and it plays a critical role in immune cell trafficking, infiltration and activation in the tumor microenvironment. CXCR4 signaling is disrupted in a broad range of cancers, facilitating tumor growth by allowing cancer cells to evade immune detection and creating a pro-tumor microenvironment. X4P-001-IO has the ability to help restore immunity within the tumor microenvironment and has the potential to enhance the anti-tumor activity of approved and emerging oncology agents, such as checkpoint inhibitors and targeted therapies. X4P-001-IO is being investigated in several clinical studies in solid tumors.