On May 15, 2018 Onconova Therapeutics, Inc.(NASDAQ:ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS), reported financial results for the first quarter of 2018 ended March 31, 2018 (Press release, Onconova, MAY 15, 2018, View Source [SID1234526651]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We have strengthened our balance sheet after completing a $28.75 million upsized underwritten public offering this month. Combined with the funds raised in February, we now have the resources necessary to advance our INSPIRE Phase 3 clinical trial of IV Rigosertib towards complete enrollment, which we expect in the first half of 2019," said Dr. Ramesh Kumar, President and Chief Executive Officer. "After enrollment of our expanded Phase 2 combination therapy trial and the advance of our CDK inhibitor preclinical program towards the clinic, we are well-positioned in our quest to serve the unmet needs of cancer patients."

Recent Highlights

In May, we strengthened our balance sheet with a $28.75 million upsized underwritten public offering. This financing, combined with the $10.0 million offering completed in February, should permit the Company to advance its late stage programs in MDS to key milestones;
We executed a licensing agreement with Pint Pharma to commercialize Rigosertib for treatment of Myelodysplastic Syndromes in Latin America;
We presented promising Phase 2 data from the expansion study of oral Rigosertib and Azacitidine combination in patients with Myelodysplastic Syndromes at the 6th International Bone Marrow Failure Disease Symposium on March 26th;
We completed the Pre-IND consultation with the US Food and Drug Administration (FDA) regarding ON 123300, a dual ARK5+CDK4/6 inhibitor, in collaboration with our partner, HanX Biopharmaceuticals. This guidance will help advance our differentiated compound to the clinic;
We presented data on our first-in-class dual inhibitor of CDK4/6 + ARK5 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018 on April 19th.
First Quarter 2018 Financial Results

Cash and cash equivalents as of March 31, 2018, totaled $7.3 million, compared to $4.0 million as of December 31, 2017. This excludes the proceeds from the financing completed in May 2018, in which the Company raised net proceeds of approximately $25.6 million in a public offering, including the exercise in full of the underwriter’s over-allotment option. Based on the Company’s current projections, Onconova expects that cash and cash equivalents will be sufficient to fund ongoing trials and operations into the fourth quarter of 2019.

Net loss was $5.1 million for the first quarter ended March 31, 2018, compared to $8.3 million for the first quarter ended March 31, 2017, primarily due to a decrease in the fair value of warrant liability, and the recognition of revenue during the quarter from our license and collaborative development agreement with HanX Biopharmaceuticals. Research and development expenses were $4.6 million for the first quarter ended March 31, 2018, and $4.9 million for the comparable period in 2017. General and administrative expenses were $1.9 million for the first quarter ended March 31, 2018, and $2.1 million for comparable period in 2017.

The Company will host a conference call on Tuesday, May 15 at 9:00 a.m. Eastern Time to provide a corporate update and discuss first quarter 2018 financial results. Interested parties may access the call by dialing toll-free (855) 428-5741 from the US, or (210) 229-8823 internationally and using conference ID: 2573768. The call will also be webcast live. Please click here to access the webcast. A replay will be available at this link until August 15, 2018.

On May 15, 2018 Oncobiologics, Inc. (NASDAQ:ONS) reported financial results and business highlights for its three and six months ended March 31, 2018 (Press release, Oncobiologics, MAY 15, 2018, View Source;p=RssLanding&cat=news&id=2349253 [SID1234526650]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Recent Highlights:

Strengthened balance sheet with first closing of a $15.0 million private placement offering
Initiated ONS-5010 development program
Appointed Dr. Joerg Windisch and Randy Thurman to the Board of Directors
Dr. Windisch was appointed to the Compensation Committee
Mr. Thurman was appointed to the Nominating and Corporate Governance Committee and Chairman of the Compensation Committee
Oncobiologics’ Chairman and Chief Executive Officer Dr. Pankaj Mohan commented, "I am excited to report that our pipeline continues to offer significant opportunities to generate stockholder value. We recently entered into an agreement for a $15.0 million capital raise that will be used to advance the development of our portfolio, including ONS-5010, and support our operations through the end of this calendar year and have already received $7.5 million of the proceeds.

"We continue to make progress with the ONS-5010 development program and expect to initiate a clinical trial in 2018. Additionally, we are advancing our pre-clinical biosimilar product candidates and continue to engage with potential partners to lead the Phase 3 clinical trials for ONS-3010 and ONS-1045," continued Dr. Mohan.

"During the second quarter of fiscal 2018, we made progress implementing our new strategy to leverage our BioSymphony Platform to accelerate and maximize commercial revenues from our core expertise in drug development and manufacturing. The interest in leveraging our extensive development and manufacturing platform among potential biotech customers has been extremely positive. We expect to enter into our first customer agreement for our new contract development and manufacturing (CDMO) business and start recognizing revenue in the near future," concluded Dr. Mohan.

Anticipated Milestones (calendar year):
2018

Enter into first CDMO contract
Initiate clinical development program for ONS-3010 and/or ONS-1045 by partners in emerging markets
Initiate ONS-5010 clinical trials
Announce licensing/co-development partnership
2019

CDMO business cash flow positive by end of 2019
Initiate Phase 3 trial for ONS-1045 in major markets with development partner
2020

First revenue from emerging market partnerships
Initiate Phase 3 trial for ONS-3010 in major markets with development partner
Initiate ONS-3040 and ONS-4010 clinical development programs
Financial Highlights for the Fiscal Second Quarter Ended March 31, 2018
For the fiscal second quarter ended March 31, 2018, the Company reported a net loss attributable to common stockholders of $8.6 million, or $0.34 per diluted share, compared to $8.0 million, or $0.38 per diluted share for the same period of 2017. For the three months ended March 31, 2018, net loss attributable to common stockholders includes $0.3 million of income from non-cash stock-based compensation, $0.7 million of depreciation and amortization, $0.2 million of income from a decrease in the fair value of warrant liability and a $0.4 million beneficial conversion charge related to the Company’s Series A convertible preferred stock. For the three months ended March 31, 2017, net loss attributable to common stockholders included $2.3 million of non-cash stock-based compensation expense, $0.7 million of depreciation and amortization and $1.0 million of income from a decrease in the fair value of warrant liability.

For the fiscal second quarter ended March 31, 2018, the Company reported an adjusted net loss attributable to common stockholders of $8.0 million, or $0.32 per diluted share, as compared to an adjusted net loss of $6.1 million, or $0.29 per diluted share in the same period of 2017. The primary reason for the increase in adjusted net loss attributable to common stockholders from the year earlier period is higher research and development expenses related to the initiation of preparations to move ONS-5010 into clinical development in 2018.

At March 31, 2018, the Company had cash of $5.9 million, compared to $3.2 million at September 30, 2017. On May 14, 2018, the Company announced the closing of the first tranche of its $15.0 million private placement offering, receiving $7.5 million in aggregate gross proceeds.

Nasdaq Listing Update
The Company received formal notice on May 14, 2018 that the Nasdaq Hearings Panel has granted the Company’s request for an extension through June 26, 2018 to evidence compliance with all applicable requirements for continued listing on Nasdaq, including the applicable $35.0 million market capitalization requirement.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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