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.

Genprex has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Genprex, 2018, MAY 15, 2018, View Source [SID1234527544]).

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On May 15, 2018 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to probiotics to develop novel, living medicines, reported its financial results for the first quarter ended March 31, 2018 (Press release, Synlogic, MAY 15, 2018, View Source [SID1234526619]).

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Recent Highlights

Corporate

Leadership Transition: On May 10, 2018, Synlogic announced a CEO transition; Chief Medical Officer, Aoife Brennan, M.B., B.Ch., was appointed to serve as Interim President and Chief Executive Officer as successor to Jose-Carlos Gutiérrez-Ramos, Ph.D.; Peter Barrett, Ph.D., the Chairman of Synlogic’s board of directors will serve as Executive Chairman and oversee a Board committee to conduct a search for a permanent CEO.
Strengthened Company’s balance sheet: As of March 31, 2018, Synlogic had cash, cash equivalents, and short-term investments of $125.8 million. In April 2018, the Company completed a registered direct offering generating $28.9 million in net proceeds. Synlogic expects its current cash, cash equivalents and marketable securities position will be sufficient to fund operations to mid-2020 based on its current business plan.
Pipeline

Treatment of the first subject in a Phase 1/2a clinical trialevaluating SYNB1618, indevelopment for the treatment of phenylketonuria (PKU). This Phase 1/2a clinical trial is a single (SAD) and multiple (MAD) dose-escalation, randomized, double-blind, placebo-controlled study of orally administered SYNB1618 in healthy adult volunteers and adult subjects with PKU. The study is designed to evaluate safety, tolerability, kinetics, and pharmacodynamics as well as exploratory end-points associated with the ability of SYNB1618 to metabolize phenylalanine. Synlogic expects to report interim data from this trial in the second half of 2018 and the full data in 2019. More information about this study can be found at www.clinicaltrials.gov.
Treatment of the first subject in a Phase 1b/2a clinical trial evaluating SYNB1020, in development for the treatment of hyperammonemia. This Phase1b/2a clinical trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety and tolerability of SYNB1020, as well as its ability to lower blood ammonia levels, in patients with cirrhosis and elevated blood ammonia. Synlogic expects to report topline date from this trial at the end of 2018. Additional information about this study can be found at www.clinicaltrials.gov.
Fast-Track designation granted by the U.S. Food and Drug Administration (FDA) for SYNB1618 for the treatment of PKU. The FDA Fast Track program is designed to facilitate the development of important new drugs intended to treat a serious condition and to fill an unmet medical need. The designation enables early and frequent communication between the FDA and Synlogic ensuring that questions and issues are resolved quickly, and often leading to earlier drug approval and access by patients.
Presentation of preclinical data from Synlogic’s immuno-oncology (IO) program at the annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The data demonstrate that, in mouse models, Synthetic Biotic medicines stimulate an antitumor response and robustly reprogram the tumor microenvironment, potentially enabling the treatment of a variety of cancers.
First Quarter 2018 Financial Results
For the three months ended March 31, 2018, Synlogic reported a consolidated net loss of $11.2 million, or $0.55 per share, compared to a net loss of $7.4 million, or $4.49 per unit, for the corresponding period in 2017. The increase in net loss was primarily due to increases in compensation-related expenses as Synlogic continues to grow its employee headcount and hire into key positions to support its corporate goals, as well as increases in research and development expenses to support its advancing clinical programs.

Research and development expenses were $8.4 million for the three months ended March 31, 2018 compared to $5.1 million for the corresponding period in 2017. The increase was primarily due to an increase in compensation-related expenses associated with increased headcount, increased external costs associated with process and formulation development, pre-clinical and clinical studies and increased costs associated with Synlogic’s move to a larger facility.

General and administrative expenses for the three months ended March 31, 2018 were $3.6 million compared to $2.4 million for the corresponding period in 2017. The increase was primarily due to increases in compensation-related expenses associated with increased headcount and increases in expenses related to being a newly public company, including audit, legal and investor relations.

As of March 31, 2018, Synlogic had cash, cash equivalents, and short-term investments of $125.8 million.

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]).

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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 14, 2018 Medigene AG (MDG1, Frankfurt, Prime Standard), Germany, reported the significant expansion of its successful strategic alliance with bluebird bio, a leader in gene and cell therapies, focusing on the research and development of T cell receptor-modified T cell (TCR-T) immunotherapies for the treatment of cancer (Press release, MediGene, MAY 14, 2018, View Source [SID1234526577]).

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"We are delighted to broaden this outstanding collaboration for the joint research and discovery of TCR lead candidates designed for the treatment of multiple cancer indications. Medigene is contributing its unique TCR technology platform, which encompasses multiple innovative screening and assessment tools to identify and characterize specific, non-modified TCRs to selected target antigens in a highly competitive timeframe." said Dolores J. Schendel, Chief Executive Officer and Chief Scientific Officer, Medigene . "The expansion of this alliance further validates the efficiency and quality of Medigene’s TCR platform technology."

"As we continue to build our leadership in immuno-oncology, we value Medigene’s TCR technology platform which enables us to tackle intracellular tumor antigens not addressable by CAR Ts," said Philip Gregory, Ph.D., Chief Scientific Officer, bluebird bio, "Our expanded collaboration will help us broaden our pipeline of TCR lead candidates for potential future clinical development."

Under the revised terms of the agreement, the number of target antigen/MHC restriction combinations for the discovery of specific TCR lead candidates by Medigene will be increased from four to six. As part of this contractual expansion, Medigene will receive an additional one-time payment of USD 8 million. R&D funding for all work performed by Medigene in this collaboration will grow proportionally to address the broader scope of the collaboration. In addition, the aggregate amount of all potential development and commercial milestones as well as royalty payments has been significantly increased in line with the extended number of TCR projects. If successfully developed and marketed through several indications and markets, Medigene could receive up to USD 250 million in milestone payments per TCR program in addition to tiered royalty payments on net sales up to a double-digit percentage. Following the amendment of the agreement, Medigene anticipates receiving an additional payment of USD 1 million associated with the first collaboration project under the agreement.

Based on the terms of the agreement signed in September 2016, Medigene is responsible for the discovery of TCRs for each target antigen selected by bluebird bio using its TCR technology platform. Following the collaborative non-clinical development, bluebird bio will assume sole responsibility for pre-clinical¬ and clinical development and commercialization of the TCR-T cell product candidates and will receive an exclusive license for the intellectual property covering the selected TCRs.

As a result of the payments mentioned above, Medigene improves the Company’s cash burn guidance for 2018 and now anticipates a cash usage of EUR 16-19 million instead of EUR 21-25 million for the full year. Revenue, R&D expense and EBITDA guidance for 2018 will not change substantially as a result of this expansion of the agreement. Full financial guidance will be provided in Medigene’s 6-months report 2018.