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.

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 15, 2018 Altimmune, Inc. (Nasdaq:ALT), a clinical-stage immunotherapeutics company, reported financial results for the three months ended March 31, 2018 (Press release, Altimmune, MAY 15, 2018, View Source [SID1234526633]).

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Recent Corporate Highlights

Announced positive proof-of-concept data from its Phase 2a intranasal flu vaccine trial with NasoVAX vaccine when compared with a licensed injectable seasonal flu vaccine;
Announced positive pre-clinical data for survival and immunogenicity from the Company’s Phase 2 SparVax-L program when compared against BioThrax to prevent anthrax infection;
Extended its IP protection of NasoShield in the U.S. with a Notice of Allowance from the U.S. Patent Office; and
Consolidated multiple Gaithersburg sites, including laboratory buildout, into new headquarters in Gaithersburg.
"We have had a very data-rich few months with results being reported from our NasoVAX, HepTcell, and SparVax-L programs," said William J. Enright, Chief Executive Officer of Altimmune. "The positive results from our NasoVAX trial give us strong confidence that we have a truly novel approach to combat flu and we look forward to getting Phase 2b clinical trials started next year. NasoVAX has tremendous potential as an effective, easy-to-administer flu vaccine that could provide better protection than current vaccines."

"We are also excited by the results on our SparVax-L study where two doses of SparVax-L produced levels of protective immunity that were significantly greater than that obtained following two doses of the licensed vaccine and we look forward to moving that program forward once we secure additional government funding," Mr. Enright added. "We continue to evaluate our HepTcell results and will update investors on our next steps after we complete the data analysis from the remaining timepoints and better understand our initial results. Operationally, we are focused on executing and moving our programs forward towards licensure as we believe our vaccines offer significant advantages."

Financial Results for the first-quarter of 2018

Revenues for the first-quarter of 2018 were $2.7 million compared to $0.3 million for the same period in 2017. The change was primarily due to a $1.6 million increase in revenue from our contract with the Biomedical Advanced Research and Development Authority ("BARDA") compared to the same period in 2017. Revenue for first-quarter 2018 also included $0.8 million from a contract with the National Institute of Allergy and Infectious Disease ("NIAID").

Research and development expenses were $5.7 million for the first-quarter of 2018 as compared to $2.8 million for same period in 2017. The change was due to an increase of $1.2 million in spending on the development of the NasoShield product candidate; an increase of $0.6 million in HepTcell costs from additional study analysis efforts; an increase of $0.4 million related to the addition of research and development costs of the SparVax-L asset; an increase of $0.3 million in costs due to our NasoVAX Phase 2 trial and an increase of $0.5 million in other research and development costs, compared to the same period in 2017.

General and administrative expenses were $2.4 million for the first-quarter of 2018 as compared with $2.0 million for the same period in 2017. The change was the combined result of an increase of $0.9 million in public company costs, an increase of $0.2 million in salaries and benefits, offset by a decrease of $0.8 million in costs related to the merger with PharmAthene compared to the same period in 2017.

Goodwill impairment charges of $0.5 million reported during the first-quarter of 2018 represented an adjustment recorded during the measurement period to reduce the tax refund receivable acquired in connection with the merger. The adjustment to reduce the tax refund receivable resulted in a corresponding increase in goodwill which was determined to be fully impaired during the year ended December 31, 2017. The non-cash charge has no effect on our current cash balance or operating cash flows.

Net loss attributed to common stockholders for the first-quarter of 2018 was $5.1 million as compared to $4.7 million for the same period in 2017. Excluding the non-cash goodwill impairment charges, net loss attributed to common stockholders for the first quarter of 2018 would have been $4.6 million.

Net loss per share attributed to common stockholders for the first-quarter of 2018 was $0.25 compared with $0.68 for the same period of 2017. Excluding the non-cash goodwill impairment charges, net loss per share attributable to common stockholders for the first quarter of 2018 would have been $0.23, compared to $0.68 for the same period of 2017.

At March 31, 2018, the Company had cash and cash equivalents of $8.1 million

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]).

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"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.