ProMIS Neurosciences Appoints James Kupiec, MD as Chief Medical Officer

On September 13, 2018 ProMIS Neurosciences, Inc. (TSX: PMN; OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics selectively targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported the appointment of James Kupiec, MD, to the position of Chief Medical Officer (Press release, ProMIS Neurosciences, SEP 13, 2018, View Source [SID1234529443]). In this newly created role, reporting to both the Executive Chairman and CEO, Dr. Kupiec will lead ProMIS’ clinical development programs, in particular the initiation of clinical trials of PMN310 for the treatment of Alzheimer’s disease (AD) in the second half of 2019.

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"We are very pleased to welcome Dr. Kupiec to our senior management team," said ProMIS Executive Chairman, Eugene Williams. "Jim’s expertise and experience as an accomplished leader of clinical development programs in Alzheimer’s disease and other neurodegenerative disorders will be a great source of strength for ProMIS. He will not only provide outstanding clinical trial leadership but will also play a significant role in interaction with regulatory authorities, key neuroscience opinion leaders and potential pharmaceutical partners."

Dr. Kupiec is a physician-scientist with over two decades of broad, hands-on experience in translational, early- and late-stage neuroscience drug development in the pharmaceutical industry.

"I am thrilled to join the ProMIS leadership team at this critical stage," said Dr. Kupiec. "ProMIS’ innovative approach selectively targeting toxic oligomers for treatment of neurodegenerative disorders is unique and provides a real opportunity for transformative, novel therapies. I am delighted to contribute to the advancement of the ProMIS clinical pipeline."

Dr. Kupiec most recently served as VP, Global Clinical Leader for Parkinson’s Disease, and Clinical Head of the Neuroscience Research Unit in Cambridge for Pfizer, Inc. He joined Pfizer in 2000 after seven years at Sanofi-Synthelabo, and two years with Ciba-Geigy Pharmaceuticals. During his career at Pfizer, he had extensive governance, business development, alliance and leadership responsibilities. Much of his work during the last decade has focused on developing potential disease modifying and symptomatic therapies for Alzheimer’s disease and other neurodegenerative disorders, including monoclonal antibodies. As project leader and Clinical Head, Dr. Kupiec created and implemented global drug development strategies, met with worldwide regulatory authorities, and chaired numerous joint development committees with other pharmaceutical companies.

He earned his BS with Honors in Biochemistry at Stony Brook University and his MD from the Albert Einstein College of Medicine. He completed his residency training at the Strong Memorial Hospital, University of Rochester School of Medicine, and is certified by the American Board of Internal Medicine.

ERYTECH to Attend Upcoming Investor Conferences

On September 13, 2018 ERYTECH Pharma (Euronext Paris: ERYP – Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating drug substances inside red blood cells, reported that members of its management team will present and host investor meetings at the following investor conferences in September 2018 (Press release, ERYtech Pharma, SEP 13, 2018, View Source;p=RssLanding&cat=news&id=2367187 [SID1234529508]):

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Conference Details:

Morgan Stanley Global Healthcare Conference
Attendee: Gil Beyen, Chief Executive Officer
Location: New-York
Date / Presentation Time: September 13, 2018 at 4:40 PM EST
Webcast details: The presentation will be webcast live and can be accessed on Erytech’s Investor Relations website at View Source An archived version will be available within approximately two hours of the live presentation and can be accessed at the same location for 60 days.

BoursoCap/Investir Event
Attendee: Eric Soyer, Chief Financial Officer & Chief Operating Officer
Location : Groupe Les Echos – Le Parisien, Auditorium "10 Grenelle" Paris, France
Date / Presentation Time: September 18, 2018 at 06:00 PM CET

Onxeo to attend Key Investor and Partnering Conferences in the Coming Months

On September 13, 2018 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO – FR0010095596), a clinical-stage biotechnology company specializing in the development of innovative drugs in oncology, reported that its management team will attend the following key investor and partnering conferences in the coming months (Press release, Onxeo, SEP 13, 2018, View Source [SID1234529680]):

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European Large & Midcap Event

October 8-9, 2018

Paris, France

BIO-Europe

November 5-7, 2018

Copenhagen, Denmark

Boursocap / Les Echos – Investir Event

November 21, 2018

Paris, France

Investor meetings during the JP Morgan Healthcare Conference 2019

January 7-10, 2019

San Francisco, US

BioMed Event

January 22, 2019

Paris, France

180913_Onxeo_conferences_Q418_EN

Champions Oncology Reports Record Quarterly Revenue of $6.2 Million

On September 13, 2018 Champions Oncology, Inc. (Nasdaq: CSBR), engaged in an end-to-end range of research and development technology solutions and services to improve the development and use of oncology drugs, reported its financial results for the first fiscal quarter ended July 31, 2018 (Press release, Champions Oncology, SEP 13, 2018, View Source [SID1234529644]).

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First Quarter and Recent Business Highlights:

Record quarterly revenue of $6.2 million, an increase of 23.7% year-over-year

Record net income of $482,000, including stock-based compensation and depreciation

Granted Full Accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International for its new facility located in Rockville, MD

Reiterated forecast of at least 20% revenue growth in fiscal 2019 and sustained, quarterly operational profitability
Ronnie Morris, CEO of Champions, commented, "As we expected, our upward revenue trajectory continued in the first quarter of fiscal 2019 with year-over-year growth above 20% as we build upon existing customer relationships and bring on new customers. Accordingly, we are increasingly optimistic about our fiscal 2019 outlook for annual revenue growth in excess of 20%."

David Miller, CFO of Champions added, "We have reached the inflection point where our growing sales volume and resulting revenues should consistently exceed our costs leading to operational profitability on a quarterly basis."

Financial Results

For the first quarter of fiscal 2019, revenue increased 23.7% to $6.2 million compared to $5.0 million for the first quarter of fiscal 2018. Total operating expenses for the first quarter of fiscal 2019 were $5.74 million compared to $5.65 million for the first quarter of fiscal 2018, an increase of $92,000 or 1.63%.

For the first quarter of fiscal 2019, Champions reported income from operations of $481,000, including $83,000 in stock-based compensation and $118,000 in depreciation expenses, an improvement of $1.1 million or 177.7% compared to the loss from operations of $619,000, inclusive of $564,000 in stock-based compensation and $42,000 depreciation expenses, in the first quarter of fiscal 2018. Excluding stock-based compensation and depreciation, Champions reported income from operations of $681,000 for the first quarter of fiscal 2019 compared to a loss from operations, excluding stock-based compensation and depreciation, of $13,000 in the first quarter of fiscal 2018 an improvement of $694,000.

Exhibit 99.1

Cost of oncology solutions was $3.1 million for the three months ended July 31, 2018, an increase of $441,000, or 16.7% compared to $2.6 million for the three months ended July 31, 2017. The increase in cost of sales was due to an increase in TOS studies. For the three months ended July 31, 2018, gross margin was 50.5% compared to 47.5% for the three months ended July 31, 2017. Gross margin varies based on timing differences between expense and revenue recognition; however, the improvement can be attributed to leveraging the fixed cost component of cost of sales against a growing revenue base.

Research and development expense was $1.09 million for the three months ended July 31, 2018, a decrease of $30,000, or (2.7%), compared to $1.12 million for the three months ended July 31, 2017. Sales and marketing expense for the three months ended July 31, 2018 was $518,000, a decrease of $165,000, or (24.2%), compared to $683,000 for the three months ended July 31, 2017. The decrease is mainly due to a reduction in salary expenses. General and administrative expense was $1.1 million for the three months ended July 31, 2018 compared to $1.2 million for the three months ended July 31, 2017, a decrease of $154,000 or (12.7%).

Net cash generated was $160,000 for the three months ended July 31, 2018. Net cash used for the same period last year was $2.9 million. The improvement in cash flow is the result of revenue growth.

The Company ended the quarter with $1.0 million of cash and cash equivalents and reiterated its position that it does not need to raise capital to fund operations.

Conference Call Information:

The Company will host a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT) to discuss its first quarter financial results. To participate in the call, please call 877-407-8035 (domestic) or 201-689-8035 (international) 10 minutes ahead of the call and give the verbal reference "Champions Oncology."

Full details of the Company’s financial results will be available Monday, September 17, 2018 in the Company’s Form 10-Q at www.championsoncology.com.

* Non-GAAP Financial Information

See the attached Reconciliation of GAAP net loss to non-GAAP net loss for an explanation of the amounts excluded to arrive at non-GAAP net loss and related non-GAAP net loss per share amounts for the three months ended July 31, 2018 and 2017. Non-GAAP financial measures provide investors and management with supplemental measures of operating performance and trends that facilitate comparisons between periods before and after certain items that would not otherwise be apparent on a GAAP basis. Certain unusual or non-recurring items that management does not believe affect the Company’s basic operations do not meet the GAAP definition of unusual or non-recurring items. Non-GAAP net loss and non-GAAP loss per share are not, and should not be viewed as a substitute for similar GAAP items. Champions’ defines non-GAAP dilutive loss per share amounts as non-GAAP net loss divided by the weighted average number of diluted shares outstanding. Champions’ definition of non-GAAP net loss and non-GAAP diluted loss per share may differ from similarly named measures used by others.

Moleculin’s Brain Cancer Drug Candidate Begins Patient Dosing at Clinical Trial Being Conducted at MD Anderson

On September 13, 2018 Moleculin Biotech, Inc., (Nasdaq: MBRX) reported that it has initiated a Phase 1 clinical trial of a new first-in-class cancer drug candidate, a small molecule compound discovered by Prof. Waldemar Priebe at The University of Texas MD Anderson Cancer Center and known as WP1066 (Press release, Moleculin, SEPT 13, 2018, View Source [SID1234529417]). The compound has been shown in animal models to both inhibit an important cell signaling protein STAT3 that is involved in cell growth and proliferation and considered critical to tumor development, while also stimulating an immune response. The first glioblastoma patient has received the initial doses of WP1066, which were apparently well tolerated, in the physician-sponsored IND (investigational new drug) study at MD Anderson Cancer Center.

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Built from the chemical backbone of the active ingredient in propolis, a natural product of honey bees, WP1066 is the first anticancer agent with drug-like properties that consistently inhibits the activated form of STAT3 within cancer cells, a target that has been long-sought because of its broad range of tumor promoting effects.

Importantly, activated STAT3 supports the survival and proliferation of tumor cells, evasion of the immune response and metastasis to distant organs, as well as angiogenesis (growth of blood vessels) essential for tumor growth. Activated STAT3 is not only connected with directly supporting tumor activity, but also suppressing the immune system, making this target even more important to cancer therapy.

With the support of extensive preclinical studies demonstrating high antitumor activity and the critically important ability to cross the blood-brain barrier, WP1066 in this Phase 1 clinical trial will focus on treating aggressive brain tumors which all share a grim prognosis. The intent is to eventually treat up to 15 relapsed brain cancer patients over the next six to eight months. Phase 1 clinical trials typically focus on exploring safe and well tolerated doses, as well as evaluating initial signals of effectiveness. Each treatment is completed over three weeks.

"Treating the first brain tumor patient with WP1066 is the start of a very exciting and encouraging program for doctors treating the worst types of brain cancers. There has been very little progress in recent years toward improved therapies for glioblastoma and other aggressive primary or metastatic brain tumors. WP1066 has shown extremely promising results based on animal studies where we have seen inhibition of tumor growth and improvements in survival," said Dr. Sandra Silberman, a world-renowned oncologist and Moleculin’s Chief Medical Officer. "This is based on the fact that although STAT3 has long been identified as an important target for treating tumors, for years most efforts have focused on attempts to indirectly inhibit STAT3 from upstream signaling, not from within the cancer cell itself. WP1066 appears to be unique in its ability in vitro and in animal models to consistently and directly inhibit the activated form of STAT3 and produce significant anticancer effects, including tumor growth inhibition and increased life span of treated animals."

"This represents a major milestone for Moleculin," commented Walter Klemp, Chairman and CEO. "There has been tremendous enthusiasm within the oncology community for targeting STAT3, a key molecular hub of multiple pathways promoting tumor growth. Although the industry has been struggling to find a way to target STAT3, we at Moleculin believe that most of these efforts have been mechanistically misguided and ended in failure because their approach would ultimately be ineffective at adequately blocking the activation of STAT3 and lack the necessary drug-like properties to succeed. The opportunity to test a unique STAT3 therapy in these patients is significant in supporting Moleculin’s mission to provide benefit for those who need new and better treatments."

How WP1066 Works in Tumor Cells

WP1066 is a small molecule compound that can not only directly kill tumor cells, but also has the ability to overcome the tumor’s ability to evade the natural immune response, which would otherwise be working to eliminate the cancerous activity. This compound is a first in class drug candidate capable of down-regulating the activated form of STAT3, a target that has been long-sought because of its role in supporting the survival and growth of tumor cells.

The compound has been shown to prevent tumor progression and increase survival in a wide range of animal models by directly attacking tumors and blocking the cell signaling by STAT3 that supports tumor development and simultaneously suppressing regulatory T cells (Tregs), which then allows stimulation of an enhanced natural anti-tumor immune response. The compound’s dual functions have been shown to increase survival in a wide range of animal models, which have been documented in more than 50 peer-reviewed articles.