Innate Pharma reports first half 2018 financial results and business update

On September 14, 2018 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH), reported its consolidated financial results for the first six months of 2018 (Press release, Innate Pharma, SEP 14, 2018, View Source [SID1234529426]). The financial statements are attached to this press release.

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"In the first half of 2018 we have continued to advance our innovative portfolio, both with our partnered and proprietary immuno-oncology programs. We are encouraged by the emerging clinical data from our lead antibody, monalizumab, and look forward to presenting the updated data set from the Phase I/II study of monalizumab in combination with cetuximab in patients with recurrent or metastatic head and neck cancer at the upcoming ESMO (Free ESMO Whitepaper) 2018 congress," commented Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "Our commitment to continue the clinical development momentum remains a priority. Together with our partner AstraZeneca/MedImmune, we recently decided to recruit additional patients into the monalizumab plus cetuximab study to gain more experience in patients with advanced SCCHN** previously treated with anti-PD-1/L1. The Phase I trial evaluating IPH5401 in combination with durvalumab has been initiated and we look forward to share new data on IPH4102."

A conference call will be held today at 2:00pm (CEST)

Dial in numbers:

France and International: +33 (0)1 72 72 74 03 US only: +1 646 722 4916

PIN code: 53841185#

The presentation is available at the bottom of this page.

A replay is available on Innate Pharma’s website.

Financial highlights of the first half of 2018

The key elements of Innate Pharma’s financial results for the first half of 2018 are as follows:

Cash, cash equivalents and financial assets (current and non-current) amounting to €141.6m (million euros) as of June 30, 2018 (€176.6m as of December 31, 2017).
Financial liabilities amounting to €5.2m, including €3.9m of non-current liabilities (€5.9m as of December 31, 2017, including €4.5m of non-current liabilities).
Revenue and other income amounting to €23.7m (€21.2m for the first half of 2017). This amount mainly results from revenue from licensing and collaboration agreements (€16.9m) and from research tax credit (€6.2m).
Revenue related to the licensing and collaboration agreements mainly results from phasing of initial payment received by Innate Pharma in the context of the agreement signed in April 2015 relating to monalizumab with AstraZeneca/MedImmune (€16.7m).
Operating expenses amounting to €39.4m (€37.1m for the first half of 2017), of which 86% are related to research and development.
R&D expenses were up €4.6m during the periods under review, in line with the broadening and progress of Innate’s pipeline.Share-based payments were down €4.0m, including €1.9m in R&D and €2.1m in G&A, making up the most of G&A expenses decrease.
A net loss for the first half of 2018 amounting to €16.2m (€16.6m for the first half of 2017).

GT BIOPHARMA ANNOUNCES POSTIVE RESULTS FOR TWO NEXT GENERATION TRIKES IN SOLID TUMORS

On September 13, 2018 GT Biopharma Inc. (OTCQB: GTBP) and (Euronext Paris: GTBP) reported the positive results for two next generation Trispecific Killer Engagers (TriKEs) in solid tumors (Press release, GT Biopharma , SEP 13, 2018, View Source [SID1234539522]). These efforts were headed by Dr. Daniel Vallera, Director, Section of Molecular Cancer Therapeutics and Dr. Martin Felices, Co-Director of the Translational Therapy Laboratory at the Masonic Cancer Center, University of Minnesota.

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Two animal models were tested. One in ovarian cancer and one in head and neck cancers. In the ovarian cancer model, animals that were treated with our CD16-IL15-B7H3 TriKE demonstrated significant tumor resolution. An additional observation was the persistence of natural killer (NK) cells in the treated animals which is thought to be directly related to its tumor-killing abilities. In the head and neck cancer animal model, animals treated with our CD16-IL15-EpCAM TriKE displayed a significant decrease in tumor burden.

Solid tumors represent approximately 80% of all cancers. In addition, there are tremendous unmet medical needs in both ovarian and head and neck cancers.

Dr. Martin Felices said, "These promising results certainly warrant further investigation. If these results are seen in human ovarian as well as head and neck cancers it can dramatically change the poor outcomes these patients currently face."

Dr. Daniel Vallera said: "Based on this compelling data we continue to be incredibly excited about the use of the TriKEs in solid tumors. This would be a ground-breaking advancement for the treatment of these hard to treat cancers."

GT Biopharma’s Chairman and Chief Executive Officer (CEO) Dr. Raymond Urbanski said: "These results further demonstrate the immense potential of our NK cell engager TriKE and TetraKE platforms for the treatment of both liquid and solid tumors. They could represent a complete paradigm shift in the treatment of cancer"

Helix BioPharma Corp. Initiates Enrollment of the Second Last Cohort in U.S. Combination Treatment Study of Its Lung Cancer Drug Candidate L-DOS47

On September 13, 2018 Helix BioPharma Corp. (TSX, FSE: HBP) ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported that the Safety Review Committee ("SRC") reviewed safety data from the fifth dosing cohort of the Company’s LDOS001 study and recommended that Helix begin enrollment of patients into the sixth dosing cohort (Press release, Helix BioPharma, SEP 13, 2018, View Source [SID1234530408]). LDOS001 is a dose escalation study of L-DOS47 with pemetrexed and carboplatin in recurrent or metastatic non-squamous non-small cell lung cancer. Patients enrolled in the sixth dosing cohort will receive the next L-DOS47 dose level which is 9.0 micrograms of L-DOS47 per kilogram of patient body weight. Cohort 6 and Cohort 7 are the final two dose escalation groups in the approved protocol.

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"The Company has made good progress in advancing this trial, the FDA approved amendment helped to accelerate dose escalation and the completion of the last two cohorts will provide additional important clinical data " said Heman Chao, Helix’s Chief Executive Officer.

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.