On September 12, 2016 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing new therapeutics and molecular diagnostics that target the underlying mechanisms of cancer, reported that it has submitted a formal response to the U.S. Food and Drug Administration (FDA) regarding the previously announced clinical hold of Aptose’s Phase 1b clinical trial of APTO-253 in patients with hematologic cancers (Press release, Aptose Biosciences, SEP 12, 2016, View Source;p=RssLanding&cat=news&id=2201082 [SID:SID1234515091]). Aptose provided responses to all of the questions cited in the clinical hold letter issued by the FDA.

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"This submission represents months of disciplined labor to resolve a manufacturing matter related to APTO-253 that arose during our Phase 1b Trial in patients with AML and high-risk MDS," commented Dr. William G. Rice, Chairman, President and Chief Executive Officer. "Although the FDA will make the ultimate decision whether our clinical trial may resume, all of their questions have been addressed."

During a Phase 1b clinical trial with APTO-253, a clinical site experienced stoppage of the infusion pump during an IV infusion caused by back pressure as a result of clogging of the in-line filter. The Company determined the root cause was a chemistry-based issue with the molecule, and the Company is now working with a drug product that does not cause filter clogging or pump stoppage during mock infusion studies performed to confirm the acceptability of the updated product through the clinical infusion procedures. Such improvements to the APTO-253 manufacturing process required to address the filter clogging event will be incorporated into a Chemistry, Manufacturing and Control (CMC) amendment to our Investigational New Drug application.

On September 9, 2016 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of cell therapies, reported the successful completion of the 21-day safety follow-up of the last patient enrolled at the fourth dose level in its Phase I clinical trial evaluating the safety and feasibility of its NKR-2 T-cell therapy – in Acute Myeloid Leukemia and Multiple Myeloma patients (Press release, Celyad, SEP 9, 2016, View Source [SID1234516410]). No safety issues or toxicities were reported.

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Dr. Christian Homsy, CEO of Celyad: "We are pleased that no adverse safety signal has been reported. Based on the successful completion of the fourth cohort, we are looking forward to starting the global Ph I/IIa multiple dose trial, in the US and EU, of our NKR-2 autologous therapy in the fourth quarter of this year."

Dr. Frédéric Lehmann, Head of Immuno-Oncology at Celyad: "The absence of any safety or toxicity signal up to this point continues to support our belief that this unique engineered T-cell construct can be safely administered and potentially lead to a therapeutic effect providing hope to the thousands of patients who need better treatments for both AML and MM."

On September 9, 2016 Champions Oncology, Inc. (Nasdaq: CSBR), engaged in the development of advanced technology solutions and services to personalize the development and use of oncology drugs, reported its financial results for the first quarter ended July 31, 2016 (Filing, Q1, Champions Oncology, 2016, SEP 9, 2016, View Source [SID:1234515018]).

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First Quarter and Recent Business Highlights:
• First quarter revenue of $3.7 million; significantly above revenue guidance range of $3.25 – $3.5 million
• Reaffirms full year revenue guidance for FY2017 of $16 – $18 million
• Delivered third consecutive quarter of record TOS bookings
• Signed significant AML study with major pharmaceutical company
• Signed second co-clinical trial
• Enrolled first patient in co-clinical trial

Joel Ackerman, Champions Oncology CEO, stated, "we continued to build momentum achieving another quarter of strong revenue growth and delivering our third consecutive quarter of record TOS bookings, setting the stage for continued positive results heading into next quarter.. We have produced this revenue growth while controlling our expenses, putting us on a path to cash flow breakeven by the end of our fiscal year."

Financial Results

For the first quarter of 2017, revenue was $3.7 million, as compared to $2.8 million for the first quarter 2016, an increase of 30%. Total operating expense for the first quarter 2017 was $6.2 million as compared to $5.7 million for the first quarter 2016, an increase of 8.3%.

For the first quarter of 2017 and 2016, Champions reported a loss from operations of $2.5 million and $2.9 million, respectively. Excluding stock-based compensation of $1.1 million and $775,000 for the three months ended July 31, 2016 and 2015, Champions recognized a loss from operations of $1.4 million and $2.1 million, respectively.

Operating Results

Translational Oncology Solutions (TOS):

Exhibit 99.1

TOS revenue was $3.2 million and $2.3 million for the three months ended July 31, 2016 and 2015, respectively, an increase of $900,000 or 35.2%. The increase is due to increased bookings in prior quarters, both in the number and size of the studies, and the addition of new customers.

TOS cost of sales was $2.0 million and $1.6 million for the three months ended July 31, 2016 and 2015, respectively, an increase of $400,000, or 27.1%. For the three months ended July 31, 2016 and 2015, gross margin for TOS was 35.1% and 31.0%, respectively. The increase in TOS cost of sales was due to an increase in TOS studies. The improvement in gross margin was due to higher TOS revenue leveraged off the fixed cost component of the lab and effective management of the variable lab costs.

Personalized Oncology Solutions (POS):

POS revenue was $511,000 and $485,000 for the three months ended July 31, 2016 and 2015, respectively, an increase of $26,000 or 5.4%. The increase is primarily the result of growth in sequencing revenue of $115,000 offset by a decline in implant and drug panel revenue of $29,000 and $60,000, respectively.

POS cost of sales was $474,000 and $661,000 for the three months ended July 31, 2016 and 2015, respectively, a decrease of $187,000, or (28.3%). For the three months ended July 31, 2016 and 2015, gross margin for POS was 7.2% and negative (36.3%), respectively. The improvement is attributed to the increase in higher margin sequencing revenue and aggressively managing our lab costs.

Research and development expense was $1.2 million and $1.1 million for the three months ended July 31, 2016 and 2015, respectively, an increase of $100,000, or 10.1%. The increase is primarily due to an increase in salary expense. Sales and marketing expense for the three months ended July 31, 2016 and 2015 was $925,000 and $1 million, respectively, a decrease of $75,000, or (10.1%). The decrease is due to the consolidation of sales and marketing personnel resources of the POS and TOS division. General and administrative expense was $1.5 million and $1.3 million for the three months ended July 31, 2016 and 2015, respectively, an increase of $200,000, or 16.5%. The increase is due to an increase of $354,000 in stock compensation expense.

On September 12, 2016 AVEO Pharmaceuticals, Inc. ("AVEO") reported discontinuation of the FOCAL study, a Phase 2, global, randomized, double-blind, placebo controlled clinical study, evaluating ficlatuzumab, AVEO’s HGF inhibitory antibody, in combination with erlotinib (Tarceva), an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) in first line, VeriStrat (BDX 004) Poor (VSP), EGFR-mutated NSCLC patients (Filing, 8-K, AVEO, SEP 9, 2016, View Source [SID:SID1234515089]). VeriStrat is a proprietary biomarker test developed by Biodesix to select patients for entry into the trial.

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The FOCAL study was prospectively designed to confirm results from a retrospective exploratory analysis of a randomized Phase 2 clinical trial ("Study P06162") comparing the combination of ficlatuzumab and gefitinib (IRESSA), an EGFR TKI therapy, to gefitinib monotherapy in previously untreated Asian patients with advanced NSCLC who had tested positive for both EGFR mutation and VSP. Study P06162 demonstrated a statistically significant improvement in overall survival (OS) and progression free survival (PFS) for patients in the gefitinib plus ficlatuzumab arm that were classified as VSP.

After experiencing slower than expected enrollment, a blinded interim analysis of the FOCAL study was conducted and found that patients who were positive for both VSP and EGFR mutations, who were known to be selected for poor prognosis, experienced materially higher discontinuation rates than observed in both the general ITT population and retrospective exploratory subgroup population of Study P06162, which was the basis for the FOCAL study design. This observation significantly compromised the feasibility of the trial. The parties have mutually agreed to discontinue the study. The parties intend to further discuss the details for the discontinuation of the study and future development of ficlatuzumab.

On September 8, 2016 BioLineRx Ltd. (NASDAQ/TASE: BLRX) reported that the successful final results of BL-8040’s Phase 2a clinical trial in relapsed or refractory acute myeloid leukemia (r/r AML) were presented yesterday evening at the 4th Annual Meeting of the Society of Hematologic Oncology (SOHO), being held September 7-10, 2016, in Houston, Texas (Press release, BioLineRx, SEP 8, 2016, View Source;p=RssLanding&cat=news&id=2200457 [SID:1234514998]).

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BL-8040, BioLineRx’s lead oncology platform, is a short cyclic peptide that functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. The Phase 2a study assessed the efficacy of BL-8040, as a single agent and in combination with Cytarabine (Ara-C), for the treatment of r/r AML. The reported data set includes 45 patients. The majority of patients in the study were heavily pretreated, with 45% of patients being refractory to one or two remission induction treatments, 19% of patients having relapsed after a short first remission of less than 12 months, and 17% of patients having undergone two or more relapses. In addition, the treated patient population included patients that had relapsed post allogeneic stem-cell transplantation (17%), as well as secondary AML patients (24%), both conditions which represent difficult-to-treat populations with poor prognoses.

Results show that treatment with BL-8040 in combination with Ara-C was safe and well tolerated at all doses tested up to and including the highest dose level of 2.0 mg/kg. Response to treatment was associated with efficient CXCR4 inhibition, resulting in high mobilization of blasts and induction of their differentiation. The composite complete remission rate, including both complete remission (CR) and complete remission with incomplete blood count recovery (CRi), was 38% in subjects receiving up to two cycles of BL-8040 treatment at doses of 1 mg/kg and higher (n=39). In the 1.5 mg/kg dose selected for the expansion phase of the study (n=22), the composite complete remission rate was 41%. These response rates are superior to the historical response rate of approximately 20% reported for high-risk AML patients treated with Ara-C alone.

In addition, the ongoing follow-up of patients participating in the study’s expansion phase and responding to the combination treatment suggests long durability of the remissions achieved, with two-thirds of these patients still alive, based on a follow-up period to date of up to 12 months.

Philip Serlin, Chief Financial and Operating Officer of BioLineRx, commented, "The results from this study clearly confirm the anti-leukemic activity of BL-8040 and reinforce our interest in the AML space. The data demonstrate that sustained inhibition of the CXCR4-CXCL12 axis with BL-8040 is safe and well tolerated, and when given in combination with Ara-C, improves the response rate historically achieved with Ara-C alone. In addition, treatment with BL-8040 as a single agent rapidly and efficiently induces mobilization, differentiation and cell death of AML cells. This selective effect on chemotherapy-resistant cells may be translated into reduction of residual disease, thus pointing to incorporation of BL-8040 into earlier AML treatment lines."

"As previously reported, we are currently in the midst of a large, randomized, controlled, Phase 2b study in the AML consolidation treatment line. In light of the data seen in the Phase 2a study, we have been allocating additional resources to this Phase 2b study. In this regard, we have recently engaged an additional AML research group to participate in the study, and last month we met with regulatory authorities to discuss the development pathway towards registration for this treatment line. In addition, yesterday we announced a significant new cancer immunotherapy collaboration with Genentech, which includes, among other studies, a Phase 1b study in the AML maintenance treatment line. This new study emphasizes our commitment to further develop BL-8040 as a treatment for AML and validates the anti-leukemic effect of BL-8040 seen in the Phase 2a study," concluded Mr. Serlin.

About BL-8040

BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors, and certain hematological indications. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells from the bone marrow, thereby sensitizing these cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing apoptosis. In addition, BL-8040 has also demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, and T, B and NK cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.