On December 7, 2017 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported that it received written responses from the U.S. Food and Drug Administration (FDA) following its Type C meeting regarding its planned registrational HS-110 clinical trial design for the treatment of non-small cell lung cancer (NSCLC) (Press release, Heat Biologics, DEC 7, 2017, View Source [SID1234522426]).

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The discussion focused on elements of proposed clinical trial designs, both single-arm and controlled, which the FDA agreed would be appropriate to support a registrational trial of HS-110. Clinical endpoints and post-marketing commitments were also discussed in the context of accelerated approval.

"We are very pleased with the outcome of our recent Type C guidance meeting with the FDA," said George Peoples, M.D., Chief Medical Officer for Heat. "The FDA clearly understands the significant unmet need for more effective second-line treatments for NSCLC. We look forward to incorporating their guidance as we prepare to advance HS-110 into registrational trials."

HS-110 is currently in Phase 2 as a treatment for NSCLC. Trial design details and next steps are expected to be announced following the read-out of the Phase 2 data, anticipated in 2H 2018.

On December 7, 2017 Ablynx NV [Euronext Brussels and Nasdaq: ABLX] reported that the Ablynx management team will host a conference call and webcast to present additional data from the Phase III HERCULES study of caplacizumab in acquired thrombotic thrombocytopenic purpura (aTTP), following its presentation by Professor Marie Scully in the late-breaking abstracts session at the 59th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Atlanta, GA, USA (Press release, Ablynx, DEC 7, 2017, View Source [SID1234522437]).

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The late-breaking data presentation will include positive topline results from the Phase III HERCULES study of caplacizumab announced on 2 October 2017 together with important data from additional analyses on the use of plasma exchange (PEX) and length of intensive care unit and hospital stay. The slides will be made available on the Ablynx website under Events & Presentations immediately after the presentation on 12 December 2017 at 7.30 am ET/1.30 pm CET.

Following the late-breaking data presentation, the Ablynx management team will host a conference call and webcast on 12 December 2017 at 4.00 pm CET/10.00 am ET. The live webcast and replay will be available via this link. If you wish to participate in the Q&A session, please dial +32(0)2 400 69 26 or +1 646 828 8193 and use confirmation code 9477994.

Late-breaking abstracts session at ASH (Free ASH Whitepaper), Atlanta, GA, USA
Date: Tuesday 12 December 2017
Abstract (LBA-1): Results of the Randomized, Double-Blind, Placebo-Controlled, Phase III HERCULES study of Caplacizumab in Patients with Acquired Thrombotic Thrombocytopenic Purpura
Presentation Time: 7.30 am ET (1.30 pm CET)
Presenter: Professor Marie Scully, M.D., Department of Haematology, University College London Hospitals NHS Trust, London, UK
Room: Building C, Level 1, Hall C2-C3 (Georgia World Congress Center)

About HERCULES
The HERCULES study recruited 145 patients and is the largest randomised, double-blind, placebo-controlled study conducted in patients with aTTP. Patients with an acute episode of aTTP were randomised 1:1 to receive either caplacizumab or placebo in addition to daily plasma exchange and immunosuppression. Patients received a single intravenous bolus of 10mg caplacizumab or placebo followed by a daily subcutaneous dose of 10mg caplacizumab or placebo for 30 days after the last daily PEX. If at the end of this treatment period there was evidence of persistent underlying disease activity (indicative of an imminent risk for recurrence), treatment could be extended for additional seven-day periods up to a maximum of 28 days and was to be accompanied by optimisation of immunosuppression. Patients were followed for a further 28 days after discontinuation of treatment.
A three-year follow-up study (NCT02878603) of patients who have completed the HERCULES study is in progress and will further evaluate the long-term safety and efficacy of caplacizumab and repeated use of caplacizumab, as well as characterising the long-term impact of aTTP.

About caplacizumab
Caplacizumab is a bivalent anti-vWF Nanobody that received Orphan Drug Designation in Europe and the United States in 2009. Caplacizumab blocks the interaction of ultra-large vWF multimers (ULvWF) with platelets and, therefore, has an immediate effect on platelet aggregation and the ensuing formation and accumulation of the micro-clots that cause the severe thrombocytopenia, tissue ischemia and organ dysfunction in aTTP. This immediate effect of caplacizumab has the potential to protect the patient from the manifestations of the disease while the underlying disease process resolves.

In February 2017, based on the Phase II study results, a Marketing Authorisation Application (MAA) was submitted to the European Medicines Agency (EMA) for approval of caplacizumab in aTTP. In July 2017, Ablynx received Fast Track designation from the Food and Drug Administration (FDA) for caplacizumab for the treatment of aTTP. In October 2017, positive results from the Phase III HERCULES study, meeting primary and two key secondary endpoints, were announced. These data are expected to further support the MAA, as well as a planned Biologics License Application (BLA) filing in the United States in 2018. If approved by regulatory authorities, caplacizumab would be the first therapeutic specifically indicated for the treatment of aTTP.
About aTTP

aTTP is a rare, acute, life-threatening, autoimmune blood clotting disorder. It is caused by impaired activity of the ADAMTS13 enzyme, leaving ULvWF molecules uncleaved (vWF is an important protein involved in the blood clotting process). These ULvWF molecules spontaneously bind to blood platelets, resulting in severe thrombocytopenia (very low platelet count) and clot formation in small blood vessels throughout the body1, leading to ischemia and widespread organ damage2.

Despite the current standard-of-care treatment consisting of PEX and immunosuppression, episodes of aTTP are still associated with a mortality rate of up to 20%, with most deaths occurring within 30 days of diagnosis3. Furthermore, patients are at risk of acute thromboembolic complications (e.g. stroke, myocardial infarction) and of recurrence of disease. Some patients are refractory to therapy1, which is associated with a poor prognosis for survival of an acute episode of aTTP. Long term, patients are at increased risk for hypertension, major depression, and premature death4.

On December 7, 2017 Neon Therapeutics, a clinical-stage immuno-oncology company developing neoantigen-based therapeutics, reported that it has entered a clinical trial collaboration with Merck (known as MSD outside the United States and Canada) to evaluate Neon Therapeutics’ proprietary personal neoantigen vaccine, NEO-PV-01, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), along with chemotherapy (Press release, Neon Therapeutics, DEC 7, 2017, View Source [SID1234522428]).

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NEO-PV-01 is Neon Therapeutics’ most advanced product candidate, and is a personal neoantigen vaccine based on DNA mutations from each patients’ tumor. Neon Therapeutics and Merck will collaborate on a Phase 1b clinical trial that will examine the safety, tolerability and preliminary efficacy of NEO-PV-01 in combination with KEYTRUDA, pemetrexed and carboplatin in patients with untreated advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC). Additionally, the trial will assess neoantigen-specific immune responses in peripheral blood and tumor tissue, and other markers of immune response.

"We believe there is a strong mechanistic rationale to explore the combination of a personal neoantigen cancer vaccine, anti-PD-1 therapy and chemotherapy," said Richard Gaynor, M.D., president of research and development at Neon Therapeutics. "Together with a growing set of clinical collaborators, we are working to amass a diverse set of clinical data to understand the potential of NEO-PV-01 to improve durability and response rates in combination with multiple immuno-oncology targets."

The collaboration agreement is between Neon Therapeutics, Inc. and Merck, through a subsidiary. Additional details were not disclosed.

On December 7, 2017 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 second fiscal quarter and six months ended October 31, 2017 (Press release, Champions Oncology, DEC 7, 2017, View Source [SID1234522440]).

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Second Quarter and Recent Business Highlights:

•
Record quarterly revenue of $5.2 million, an increase of 16.7% year-over-year
•
Record Translational Oncology Services ("TOS") revenue of $4.8 million, an increase of 21.8% year-over-year
•
Awarded a two-year, $2 million, competitively-bid contract through the Small Business Innovation Research (SBIR) program to build and study an ethnically diverse cohort of metastatic prostate patient-derived xenograft (PDX) models
•
Clinical correlation between patient-derived xenograft (PDX) model responses and patient responses to oncology therapies highlighted in journal, Annals of Oncology; the report was published by the European Society for Medical oncology (ESMO) (Free ESMO Whitepaper), the leading European professional organization for medical oncology in Europe.
•
Reiterated expectations for fiscal year 2018 revenue growth of at least 20% over fiscal year 2017

Ronnie Morris, CEO of Champions, commented, "The continued execution of our strategic growth plan and disciplined management of expenses resulted in quarterly operating profitability and another quarter of record revenue, reinforcing our confidence in achieving at least 20% revenue growth for fiscal 2018 and the longer-term prospects for our business. As expected, revenues reached a level that exceeded our expenses, establishing a trajectory for long-term profitability. As we continue to scale, we expect to further minimize the impact of quarter-to-quarter fluctuations and generate consistent profitability."

"Engagement with existing and potential new clients remains solid, and we are encouraged by the level of interest being expressed for our services and the future growth opportunities we see before us," added Morris. "As we continue to expand our presence and collaborate with pharmaceutical companies on new projects, we are further increasing the value and importance of our models in the pre-clinical and clinical drug development process."

Financial Results

Exhibit 99.1

For the second quarter of fiscal 2018, revenue increased 16.7% to $5.2 million, as compared to $4.5 million for the second quarter of fiscal 2017. Total operating expenses for the second quarter fiscal 2018 and 2017 was $5.3 million and $5 million, respectively, an increase of $300,000 or 6.5%. Revenue was $10.2 million and $8.1 million for the six months ended October 31, 2017 and 2016, respectively, an increase of $2.1 million or 26%. Total operating expenses for the six months ended October 31, 2017 and 2016 was $10.9 million and $11.1 million, respectively, a decrease of $200,000 or (2%).

For the second quarter of fiscal 2018, Champions reported a loss from operations of $70,000, including $148,000 in stock-based compensation, an improvement of $423,000 or 85.8% compared to the loss from operations of $493,000, inclusive of $535,000 in stock-based compensation, in the second quarter of fiscal 2017. Excluding stock based compensation and depreciation, Champions recognized net income from operations of $175,000 for the second quarter 2018.

Net cash generated was $229,000 for the three months ended October 31, 2017. Net cash used for the same period last year was $134,000. The improvement in cash flow is the result of revenue growth and expense management.

The Company ended the quarter with $660,000 of cash and cash equivalents and reiterates its position that it does not currently intend to raise capital in the equity market.

TOS revenue was $4.8 million for the three months ended October 31, 2017 compared to $4 million for the three months ended October 31, 2016, an increase of $800,000 or 21.8%.

TOS cost of sales was $2.4 million for the three months ended October 31, 2017, an increase of $600,000, or 30.9%, compared to $1.8 million for the three months ended October 31, 2016. For the three months ended October 31, 2017 and 2016, gross margin for TOS was 50.4% and 53.8%, respectively. The increase in TOS cost of sales was due to an increase in the number and size of TOS studies. The gross margin often fluctuates quarter to quarter, resulting from timing differences between revenue and expense recognition.

Personalized Oncology Services ("POS") revenue was $378,000 and $497,000 for the three months ended October 31, 2017 and 2016, respectively, a decrease of $119,000 or (23.9%). The decrease is due mainly to a decrease in implant and drug study revenue.

POS cost of sales was $259,000 for the three months ended October 31, 2017, a decrease of $115,000, or (30.7%), compared to $374,000 for the three months ended October 31, 2016. For the three months ended October 31, 2017 and 2016, gross margin for POS was 31.5% and 24.8%, respectively. The improvement is attributed to the increase in higher margin sequencing revenue.

Research and development expense was $1.1 million for the three months ended October 31, 2017, an increase of $100,000, or 10.6%, compared to $1 million for the three months ended October 31, 2016. Sales and marketing expense for the three months ended October 31, 2017 was $551,000, a decrease of $166,000, or (23.2%), compared to $717,000 for the three months ended October 31, 2016. The decrease is mainly due to a reduction of marketing resources for the POS division. General and administrative expense was $1 million for both the three months ended October 31, 2017 and 2016.

Year-to-Date Financial Results

Exhibit 99.1

For the first six months of fiscal 2018, revenue increased 26.0% to $10.2 million, as compared to $8.1 million for the first six months of fiscal 2017. Total operating expenses for the first six months of fiscal 2018 were $10.9 million compared to $11.1 million for the first six months of fiscal 2017, a decrease of $200,000 or (1.9%).

For the first six months of fiscal 2018, Champions reported a loss from operations of $689,000, including $711,000 and $132,000 in stock-based compensation and depreciation, respectively, an improvement of $2.3 million, or 77.2%, compared to the loss from operations of $3 million, inclusive of $1.7 million and $87,000 in stock-based compensation and depreciation, respectively, in the first six months of fiscal 2017. Excluding stock-based compensation and depreciation, Champions recognized income from operations of $155,000 for the six months ended October 31, 2017 compared to net loss of $1.3 million for the six months ended October 31, 2016.

TOS revenue was $9.4 million for the six months ended October 31, 2017 compared to $7.1 million for the six months ended October 31, 2016, an increase of $2.3 million or 32.3%.

TOS cost of sales was $4.6 million for the six months ended October 31, 2017, an increase of $700,000, or 19.8%, compared to $3.9 million for the six months ended October 31, 2016. Gross margin for TOS was 50.7% for the first six months of fiscal 2018 compared to 45.5% for the first six months of fiscal 2017.

POS revenue was $818,000 for the six months ended October 31, 2017 compared to $1.0 million for the six months ended October 31, 2016, a decrease of $182,000 or (18.8%).

POS cost of sales was $646,000 for the six months ended October 31, 2017, a decrease of $201,000, or (23.7%), compared to $847,000 for the six months ended October 31, 2016. Gross margin for POS for the six months ended October 31, 2017 was 21% compared to 15.9% for the six months ended October 31, 2016.

Research and development expense was $2.2 million for both the six months ended October 31, 2017 and 2016. Sales and marketing expense for the six months ended October 31, 2017 was $1.2 million, a decrease of $400,000, or (24.8%), compared to $1.6 million for the six months ended October 31, 2016. General and administrative expense was $2.2 million for the six months ended October 31, 2017, a decrease of $400,000 or (15.3%), compared to $2.6 million for the six months ended October 31, 2016.

Net cash used in operations was $1.7 million for the six months ended October 31, 2017 compared to $2.6 million for the six months ended 2016, a decrease of $900,000 or 34.3%.

Conference Call Information:

The Company will host a conference call today at 4:30 p.m. EST (1:30:00 p.m. PST) to discuss its second quarter financial results. To participate in the call, please call 888-567-1602 (domestic) or 404-267-0373 (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 Friday, December 15, 2017 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 and six months ended October 31, 2017 and 2016. 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.

On December 7, 2017 Sanofi reported that it has launched two new late-stage clinical studies to determine if an investigational biologic called isatuximab, when used in combination with other commonly used cancer treatments, might be an effective treatment option for certain people with multiple myeloma, a rare blood cancer related to lymphoma and leukemia. Isatuximab is an investigational anti-CD38 monoclonal antibody being studied for the treatment of patients with relapsed and previously untreated multiple myeloma (Press release, Sanofi Genzyme, DEC 7, 2017, View Source [SID1234522429]).

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"The start of two new Phase 3 trials will provide further clinical data as we continue to advance the development of isatuximab," said Joanne Lager, M.D. Head of Oncology Development, Sanofi. "Our multi-study program across major multiple myeloma segments aims to demonstrate the value of isatuximab in combination with emerging standard treatment regimens. We are committed to developing a potential new treatment option for a continuum of patients with multiple myeloma, a population with high unmet need."

Late-stage studies include approximately 750 patients with multiple myeloma

IKEMA study is a 325-patient randomized, open-label, global multicenter Phase 3 trial that will compare isatuximab in combination with carfilzomib and dexamethasone against carfilzomib and dexamethasone in patients with relapsed and refractory multiple myeloma that have previously been treated with one-to-three lines of therapy.
IMROZ study is a 425-patient randomized, open-label, global multicenter Phase 3 trial that will compare isatuximab in combination with bortezomib, lenalidomide and dexamethasone against bortezomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients not eligible for transplant.
Both studies will evaluate progression-free survival as the primary endpoint. Key secondary endpoints include overall survival, overall response rate, depth of response, safety and quality of life.

Isatuximab granted orphan designation
Isatuximab has been granted orphan designation in the U.S. and European Union. In December 2016, Sanofi started an additional Phase 3 study (ICARIA), comparing isatuximab in combination with pomalidomide and dexamethasone against pomalidomide and dexamethasone in patients with relapsed and refractory multiple myeloma. The development program for isatuximab will now total three Phase 3 studies.

Other isatuximab data being presented at upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) meeting
Findings from additional ongoing studies of isatuximab will be presented during poster sessions at this year’s American Society of Hematology (ASH) (Free ASH Whitepaper) meeting, December 8-12, in Atlanta, GA, including the following abstracts:

Saturday, December 9, 5:30 p.m.-7:30 p.m.:

Updated Results from a Phase Ib Study of Isatuximab Plus Pomalidomide (Pom) and Dexamethasone (dex) in Relapsed/Refractory Multiple Myeloma (RRMM)
Abstract: 1887
Presenter: Dr. Paul Richardson
"In Vivo Vaccination" Effect in Clinical Responders to Anti-Myeloma Monoclonal Antibody Isatuximab
Abstract: 1830
Presenter: Dr. Tim Luetkens
Sunday, December 10, 6:00 p.m. -8:00 p.m.:

A Phase Ib Study of Isatuximab in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone (VCDI) in Patients with Newly Diagnosed Multiple Myeloma Non-Eligible for Transplantation
Abstract: 3160
Presenter: Dr. Enrique M. Ocio
Pre-Clinical Efficacy of the Anti-CD38 Monoclonal Antibody (mAb) Isatuximab in Acute Myeloid Leukemia (AML)
Abstract: 2655
Presenter: Tomas Jelinek