On July 15, 2019 ESSA Pharma Inc. ("ESSA" or "the Company") (NASDAQ: EPIX; TSX-V: EPI), a pharmaceutical company focused on the developing novel therapies for the treatment of prostate cancer, reported the appointment of Dr. Alessandra Cesano, M.D., PhD as Chief Medical Officer ("CMO") (Press release, ESSA, JUL 15, 2019, View Source [SID1234537539]). With over 25 years of drug development, regulatory and medical affairs activities, Dr. Cesano will provide leadership in advancing the Company’s lead clinical candidate, EPI-7386 into Phase 1 clinical testing.

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"Dr. Cesano is an accomplished drug development executive with an extensive and successful track record of leading drug candidates though development, approval and commercial launch. She also has broad expertise in the development and clinical use of biomarkers for the more efficient development of targeted therapeutics. Her expertise will be instrumental in advancing the clinical development of ESSA’s novel N-terminal domain inhibitor of the androgen receptor in men with prostate cancer." said David Parkinson, MD, President & Chief Executive Officer of ESSA.

Dr. Cesano is an accomplished drug development leader with extensive experience in drug discovery and development. She played key roles at Amgen in the approval of Vectibix and Kepivance. Prior to joining ESSA, Dr. Cesano was the CMO at NanoString Technologies, Inc. She had previously served as the CMO at Cleave Biosciences, Inc. and CMO and COO at Nodality, Inc. Dr. Cesano spent 12 years researching tumor immunology, including nine years at the Wistar Institute of the University of Pennsylvania. She also holds memberships in several professional and scientific societies and has been an author on over 100 research publications. Dr. Cesano received an M.D., a Board Certification in Oncology and a Ph.D. in Tumor Immunology from the University of Turin. She holds a B.S. in Science and Economics from Istituto Tecnico Commerciale.

On July 15, 2019 Boehringer Ingelheim reported its acquisition of all shares of AMAL Therapeutics SA, a private Swiss biotechnology company focused on cancer immunotherapy and advancing first-in-class therapeutic cancer vaccines derived from its technology platform KISIMA (Press release, Boehringer Ingelheim, JUL 15, 2019, View Source [SID1234537524]). AMAL’s lead vaccine ATP128 is currently developed for stage IV colorectal cancer and is slated to begin first-in-human trials later this month. Boehringer Ingelheim plans to develop new therapies by combining assets from its cancer immunology portfolio with AMAL’s proprietary KISIMA immunization platform.

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Michel Pairet
"Acquiring AMAL is part of Boehringer Ingelheim’s long-term strategy to enhance our existing position as an innovator of novel cancer therapies, including immuno-oncology treatments, which leverage cutting-edge scientific discoveries and their applications," said Michel Pairet, member of Boehringer Ingelheim’s Board of Managing Directors with responsibility for the company’s Innovation Unit. "We want to pioneer new paradigms of biology-based care for cancer patients, and the technologies and expertise developed at AMAL are critical to our efforts."

The total transaction could amount up to EUR 325 million, and is comprised of an upfront payment as well as contingent clinical, development and regulatory milestones plus up to EUR 100 million if certain commercial milestones are hit.

"I am extremely proud of the hard work of AMAL’s entire team, which is validated by this acquisition, and very excited to further develop the KISIMA technology platform within Boehringer Ingelheim," said Madiha Derouazi, Ph.D., Founder and Chief Executive Officer of AMAL Therapeutics. "Our new relationship with Boehringer Ingelheim will enable us to realize the full potential of our KISIMA platform to fight solid cancers while preserving AMAL’s approach to biotechnology research and our scientific and academic networks. Moreover, sharing resources and capabilities in clinical development will greatly help us to move ATP128 and other assets forward."

Boehringer Ingelheim’s Cancer Immunology group is built to discover therapies that engage triggering of immune responses against non-inflamed, "cold" tumors, which represent a large group of cancer types refractory to many treatments, including checkpoint inhibitor drugs. Immune targeting of cold tumors is a particular challenge. AMAL’s KISIMA vaccine technology, designed to stimulate potent immune responses, is a promising therapeutic option for patients with these type of cancers.

The AMAL acquisition, along with that of the 2018 acquisition of Vira Therapeutics (Vira-T) and in-license of OSE Immunotherapeutics’ SIRP-alpha targeting antibody, significantly strengthens Boehringer Ingelheim’s strategic focus on immune cell-directed therapies. By combining its world-class in-house research and development with that of highly innovative biotechnology companies, Boehringer Ingelheim is developing innovative immuno-oncology therapies and accelerating the delivery of the next-generation of cancer treatments.

AMAL is headquartered on the medical campus of the University of Geneva, from which it was spun-out in 2012, with financial backing from a syndicate of both corporate and institutional investors, including the Boehringer Ingelheim Venture Fund and High-Tech Gründerfonds as the initial seed investors. Additional investments were provided by VI Partners, Helsinn Investment Fund, BioMed Partners and Schroder Adveq. AMAL’s technology platform and derived products are protected by a broad portfolio of patents and licenses.

KISIMA
Unlike prophylactic vaccines that immunize a patient to prevent an infection before it occurs, therapeutic vaccines combat existing diseases. Anti-cancer therapeutic vaccines carry antigens, pieces of protein that also are in tumors. By presenting antigens to the patient’s immune system, a vaccine can prompt tailor-made responses, including activation of killer T cells that target the tumor and can boost memory immunity to reduce the risk of relapse.

AMAL’s proprietary technology platform KISIMA enables the assembly of three functional components into one patented fusion protein used as a vaccine: First, a proprietary cell-penetrating peptide for antigen delivery; second, a proprietary toll-like receptor (TLR) peptide agonist as an adjuvant, and third, a multi-antigenic cargo that can be tailored for specific indications.

ATP128
AMAL’s lead candidate, ATP128, is a therapeutic chimeric recombinant protein vaccine designed using KISIMA and currently developed for stage IV colorectal cancer. AMAL will conduct KISIMA-01, an international Phase Ib clinical study to evaluate the combination of ATP128 with Boehringer Ingelheim’s anti-PD1 compound BI754091, via a May 2019 collaborative agreement, in Microsatellite Stable (MSS) patients with stage IV colorectal cancer.

This first-in-human study will investigate ATP128 as single agent and in combination with BI754091 using safety and tolerability as primary endpoints. The study will also measure anti-tumor activity and characteristics of the immune response as secondary and exploratory endpoints.

On July 15, 2019 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that plans to report second quarter 2019 financial results on July 30, 2019. Ligand’s CEO John Higgins, President and COO Matt Foehr, and Executive Vice President and CFO Matt Korenberg will host the conference call (Press release, Ligand, JUL 15, 2019, View Source [SID1234537525]).

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Second Quarter 2019 Earnings Call

What:

Ligand conference call to discuss financial results and provide general business updates

When:

Tuesday, July 30, 2019

Time:

9:00 a.m. Eastern time (6:00 a.m. Pacific time)

Conference Call:

(833) 591-4752 within the U.S.

(720) 405-1612 outside the U.S.

Conference ID – 1997313

Webcast:

Live conference call webcast and replay accessible at www.ligand.com

On July 15, 2019 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 fourth fiscal quarter and 12 months ended April 30, 2019 (Press release, Champions Oncology, JUL 15, 2019, View Source [SID1234537542]).

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Fiscal Year 2019 Financial and Recent Business Highlights:

Record annual revenue of $27.1 million, an increase of 34% year-over-year

Record quarterly revenue of $7.7 million, an increase of 57% year-over-year

Launched ex-vivo platform and clinical flow services

Forecast of revenue growth of 15% – 30% in FY 2020

Ronnie Morris, CEO of Champions, commented, "we’ve completed another year having achieved significant accomplishments for the Company. We’ve grown our year over year revenue by 34%, recorded annual profitable results while also adding to our product line by launching our ex-vivo platform and flow cytometry services. Expanding our suite of services is an important step in our long-term growth strategy for the Company."

David Miller, CFO of Champions added, "Our record quarterly and annual revenue demonstrates the continued strength in our core business lines. As we look ahead to fiscal year 2020, our PDx services will lead our anticipated revenue growth while sales of flow cytometry will set the stage for sustained financial success over the long term."

Fourth Fiscal Quarter Financial Results

For the fourth quarter of fiscal 2019, revenue increased 56.8% to $7.7 million compared to $4.9 million for the fourth quarter of fiscal 2018. The overall increase in revenue is due to the continuing increase in sales, both in number and size of studies, expanding our customer base, and demand for our services. Total costs and operating expenses for the fourth quarter of fiscal 2019 were $7.8 million compared to $5.5 million for the fourth quarter of fiscal 2018, an increase of $2.3 million or 42.0%.

For the fourth quarter of fiscal 2019, Champions reported loss from operations of $117,000, which includes $143,000 in stock-based compensation and $174,000 in depreciation, an improvement of $477,000, compared to the loss from operations of $594,000, inclusive of $172,000 in stock-based

Exhibit 99.1

compensation and $110,000 depreciation expense, in the fourth quarter of fiscal 2018. Excluding stock-based compensation and depreciation, Champions reported income from operations for the quarter of $200,000, an improvement of $512,000 compared to a loss of $312,000 in the year ago period.

Cost of oncology solutions was $4.3 million for the three months ended April 30, 2019, an increase of $1.5 million, or 52.6% compared to $2.8 million for the three months ended April 30, 2018. The increase in cost of sales was primarily due to an increase resulting from study volume as evidenced by the growth in revenue; and, approximately $500,000 in expenses due to repeating studies. For the three months ended April 30, 2019, gross margin was 44.3% compared to 42.7% for the three months ended April 30, 2018. The gross margin in the fourth quarter of fiscal 2019 was impacted by the additional expenses related to study delays.

Research and development expense was $1.2 million for the three months ended April 30, 2019 an increase of $154,000, or 14.1% compared to $1.1 million in the prior year. The increase is due to costs associated with the development of our ex-vivo and flow products. Sales and marketing expense for the three months ended April 30, 2019 was $918,000, an increase of $203,000, or 28.4% compared to $715,000 for the three months ended April 30, 2018. The increase is mainly due to an increase in salaries. General and administrative expense was $1.37 million for the three months ended April 30, 2019 compared to $888,000 for the three months ended April 30, 2018, an increase of $479,000 or 53.9%. The increase is mainly due to an increase in salaries and professional fees.

Year-to-Date Financial Results

For the twelve months of fiscal 2019, revenue increased 33.7% to $27.1 million, as compared to $20.2 million for the twelve months of fiscal 2018. For the twelve months of fiscal 2019, total operating expenses increased 24.1% to $26.8 million, as compared to $21.6 million for the twelve months of fiscal 2018.

For the twelve months ended April 30, 2019, Champions reported income from operations of $270,000, which includes $649,000 in stock-based compensation and $606,000 in depreciation, an improvement of $1.6 million, compared to the loss from operations of $1.4 million, inclusive of $1.0 million in stock-based compensation and $360,000 depreciation, for the twelve months ended April 30, 2018. Excluding stock-based compensation and depreciation, Champions reported operating income of $1.5 million for the twelve months ended April 30, 2019.

Net cash provided by operations was $1.9 million for the twelve months ended April 30, 2019 compared to the net cash used in operations of $1.2 million for the twelve months ended April 30, 2019, an increase of $3.1 million. The increase in cash is the result of our sales growth.

Cost of oncology solutions was $14.3 million for the twelve months ended April 30, 2019 compared to $10.6 million for the twelve months ended April 30, 2018, an increase of $3.7 million or 35.2%. The increase in cost of sales was due to an increase in salary and mice costs resulting from the increase in study volume along with expenses from repeating studies. Gross margin was 47.3% for the twelve months ended April 30, 2019 compared to 47.9% for the twelve months ended April 30, 2018.

Research and development expense was $4.8 million for the twelve months ended April 30, 2019 an increase of $397,000, or 9.0% compared to $4.4 million for the twelve months ended April 30, 2018. The increase was due to the costs associated with the development of new products. Sales and marketing expense for the twelve months ended April 30, 2019 was $3.1 million, an increase

Exhibit 99.1

of $486,000, or 18.9% compared to $2.6 million for the twelve months ended April 30, 2018. The increase is mainly due to commissions paid to the business development team on bookings. General and administrative expense was $4.7 million for the twelve months ended April 30, 2019, an increase of $607,000 or 14.9% compared to $4.1 million for the twelve months ended April 30, 2018. The increase was mainly due to an increase in recruiting and salary expenses.

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 fourth quarter financial results. To participate in the call, please call 877-407-8035 (domestic) or 201-689-8035 (international) ten minutes ahead of the call and give the verbal reference "Champions Oncology."

Full details of the Company’s financial results will be available Monday July 29, 2019 in the Company’s Form 10-K at www.championsoncology.com.

* Non-GAAP Financial Information

See the attached Reconciliation of GAAP to non-GAAP Net Income (Loss) (Unaudited) for an explanation of the amounts excluded to arrive at non-GAAP net income (loss) and related non-GAAP net income (loss) per share amounts for the three and twelve months ended April 30, 2019 and 2018. 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 income (loss) and non-GAAP income (loss) per share are not, and should not be viewed as a substitute for similar GAAP items. Champions’ defines non-GAAP dilutive income (loss) per share amounts as non-GAAP net income (loss) divided by the weighted average number of diluted shares outstanding. Champions’ definition of non-GAAP net income (loss) and non-GAAP diluted income (loss) per share may differ from similarly named measures used by others.

On July 15, 2019 Neon Therapeutics, Inc. (Nasdaq: NTGN), a clinical-stage immuno-oncology company developing neoantigen-based therapeutics, reported top-line results, with at least 12-month median follow-up, from the ongoing, multicenter Phase 1b clinical trial evaluating NEO-PV-01, Neon’s personal neoantigen vaccine candidate, in combination with OPDIVO in patients with advanced or metastatic melanoma, smoking-associated non-small cell lung cancer (NSCLC) and bladder cancer (Press release, Neon Therapeutics, JUL 15, 2019, View Source [SID1234537527]). Across all three distinct tumor types, results demonstrated prolonged and consistent improvements in progression-free survival (PFS) that compare favorably to that observed with checkpoint inhibitor monotherapy, based on historical benchmark data. At 13.4-month median follow-up in 34 patients with metastatic melanoma, median PFS had not yet been reached. In 27 patients with metastatic NSCLC, median PFS was 5.6 months; and in 21 patients with metastatic bladder cancer, median PFS was 5.6 months. These top-line data, which come from 82 patients who received at least one dose of OPDIVO in the Phase 1b NT-001 trial (Intention-to-Treat analysis, or ITT), support further development of NEO-PV-01, including randomized Phase 2 trials of NEO-PV-01 in metastatic disease settings. The NT-001 trial was initiated in November 2016 and completed enrollment in July 2018.

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"Collectively, these data demonstrate a promising new approach in the field of cancer immunotherapy with the potential to further broaden and extend the benefits of checkpoint inhibitor treatment to improve patient outcomes in multiple cancer settings. Monotherapy checkpoint inhibitors have historically shown a range in median progression-free survival in metastatic melanoma, non-small cell lung and bladder cancers of approximately 3-7 months, 2-4 months and 2-3 months, respectively. With these NT-001 results, we are observing consistent prolongation of progression-free survival across all three tumor types compared with historical checkpoint inhibitor monotherapy studies involving patients with similar baseline characteristics. This is an exciting step in establishing the potential of neoantigen-based therapies as a vital component of the cancer treatment landscape," said Patrick Ott, M.D. Ph.D., Clinical Director, Melanoma Center, Center for Immuno-Oncology at the Dana-Farber Cancer Institute and a lead investigator in the NT-001 trial. "Importantly, these clinical outcome improvements, when coupled with the immune and pathological changes seen after vaccination that were presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2019 Annual Meeting, are consistent with the mechanism of action of NEO-PV-01."

NT-001 Clinical Trial Top-Line Results1
ITT analysis includes 82 patients receiving at least one dose of OPDIVO (as of April 2019 data cut)

Metastatic Melanoma
(N=34)
Metastatic Non-Small Cell Lung Cancer
(N=27)
Metastatic Bladder
Cancer
(N=21)
Median Follow-up (months)
13.4
12.0
14.7
Median PFS (months)
Not Yet Reached
(12-Month PFS = 56%)
5.6
5.6
Objective Response Rate
47%
22%
24%
Prior therapy %
41%
67%
71%
1 Please see accompanying presentation at View Source for additional details

As previously presented at the AACR (Free AACR Whitepaper) 2019 Annual Meeting, in data available from the melanoma cohort from an August 2018 data cut, evidence of patients experiencing immune pressure on their tumors in the form of both cascading immune response (epitope spread) and decreased tumor cellularity (biopsies obtained following vaccine treatment) was observed in a majority of patients in the trial who had not progressed at nine months. This evidence of complete histological response of biopsied tumor is a potential correlate for durable clinical benefit and suggests that traditional radiographic analyses may underrepresent the effect that a neoantigen vaccine may have on tumor killing.

"By targeting neoantigens that are specific to each patient’s tumor, we believe that our NEO-PV-01 personal cancer vaccine candidate is helping direct a patient’s immune system to these new cancer targets, which can lead to prolonged clinical benefit. Consequently, we believe that the evidence we are seeing in this clinical trial of broadened neoantigen immune response, epitope spread and histological response suggest that NEO-PV-01 may play an important role in prolonging clinical benefit in combination with checkpoint inhibition, as evidenced by the extended PFS reported in this trial," said Richard Gaynor, M.D., Neon’s President of Research and Development.

The safety data for NT-001 were consistent with the safety profile for OPDIVO monotherapy. In the 60 patients who had received at least one vaccine dose, no serious adverse events were observed that were related to the NEO-PV-01/OPDIVO combination. Low grade adverse events attributable to the NEO-PV-01/OPDIVO combination included injection site reactions, fatigue and influenza-like illness.

"Our NT-001 trial is the first demonstration of improved clinical outcomes for this new class of personal neoantigen therapies in metastatic cancer. We believe Neon is pioneering this exciting new potential approach to treating cancer. The dataset we are presenting today represents an important milestone for Neon and the entire neoantigen field. We believe these data further validate our neoantigen-based platform, including our class-leading RECON bioinformatics platform, and position us well to initiate Phase 2 development of NEO-PV-01 and advance our personal T cell therapy into the clinic," said Hugh O’Dowd, Neon’s Chief Executive Officer.

Continued Development of NEO-PV-01

These top-line results support further development of NEO-PV-01, including randomized Phase 2 trials of NEO-PV-01 in metastatic disease settings. Neon plans to present more detailed data from its NT-001 clinical trial at an upcoming medical society meeting.

Melanoma: Neon plans to initiate a randomized Phase 2 clinical trial in combination with checkpoint inhibitor therapy in a biomarker-defined population of first-line metastatic melanoma patients in 2020. Data analysis from the NT-001 trial is ongoing and will further inform potential biomarker selection. In addition, Neon is conducting its NT-003 trial to evaluate NEO-PV-01 and OPDIVO in combination with other agents, including a CD40 agonist or a CTLA-4 antagonist, to potentially further enhance NEO-PV-01-induced neoantigen immune response and improve clinical outcomes. Neon plans to present immune monitoring data from this trial in the second half of 2020.

NSCLC and Bladder Cancer: Neon also believes that the NT-001 results in advanced or metastatic NSCLC and bladder cancers support continued development of NEO-PV-01 in these settings. The NT-001 data provide increased confidence in NEO-PV-01’s potential to improve clinical benefit in combination with standard of care, such as with checkpoint inhibitor therapy and chemotherapy, for these difficult to treat cancers. As announced in April 2019, Neon has completed enrollment in NT-002, its Phase 1b clinical trial evaluating NEO-PV-01 in combination with the current standard of care, KEYTRUDA (pembrolizumab) and chemotherapy, in first-line patients with untreated advanced or metastatic NSCLC. Neon expects to

report immune monitoring and clinical outcome data from this trial by the end of the third quarter of 2020, which will inform future randomized clinical trials.

OPDIVO is a registered trademark of Bristol-Myers Squibb Company. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Conference Call Information

Neon will host a conference call and webcast today at 8:30 A.M. ET to discuss the top-line results from its Phase 1b NT-001 clinical trial. The live webcast can be accessed on the investor page of Neon’s website at View Source. The conference call can be accessed by dialing (866) 353-0265 and using the conference ID 5596197. A replay of the webcast will be available on Neon’s website approximately two hours after the completion of the event and will be archived for up to 30 days.

About NEO-PV-01

NEO-PV-01 is Neon’s investigational personal neoantigen vaccine, which is custom-designed and manufactured based on the unique mutational fingerprint of each individual patient. NEO-PV-01, which is designed to include up to 20 neoantigen-targeting peptides selected by Neon’s RECON bioinformatics engine, is intended to generate an anti-tumor immune response directing T cells to target particular neoantigens in the patient’s tumor. NEO-PV-01 is being studied in multiple ongoing Phase 1 clinical trials.

About Neon’s NT-001 Clinical Trial

NT-001 is a Phase 1b clinical trial evaluating Neon’s investigational personal neoantigen vaccine, NEO-PV-01, in combination with OPDIVO (nivolumab) in checkpoint-naïve patients with metastatic melanoma, smoking-associated NSCLC or bladder cancer. OPDIVO is a PD-1 immune checkpoint inhibitor designed to overcome immune suppression. Neon’s NT-001 trial is intended to evaluate the combination of NEO-PV-01 with OPDIVO and the potential to broaden a patient’s anti-tumor immune response, resulting in improved duration of clinical benefit. The NT-001 trial is being conducted at nine leading U.S. cancer centers and includes first-, second- and later-line metastatic patients who were eligible to participate if they had received no more than one prior systemic treatment. The primary endpoint of the trial is to evaluate the safety of NEO-PV-01 in combination with OPDIVO and secondary endpoints include the clinical efficacy of the combination over two years of follow-up. Exploratory endpoints include correlative immune response with clinical outcome endpoints.