On July 15, 2019 Advaxis, Inc. (NASDAQ: ADXS), a clinical-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported new immune data from its ongoing ADXS-NEO Phase 1 clinical trial that further support the clinical potential for the company’s platform in neoantigen-directed immunotherapies (Press release, Advaxis, JUL 15, 2019, View Source [SID1234537523]).

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ADXS-NEO is a personalized immunotherapy that is designed to help a patient’s immune system recognize and respond to mutation-derived tumor antigens, or neoantigens, that are unique to his or her tumor. ADXS-NEO is designed to express tLLO fused to up to 40 patient-specific neoantigens arranged sequentially as beads-on-a-string. As a live attenuated bacterial vector, ADXS-NEO can be rapidly taken up by antigen presenting cells, which recognize it as foreign and present the tLLO-NEO fusion proteins to T cells by the major histocompatibility complex class I and II pathways.

ADXS-NEO is being evaluated in an open-label, dose-escalation, multicenter Phase 1 clinical trial in the United States. Part A of the study is open to patients with metastatic non-small cell lung cancer (NSCLC), metastatic microsatellite stable colorectal cancer (MSS-CRC) and metastatic squamous cell carcinoma of the head and neck (SCCHN) who will receive ADXS-NEO as monotherapy. Part B of the study, anticipated to begin later this year, will be open to NSCLC patients as well as patients with melanoma SCCHN and bladder cancer and, for this part, ADXS-NEO will be administered in combination with a checkpoint inhibitor.

The new data were derived from deconvolution of neoantigen pools using single peptides and in vitro stimulation ELISpot assays (minimal CD8+ peptides). This has now been completed for the first two patients enrolled in this study, one with NSCLC and one with MSS-CRC. Highlights of the new post-vaccination data with ADXS-NEO are as follows:

CD8+ T cells were generated against 90% of the 40 neoantigen targets contained in the drug construct for the MSS-CRC patient (the NSCLC patient did not have 40 neoantigen targets and there were certain other issues with this patient’s sample that, together, made it unsuitable for inclusion in this "hit rate" analysis). This is consistent with Advaxis’ previously reported data from its preclinical studies as well as from clinical studies using pooled neoantigen peptides which were presented at the American Association of Cancer Research Annual Meeting last year and earlier this year, respectively. This is the highest "hit rate" publicly reported to-date in the neoantigen field. This high "hit rate", along with the rapid immune responses seen and antigen spreading, lay the foundation for the ADSX-NEO platform to be best-in-class for personalized, neoantigen-directed immunotherapies.

CD8+ T cells were also generated against the hotspot mutations found within each of the two patients’ tumors (i.e., EGFRL858R in the NSCLC patient and KRAS G12A in the MSS-CRC patient). This is important for the ADXS-NEO program as Advaxis believes a number of patient tumors likely will present with hotspot mutations, and generating or maintaining CD8+ T cell activity against these targets may increase the potential for killing cancer cells. All of the first four patients in this Phase 1 trial had a hotspot mutation. This is also relevant for the company’s ADXS-HOT program in that this is the first time Advaxis has observed the ability to generate or maintain specific CD8+ T cell activity against hotspot mutations. Hotspot mutations are important targets contained within the numerous drug constructs within the ADXS-HOT program and the specific hotspot mutations in these two patients, EGFRL858R and KRAS G12A, are included in the company’s ADXS-503 (HOT Lung) and ADXS-508 (HOT Colorectal) drug constructs, respectively.

Antigen spreading was confirmed in the MSS-CRC patient showing specific CD8+ T cells against neoepitopes that were not contained in the drug construct prepared for this patient (the NSCLC patient’s sample was not re-tested for antigen spreading). Thus, Advaxis believes ADXS-NEO may be able to induce a specific immune response against neoantigen-bearing tumor cells with the resultant cell death releasing secondary (nontargeted) tumor antigens. These secondary antigens can then prime subsequent immune responses (antigen spread) that are thought to be responsible for the improved clinical outcomes documented with other immunotherapies. Of note, antigen spreading has also been induced with other Lm constructs such as ADXS-HPV and ADXS-PSA in cervical and prostate cancer patients, respectively.

To date, dosing of ADXS-NEO at 1×108 colony forming units (CFU) has been well-tolerated in two patients. ADXS-NEO dosed at 1×109 CFU was beyond the maximum tolerated dose with reversible Grade 3 hypoxia (n=2) and Grade 3 hypotension (n=1) dose-limiting toxicities.

"This preliminary dataset of the deconvolution assays shows the generation of specific CD8+ T cell response in one MSS-CRC patient against 90% of the neoantigens in that patient’s personalized Lm construct together with antigen spreading, both of which we believe are critical for potential clinical benefit. These encouraging results are consistent with data from our previous preclinical and ELISpot-pooled clinical studies, and we look forward to presenting data from all patients in the monotherapy arm later in the year," said Andres Gutierrez, M.D., Ph.D., Chief Medical Officer of Advaxis. "In addition, we are gaining valuable insight from our ADXS-NEO platform to help advance our ADSX-HOT drug constructs, as for the first time we observed the ability to generate specific CD8+ T cell activity against hotspot mutations in the clinic. We continue to enroll patients in this Phase 1 study for ADXS-NEO and look forward to starting Part B with ADXS-NEO in combination with a checkpoint inhibitor later this year."

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.