Sosei Heptares Enters Into Multi-target Research Collaboration and License Agreement With Genentech

On July 16, 2019 Sosei Group Corporation ("the Company") (TSE: 4565) reported that it has entered into a multi-target research collaboration and license agreement with Genentech, a member of the Roche Group, to discover and develop novel medicines (new small molecules and/or biologics) that modulate G protein-coupled receptor (GPCR) targets of interest to Genentech (Press release, Sosei, JUL 16, 2019, View Source [SID1234537536]).

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Under the terms of the agreement, the collaboration will combine the proprietary GPCR-focused structure-based drug design capabilities at Sosei Heptares with Genentech’s discovery, development and therapeutic area expertise directed towards multiple GPCR targets nominated by Genentech. The nominated targets represent promising new therapeutic intervention points across a range of diseases.

Genentech will be responsible for developing and commercializing potential new medicines for each novel target and will have exclusive global rights to these agents.

Sosei Heptares is eligible to receive US$26 million in upfront and near-term payments, in addition to future milestone payments that may exceed US$1 billion for achieving pre-specified research, development and commercialization events. Sosei Heptares is also eligible to receive royalty payments on the net sales of potential future medicines resulting from the collaboration.

Dr. Malcolm Weir, Executive Vice President and Chief R&D Officer of Sosei Heptares, said: "Sosei Heptares has strived to collaborate with leaders in the industry who appreciate the potential of combining their extensive drug development and commercialization expertise with our world-leading GPCR structure-based drug design approach to generate and advance new therapeutics across multiple disease areas. We are therefore delighted to enter this new partnership with Genentech, one of the most innovative companies in the biopharmaceutical industry, and excited to see what the combination of our respective capabilities can deliver."

James Sabry, M.D., Ph.D., Global Head of Pharma Partnering, Roche, added: "We believe GPCRs are an important target class that play a role in many serious diseases. Sosei Heptares brings truly unique capabilities to enable and accelerate GPCR drug discovery. We look forward to collaborating with the Sosei Heptares team to hopefully bring novel GPCR-targeted medicines to patients as quickly as possible."

Shinichi Tamura, Chairman, President and CEO of Sosei Heptares, added: "In the past five years, Sosei Heptares has partnered with several of the world’s most successful pharmaceutical companies, as well as some of the most innovative biotechnology companies. Our powerful and unique approach to addressing GPCRs, as the largest and most diverse class of therapeutic targets, has enabled us to build an extensive pipeline of drug candidates across a broad range of diseases. The collective experience gained through these collaborations is driving our growth and development and enabling the company to become a truly world-class and global organization."

Entry into a Material Definitive Agreement.

On July 15, 2019, Xenetic Biosciences, Inc. (the "Company") amended (i) that certain Share Purchase Agreement among the Company, Hesperix SA, a Swiss corporation ("Hesperix"), the owners of Hesperix (each, a "Seller" and collectively, the "Sellers"), and Alexey Andreevich Vinogradov, as the representative of each Seller, dated March 1, 2019, and (ii) that certain assignment agreement between the Company and OPKO Pharmaceuticals, LLC, dated as of March 1, 2019, to amend the date by which the parties will consummate the transaction pursuant to which the Company will acquire the XCART platform technology, as described in the proxy statement/prospectus for the Special Meeting, dated May 22, 2019, from July 15, 2019 to July 31, 2019 (Filing, 8-K, Xenetic Biosciences, JUL 15, 2019, View Source [SID1234537831]). A copy of the amendments are filed as Exhibit 2.1 and Exhibit 10.1 to this report and incorporated herein by reference.

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Teneobio Doses First Patient in Phase 1 Study of TNB-383B for the Treatment of Patients with Multiple Myeloma

On July 15, 2019 Teneobio, Inc. a clinical-stage biotechnology company developing engineered bispecific antibodies for the treatment of cancer reported that the first patient has been dosed with TNB-383B in a Phase 1 clinical study to evaluate the safety and tolerability of its differentiated anti-BCMAxCD3, a bispecific antibody that redirects T-cells to kill multiple myeloma cells with minimal cytokine release (Press release, TeneoBio, JUL 15, 2019, View Source [SID1234537548]). Earlier this year, Teneobio’s affiliate TeneoOne, Inc. and AbbVie entered a strategic partnership, giving AbbVie the exclusive right to acquire TeneoOne post-Phase 1 studies and lead the subsequent global development and commercialization of TNB-383B.

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"Redirecting T-cells to kill cancer cells is a powerful therapeutic approach in the immuno-oncology space. We designed TNB-383B to efficiently kill multiple myeloma cells expressing BCMA and minimize cytokine release from CD3-activated T-cells. This latter attribute is a hallmark of our unique T-cell CD3 engaging therapeutic platform, which is in a number of our follow-on programs and lead clinical candidates," said Roland Buelow, CEO at Teneobio. "Our new class of T-cell engagers were designed to increase the therapeutic window as monotherapies and they may also afford the opportunity for combination treatments of patients."

The TNB-383B Phase 1 study involves a dose-escalation study that will characterize the safety and tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary anti-cancer activity of intravenous administration of TNB-383B in patients with relapsed or refractory multiple myeloma. For more information about the trial please visit View Source (identifier: NCT03933735).

Champions Oncology Reports Record Quarterly Revenue of $7.7 Million For The Fourth Quarter Ended April 30, 2019

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.

ESSA Expands Leadership Team by appointing Alessandra Cesano as Chief Medical Officer

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.