On December 16, 2019 Champions Oncology, Inc. (Nasdaq: CSBR), engaged in an end-to-end range of research and development technology solutions and services to improve the development and use of oncology drugs, reported its financial results for the second fiscal quarter ended October 31, 2019 (Press release, Champions Oncology, DEC 16, 2019, View Source [SID1234552393]).

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Second Quarter and Recent Business Highlights:

Quarterly revenue of $7.6 million, an increase of 14% year-over-year

Reported income of $546,000, excluding stock-based compensation and depreciation

Achieved record quarterly bookings

Formed strategic partnership to expand our ex-vivo platform and services

Ronnie Morris, CEO of Champions, commented, "Our second quarter results were strong with revenue easily surpassing $7 million and a return to profitability."

Morris added, "We’re excited about our recently formed strategic partnership with PhenoVista Biosciences which will enhance the capabilities of our successful ex-vivo platform. Combined with our growing pipeline of opportunities in GCLP flow cytometry services, we continue to broaden our capabilities beyond our core PDX offerings, solidifying our position as a leader in end-to-end translational oncology solutions."

David Miller, CFO of Champions added, "As predicted, our revenue rebounded off of first quarter levels, rising to $7.6 million, resulting in 14% year over year quarterly growth. Additionally, we anticipate to continue our quarterly profitability trend for the remainder of the year."

Second Fiscal Quarter Financial Results

For the second quarter of fiscal 2020, revenue increased 13.9% to $7.6 million compared to $6.7 million for the second quarter of fiscal 2019. The increase in revenue is due to increased sales, both in number and size of studies. Additionally, our enhancements in products and study designs provided Pharma the tools to conduct more extensive and complex testing. Total costs and operating expenses for the second quarter of fiscal 2020 were $7.3 million compared to $6.4 million for the second quarter of fiscal 2018, an increase of $916,000 or 14.3%.

Exhibit 99.1

For the second quarter of fiscal 2020, Champions reported income from operations of $291,000, including $77,000 in stock-based compensation and $178,000 in depreciation expenses, an increase of $16,000 compared to the income from operations of $275,000, inclusive of $88,000 in stock-based compensation and $151,000 depreciation expenses, in the second quarter of fiscal 2018. Excluding stock-based compensation and depreciation, Champions reported income from operations of $546,000 for the second quarter of fiscal 2020 compared to income from operations, excluding stock-based compensation and depreciation, of $480,000 in the second quarter of fiscal 2018 an increase of $66,000.

Cost of oncology solutions was $3.9 million for the three-months ended October 31, 2019, an increase of $430,000, or 12.5% compared to $3.5 million for the three-months ended October 31, 2018. For the three- months ended October 31, 2019, gross margin was 49.1% compared to 48.4% for the three-months ended October 31, 2018. The increase in cost of oncology services for the three-month period was mainly due to an increase in salary and lab supply expenses. The increase is generally in line with the expected contribution based on the increase in revenue and study volume.

Research and development expense was $1.3 million for the three-months ended October 31, 2019, an increase of $148,000, or 12.4%, compared to $1.2 million for the three-months ended October 31, 2018. The increase is due to the increase in salary and lab supply expenses related to new product development and platform testing. Sales and marketing expense for the three-months ended October 31, 2019 was $977,000, an increase of $237,000, or 32.0%, compared to $740,000 for the three-months ended October 31, 2018. The increase was mainly due to the annualized quarterly accrual of commissions and expansion of the sales force. General and administrative expense was $1.1 million for the three-months ended October 31, 2019 compared to $1.0 million for the three-months ended October 31, 2018, an increase of $101,000 or 9.8%. The increase was mainly due to an increase in salary, stock-based compensation and depreciation expenses offset by a reduction in recruiting costs.

Net cash generated from operating activities was $360,000 for the three-months ended October 31, 2019 compared to $214,000 for the same period last year. The increase in cash flow from operations is primarily due to the improvement in financial operating results.
The Company ended the quarter with $2.8 million of cash and reiterated its position that it does not intend to raise capital to fund operations.

Year-to-Date Financial Results

For the first six months of fiscal 2020, revenue increased 11.2% to $14.4 million, as compared to $12.9 million for the first six months of fiscal 2019. For the first six months of fiscal 2020, total operating expenses increased 20.7% to $14.7 million, as compared to $12.2 million for the first six months of fiscal 2019. The increase in revenue is due to increased sales, both in number and size of studies, and expanding our customer base. Additionally, we’ve introduced product enhancements, providing our Pharma customers the ability for more extensive study designs and testing.

For the first six months of fiscal 2020, Champions reported a loss from operations of $323,000, which includes $208,000 in stock-based compensation and $360,000 in depreciation, a decrease of $1.1 million or 142.7%, compared to income from operations of $757,000, inclusive of $171,000 in stock-based compensation and $269,000 depreciation, for the first six months of fiscal 2019. Excluding stock-based compensation and depreciation, Champions reported operating income of $245,000 for the first six months of fiscal 2020 compared to income of $480,000 in the same period last year.

Exhibit 99.1

Cost of oncology solutions was $7.6 million for the first six months of fiscal 2020 compared to $6.5 million for the first six months of fiscal 2019, an increase of $1.1 million or 16.8%. Gross margin was 46.9% for the first six months of fiscal 2020 compared to 49.4% for the first six months of fiscal 2019. The increase in cost of oncology services for the six-month period was mainly due to an increase in salary, mice, and lab supply expenses. Gross margin varies based on timing differences between expense and revenue recognition and was impacted by the increase in costs on growing study volume in advance of revenue recognition.

Research and development expense was $2.6 million for the first six months of fiscal 2020 an increase of $362,000, or 15.9% compared to $2.3 million for the first six months of fiscal 2019. The increase is due to increased salary and lab supply expenses related to new product development and platform testing. Sales and marketing expense for the first six months of fiscal 2020 was $1.8 million, an increase of $588,000, or 46.7% compared to $1.3 million for the first six months of fiscal 2019. The increase was mainly due to the annualized quarterly accrual of commissions and expansion of the sales force. General and administrative expense was $2.6 million for the first six months of fiscal 2020, an increase of $473,000 or 22.7% compared to $2.1 million for the first six months of fiscal 2019. The increase for the six-month period was mainly due to an increase in salary, professional fees, and stock-based compensation and depreciation expenses offset by a reduction in recruiting costs.

Net cash provided by operations was $81,000 for the first six months of fiscal 2020 compared to net
provided by operations of $400,000 in 2019, a decrease of $319,000 or 80%.

Conference Call Information:

The Company will host a conference call today at 4:30 p.m. EST (1:30 p.m. PST) to discuss its second quarter financial results. To participate in the call, please call 844-369-8770 (domestic) or 862-298-0840 (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, December 16, 2019 in the Company’s Form 10-Q at www.championsoncology.com.

* Non-GAAP Financial Information

See the attached Reconciliation of GAAP net (loss) income to Non-GAAP net (loss) income for an explanation of the amounts excluded to arrive at Non-GAAP net (loss) income and related Non-GAAP (loss) earnings per share amounts for the nine months ended October 31, 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 (loss) income and Non-GAAP (loss) earnings per share are not, and should not, be viewed as a substitute for similar GAAP items. Champions’ defines Non-GAAP dilutive (loss) earnings per share amounts as Non-GAAP net (loss) earnings divided by the weighted average number of diluted shares outstanding. Champions’ definition of Non-GAAP net (loss) earnings and Non-GAAP diluted (loss) earnings per share may differ from similarly named measures used by other companies.

On December 16, 2019 Platelet BioGenesis, Inc. (PBG), the leader in stem cell-derived, on-demand human platelets (PLTs+) and genetically engineered platelet-based therapeutics, reported it received an award of $2.3 million from the Medical Technology Enterprise Consortium (MTEC) – a 501(c)(3) biomedical technology consortium collaborating with the U.S. Army Medical Research and Development Command (USAMRDC) (Press release, Platelet BioGenesis, DEC 16, 2019, View Source [SID1234552409]). PBG will use the funding to accelerate the development of an automated, mobile bioreactor that produces PLT+ packs for use at field hospitals and other military medical posts.

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MTEC partners with private industry, academic institutions, government agencies and other research organizations seeking to accelerate the development of medical solutions that prevent and treat injuries to U.S. military members. One of the organization’s current objectives is to identify devices or therapies that empower medics to do more treatment at the point of injury. MTEC’s work with PBG will enable the development of a mobile bioreactor that can produce PLTs+ on-demand in the regions where military operations are underway, alleviating platelet shortages in conflict zones caused by lack of donor availability, short platelet shelf life and sterility concerns.

"Military conflict zones are often in remote locations, meaning that medical technology innovations are paramount to effective interventions and recoveries," said Kathy Zolman, MTEC Director of Program Operations. "The work Platelet BioGenesis is doing could help resolve the shortages that often affect U.S. military units. Developing the bioreactor for remote applications would enable platelets to be available on-demand, which would make an immense difference in treating traumatic injuries sustained during military activity."

In another important development, PBG has added Uma Lakshmipathy, Ph.D. and Teresa Foy, Ph.D. to its Scientific Advisory Board (SAB) to support the continued research and development of platelet-based therapeutic solutions. Dr. Lakshmipathy is the R&D Director at Thermo Fisher Scientific and is involved in the development of reprogramming, engineering and characterization solutions that support translation of primary and stem cells towards novel cell therapy platforms. Dr. Foy is Senior Vice President at Bristol-Myers Squibb (BMS, formerly Celgene), leading the Thematic Research Center for Immuno-Oncology (IO) and Cellular Therapy (CT). She is responsible for BMS’s IO/CT discovery and early development pipeline, leading a team that is advancing novel drug and cell therapy candidates from discovery through clinical proof-of-concept.

"Dr. Lakshmipathy and Dr. Foy bring to PBG extensive experience in the development of cell therapies, which will be invaluable as we enter IND-enabling studies of our human stem cell-derived, donor-independent platelets in 2020. We look forward to working closely with both of these distinguished industry veterans as we continue to advance our novel platelet-based cell therapy platform," said Sam Rasty, Ph.D., the company’s President and CEO. "In addition to bolstering our SAB with these highly experienced advisors, the MTEC award provides us with further non-dilutive funding and validation of our science and technology platform. We look forward to partnering with MTEC to advance the development of our mobile, automated PLT+ bioreactor."

On December 16, 2019 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that Professor Dr. Richard P. Baum reported his initial independent clinical experience with FAP-2286 in named-patient use at the International Centers for Precision Oncology (ICPO) Foundation Symposium in Bad Berka, Germany (Press release, Clovis Oncology, DEC 16, 2019, View Source [SID1234552394]). At Prof. Dr. Baum’s clinic, FAP-2286 was linked to Gallium-68 as a tumor-imaging compound using PET/CT and to Lutetium-177 as a therapeutic agent.

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In the first named-patient experience with FAP-2286, Prof. Dr. Baum imaged 10 patients with advanced solid tumors, including breast, pancreatic, colorectal and ovarian cancers, with PET/CT using FAP-2286 linked to the commonly used imaging agent Gallium-68 for PET/CT imaging. In each case, Prof. Dr. Baum found that the FAP-PET/CT showed consistency with standard of care 18F-FDG-PET/CT scans for the same patients, including identification of both primary and metastatic lesions in liver, lung, bones, lymph nodes and other sites. Prof. Dr. Baum did not observe accumulation of FAP-2286 in healthy tissues of these 10 patients, except, as anticipated in the kidneys where FAP-2286 is excreted.

In addition, Prof. Dr. Baum treated 10 patients with FAP-2286 linked with Lutetium-177. Lutetium-177 is a radionuclide approved for use with somatostatin receptor targeting agents and is in development for use with other compounds. The initial single dose administration showed significant, specific accumulation in primary tumors and metastatic lesions. In this first-in-human experience, patients received a relatively low dose of Lutetium-177. Prof. Dr. Baum reported a lack of significant adverse effects within the first two months of follow-up and an absence of myelosuppression or damage to any other tissue, including the kidneys. Prof. Dr. Baum intends to administer a second dose of FAP-2286 linked with Lutetium-177 this month.

"I’m extremely pleased with our experience thus far with FAP-2286," said Prof. Dr. Baum, Chairman and Clinical Director, Theranostics Center for Radiomolecular Precision Oncology at Zentralklinik, Bad Berka, Germany. "As an imaging agent alone, it appears consistent with 18FDG-PET/CT scanning on a schedule that is much more convenient for patients. In addition, while obviously early, when linked to Lutetium-177, FAP-2286 was very well-tolerated, showed encouraging residence time in the tumor lesions, and appears to have, after only one low dose, provided symptomatic relief in several of the patients treated. I believe that FAP as a target and FAP-2286 as a drug candidate represent a very exciting new area of research in molecular targeted radiotherapy."

"While these examples from named-patient use do not represent a clinical study, we are pleased that the initial imaging and treatment experience with FAP-2286 are consistent with the preclinical data that led to our enthusiasm for FAP as a target and for FAP-2286 as a highly differentiated targeted radionuclide therapy," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We look forward to completing the pre-clinical work in order to file our IND for FAP-2286 in the second half of 2020 and to initiating formal clinical development for this very promising compound."

Physicians in Germany and certain other countries may treat patients suffering from a life-threatening disease or a disease leading to severe disability with experimental drugs if no other appropriate options are available under named-patient and similar programs. A physician may initiate treatment for specific patients until there is commercial product available and patients are encouraged to enroll in clinical trials where possible. Named-patient programs are not clinical trials and the treating physician is solely responsible for all decisions, including dose and assessment of efficacy and safety, and the drug sponsor has no role in decisions.

About FAP-2286

FAP-2286 is a preclinical candidate discovered by 3B Pharmaceuticals under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein alpha (FAP). FAP is highly expressed in cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas. Clovis is planning to file an investigational new drug application (IND) for FAP-2286 in the second half of 2020. Clovis will conduct the global clinical trials and holds U.S. and global rights, excluding Europe.

FAP-2286 is an unlicensed medical product.

About Fibroblast Activation Protein Alpha (FAP)

Fibroblast activation protein alpha, or FAP, is highly expressed in cancer-associated fibroblasts (CAFs) which are found in the majority of cancer types, potentially making it a suitable target across a wide array of solid tumors. FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas.1 CAFs are highly prevalent in the tumor microenvironment of many cancers and persist through all malignant stages of a tumor, from primary tumor to metastasis. FAP has limited expression on normal fibroblasts, reducing the potential for effects in normal tissue.

About Peptide-Targeted Radionuclide Therapy (PTRT)

Peptide-targeted radionuclide therapy involves a small amount of radioactive material (radionuclide) that is combined with a cell-targeting moiety peptide for the treatment of cancer; PTRT is considered a form of radiopharmaceuticals. The targeting peptide is able to recognize and bind to specific features of tumors, such as antigens and cell receptors. When injected into the patient’s bloodstream, the peptide attaches to cancer cells or cancer-associated stromal cells, delivering a high dose of radiation to the tumor while sparing normal tissues.

About FAP-Targeted Radiopharmaceuticals

Clinical studies of small molecule imaging agents targeting FAP have validated this target in a diverse number of cancer indications and support the further evaluation of peptide-targeted radionuclide therapy. FAP-targeted radiopharmaceuticals have at least two potential modes of anti-tumor activity: radiation crossfire, in which tumor cells are irradiated due to their close proximity to CAFs; and depletion of CAFs, disrupting the communication between the tumor cells and the tumor stroma. In addition, in certain tumor types, such as sarcoma and mesothelioma, FAP is expressed on the tumor cells themselves, and in those tumors, FAP-targeted radiopharmaceuticals may have a direct effect.

On December 16, 2019 Medivir AB (Nasdaq Stockholm: MVIR) reported that the independent safety committee (IDMC) for the phase II study of birinapant in combination with pembrolizumab (Keytruda) in patients with MSS colorectal cancer has performed the planned futility analysis (Press release, Medivir, DEC 16, 2019, View Source [SID1234552410]). The primary objective of the phase II study was an improved clinical response to treatment measured as 20% ORR (Overall Response Rate). IDMC’s recommendation is that the study should be terminated as the analysis indicates that it is unlikely that the study’s objectives will be met. Medivir has therefore decided to discontinue the recruitment of patients and to end the study.

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"We are disappointed that the combination therapy with birinapant and pembrolizumab did not work better in this difficult-to-treat patient group where monotherapy with pembrolizumab has very limited effect", said Dr Uli Hacksell, CEO of Medivir. "But we still see a potential for other combination therapies where birinapant could offer patients improved treatment. One example is the ongoing phase I study of a combination of birinapant and radiation therapy in patients with head and neck cancer."

A total of 15 patients with advanced MSS colorectal cancer were recruited in the phase II study, 14 of which were included in the futility analysis. The combination therapy was considered acceptable from a safety perspective, but none of the patients showed a clear clinical efficacy response. Four patients were judged to have stable disease while 10 were judged to have disease progression.

The phase II study was conducted as a collaboration between Medivir and MSD, who provided pembrolizumab.

For further information, please contact:
Uli Hacksell, CEO, Medivir AB, phone: +46-(0)-8-5468-3100.

Medivir AB is obliged to make this information public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 16.00 CET on 16 December, 2019.

About Birinapant

Birinapant is being developed to enhance responses, and extend survival, of patients with solid tumors where existing treatments do not provide sufficient survival benefit, or where patients no longer have treatment options. Based on its unique design and mechanism, birinapant has the potential to enhance patients’ responses in combination with other treatments.

On December 16, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, reported that Ryan Spencer has been appointed Chief Executive Officer and to the Board of Directors (Press release, Dynavax Technologies, DEC 16, 2019, View Source [SID1234552395]). David Novack has been appointed President and Chief Operating Officer, reporting to Mr. Spencer. These appointments are effective December 16, 2019.

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"Through a rigorous, comprehensive search process, Ryan emerged as the right business leader to guide Dynavax, given his strong command of our business and proven ability to lead and drive commercial execution in a complex operating environment," commented Arnold L. Oronsky, Ph.D., Chairman of the Board of Directors. "Ryan’s expertise across corporate strategy, finance, and commercialization, with a track record of leadership, combined with David’s tremendous experience in vaccine development and manufacturing, results in an executive leadership team with the full complement of experience required to drive the growth and success of Dynavax."

Mr. Spencer, who joined Dynavax in 2006, has held roles of increasing responsibility, building from a foundation in corporate finance to business strategy and investor relations, and culminating in his role as Senior Vice President, Commercial. Since May of 2019, Mr. Spencer has served as the Company’s interim co-President, a role he shared with Mr. Novack.

Mr. Novack joined Dynavax in 2013, and has led the company’s technical operations, supply chain, and quality teams through FDA approval, launch, and commercialization of HEPLISAV-B. Mr. Novack has more than 30 years of relevant industry experience, with more than 20 years of direct vaccine industry experience. Prior to Dynavax, Mr. Novack was at Novartis where he served in various roles, including Global Head of Technical Operations and Supply Chain for Diagnostics, and Global Head of Manufacturing Strategy for Vaccines.

"I am honored to take on this role at a transformational time for Dynavax as we continue to build on our commercial success with HEPLISAV-B," commented Ryan Spencer, Chief Executive Officer. "It is a privilege to work with a fantastic team and a product that, based on its proven clinical profile, has the potential to become the standard-of-care, adult hepatitis B vaccine in the U.S. Dynavax is well positioned to build a global vaccine business that improves patients’ lives, starting with HEPLISAV-B."