On September 16, 2019 Genprex, a clinical-stage gene therapy company developing potentially life-changing technologies for cancer patients, reported raising the standard in cancer treatment by developing what it calls an "immunogene therapy," which harnesses the power of immunotherapy’s immunomodulation through the delivery of a gene therapy (Press release, Genprex, SEP 16, 2019, https://www.genprex.com/news/genprex-is-defining-a-new-immunogene-therapy-that-could-change-the-course-of-cancer/ [SID1234551276]).

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Gene therapies and immunotherapies are two different types of treatment. Simply put, gene therapies insert a gene into a patient’s cells1while immunotherapies boost the body’s natural defenses to fight diseases, such as cancer.2 Genprex’s cancer fighting drug candidate for non-small cell lung cancer (NSCLC), Oncoprex immunogene therapy, is a gene therapy that also has immunomodulatory effects.

Oncoprex classifies as a gene therapy because it consists of a tumor suppressor gene that is injected intravenously and can specifically target cancer cells. As a gene therapy, Oncoprex works to fight off cancer by interrupting cell signaling pathways that cause replication and proliferation of cancer cells. It also stimulates apoptosis, or the death of cancer cells.

Oncoprex also works as an immunotherapy because it modulates the body’s immune response against cancer. The TUSC2 gene, which is the active agent in Oncoprex, has been shown to upregulate Natural Killer cells, or NK cells. These NK cells are known for their ability to kill tumor cells.3TUSC2 has also been shown to downregulate PD-L1, or programmed cell death ligand-1, receptors. These receptors, which are also known as immune checkpoint proteins, can sometimes help cancer evade detection. TUSC2 works to downregulate, or suppress them, which helps the body’s immune system to fight against the cancer.

Genprex’s immunogene therapy is unlike the approved targeted gene therapies and immunotherapies available today. Because Oncoprex is a gene therapy with immunotherapy characteristics, it is poised and positioned to help NSCLC patients who cannot benefit from today’s treatment options.

*Oncoprex is currently in development and is not FDA approved.

References:

(2019). What is gene therapy?. [online] U.S. National Library of Medicine. Available at: View Source [Accessed 5 Sep. 2019].
Cancer.org. (2019). Cancer Immunotherapy. [online] Available at: View Source [Accessed 5 Sep. 2019].
Eissmann, P. (2019). Natural Killer Cells | British Society for Immunology. [online] Immunology.org. Available at: View Source [Accessed 5 Sep. 2019].

On September 16, 2019 INmune Bio, Inc. (NASDAQ: INMB), an immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported that RJ Tesi, M.D., Co-Founder and CEO, and Mark Lowdell, Ph.D., Co-Founder and Chief Scientific Officer, will present at the first ever Targeting Innate Immunity Congress, taking place in the biotech hub of Cambridge, Mass. from Sept. 23 through 25 (Press release, INmune Bio, SEP 16, 2019, View Source [SID1234539636]).

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The conference is an opportunity for INmune Bio to showcase its two leading innate compounds in the hopes of improving the treatment of cancer to industry leaders, experts, academic researchers and clinicians in the field of innate immunity. In addition to presenting at the conference, Dr. Tesi and Dr. Lowdell will be instructing a course on the role of the tumor microenvironment (TME) in immunosuppression.

"This panel will bring together other experts from industry and academia to explore the role of the innate immune system in the TME and in cancer drug development," said Dr. Tesi.

In addition to speaking at the Targeting Innate Immunity Congress this month, Dr. Tesi will also take part in a speaking engagement at the second annual MarketsandMarkets Next Gen Immuno-Oncology Congress on Sept. 19 in Philadelphia.

Below is a schedule of upcoming presentations:

MarketsandMarkets Next Gen Immuno-Oncology Congress
Thursday, September 19 at 11:40 a.m.
"Reversing Trastuzumab Resistance in HER2+ Breast Cancer"
Dr. Tesi will discuss Mucin 4 (MUC4) protein and how it predicts trastuzumab resistance in HER2+ breast cancer, the role of soluble tumor necrosis factor (TNF) in MUC4 expression and how INmune Bio’s drug candidate, INB03 works in combination with trastuzumab to reverse resistance in MUC4/HER+ breast cancer.

Targeting Innate Immunity Congress
Monday, September 24 at 3:30 – 6:00 p.m.
Short Course: "Understanding and Modulating Tumor Microenvironment for Immunotherapy"
Dr. Tesi and Dr. Lowdell will instruct an interactive short course on the role of the tumor microenvironment (TME) in immunosuppression. They will discuss strategies to change the immunosuppressive nature of the TME to one that supports immune responses and enhances the impact of tumor immunotherapy. Those who attend will walk away with an understanding of the following:

•Role of the TME in immunosuppression
•Checkpoint inhibitor optimization
Targeting of regulatory cells
•Reprogramming of immunosuppressive cells
•Modulation of chemokines and cytokines in the TME
•Modification of tumor-reactive lymphocytes to evade the TME
Wednesday, September 25 at 11:40 a.m.
"Myeloid Derived Suppressor Cell (MDSC): The Queen Bee of the Tumor Microenvironment (TME)"
As part of the "Modulating Macrophages in the Tumor Microenvironment" panel, Dr. Tesi will discuss targeting myeloid derived suppressor cells (MDSCs) as an efficient way to reverse tumor microenvironment (TME) immunobiology. His discussion will address the complexity of TME and how it contributes to failure of therapy, as well as understanding how targeting soluble tumor necrosis factor (TNF) offers a solution to the resistance to therapy when part of combination therapy. Dr. Tesi will also discuss the results of the Phase I trial for INmune Bio’s drug candidate, INB03 in patients with advanced cancer.

Wednesday, September 25 at 1:45 p.m.
"What do Tumor Cells do to NK Cells? – Harnessing the Tumor-NK Interaction for Clinical Benefit"
Dr. Lowdell will participate in the "Advancing Innate Cell Therapies to the Clinic" portion of the conference to discuss how relapsed cancer cells evade natural killer (NK) cells, and how priming NK cells could effectively kill these cancer cells. Dr. Lowdell will also discuss INmune Bio’s INKmune drug candidate.

On September 16, 2019 Pfenex Inc. (NYSE American: PFNX), a clinical-stage development and licensing biotechnology company focused on leveraging its Pfēnex Expression Technology to improve protein therapies for unmet patient needs, reported that Eef Schimmelpennink, President and Chief Executive Officer, will be presenting at the Cantor Healthcare Conference on Thursday, October 3rd, taking place at the Intercontinental Hotel in New York City, October 2nd through 4th (Press release, Pfenex, SEP 16, 2019, View Source [SID1234539602]).

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Cantor Healthcare Conference

Date: Thursday, October 3, 2019

Time: 10:05 a.m. Eastern Time

Interested parties can access the live audio webcast and archive from the Investors Section of Pfenex’s website at www.pfenex.com.

On September 16, 2019 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, reported the closing of a global offering of 2,000,000 ordinary shares comprised of 1,675,000 ordinary shares in the form of American Depositary Shares ("ADSs") offered in the United States, Canada and certain countries outside of Europe at a price per ADS of $10.00 (the "U.S. offering"), and 325,000 ordinary shares in Europe and certain countries outside of the United States and Canada in a concurrent private placement at a price per share of €9.08 (together with the U.S. offering, the "global offering") (Press release, Celyad, SEP 16, 2019, View Source [SID1234539580]). Each ADS represents the right to receive one ordinary share. The gross proceeds to Celyad from the global offering amounted to approximately $20.0 million (approximately €18.2 million), before deducting underwriting discounts and commissions and estimated offering expenses. In connection with the global offering, Celyad has granted the underwriters a 30-day option to purchase up to an additional 300,000 ordinary shares (which may be in the form of ADSs) on the same terms and conditions.

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Our ADSs and our ordinary shares are listed under the symbol "CYAD" on the Nasdaq Global Market and on the Euronext Brussels and Euronext Paris, respectively.

Wells Fargo Securities, LLC, William Blair & Company, L.L.C. and Bryan, Garnier & Co. Limited acted as joint bookrunning managers for the offering. Kempen & Co U.S.A., Inc. acted as co-manager for the offering. LifeSci Capital, LLC is Celyad’s advisor in connection with the offering.

The securities were offered pursuant to an effective shelf registration statement that was previously filed with, and declared effective by, the U.S. Securities and Exchange Commission (SEC). A final prospectus supplement dated September 11, 2019 and accompanying prospectus relating to and describing the terms of the offering was filed with the SEC on September 12, 2019, and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus can be obtained for free from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York, 10152, or by telephone at (800) 326-5897 or by email to [email protected]; William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, Illinois 60606, or by telephone at (800) 621-0687, or by email at [email protected]; or from Bryan, Garnier & Co. Limited, Beaufort House, 15 Saint Botolph Street, London EC3A 7BB, United Kingdom, or by telephone at +44 20 7332 2500, or by email at [email protected].

On September 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 first fiscal quarter ended July 31, 2019 (Press release, Champions Oncology, SEP 16, 2019, View Source [SID1234539577]).

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First Quarter and Recent Business Highlights:

Quarterly revenue of $6.7 million, an increase of 8.2% year-over-year

Record quarterly bookings

Launched clinical flow services

Ronnie Morris, CEO of Champions, commented, "While our first quarter financial results were slightly weaker than expected, the cause was mainly due to the timing of study completions and revenue recognition."

Morris added, "We began aggressively selling our recently launched flow cytometry services during the quarter, expanding sales efforts beyond our core PDX offerings. We have multiple opportunities in the pipeline and look forward to finalizing deals in the coming months. With the combination of continued strength in our core bookings and new product launches, we remain confident in the long term prospects for the Company."

David Miller, CFO of Champions added, "As expected, our revenue declined from the fourth quarter but grew 8% year over year. We anticipate this growth rate will be the low point for the year. The overall health of our business remains strong with continued growth from our core products. With the launch of our clinical flow cytometry services, we expect meaningful contribution to our financial results over the long term."

First Fiscal Quarter Financial Results

For the first quarter of fiscal 2020, revenue increased 8.2% to $6.7 million compared to $6.2 million for the first quarter of fiscal 2019. The increase in revenue is due to increased sales, both in number and size of studies, and growth of the platform. Total costs and operating expenses for the first quarter of fiscal 2020 were $7.4 million compared to $5.7 million for the first quarter of fiscal 2018, an increase of $1.6 million or 28.0%.

Exhibit 99.1

For the first quarter of fiscal 2020, Champions reported a loss from operations of $614,000, including $131,000 in stock-based compensation and $182,000 in depreciation expenses, an increase in the loss of $1.1 million compared to the income from operations of $481,000, inclusive of $83,000 in stock-based compensation and $118,000 depreciation expenses, in the first quarter of fiscal 2018. Excluding stock-based compensation and depreciation, Champions reported loss from operations of $301,000 for the first quarter of fiscal 2020 compared to an income from operations, excluding stock-based compensation and depreciation, of $682,000 in the first quarter of fiscal 2018 a decrease of $983,000.

Cost of oncology solutions was $3.8 million for the three months ended July 31, 2019, an increase of $669,000, or 21.7% compared to $3.1 million for the three months ended July 31, 2018. For the three months ended July 31, 2019, gross margin was 44.3% compared to 50.5% for the three months ended July 31, 2018. The increase in cost of oncology services for the three month period was mainly due to an increase in salaries, mice costs, and lab supplies resulting from the increase in study volume. Gross margin varies based on timing differences between expense and revenue recognition and was impacted by the increase in cost ahead of the revenue related to the studies performed.

Research and development expense was $1.3 million for the three months ended July 31, 2019, an increase of $215,000, or 19.8%, compared to $1.1 million for the three months ended July 31, 2018. The increase is due to lab costs and salaries related to new product development costs. Sales and marketing expense for the three months ended July 31, 2019 was $870,000, an increase of $352,000, or 68.0%, compared to $518,000 for the three months ended July 31, 2018. The increase was mainly due to the expansion of the sales force and commission accrual. General and administrative expense was $1.4 million for the three months ended July 31, 2019 compared to $1.1 million for the three months ended July 31, 2018, an increase of $371,000 or 35.2%. The increase for the three month period is mainly due to the increase in salary expense and audit fees.

Net cash used was $1.0 million for the three months ended July 31, 2019 compared to cash generated of $160,000 for the same period last year. Included in the $1.0 million spend for the quarter was an investment of $750,000 in new lab equipment.

The Company ended the quarter with $2.2 million of cash and reiterated its position that it does not intend to raise capital to fund operations.

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 first quarter financial results. To participate in the call, please call 844-602-0380 (domestic) or 862-298-0970 (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 Monday, September 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 July 31, 2019 and 2018. Non-GAAP financial measures provide investors and management with supplemental measures of operating performance and

Exhibit 99.1

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.