Salarius Pharmaceuticals to Present at the 29th Annual Oppenheimer Healthcare Conference

On March 18, 2019 Salarius Pharmaceuticals, LLC, a clinical-stage oncology company targeting the epigenetic causes of cancers, reported that its Chief Executive Officer David Arthur will present at the 29th Annual Oppenheimer Healthcare Conference held March 19-20, 2019, at the Westin New York Grand Central Hotel (Press release, Salarius Pharmaceuticals, MAR 18, 2019, View Source [SID1234534475]).

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Mr. Arthur will present an overview of Salarius’ business, including its development strategy for its lead compound, Seclidemstat, which targets the epigenetic dysregulation underlying Ewing sarcoma, a devastating pediatric, adolescent and young adult bone cancer for which no targeted therapies currently exist. Salarius is currently enrolling patients in an open-label Phase 1 dose escalation/dose expansion study, which is expected to conclude in 2020.

Details of Salarius’ presentation are as follows:

Event:

29th Annual Oppenheimer Healthcare Conference

Date:

Wednesday, March 20, 2019

Time:

11:30 a.m. (Eastern Time)

Location:

Westin New York Grand Central; Track 2

An audio webcast will be accessible via the News and Events section of the Salarius Pharmaceuticals website: View Source An archive of the audio will remain available for 90 days following the presentation.

Cellesce Announces License Agreement with Hubrecht Organoid Technology (HUB) for the Expansion of Breast Cancer Organoids at Scale

On March 18, 2019 Cellesce and Hubrecht Organoid Technology (HUB) have reported a licence agreement for the expansion of organoids using Cellesce’s own bioprocessing technology and HUB Organoid Technology for the scale up of breast organoids (Press release, Cellesce, MAR 18, 2019, View Source [SID1234553993]).

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Cellesce and HUB have an ongoing agreement for the expansion of organoids using HUB Technology. In a new project, funded by Innovate UK, Cellesce will expand breast cancer organoids using a combination of HUB Organoid Technology and Cellesce’s own bioprocessing technology. The project aims to confirm that breast cancer organoids remain genetically and phenotypically stable and continue to faithfully recapitulate the characteristics of the tumours from which they were originally derived. The project will provide support for the scaling of organoid expansion to generate the quantities of organoids required by commercial and academic researchers in drug discovery programmes.

Cellesce Chief Executive, Dr Mark Treherne, commented: "By partnering with HUB Cellesce will be in a position to provide an integrated drug discovery solution. This will be a comprehensive package that supplies organoids at scale which will increase the impact that organoid models are having on the cancer research community."

"HUB Organoid Technology will benefit from Cellesce’s innovative technology to expand large quantities of organoids such as breast cancer organoids." added Dr Rob Vries, Managing Director of the HUB.

Moleculin Biotech, Inc. to Present at the Oppenheimer 29th Annual Healthcare Conference and the 31st Annual ROTH Conference

On March 18, 2019 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical-stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the MD Anderson Cancer Center, reported that Walter Klemp, Chairman and CEO and Jonathan Foster, Chief Financial Officer, will present at the following investor conferences (Press release, Moleculin, MAR 18, 2019, View Source [SID1234534425]):

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Oppenheimer 29th Annual Healthcare Conference – Management will present on Wednesday, March 20, 2019 at 3:20 p.m. ET. The Conference will be held at the Westin New York Grand Central Hotel in New York City.
31st Annual ROTH Conference – Management will be available on Monday, March 18, 2019 for one-on-one meetings with investors. The Conference will be held at the Ritz-Carlton Hotel in Dana Point, CA.

Champions Oncology Reports Quarterly Revenue of $6.4 Million

On March 18, 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 third fiscal quarter ended January 31, 2019 (Press release, Champions Oncology, MAR 18, 2019, View Source [SID1234534459]).

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Third Quarter and Recent Business Highlights:

Quarterly revenue of $6.4 million, an increase of 26% year-over-year

Reiterated forecast of at least 20% revenue growth in fiscal 2019

Launched ex-vivo platform and clinical flow services

Opened a new lab facility to support new product offerings

Ronnie Morris, CEO of Champions, commented, "With our third consecutive quarter of revenue in excess of $6 million, we remain in line with our guidance to deliver full fiscal year growth of at least 20%."

Morris added, "We officially launched our new ex-vivo platform and clinical flow cytometry services during the quarter, expanding beyond our core PDX offering. Broadening our product line is an important step in our long-term strategy of providing additional services to meet the growing needs of Pharma and bio-tech companies."

David Miller, CFO of Champions added, "The overall health of our business remains robust and we expect continued growth from our core products. We are very excited with our new product launches and, although clinical flow cytometry services have a longer cycle time between bookings and revenue recognition, we are building a strong pipeline which will contribute meaningfully to our financial results over the long term."

Exhibit 99.1

Third Fiscal Quarter Financial Results

For the third quarter of fiscal 2019, revenue increased 26.5% to $6.4 million compared to $5.1 million for the third quarter of fiscal 2018. The increase in revenue is due to increased sales, both in number and size of studies, expanding our customer base, and growth of the platform. Total costs and operating expenses for the third quarter of fiscal 2019 were $6.8 million compared to $5.1 million for the third quarter of fiscal 2018, an increase of $1.7 million or 32.1%.

For the third quarter of fiscal 2019, Champions reported a loss from operations of $370,000, including $335,000 in stock-based compensation and $164,000 in depreciation expenses, an increase in the loss of $303,000 compared to the loss from operations of $67,000, inclusive of $152,000 in stock-based compensation and $105,000 depreciation expenses, in the third quarter of fiscal 2018. Excluding stock-based compensation and depreciation, Champions reported income from operations of $129,000 for the third quarter of fiscal 2019 compared to an income from operations, excluding stock-based compensation and depreciation, of $190,000 in the third quarter of fiscal 2018 a decrease of $61,000 or 32.1%.

Cost of oncology solutions was $3.4 million for the three months ended January 31, 2019, an increase of $956,000, or 38.7% compared to $2.5 million for the three months ended January 31, 2018. For the three months ended January 31, 2019, gross margin was 46.7% compared to 51.3% for the three months ended January 31, 2018. The increase in cost of oncology services was mainly due to an increase in salary and mice costs resulting from the increase in study volume. Gross margin varies based on timing differences between cost recognized on study work performed in advance of revenue recognized on study completion.

Research and development expense was $1.3 million for the three months ended January 31, 2019, an increase of $224,000, or 21.4%, compared to $1.0 million for the three months ended January 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 January 31, 2019 was $879,000, an increase of $252,000, or 40.2%, compared to $627,000 for the three months ended January 31, 2018. The increase is mainly due to commissions paid. General and administrative expense was $1.2 million for the three months ended January 31, 2019 compared to $1.0 million for the three months ended January 31, 2018, an increase of $219,000 or 21.8%. The increase is mainly due to an increase in stock-based compensation and salary expenses.

Net cash generated was $1.4 million for the three months ended January 31, 2019 compared to $402,000 for the same period last year. The improvement in cash flow is primarily due to improving operational results.

The Company ended the quarter with $3.3 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 nine months of fiscal 2019, revenue increased 26.3% to $19.3 million, as compared to $15.3 million for the first nine months of fiscal 2018. The increase in revenue is due to increased sales, both in number and size of studies, expanding our customer base, and growth of the platform. For the first nine months of fiscal 2019, total costs and operating expenses increased 18.0% to $19.0 million, as compared to $16.1 million for the first nine months of fiscal 2018. The increase in costs is mainly due to an increase in cost of sales resulting from growth in revenue.

Exhibit 99.1

For the first nine months of fiscal 2019, Champions reported an income from operations of $386,000, which includes $498,000 in stock-based compensation and $433,000 in depreciation, an improvement of $1.1 million or 151.1%, compared to the loss from operations of $755,000, inclusive of $848,000 in stock-based compensation and $253,000 depreciation, for the first nine months of fiscal 2018. Excluding stock-based compensation and depreciation, Champions reported operating income of $1.3 million for the first nine months of fiscal 2019 compared to $346,000 in the same period last year.

Net cash provided by operations was $1.6 million for the first nine months of fiscal 2019 compared to net cash used in operations of $1.2 million in 2018, an increase of $2.8 million or 230.4%. The improvement in cash flow is primarily the result of the increase in net income and improving financial results.

Cost of oncology solutions was $10.0 million for the first nine months of fiscal 2019 compared to $7.7 million for the first nine months of fiscal 2018, an increase of $2.2 million or 28.8%. Gross margin was 48.5% for the first nine months of fiscal 2019 compared to 49.5% for the first nine months of fiscal 2018. The increase in cost of oncology services was mainly due to an increase in salary and mice costs resulting from the increase in study volume. Gross margin varies based on timing differences between expenses and revenue recognition and was impacted by the increase in costs incurred in advance of revenue recognized.

Research and development expense was $3.6 million for the first nine months of fiscal 2019 an increase of $242,000, or 7.3% compared to $3.3 million for the first nine months of fiscal 2018. The increase is due to lab costs and salaries related to new product development costs. Sales and marketing expense for the first nine months of fiscal 2019 was $2.1 million, an increase of $276,000, or 14.8% compared to $1.9 million for the first nine months of fiscal 2018. The increase is mainly due to commissions paid for business development. General and administrative expense was $3.3 million for the first nine months of fiscal 2019, an increase of $144,000 or 4.5% compared to $3.2 million for the first nine months of fiscal 2018. The increase is primarily 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. EST (1:30 p.m. PST) to discuss its third quarter financial results. To participate in the call, please call 877-407-8035 (domestic) or 201-689-8035 (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, March 18, 2019 in the Company’s Form 10-Q at www.championsoncology.com.

* Non-GAAP Financial Information

See the attached Reconciliation of GAAP net loss to Non-GAAP net income (loss) for an explanation of the amounts excluded to arrive at Non-GAAP net income (loss) and related Non-GAAP earnings (loss) per share amounts for the nine months ended January 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-

Exhibit 99.1

GAAP net income (loss) and Non-GAAP earnings (loss) per share are not, and should not be viewed as a substitute for similar GAAP items. Champions’ defines Non-GAAP dilutive earnings (loss) per share amounts as Non-GAAP net earnings (loss) divided by the weighted average number of diluted shares outstanding. Champions’ definition of Non-GAAP net earnings (loss) and Non-GAAP diluted earnings (loss) per share may differ from similarly named measures used by other companies.

Cytovation initiates clinical development programme with CyPep-1,a first-in-class lytic agent for tumor immunotherapy

On March 18, 2019 Cytovation AS, a privately held biotech company, reported that the first patients have been treated in a Phase I clinical study with CyPep-1, a novel therapeutic agent being developed as a new topical therapy for HPV-induced warts (Press release, Cytovation, MAR 18, 2019, View Source [SID1234561559]). The initiation of this clinical trial marks the start of the clinical development of CyPep-1 in dermatology and oncology applications, with a Phase I trial of CyPep-1 in malignant tumors planned to start in the second half of 2019.

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First patients treated in a Phase I study with CyPep-1 as an investigational therapy for benign, HPV-induced cutaneous tumors (warts).
Novel targeted lytic mechanism offers broad application for multiple indications.
Further clinical trial in malignant tumors to start in 2H 2019.
CyPep-1 has been designed and developed by Cytovation. It is a first-in-class lytic agent with broad application across benign and malignant tumors as a result of its novel mechanism of action. CyPep- 1 selectively targets tumor cells, forming pores that destabilise and rupture the membrane to kill the cell and release neoantigens into the microenvironment and circulation, while leaving healthy cells intact. The release of neoantigens enables cytotoxic CD8 positive T-cells to mount a systemic immune response offering the possibility of long-lasting immunity against the tumor and, in the case of warts, HPV infection. For more information about the mode of action, click here.

Cytovation has formulated CyPep-1 as a cream for the topical treatment of HPV-induced warts, a large medical need for which there are currently no approved drug therapies. The Company has also developed CyPep-1 as a solution for intra-tumoral injection, as a single agent or in combination with checkpoint inhibitors.

Cytovation’s Chief Scientific Officer, Lars Prestegarden, said: "We are very pleased to achieve this first clinical milestone with CyPep-1 and to begin its formal clinical development. We have designed CyPep-1 to exploit key differences between healthy and tumor cells and have seen strong evidence of its efficacy in preclinical tumor models. We are excited to see if these results can be translated to humans both with this new trial in warts and the future trial in cancer. Both trials are expected to start during 2019 and we are looking forward to reporting first findings later in the year."

The clinical trial with CyPep-1 is a randomized, placebo-controlled, double-blind Phase I study. The study is being conducted at the Centre for Human Drug Research (Leiden, the Netherlands) and will enrol 58 patients with cutaneous warts. Results are expected in the late 2019. (ClinicalTrials.gov Identifier: NCT03846648).