Mustang Bio Reports Full-Year 2018 Financial Results and Recent Corporate Highlights

On March 18, 2019 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported financial results and recent corporate highlights for the full year ended December 31, 2018 (Press release, Mustang Bio, MAR 18, 2019, View Source [SID1234534424]).

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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "2018 was a transformational year for Mustang that positioned the company for further exciting advances in 2019. We enhanced our pipeline of therapies in August by adding a clinical-stage lentiviral gene therapy product candidate with curative potential for X-linked severe combined immunodeficiency ("XSCID"), for which we’re expecting compelling data to be published in a major medical journal this year. In June, we opened our cell processing facility in Worcester, Mass., which is now fully operational. We anticipate processing patients’ cells in the coming months under Mustang’s first IND—a significant milestone for the company. In December, the U.S. Food and Drug Administration ("FDA") granted Orphan Drug Designation to MB-102 (CD123 CAR T) for the treatment of blastic plasmacytoid dendritic cell neoplasm ("BPDCN"), a rare and incurable blood cancer. Most recently, in February we licensed an oncolytic virus (C134) that we plan to combine with MB-101 (IL13Rα2-specific CAR) to potentially enhance efficacy in treating glioblastoma multiforme. With these achievements, Mustang has built a strong foundation for success in the coming year."

Financial Results:

·As of December 31, 2018, Mustang’s consolidated cash, cash equivalents, short-term investments (certificates of deposit) and restricted cash totaled $34.6 million, compared to $41.3 million as of September 30, 2018, and $61.5 million as of December 31, 2017, a decrease of $6.7 million for the fourth quarter and a decrease of $26.9 million year-to-date.
·Research and development expenses were $21.1 million for the year ended December 31, 2018. This compares to $7.9 million for 2017. Non-cash, stock-based compensation expenses included in research and development were $3.4 million for the year ended December 31, 2018, compared to $0.7 million for 2017.
·Research and development expenses from license acquisitions totaled $3.4 million for the year ended December 31, 2018, compared to $12.4 million for 2017. Non-cash, stock-based compensation expenses included in research and development – licenses acquired were $2.1 million for the year ended December 31, 2018, compared to $9.6 million for 2017.
·General and administrative expenses were $6.8 million for the year ended December 31, 2018. This compares to $11.4 million for 2017. Non-cash, stock-based compensation expenses included in general and administrative expenses were $1.5 million for the year ended December 31, 2018, compared to $2.6 million for 2017.
·Net loss attributable to common stockholders was $30.7 million, or $1.14 per share, for the year ended December 31, 2018, compared to a net loss attributable to common stockholders of $31.3 million, or $1.24 per share, for 2017.

2018 and Recent Corporate Highlights:

·In May 2018, Mustang announced the publication of preclinical data in JCI Insight demonstrating that glioblastoma-targeted CD4+ CAR T cells mediate superior antitumor activity over CD8+ CAR T cells. The data, published by research partner City of Hope, will be applied in the ongoing Phase 1 trial of Mustang’s IL13Rα2-specific CAR T MB-101 in glioblastoma.

·In June 2018, Mustang opened a proprietary CAR T cell therapy manufacturing facility at UMass Medicine Science Park in Worcester, Mass. The facility will support the clinical development and commercialization of Mustang’s CAR T and gene therapy product candidates and enable proprietary cell therapy research.
·Also in June 2018, Mustang was added to the Russell 2000, 3000 and Microcap Indexes.
·In July 2018, Mustang completed a pre-Investigational New Drug ("pre-IND") meeting with the FDA for MB-102 (CD123 CAR T). Based on the meeting, Mustang expects to initiate a multicenter Phase 1/2 trial of MB-102 in acute myeloid leukemia ("AML"), BPDCN and high-risk myelodysplastic syndrome in the second half of 2019.
·In August 2018, Mustang announced that it entered into an exclusive worldwide license agreement with St. Jude Children’s Research Hospital for the development of a potentially first-in-class ex vivo lentiviral gene therapy for the treatment of XSCID, also known as bubble boy disease. The therapy is currently being evaluated in a Phase 1/2 multicenter trial in infants under the age of two. This study is the world’s first lentiviral gene therapy trial for infants with XSCID. The therapy is also being investigated in patients over the age of two in a second Phase 1/2 trial at the National Institutes of Health ("NIH"). The company believes these may be registration trials.
·In October 2018, Mustang announced that City of Hope initiated a first-of-its-kind Phase 1 clinical trial evaluating the safety and effectiveness of intraventricular delivery of CAR T cells to the brains of patients with HER2-positive breast cancer with brain metastases; the first patient was dosed in December 2018. In addition, Mustang announced that City of Hope dosed the first patient in a Phase 1 clinical trial of HER2-specific CAR T cells in treating recurrent or refractory grade III-IV glioma. The trial is evaluating the side effects and best dose of HER2-specific CAR T cells in treating patients with grade III-IV glioma that has come back or does not respond to treatment.
·In November 2018, Mustang announced that additional safety and efficacy Phase 1 data evaluating MB-102 (CD123 CAR) in relapsed or refractory AML and BPDCN were presented in an oral session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Special Conference on Tumor Immunology and Immunotherapy.
·In December 2018, the FDA granted Orphan Drug Designation to MB-102 (CD123 CAR T) for the treatment of BPDCN.
·In February 2019, Mustang announced that it partnered and entered into an exclusive worldwide license agreement with Nationwide Children’s Hospital to develop an oncolytic virus (C134) for the treatment of glioblastoma multiforme. Mustang intends to combine the oncolytic virus with MB-101 (IL13Rα2-specific CAR) to potentially enhance efficacy in treating glioblastoma multiforme.

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.

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.

Mogrify Awarded $555,000 USD (£420,000 GBP) Innovate UK Funding to Accelerate Regenerative Cell Therapies

On March 18, 2019 Cell Mogrify Ltd (Mogrify), a UK company aiming to transform the future development of cell therapies, reported that it has been awarded $555,000 USD (£420,000 GBP) funding from Innovate UK, the UK’s innovation agency, through the investment accelerator for innovation in precision medicine (Press release, Mogrify, MAR 18, 2019, View Source [SID1234553931]). This funding will support the application of Mogrify’s bioinformatic approach to transition three cell therapy products to preclinical stage, with potential application in wound healing, and oncology immunotherapy.

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Mogrify will utilize its patented systematic big-data approach (Rackham et al., Nature Genetics, 2016) to identify, from next-generation sequencing and gene-regulatory networks, the sets of highly influential and non-redundant transcription factors (in vitro) or small molecules (in vivo), needed to drive the direct conversion of one mature cell type (e.g. fibroblasts) into another (e.g. T cells). The reprogramed cells will then be subjected to a number of functional tests to demonstrate bioequivalence and potential as cell therapies, such as CAR-T for the treatment of cancers.

At present, cells used in cell therapies either need to be extracted and sorted from the patient themselves or a donor, or derived via experimental protocols that can take several years to develop, all of which can delay cell therapies reaching the clinic. Mogrify aims to accelerate this process by using its novel, bioinformatic platform to deliver an efficient, safe and scalable source of cells for the development of multiple personalized regenerative cell therapy products.

Dr. Darrin M. Disley, OBE, CEO, Mogrify, said: "Mogrify’s mission is to place ourselves, and as a result the UK, at the forefront of the next generation of cell therapy companies. By embracing systematic data science approaches built on large-scale transcriptomic, cell regulatory network and epigenetic data we believe better cell therapies can be developed at a lower cost across all therapeutic areas. The funding from Innovate UK will enable Mogrify to expand its portfolio of cell types and extend its reach into new therapeutics areas to address the global cell therapy opportunity, worth an estimated $30 billion USD."

Professor Julian Gough, PhD, Co-founder and CSO, Mogrify, said: "We have already used our bioinformatic-approach to produce chondrocytes and microvascular endothelial cells by transdifferentiation and speed up the protocols for acquiring astrocytes, neurons and chondrocytes from induced pluripotent stem cells. We are already engaging with companies that would like us to support development of autologous and allogeneic T-cell therapies, and are confident that our technology has the potential to provide a platform technology on which any cell for cell therapy can be developed."

Rackham OJL et al. A predictive computational framework for direct reprogramming between human cell types. Nature Genetics. 2016 Mar;48(3):331-5. doi: 10.1038/ng.3487. Epub 2016 Jan 18.