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Celyad’s 2019 R&D Day Highlights shRNA Platform and Pipeline of Next-generation NKG2D-based and Off-the-Shelf Non-gene Edited CAR-T Candidates

On March 18, 2019 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, reported at R&D Day in New York the continued progress of the its pipeline of proprietary CAR-T therapies for the treatment of hematological malignancies and solid tumors, based on its short hairpin RNA (shRNA) platform (Press release, Celyad, MAR 18, 2019, View Source [SID1234534464]).

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"We are very pleased with the recent progress of our preclinical CAR-T pipeline," noted Dr. Christian Homsy, CEO of Celyad. "Together with CYAD-101, our next generation allogenic shRNA platform should allow us to leapfrog the competition in the allogeneic CAR-T landscape. In addition, CYAD-02 has shown encouraging preclinical data of increased CAR-T cell expansion, persistence and anti-tumor efficacy. We continue to tap into our deep expertise and knowledge in cell therapy manufacturing and our all-in-one vector approach provides tremendous flexibility, versatility and efficiency in the design of novel, CAR-T therapies."

Corporate Updates

Lead asset CYAD-01 continues to advance in clinical trials for the treatment of patients with relapsed/refractory (r/r) acute myeloid leukemia (AML). The Company reported that additional dosing and schedule optimization are under evaluation in the THINK Phase 1 trial. In addition, the Company reported that interim data from the DEPLETHINK Phase 1 trial evaluating CYAD-01 following preconditioning chemotherapy shows the CAR-T cell therapy is well-tolerated at the initial dose levels following preconditioning chemotherapy. Future clinical updates from the Phase 1 THINK and DEPLETHINK trials are anticipated by mid-2019.
Company also highlighted its operational excellence for 2018 including a 94% manufacturing success rate and a twofold increase year-over-year in the number of patients treated.
shRNA Platform

In October 2018, Celyad announced it had entered into an exclusive agreement with Horizon Discovery Group for the use of its shRNA technology to generate a novel, next-generation, non-gene-edited allogeneic platform for CAR-T therapies. Horizon Discovery’s SMARTvector technology to express shRNA optimized by Celyad provides an alternate method to knockout the TCR complex in allogeneic CAR-T therapies compared to gene editing techniques as well as the specificity to target a broad range of proteins.
Utilization of the shRNA platform allowed the Company to develop the next generation of autologous, NKG2D-based CAR-T candidate, CYAD-02, and the novel, non-gene edited allogeneic CYAD-200 series of CAR-T candidates.
In addition, the shRNA platform complements the Company’s strong intellectual property of six U.S. patents related to allogeneic T-cell technology and producing TCR deficient cells expressing a CAR construct.
Autologous CAR-T candidate: CYAD-02

CYAD-02 incorporates shRNA technology to target NKG2D ligands MICA/MICB. In preclinical AML models, CYAD-02 shows an encouraging increase in in vitro proliferation and in vivo persistence and anti-tumor activity. The Company plans to generate additional preclinical proof-of-concept data for the program throughout 2019 and plans to submit an Investigational New Drug (IND) application for CYAD-02 in first half 2020.
Non-gene edited allogeneic CAR-T candidates: CYAD-200 series

Celyad utilizes two technologies based on non-gene edited approaches to modulate the T-cell receptor (TCR) complex to generate allogeneic CAR-T therapies. The first approach utilizes our TCR-inhibitor molecule (TIM) and is tailored to our NKG2D-based CAR-T clinical candidate CYAD-101. The second approach leverages shRNA technology exclusively licensed from Horizon Discovery to target the CD3ζ component to knockdown the expression of the TCR/CD3 complex on the surface of the T-cell.
In vivo data demonstrate that shRNA targeting of CD3ζ effectively protects against Graft-versus-Host Disease (GvHD) to a level equivalent to CRISPR-Cas9 based knock-out. Furthermore, results from preclinical tests show significant increase in persistence of allogeneic T cells using shRNA targeting when compared to gene editing technologies, such as CRISPR-Cas9.
Celyad announced plans to develop three disruptive first-in-class non-gene-edited allogenic CAR-T candidates leveraging the shRNA SMARTvector platform, including:
CYAD-211: B-cell maturation antigen (BCMA) targeting CAR-T therapy for the treatment of multiple myeloma, which is expected to enter the clinic by mid-2020.
CYAD-221: CD19 targeting CAR-T therapy for the treatment of B-cell malignancies, which is expected to enter the clinic by late 2020.
CYAD-231: Dual specific CAR-T targeting NKG2D and an undisclosed membrane protein, which is expected to enter the clinic by early 2021.
In addition, the company continues to investigate additional undisclosed targets using the shRNA platform to pair with CARs to develop, differentiated next-generation cell therapies for the treatment of both hematological malignancies and solid tumors.

BioTime to Present at Oppenheimer & Co. 29th Annual Healthcare Conference on March 20, 2019

On March 18, 2019 BioTime, Inc. (NYSE American and TASE: BTX), a clinical-stage biotechnology company focused on degenerative diseases, reported that Brian M. Culley, Chief Executive Officer, will be presenting at the Oppenheimer & Co. 29th Annual Healthcare Conference on March 20th, 2019 at 2:45pm Eastern Time at the Westin New York Grand Central in the Track 2 Room in New York, NY (Press release, BioTime, MAR 18, 2019, View Source;p=RssLanding&cat=news&id=2391558 [SID1234534463]).

Interested parties can access a live audio webcast on the Events and Presentations section of BioTime’s website and an archived presentation will be available for 30 days. Interested parties may follow @OppenheimerCo on Twitter and use #OPCOHealthcare for the latest conference updates.

RedHill Biopharma to Present at the BIO-Europe Spring 2019 Conference

On March 18, 2019 RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on gastrointestinal (GI) diseases, reported that Mr. Adi Frish, senior vice president of business development and licensing, will present a corporate overview at the BIO-Europe Spring 2019 conference on Wednesday, March 27, 2019, at 9:45 a.m. CET at the Messe Wien Exhibition and Congress Center in Vienna, Austria (Press release, RedHill Biopharma, MAR 18, 2019, View Source [SID1234534462]).

A copy of the presentation to be delivered by Mr. Frish will be available on the Company’s website and may be viewed at: View Source

APOLLO ENDOSURGERY, INC. REPORTS FOURTH QUARTER AND FULL YEAR 2018 RESULTS

On March 18, 2019 Apollo Endosurgery, Inc. ("Apollo") (Nasdaq: APEN), a leader in less invasive medical devices for bariatric and gastrointestinal procedures, reported financial results for the fourth quarter and year ended December 31, 2018 (Press release, Lpath, MAR 18, 2019, View Source [SID1234534460]).

Highlights
•Fourth quarter ESS revenue contributed 64% of continuing product sales and increased 46%
•ESS revenue for the full year 2018 of $23.4 million increased 42% compared to 2017
•Sale of the Surgical product line completed on December 17, 2018
•New credit facility with Solar Capital completed March 15, 2019

Todd Newton, CEO of Apollo, said, "With the sale of the Surgical product line in December, moving forward we are able to direct our attention exclusively on the growth opportunities of our Endo-bariatric product line. Demand for OverStitch was strong in the fourth quarter as the treatments possible with this unique technology continue to gain physician adoption and as of the beginning of February we are into the full launch of the new single channel compatible OverStitch Sx in the United States and Europe."

Apollo reported Endo-bariatric product revenues of $10.8 million in the fourth quarter of 2018, an increase of 10%. Fourth quarter total revenues which included sales of the divested Surgical product line, were $15.2 million a decrease of 6%. For the year, Endo-bariatric product revenues were $41.1 million, an increase of 15%. Total revenue for the year which includes sales of the divested Surgical products were $60.9 million, a decrease of 5%.

Fourth quarter Endoscopic Suturing System ("ESS") product sales increased 46% to $6.9 million from increases in product utilization in existing accounts and new user adoption. For the year, ESS product sales were $23.4 million, an increase of 42%.

Fourth quarter Intragastric Balloon ("IGB") product sales were $3.9 million, a decrease of 23%. U.S. IGB sales declined 20% due to ongoing market weakness due to negative media impressions following prior FDA communications. OUS IGB product sales decreased 24%, due primarily to lower sales in Brazil and our distributor markets which offset higher sales of Orbera365 in our direct European markets. For the year, IGB product sales were $17.7 million, a decrease of 9%.

Gross margin for the fourth quarter of 2018 was 46.6%, compared to 57.7% for the fourth quarter of 2017 primarily due to a greater proportion of our product sales coming from our ESS products, which realize a lower gross margin than our other products. During the fourth quarter of 2018 we completed two gross margin improvement projects related to both the ESS and IGB products which we expect on a combined basis to improve gross margin by approximately $2 million annually beginning in 2019. Gross margin for the year was 54.5% compared to 61.8% in 2017.

Total operating expenses were $23.9 million in the fourth quarter of 2018 and included a loss on the sale of our Surgical product line of $7.8 million. Excluding this one-time item, operating expenses were $16.2 million in the fourth quarter of 2018, an increase of 6%. Research and development costs increased as a result of expanded clinical study activities related to our Endo-bariatric products, new product development activities, and margin improvement projects. Excluding the loss on sale of the Surgical product line, operating expenses for the year were $65.5 million compared to $62.2 million, an increase of 6% due to higher research and development expenses.

Net loss for the fourth quarter 2018 was $18.4 million compared to $7.3 million for the fourth quarter 2017. For the year, net loss was $45.8 million in 2018 compared to $27.3 million in 2017.

Cash, cash equivalents and restricted cash were $25.0 million as of December 31, 2018.

Debt Financing

On March 15, 2019, we entered into a new credit facility with Solar Capital to borrow $35.0 million. The new facility may provide an additional $15.0 million upon our request, subject to further credit approval. We used $22.4 million of these proceeds to pay off the remainder of our prior credit facility. Interest on borrowings under the new credit facility is payable at

LIBOR plus 7.5% (currently 10.0%). Principal payments will begin after a 24-month interest only period payable on a straight-line basis until maturity on September 1, 2023.

Conference Call

Apollo will host a conference call on Monday, March 18, 2019 at 7:30 a.m. Central Time / 8:30 a.m. Eastern Time to discuss Apollo’s operating results for the fourth quarter and year ended December 31, 2018.

To participate in the conference call dial (877) 823-8673 for domestic callers and (647) 689-4156 for international callers. The conference ID number is 3671589. A live webcast of the conference call will be made available on the "Events and Presentations" section of our Investor Relations website: www.ir.apolloendo.com.

A replay of the webcast will remain available on Apollo’s website, www.apolloendo.com, following the call. In addition, a transcript of the earnings call will be made available on the "Events and Presentations" section of our Investor Relations website: www.ir.apolloendo.com.

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]).

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.