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Fortress Biotech Reports Second Quarter 2019 Financial Results and Recent Corporate Highlights

On August 9, 2019 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on identifying, in-licensing and developing high-potential marketed and development-stage drugs and drug candidates, reported financial results and recent corporate highlights for the second quarter ended June 30, 2019 (Press release, Fortress Biotech, AUG 9, 2019, View Source [SID1234538541]).

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Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, "We are pleased to have achieved several important milestones in the second quarter, including positive data for three of our late-stage product candidates in development across our partner companies: IV tramadol for post-surgical pain management; MB-107 gene therapy for the treatment of X-linked severe combined immunodeficiency (XSCID); and cosibelimab, an anti-programmed death ligand-1 (PD-L1) antibody for the treatment of multiple advanced cancers. Looking ahead to the remainder of 2019, we anticipate multiple potentially value-creating catalysts, including a New Drug Application filing for IV tramadol and additional important clinical data readouts for many of our product candidates. Our world-class business development team continues to focus on expanding our diverse pipeline with additional high-quality biotech and specialty pharmaceutical assets, further de-risking our product portfolio."

Financial Results:

·As of June 30, 2019, Fortress’ consolidated cash, cash equivalents, short-term investments (certificates of deposit), and restricted cash totaled $170.5 million, compared to $137.5 million as of March 31, 2019, and $99.2 million as of December 31, 2018, an increase of $33.0 million for the quarter and an increase of $71.3 million year-to-date.
·Fortress’ net revenue totaled $9.3 million for the second quarter of 2019, compared to $6.8 million for the second quarter of 2018.
· Research and development expenses were $18.5 million for the second quarter of 2019, of which $18.0 million was related to Fortress partner companies. This compares to $17.5 million for the second quarter of 2018, of which $15.1 million was related to Fortress partner companies. Non-cash, stock-based compensation expenses included in research and development were $0.8 million for both the second quarter of 2019 and 2018.
·Research and development expenses from license acquisitions totaled $0.2 million for the second quarter of 2019, compared to a nominal amount for the second quarter of 2018.
·General and administrative expenses were $13.4 million for the second quarter of 2019, of which $9.3 million was related to Fortress partner companies. This compares to $13.1 million for the second quarter of 2018, of which $7.7 million was related to Fortress partner companies. Non-cash, stock-based compensation expenses included in general and administrative expenses were $2.6 million for the second quarter of 2019, compared to $2.4 million for the second quarter of 2018.
·Net loss attributable to common stockholders was $13.1 million, or $0.24 per share, for the second quarter of 2019, compared to a net loss attributable to common stockholders of $21.6 million, or $0.50 per share, for the second quarter of 2018. For the first six months of 2019, net loss attributable to common stockholders was $11.7 million or $0.23 per share, compared to $42.6 million or $0.99 per share for the first six months of 2018.

Recent Corporate Highlights1:

Marketed Dermatology Products

·In the second quarter of 2019, our marketed products generated net revenue of $8.2 million, compared to $6.7 million in the second quarter of 2018.
· We are anticipating the launch of a second prescription oral antibiotic drug for acne during the current quarter, Q3 2019.
·This new asset, coupled with our salesforce expansion to 34 territory managers, will allow us to reach over 5,000 dermatologists across the country. This combination is expected to fuel the growth of our dermatology portfolio in 2019 and beyond.
·Our dermatology products are marketed by our partner company, Journey Medical Corporation.

IV Tramadol

·In June 2019, we announced that our second pivotal Phase 3 trial of IV tramadol achieved the primary endpoint of a statistically significant improvement in Sum of Pain Intensity Difference over 24 hours (SPID24) compared to placebo in patients with postoperative pain following abdominoplasty surgery. In addition, the trial met all of its key secondary endpoints. The study also included a standard-of-care IV opioid as an active comparator, IV morphine 4 mg. In this study, IV tramadol also demonstrated similar efficacy and safety to that of IV morphine.
·IV Tramadol is currently in development at our partner company, Avenue Therapeutics, Inc.

MB-102 (CD123 CAR T)

·In July 2019, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to MB-102 (CD123 CAR T) for the treatment of acute myeloid leukemia (AML).
·In August 2019, we announced that the FDA has approved the Investigational New Drug (IND) application to initiate a multicenter Phase 1/2 clinical trial of MB-102 (CD123 CAR T) in AML, blastic plasmacytoid dendritic cell neoplasm (BPDCN) and high-risk myelodysplastic syndrome (MDS).
·MB-102 is currently in development at our partner company, Mustang Bio, Inc.

MB-108 (Oncolytic Virus C134)

·In May 2019, the FDA granted Orphan Drug Designation to MB-108 (oncolytic virus C134) for the treatment of malignant glioma, a type of brain cancer with a median survival of less than 18 months.
·MB-108 is currently in development at our partner company, Mustang Bio, Inc.

Abeona Therapeutics Reports Second Quarter 2019 Financial Results and Business Updates

On August 9, 2019 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, reported second quarter 2019 financial results and business updates, which will be discussed on a conference call scheduled for Monday, August 12 at 10:00 a.m. ET (Press release, Abeona Therapeutics, AUG 9, 2019, View Source [SID1234538540]). Interested parties are invited to participate in the call by dialing 844-369-8770 (toll-free domestic) or 862-298-0840 (international) or via webcast at View Source

"The second quarter was highlighted by progress made in both of our MPS III programs," said João Siffert, M.D., Chief Executive Officer. "Data from our Transpher A study showed that children with MPS IIIA who were treated early with ABO-102 preserved neurocognitive development within the normative range 12-18 months post treatment. Our MPS IIIB program has also progressed, with enrollment of additional patients in cohort 2 of the Transpher B study. Our team remains highly focused on our lead programs, including the start of our VIITAL Phase 3 clinical trial in recessive dystrophic epidermolysis bullosa, continued enrollment in the MPS III programs, and preparations to start the clinical trial in CLN1 disease."

Second Quarter Financial Results:

Cash, cash equivalents and marketable securities as of June 30, 2019, were $62.5 million compared to $68.3 million as of March 31, 2019. The decrease in cash was driven primarily by the net cash used in operating activities of $15.2 million.

Research and development expenses for the second quarter ended June 30, 2019 were $16.3 million compared to $7.9 million in the same period of 2018. The increase in R&D expense was primarily attributable to increased in-house manufacturing activities and related headcount costs.

General and administrative expenses for the second quarter ended June 30, 2019 were $5.6 million compared to $4.6 million in the same period of 2018. The increase in G&A expenses was primarily due to increased headcount and related facility costs.

Net loss was $0.49 per share for the second quarter of 2019 compared to $0.26 per share in the same period of 2018.

Second Quarter and Recent Highlights:

-July 25, 2019: Announced positive interim data from the Phase 1/2 AAV9 gene therapy clinical trial in MPS IIIA showing preservation of neurocognitive function for the three youngest patients treated with ABO-102, as well as robust and sustained improvements in biomarkers of the disease. No product-related serious adverse events were reported to date.
-June 26, 2019: Appointed Dr. Victor Paulus as Senior Vice President of Regulatory Affairs and Jodie Gillon as Vice President of Patient Advocacy and Clinical Affairs
-June 18, 2019: Received FDA Fast Track Designation for ABO-202 AAV9 gene therapy in CLN1 disease
-May 21, 2019: Announced FDA clearance of Investigational New Drug application for ABO-202 AAV9 gene therapy in CLN1 disease
-May 14, 2019: Announced treatment of first patient in second cohort of Phase 1/2 clinical trial for ABO-101 AAV9 gene therapy in MPS IIIB
-May 1, 2019: Reported preclinical data demonstrating broad therapeutic potential of AIM gene therapy in retinal diseases at Association for Research in Vision and Ophthalmology Annual Meeting
-April 30, 2019: Reported preclinical data demonstrating therapeutic potential of ABO-401 for treatment of cystic fibrosis at American Society of Gene and Cell Therapy annual meeting
-April 4, 2019: Received FDA Fast Track Designation for ABO-101 AAV9 gene therapy for MPS IIIB

Steven H. Rouhandeh, Abeona’s Executive Chairman, said, "Abeona has continued the development of its breakthrough gene and cell therapies for rare genetic diseases through 2019 with important regulatory and clinical achievements secured. We look forward to progressing our MPS programs, and to starting of our Phase 3 VIITAL trial in EB before year end."

U.S. Court of Appeals Rules in Favor of Lilly in Alimta Alternate Salt Form Patent Lawsuit

On August 9, 2019 Eli Lilly and Company (NYSE: LLY) reported that the U.S. Court of Appeals for the Federal Circuit ruled in favor of Lilly, confirming that the Alimta (pemetrexed for injection) vitamin regimen patent would be infringed by competitors that had stated their intent to market alternative salt forms of pemetrexed prior to the patent’s expiration in May 2022 (Press release, Eli Lilly, AUG 9, 2019, View Source [SID1234538538]).

The ruling came in the appeals of U.S. District Court decisions in the cases of Eli Lilly and Company v. Dr. Reddy’s Laboratories and Eli Lilly and Company v. Hospira, Inc. Previous rulings in Lilly’s favor had precluded the generic companies from launching the alternative salt forms until the patent expires.

If the patent is ultimately upheld through all remaining challenges, Alimta would maintain U.S. exclusivity until May 2022, preventing marketing of generic products for as long as the patent remains in force.

"We’re pleased with this decision," said Michael J. Harrington, Lilly’s senior vice president and general counsel. "Lilly’s extensive research to discover this patent deserves intellectual property protection, which has been confirmed in every challenge in the U.S. to date."

On June 22, 2018, Lilly announced that the U.S. District Court for the Southern District of Indiana ruled in favor of Lilly that the Alimta vitamin regimen patent would be infringed by the use of Dr. Reddy’s alternative salt form of pemetrexed prior to the patent’s expiration. The district court found the generic product would infringe under the doctrine of equivalents.

In a separate decision on June 15, 2018, the District Court also ruled in favor of Lilly in the case of Eli Lilly and Company v. Hospira, Inc. denying Hospira’s motion for summary judgement and granting Lilly’s cross-motion for summary judgment.

Both Dr. Reddy’s and Hospira had appealed the district court’s decisions, leading to today’s ruling.

In March 2014, the U.S. Court for the Southern District of Indiana upheld the validity of the vitamin regimen patent. In August 2015, the same court ruled in Lilly’s favor regarding infringement of the vitamin regimen patent. The U.S. Court of Appeals for the Federal Circuit confirmed these rulings in a unanimous decision in January 2017, finding the patent is valid and would be infringed by the generic challengers’ proposed products.

Separately, Lilly announced in April 2019 that the U.S. Court of Appeals for the Federal Circuit ruled in the company’s favor regarding patentability of the vitamin regimen for Alimta, upholding an October 2017 decision by the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office.

FENNEC PROVIDES BUSINESS UPDATE AND ANNOUNCES SECOND QUARTER 2019 FINANCIAL RESULTS

On August 9, 2019 Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARKTM (a unique formulation of sodium thiosulfate (STS)) for the prevention of platinum-induced ototoxicity in pediatric patients, reported its business update and financial results for the second quarter ended June 30, 2019 (Press release, Fennec Pharmaceuticals, AUG 9, 2019, View Source [SID1234538537]).

"During the quarter, we are pleased to have successfully manufactured PEDMARK and are working closely with the FDA on our rolling NDA submission," said Rosty Raykov, chief executive officer of Fennec. "We anticipate the completion of the NDA filing by early 2020 and if approved, we plan to launch PEDMARK in the second half of 2020."

Investor Events

• 2019 Wedbush PacGrow Healthcare Conference – Rosty Raykov, CEO of Fennec, will provide an overview of the Company’s business on Wednesday, August 14 at 10:55 a.m. Eastern Time at the 2019 Wedbush PacGrow Healthcare Conference in New York City. The Fennec presentation will be webcast live and can be accessed by visiting the investors relations section of the Company’s website at View Source A replay of the presentation will also be available and archived on the site for 90 days.

• H.C. Wainwright Global Investment Conference – Rosty Raykov, CEO of Fennec, will provide an overview of the Company’s business at the H.C. Wainwright Global Investment Conference in New York City on September 9-10. The Fennec presentation will be webcast live and can be accessed by visiting the investors relations section of the Company’s website at View Source A replay of the presentation will also be available and archived on the site for 90 days.

Financial Results for the Second Quarter 2019

·Cash Position – Cash and cash equivalents were $17.5 million as of June 30, 2019. The reduction in cash balance over the quarter is the result of cash used for operating activities including the manufacturing and regulatory expenses associated with the regulatory submissions of PEDMARKTM.
·R&D Expenses – Research and development (R&D) expenses were $2.0 million for the three months ended June 30, 2019, compared to $0.8 million for the same period in 2018. The increase in R&D expenses for the comparative three months relates primarily to drug manufacturing activities and regulatory registration activities for PEDMARKTM.
·G&A Expenses – General and administrative (G&A) expenses were $2.8 million for the three months ended June 30, 2019, compared to $1.9 million for the same period in 2018. This increase is mainly the result of the additional non-cash expense resulting from the revaluing all vested options when their terms were extended at the annual shareholder’s meeting. This revaluing added and additional $1.3 million in option expense for the second quarter of 2019. Despite this addition, net total option expense for the three months ended June 30, 2019 only increased by $0.7 over the same period in 2018. The remaining increase of $0.2 in general and administrative expenses is primarily associated with increases in professional fees and employee compensation.

·Net Loss – Net loss was $4.7 million and $2.6 million for the three months ended June 30, 2019 and 2018, respectively.
·Financial Guidance – The Company believes its cash and cash equivalents on hand as of June 30, 2019 will be sufficient to fund the Company’s planned commercial launch of PEDMARKTM in the second half of 2020.

Financial Update

The selected financial data presented below is derived from our audited condensed consolidated financial statements which were prepared in accordance with U.S. generally accepted accounting principles. The complete interim unaudited consolidated financial statements for the period ended June 30, 2019 and management’s discussion and analysis of financial condition and results of operations will be available via www.sec.gov and www.sedar.com. All values are presented in thousands unless otherwise noted.

CASI PHARMACEUTICALS ANNOUNCES SECOND QUARTER AND FIRST HALF 2019 FINANCIAL AND BUSINESS RESULTS

On August 9, 2019 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing therapeutics and pharmaceutical products in China, U.S., and throughout the world, reported financial results for the second quarter and six months ended June 30, 2019 and provided a review of recent accomplishments and anticipated milestones (Press release, CASI Pharmaceuticals, AUG 9, 2019, View Source [SID1234538536]).

Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "Our financial results remained strong through the second quarter of 2019. We look forward to launching the first product from our hematology oncology pipeline, EVOMELA, this quarter and fully transitioning into a commercial organization. We are enthusiastic about our growth and momentum, and continue to pursue additional strategic assets for our pipeline, both in our hematology/oncology space as well as other high quality treatment solutions for patients."

Second Quarter and Recent Business Highlights

Acquired exclusive worldwide rights to commercialize anti-CD19 T-cell therapy in China and worldwide – On June 17, 2019, CASI signed a license agreement for exclusive worldwide commercialization rights to an autologous anti-CD19 T-cell therapy product (CNCT19) from Juventas Cell Therapy Ltd. CNCT19 targets CD-19, a B-cell surface protein widely expressed during all phases of B-cell development and is a validated target for B-cell driven hematological malignancies. CD19 antigen is the most frequently used biomarker in CAR-T cell therapy clinical trials for hematological malignancies.

Acquired exclusive worldwide rights to a novel anti-CD38 monoclonal antibody (CID-103) – On April 17, 2019, CASI acquired exclusive global rights to a novel anti-CD38 monoclonal antibody (CID-103). CID-103 is a human monoclonal antibody targeting a specific epitope of the CD38 cell surface antigen. CID-103 is at the IND/IMPD submission stage of development with initiation of the Phase 1 study targeted for early 2020.

EVOMELA (Melphalan Hydrochloride for Injection) expected to launch in China this quarter – The Company has made significant progress and commercial preparations for the launch of EVOMELA and expects commercialization this quarter. It will be the only approved melphalan product available in China.

Second Quarter and First Half 2019 Financial Results

Cash Position: As of June 30, 2019, CASI had cash and cash equivalents of $70.3 million compared to $99.7 million as of March 31, 2019. The decrease in cash is primarily due to the Black Belt and Juventas investments made during the three months ended June 30, 2019.

R&D Expenses: Research and development (R&D) expenses for the three and six months ended June 30, 2019, were $3.0 million and $5.6 million, respectively, compared to $1.7 million and $3.4 million for the same periods in 2018. The increase in R&D expenses primarily reflects costs associated with regulatory, consulting and manufacturing related services, as well as an increase in personnel costs due to growth in the number of employees.

G&A Expenses: General and administrative (G&A) expenses for the three and six months ended June 30, 2019, were $7.0 million and $12.7 million, respectively, compared to $4.0 million and $5.3 million for the same periods in 2018. The increase in G&A for both the three and six months ended June 30, 2019 was related to a combination of factors primarily resulting from the Company’s growth in China. These factors include an increase in salary, benefits and recruitment expense and facilities costs due to increases in head count, sales and marketing efforts to prepare for the anticipated launch of the Company’s first commercial product (EVOMELA), professional services fees (including audit and legal services), and an increase in non-cash stock compensation expense largely attributed to stock options issued to the President of CASI China and other new employees.

Net Loss: The Company reported a net loss for the three and six months ended June 30, 2019 of ($15.3) million, or ($0.16) per share, and ($23.4) million, or ($0.25) per share, respectively, compared to ($5.9) million, or ($0.07) per share, and ($9.5) million, or ($0.12) per share for the same periods in 2018. The larger net loss is primarily due to acquired in-process research and development expenses related to the Black Belt license, and the increase in both G&A and R&D expenses primarily due to the Company’s growth in China to support the Company’s first commercial product (EVOMELA).

Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, can be found at www.casipharmaceuticals.com.