Matinas BioPharma Holdings Inc (NYSEAMERICAN:MTNB) CEO Jerome D Jabbour said Monday that the company was excited to have advanced both its clinal assets into key efficacy trials in 2020 as it reported financial and business results for the fourth quarter and full-year 2019.
The Bedminster, New Jersey-based clinical-stage biopharmaceutical company said it has initiated a head-to-head pharmaceutical study of its omega-3 drug candidate MAT9001 against a drug called Vascepa, in a battle to treat elevated triglycerides.
The study, known as ENHANCE-IT, will measure how effectively the drugs reduce triglyceride levels and other important lipid markers, in addition to gathering data on bioavailability and omega-3 fatty acids in the blood.
READ: Matinas BioPharma launches comparison study of its omega-3 drug candidate MAT9001 against Vascepa
“Topline data is expected in the fourth-quarter of 2020,” said the company.
In addition to MAT9001, Matinas is also developing MAT2203, which applies the company’s lipid nano-crystal (LNC) drug delivery technology to orally deliver amphotericin B, an otherwise IV-only, highly toxic fungicidal drug, to treat serious invasive fungal infections.
In a statement accompanying the company’s latest numbers, Jabbour said 2019 was a year of “significant operational progress” for Matinas and the company is “very excited” to advance MAT9001 and MAT2203 into key efficacy trials in 2020.
“ENHANCE-IT represents a significant opportunity to once again highlight the superior profile of MAT9001 against the leading therapy in the prescription omega-3 space. We are also enthusiastic about the EnACT study of MAT2203 in patients with cryptococcal meningitis,” said Jabbour.
He added that the potential to “effectively and safely” deliver amphotericin B orally while crossing the “blood brain barrier" utilizing the firm's LNC platform delivery technology could be an important breakthrough for patients and physicians.
“Importantly, the timelines to impactful data from these studies are relatively compressed,” emphasized Jabbour. “We expect topline data from ENHANCE-IT in the fourth quarter of this year and should be in position to announce cohort progression in the EnACT trial as soon as the second quarter of this year.”
The Matinas BioPharma boss said the company had taken “meaningful steps to financially strengthen the company well in advance of major potential value-creating clinical milestones” for its lead assets.
“We capitalized on expressed interest from well-regarded current and new institutional investors, and successfully completed a transformational financing earlier this year which extends our cash runway into the second half of 2022,” said Jabbour.
“As a result, we can now focus exclusively on execution as we continue to advance our product candidates,” he added.
MAT9001 program update
• Initiated ENHANCE-IT, a second head-to-head comparative study of MAT9001 versus Vascepa in the first quarter of 2020 and remain on track to announce topline data in the fourth quarter of 2020;
• Pre-screened approximately 175 patients for ENHANCE-IT across eight clinical trial centers in the United States;
• Completed the clinical dosing for a comparative clinical bridging bioavailability study and the in-life portion of a 90-day comparative toxicology study in the first quarter of 2020. The studies were in support of a planned 505(b)(2) registration pathway. Matinas expects to hold an end-of-phase 2 meeting with the FDA in the third quarter of 2020 to discuss the data, as well as the protocol for a Phase 3 registration trial of MAT9001 in patients with severe hypertriglyceridemia.
MAT2203 and LNC platform delivery technology update
• In the first quarter of 2020, MAT2203 advanced into the efficacy phase of the EnACT (Encochleated oral Amphotericin for cryptococcal meningitis trial) study for the treatment of HIV-infected patients with cryptococcal meningitis, a life-threatening invasive fungal infection commonly seen in immunocompromised patients;
• The independent Data Safety Monitoring Board (DSMB) unanimously voted to proceed with dosing in the efficacy phase at 2g/day, the highest dose tested in the dose-escalation phase of EnACT;
• The company plans to make announcements as to progression from cohort to cohort over the course of 2020, but full data from EnACT will not be available until the second half of 2021;
• During the fourth quarter of 2019, the FDA granted MAT2203 orphan drug designation for the treatment of cryptococcosis. This designation was made in addition to four separate Qualified Infectious Disease Product Designations (QIDP) with Fast Track status for MAT2203 including the treatment of cryptococcosis, the prevention of invasive fungal infections due to immunosuppressive therapy, the treatment of invasive candidiasis and the treatment of invasive aspergillosis. The combination of orphan drug and QIDP designations positions MAT2203 to potentially receive up to 12 years of regulatory exclusivity upon approval;
• In the fourth quarter of 2019, the company announced a feasibility evaluation with Genentech, a member of the Roche Group, for the development of oral formulations using Matinas’ LNC platform delivery technology. This is the third pact with a large drug company pairing the company’s LNC platform delivery technology with difficult-to-deliver molecules.
Strong financial footing
The company said cash, equivalents and marketable securities on December 31, 2019 totaled around $27.8 million, compared to $12.4 million on December 31, 2018. In January 2020, Matinas completed a follow-on financing and sold 32,260,000 shares at $1.55 per share for net proceeds of approximately $46.7 million.
Based on current projections, cash on hand is sufficient to fund operations into the second half of 2022, said the company.
For the fourth quarter period ended on December 31, 2019, the company posted a net loss of $5.8 million, or a net loss per share of $0.04, compared to a net loss of $3.9 million, or net loss per share of $0.04 for the same period in 2018.
For the full year, net loss was $18.3 million, or $0.13 per share, compared to a net loss of $15 million, or $0.15 per share for the whole of 2018. “The increases for both periods were due primarily to an increase in research and development expenses,” explained the company.
Research and development (R&D) expenses for the fourth quarter totaled $3.4 million, compared to $1.7 million for the same period in 2018. For the whole of 2019, R&D expenses totaled $11.2 million, compared to $6.8 million for all of 2018. The increases for both the three-month and 12-month periods were due primarily to “higher preclinical and clinical development expenses, employee compensation and manufacturing process development costs” related to the development of MAT9001 and MAT2203.
General and admin expenses for the fourth quarter totaled $2.3 million, compared to $2.5 million in the same period in 2018. The drop was due to decreased employee compensation expenses.
Contact the author Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive