On June 21, 2019 Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing novel drug candidates in indications of high unmet medical need, reported financial results for the first quarter ended March 31, 2019 (Press release, Applied Therapeutics, JUN 21, 2019, View Source [SID1234537207]).
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"Since the launch of Applied Therapeutics just three years ago, we have built a robust pipeline of novel drug candidates with the potential to deliver a meaningful impact in multiple disease areas of high unmet medical need," said Shoshana Shendelman, PhD, President and Chief Executive Officer of Applied Therapeutics. "With the recent completion of our initial public offering, we have strengthened our cash position, extending our runway and providing additional resources to accelerate our clinical development plan. This includes our lead asset, AT-001, which is on track to enter a pivotal Phase 2/3 clinical trial in diabetic cardiomyopathy (DbCM) later this year and advance AT-007 into Phase 1/2 study into adults with Galactosemia this month."
Recent Highlights
·Received FDA Orphan Drug Designation for AT-007 in Galactosemia. In May 2019, we received orphan drug designation for AT-007 in Galactosemia. The designation allows Applied Therapeutics to qualify for a number of incentives, including: seven years of market exclusivity upon regulatory approval, if received; exemption from FDA application fees for Galactosemia; and tax credits for qualified clinical trials.
·Presented Phase 1/2 Data Highlighting Safety and Efficacy for AT-001 in DbCM at the American Diabetes Association (ADA) 79th Annual Scientific Sessions in San Francisco. In June 2019, we presented Phase 1/2 Data Highlighting Safety and Efficacy for AT-001 in DbCM at the ADA Annual Scientific Sessions. The data, presented as part of the Late Breaking session, demonstrated that AT-001 was well tolerated at all dose levels, and target engagement was confirmed by potent aldose reductase (AR) inhibition as evidenced by significant reductions in sorbitol, a pharmacodynamic biomarker of AR activity. AT-001 also improved selectivity and affinity for AR and resulted in potent AR inhibition.
·Presented Phase 1/2 Data Highlighting Safety and Proof of Biological Activity for AT-001 in DbCM at The European Society for Cardiology (ESC) 6th World Congress in Athens, Greece. In May 2019, we presented two posters at ESC, the first of which was presented in the Late Breaking session and highlighted key data from a recently completed Phase 1/2 study in approximately 120 type 2 diabetic patients demonstrating the safety and proof of biological activity for AT-001 in DbCM. Supporting preclinical data from an animal model of DbCM was also presented, demonstrating that AT-001 prevents or reduces cardiac damage in a relevant disease model.
· Completed Initial Public Offering. In May 2019, we completed our IPO, generating approximately $34.0 million in net proceeds, after deducting underwriting discounts and commissions and estimated offering expenses payable by us.
·Announced Appointment of Mark Vignola, PhD, as Chief Financial Officer. In April 2019, we announced the appointment of Mark Vignola, PhD, as Chief Financial Officer. Dr. Vignola served most recently as Head of Corporate Development & Investor Relations at Intercept Pharmaceuticals.
Financial Results
·Cash and cash equivalents totaled $14.7 million as of March 31, 2019, compared with $18.7 million at December 31, 2018. Subsequent to the close of the quarter, we completed an initial public offering resulting in net proceeds of approximately $34.0 million.
·Research and development expenses for the three months ended March 31, 2019 were $6.9 million, compared to $1.5 million for the three months ended March 31, 2018. The increase of approximately $5.4 million was primarily related to the progressing of our clinical trials through development, including an increase in clinical and pre-clinical expenses of $4.1 million and drug manufacturing and formulation expenses of $0.7 million, and personnel expenses of $0.7 million due to the hiring of research and development personnel, including the Chief Medical Officer in August 2018.
·General and administrative expenses were $1.9 million for the three months ended March 31, 2019, compared to $0.4 million for the three months ended March 31, 2018. The increase of approximately $1.4 million was primarily related to professional fees of $0.7 million due to increased legal and consulting fees, personnel expenses of $0.4 million due to the hiring of other personnel, including the interim Chief Financial Officer and the Controller, and other expenses of $0.3 million, primarily due to public relations efforts, travel expenses and rent.
·Net loss for the first quarter of 2019 was $8.7 million, or $1.58 per basic and diluted common share, compared to a net loss of $2.3 million, or $.43 per basic and diluted common share, for the first quarter of 2018.