On January 9, 2020 NeuBase Therapeutics, Inc. (Nasdaq: NBSE) ("NeuBase" or the "Company"), a biotechnology company developing next-generation antisense therapies using its scalable PATrOL platform to address genetic diseases, reported its financial results for the fiscal year ended September 30, 2019 (Press release, Ohr Pharmaceutical, JAN 9, 2020, View Source [SID1234552928]).
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"The successful execution of multiple platform milestones in 2019 has built a solid foundation to accelerate the advancement of our pipeline of PATrOL-enabled therapies in 2020 and beyond. As a result, we expect to complete and report data from preclinical studies evaluating the pharmacokinetic ("PK") and pharmacodynamic ("PD") properties of our PATrOL platform and PATrOL-enabled candidates beginning in the first quarter and in the second quarter of calendar year 2020. We believe the results from these studies will inform the development of our first indications, which include Huntington’s disease and Myotonic Dystrophy type 1, as well as allow us to expand our pipeline across a range of targets and tissues," said Dietrich Stephan, Ph.D., chief executive officer of NeuBase Therapeutics.
"As we enter this exciting period in NeuBase’s history, we’ve garnered increased industry recognition for our platform’s unique capabilities to address genetic diseases. Over the past several months, we’ve recruited renowned scientists and leading industry experts in their respective fields to several executive and research positions at NeuBase, as well as appointments to our board of directors and scientific advisory committee. The team we now have in place is positioned to quickly advance the development of our pipeline of PATrOL-enabled therapies," concluded Dr. Stephan.
Fiscal Fourth Quarter of 2019 and Recent Operating Highlights
·U.S. Patent and Trademark Office (USPTO) issued NeuBase U.S. Patent No. 10,370,415, a foundational patent that covers its proprietary DNA and RNA binding technology, which enables PATrOL-based therapies to target the secondary structures of DNA and RNA
·The Scientist magazine recognized NeuBase’s Janus Base technology as a top 10 innovation of 2019
·Management held a KOL meeting for the investment community on Huntington’s disease and NeuBase’s peptide-nucleic acid (PNA) antisense oligonucleotide (PATrOL) platform
·Announced the appointment of several preeminent scientists to NeuBase’s Scientific Advisory Board in the fourth quarter of FY2019 and in the months following, including George Church, Ph.D., Samuel Broder, M.D., and Steven Dowdy, Ph.D.
·Management rang the closing bell at the NASDAQ on August 7, 2019 to celebrate the listing of the Company’s stock on NASDAQ
Financial Results for the Fiscal Year Ended September 30, 2019:
Note for Fiscal Year 2019: The period of July 12 to September 30, 2019 includes the combined financial results for Ohr Pharmaceutical and NeuBase post-merger, which closed on July 12, 2019. The period prior to July 12, 2019 includes only the financials of NeuBase prior to the merger. Therefore, Fiscal Year 2019 is not directly comparable to prior periods.
·At September 30, 2019, the Company had cash and cash equivalents of approximately $10.3 million, compared to cash and equivalents of approximately $0.2 million at September 30, 2018. The Company believes that its current cash balance will provide sufficient capital to fund operations through the end of fiscal year 2020.
·For the fiscal year ended September 30, 2019, the Company reported a net loss of approximately $27.0 million, or ($3.26) per share, compared to a net loss of approximately $0.04 million, or ($0.01) per share, for the period from inception (August 28, 2018) to September 30, 2018. Non-GAAP adjusted net loss was $3.7 million, or ($0.45) per share, for fiscal year 2019, and $0.04 million, or ($0.01) per share, for the period from inception (August 28, 2018) to September 30, 2018. The non-GAAP adjusted net loss for fiscal year 2019 excludes certain non-cash items. Loss per share amounts have been retroactively adjusted for the reverse stock split effected on February 4, 2019.
·For the fiscal year ended September 30, 2019, total operating expenses were approximately $26.3 million, consisting of approximately $9.1 million in general and administrative expenses, $4.3 million of research and development expenses, and $13.0 million in research and development – licenses acquired – expense. This compares to total operating expenses of $0.04 million for the period from inception (August 28, 2018) to September 30, 2018, comprised of approximately $0.03 million in general and administrative expenses, and $0.01 million in research and development expenses.
Non-GAAP Financial Measures
The non-GAAP financial measures contained herein are a supplement to the corresponding financial measures prepared in accordance with U.S. GAAP. The non-GAAP financial measures presented exclude the following non-cash items: share-based compensation expense, non-cash research and development expense-licenses acquired, the change in fair value of warrant liabilities, depreciation and amortization expense and non-cash interest and amortization expense on convertible notes. Management believes that because these non-cash items have no impact on the cash position of the Company and most of these expenses and liabilities occurred as a result of the merger with Ohr Pharmaceutical, adjustments for these items will assist investors in making comparisons of period-to-period operating results. Furthermore, management believes that the excluded items are not indicative of the Company’s on-going core operating performance.
These non-GAAP financial measures have certain limitations in that they do not reflect all of the costs associated with the operations of the Company’s business as determined in accordance with GAAP. Therefore, investors should consider non-GAAP financial measures in addition to, and not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. The non-GAAP financial measures presented by the Company may be different from the non-GAAP financial measures used by other companies.
For more information on our non-GAAP financial measures and a reconciliation of GAAP to non-GAAP measures, please see the "Reconciliation of GAAP to Non-GAAP Results" table in this press release.