Applied Therapeutics Reports First Quarter 2020 Financial Results
“The first quarter was a period of tremendous growth and advancement across our clinical programs,” said
- Announced Full Data and Scientific Presentations from the Pivotal Phase 2 ACTION-Galactosemia Trial. In
April 2020, we announced new data and scientific presentations from the pivotal Phase 2 ACTION-Galactosemia trial. The topline data from the trial was originally announced in early January. The full study data, originally planned to be presented at the Society for Inherited Metabolic Disordersconference, showed that once-daily 20mg/kg AT-007 rapidly and sustainably reduced toxic galactitol levels with no accompanying increase in galactose. Additionally, positive trends on MRI outcomes were shown, including indirect measures of edema, neuronal health and brain galactitol levels in AT-007-treated patients. As no drug-related adverse events were seen at the once-daily 20mg/kg dose, a once-daily 40mg/kg dose was subsequently studied in healthy volunteers, and was also shown to be safe and well-tolerated. Evaluation of the 40 mg/kg dose in Galactosemia patients remains ongoing.
- Announced IND and Investigator-Initiated Studies of AT-001 in Critical COVID-19 Patients. In
April 2020, we announced that a COVID-19 IND has been opened with the FDA for AT-001, a novel potent Aldose Reductase inhibitor. Multiple AT-001 investigator-initiated trials are currently underway to address acute lung inflammation and cardiomyopathy in critical COVID-19 patients. Several New York Cityhospitals have initiated Emergency Investigational Drug applications for AT-001 use in critical COVID-19 patients. Additional data is being gathered through studies on the effect of AT-001 therapy in critical COVID-19 patients.
Adam Hansardas Chief Commercial Officer. In March 2020, we announced the appointment of Adam Hansardas Chief Commercial Officer. Mr. Hansardbrings extensive commercial and leadership experience across the biotech and pharmaceutical industry to Applied Therapeutics.
- Closed $143.4 Million Underwritten Public Offering. In January 2020, we completed an underwritten public offering of common stock at a price to the public of $45.50 per share, resulting in gross proceeds of approximately $143.4 million, before deducting underwriting discounts and commissions and offering expenses.
- Cash and cash equivalents and short-term investments totaled
$154.3 millionas of March 31, 2020, compared with $38.9 millionat December 31, 2019.
- Research and development expenses for the three months ended
March 31, 2020were $7.3 million, compared to $6.9 millionfor the three months ended March 31, 2019. The increase of approximately $0.4 millionwas primarily related to the increase in clinical and pre-clinical expenses of $0.8 millionfor the advancement of clinical trials, increase in personnel-related costs of $0.2 millionand $0.5 millionincrease in stock-based compensation expense due to an increase in headcount, which were offset by the decrease in drug manufacturing and formulation expenses of $1.0 millionand decrease in regulatory and other expenses of $0.1 million.
- General and administrative expenses were
$5.2 millionfor the three months ended March 31, 2020, compared to $1.9 millionfor the three months ended March 31, 2019. The increase of approximately $3.3 millionwas primarily related to the increase in personnel expenses and stock-based compensation of $0.4 millionand $0.5 million, respectively, due to the increase in headcount, including the hiring of the chief financial officer and chief accounting officer, $1.3 millionrelated to an increase in legal and professional fees due to increased costs associated with being a public company, and $1.2 millionin other expenses relating to increased costs of insurance, rent, and other office expenses.
- Net loss for the first quarter of 2020 was
$12.4 million, or $0.59per basic and diluted common share, compared to a net loss of $8.7 million, or $1.58per basic and diluted common share, for the first quarter 2019.
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “plan,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are forward-looking statements. These include, without limitation, statements regarding (i) our plan to move quickly towards regulatory filing following our pivotal Phase 2 ACTION-Galactosemia study, while preparing for Galactosemia commercial launch and growing our organization, (ii) the design, scope and results of our clinical trials, (iii) the timing of the initiation and completion of our clinical trials, (iv) the likelihood that data from our clinical trials will support future development of our product candidates, and (v) the likelihood of obtaining regulatory approval of our product candidates and qualifying for any special designations, such as orphan drug designation. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we, therefore cannot assure you that our plans, intentions, expectations or strategies will be attained or achieved. Such risks and uncertainties include, without limitation, (i) our plans to develop and commercialize our product candidates, (ii) the initiation, timing, progress and results of our current and future preclinical studies and clinical trials and our research and development programs, (iii) our ability to take advantage of expedited regulatory pathways for any of our product candidates, (iv) our estimates regarding expenses, future revenue, capital requirements and needs for additional financing, (v) our ability to successfully acquire or license additional product candidates on reasonable terms, (vi) our ability to maintain and establish collaborations or obtain additional funding, (vii) our ability to obtain regulatory approval of our current and future product candidates, (viii) our expectations regarding the potential market size and the rate and degree of market acceptance of such product candidates, (ix) our ability to fund our working capital requirements and expectations regarding the sufficiency of our capital resources, (x) the implementation of our business model and strategic plans for our business and product candidates, (xi) our intellectual property position and the duration of our patent rights, (xii) developments or disputes concerning our intellectual property or other proprietary rights, (xiii) our expectations regarding government and third-party payor coverage and reimbursement, (xiv) our ability to compete in the markets we serve, (xv) the impact of government laws and regulations and liabilities thereunder, (xvi) developments relating to our competitors and our industry, (xvii) the impact of the COVID-19 pandemic on the timing and progress of our ongoing clinical trials and our business in general and (xviii) other factors that may impact our financial results. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur at all. Factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the
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Statement of Operations
(in thousands, except share and per share data)
|Three Months Ended|
|Research and development||$||7,271||$||6,874|
|General and administrative||5,196||1,855|
|Total operating expenses||12,467||8,729|
|LOSS FROM OPERATIONS||(12,467||)||(8,729||)|
|OTHER INCOME (EXPENSE), NET:|
|Interest income (expense), net||122||(1||)|
|Other income (expense)||(24||)||—|
|Total other income (expense), net||98||(1||)|
|Net loss attributable to common stockholders—basic and diluted||$||(12,369||)||$||(8,730||)|
|Net loss per share attributable to common stockholders—basic and diluted||$||(0.59||)||$||(1.58||)|
|Weighted-average common stock outstanding—basic and diluted||20,840,658||5,513,531|
(in thousands, except share and per share data)
|As of||As of|
|Cash and cash equivalents||$||92,503||$||18,850|
|Prepaid expenses and other current assets||9,432||7,301|
|Total current assets||163,741||46,155|
|Operating lease right-of-use asset||1,942||2,035|
|Security deposits and leasehold improvements||199||199|
|LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)|
|Current portion of operating lease liabilities||364||356|
|Accrued expenses and other current liabilities||6,496||4,950|
|Total current liabilities||8,466||14,099|
|Noncurrent portion of operating lease liabilities||1,588||1,683|
|Total noncurrent liabilities||1,588||1,683|
|Additional paid-in capital||234,876||99,378|
|Accumulated other comprehensive loss||89||(2||)|
|Total stockholders' equity||155,828||32,607|
|TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY||$||165,882||$||48,389|
Source: Applied Therapeutics