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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d)
of
the Securities Exchange Act of 1934
Date of Report (Date of
earliest event reported): March 6, 2024
APPLIED THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware |
|
001-38898 |
|
81-3405262 |
(State or Other Jurisdiction of
Incorporation) |
|
(Commission File Number) |
|
(I.R.S. Employer Identification No.) |
545 Fifth Avenue, Suite 1400 New York, NY 10017 |
|
10017 |
(Address of Principal Executive Offices) |
|
(Zip Code) |
Registrant’s telephone number,
including area code: (212) 220-9226
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ | Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425) |
| |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12) |
| |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b)) |
| |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of
the Act:
Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
Common Stock |
|
APLT |
|
The Nasdaq Global Market |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or
Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02.
Results of Operations and Financial Condition.
On March 6, 2024, Applied Therapeutics, Inc. (the “Company”)
issued a press release announcing its financial results for the quarter and full year ended December 31, 2023. A copy of the press release
is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information provided in this Form 8-K, including Exhibit 99.1
hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the
“Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference
into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth
by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits:
The following exhibit is attached with this current report on Form 8-K:
SIGNATURE
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
APPLIED THERAPEUTICS, INC. |
|
|
|
Dated: March 6, 2024 |
By: |
/s/ Shoshana Shendelman |
|
Name: |
Shoshana Shendelman |
|
Title: |
President and Chief Executive Officer |
Exhibit 99.1
Applied Therapeutics Reports Fourth Quarter
and Year-end 2023 Financial Results
- NDA for
govorestat accepted and granted Priority Review by FDA for the treatment of Classic Galactosemia; PDUFA target action date of August 28,
2024; MAA under review by EMA with decision expected in 4Q 2024
- Announced
positive results from 12-month interim analysis of govorestat in ongoing INSPIRE Phase 3 trial in SORD Deficiency; Company plans to request
pre-NDA meeting with neurology division of FDA
- Strengthened
balance sheet with $100 million Private Placement, expected to extend cash runway into 2026
NEW YORK, March 6,
2024 – Applied Therapeutics, Inc. (Nasdaq: APLT) (the “Company”), a clinical-stage biopharmaceutical
company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need,
today reported financial results for the fourth quarter and full year ended December 31, 2023.
“We’ve made significant clinical and regulatory progress,
particularly with the NDA acceptance and MAA validation for govorestat for the treatment of Galactosemia, achieving key milestones for
our rare disease pipeline. Additionally, we believe that the recent positive data from the interim analysis of the INSPIRE study in SORD
Deficiency confirms the role of sorbitol as a key driver of disease progression, and we plan to request a pre-NDA meeting with the FDA,”
said Shoshana Shendelman, PhD, Founder, Chief Executive Officer, and Chair of the Board. “As Applied enters into this next stage
of growth, we are poised for continued value generation across our rare disease pipeline, supported by our recent financing and bolstered
cash position.”
Recent Highlights
| · | Govorestat
NDA Accepted and Granted Priority Review by US FDA for Treatment of Classic Galactosemia,
PDUFA Target Action Date of August 28, 2024; MAA under CHMP Review by EMA. In February 2024,
the Company announced that the U.S. Food and Drug Administration (FDA) has accepted the filing
of the New Drug Application (NDA) for govorestat (AT-007) for the treatment of Classic Galactosemia.
The NDA was granted Priority Review status and the FDA assigned a Prescription Drug User
Free Act (PDUFA) target action date of August 28, 2024. The FDA also noted that it is
planning to hold an advisory committee meeting to discuss the application. Govorestat was
previously granted Pediatric Rare Disease designation and will qualify for a Priority Review
Voucher (PRV) upon approval. The Company has also submitted a Marketing Authorization Application
(MAA) for govorestat for the treatment of Classic Galactosemia to the European Medicines
Agency (EMA), which was validated in December 2023 and is under review by the EMA’s
Committee for Medicinal Products for Human Use (CHMP). The Company expects a decision by
the EMA in the fourth quarter of 2024. The NDA and MAA submission packages include clinical
outcomes data from the Phase 3 registrational ACTION-Galactosemia Kids study in children
aged 2-17 with Galactosemia, the Phase 1/2 ACTION-Galactosemia study in adult patients with
Galactosemia, and preclinical data. |
| · | Entered into $100 Million Private Placement, Expected to Extend Cash Runway
to 2026. In February 2024, the Company entered into a securities purchase agreement for a private placement of $100 million of equity
with participation from new and existing large, healthcare dedicated institutional and mutual fund investors including Perceptive Advisors,
Janus Henderson Investors, Venrock Healthcare Capital Partners, Adage Capital Partners, Frazier Life Sciences, Logos Capital, Vestal Point
Capital, and Rock Springs Capital. The Company intends to use the net proceeds to fund commercial activities for govorestat and to further
develop other pipeline candidates, and for working capital and general corporate purposes. With cash of approximately $153.5 million as
of March 1, 2024, the Company is well-capitalized with an expected runway into the first half of 2026. |
| · | Announced
Positive Data from 12-Month Interim Analysis of Govorestat (AT-007) in Ongoing INSPIRE Phase
3 Trial in Sorbitol Dehydrogenase Deficiency. In February 2024, the Company announced
that govorestat met primary and several key secondary endpoints in a pre-specified 12-month
interim analysis of the ongoing INSPIRE Phase 3 Trial in Sorbitol Dehydrogenase (SORD) Deficiency.
The objective of this pre-specified, 12-month interim analysis was to evaluate trends in
clinical outcome measures and biomarker correlations in order to inform future regulatory
discussions and support a potential NDA submission, due to the urgent need for treatment
and absence of any other options for patients with SORD Deficiency. At the time of the interim
analysis, a statistically significant correlation between sorbitol levels and the prespecified
CMT-FOM composite clinical endpoint (10-meter walk-run test, 4 stair climb, sit to stand
test, 6-minute walk test and dorsiflexion) was observed at 12 months of treatment with govorestat
(p=0.05). Govorestat treatment provided sustained reduction in sorbitol level in patients
with SORD Deficiency over 12 months of treatment, which was statistically significant compared
to placebo (p<0.001). In addition, treatment with govorestat also resulted in a highly
statistically significant effect (p=0.01) on the CMT Health Index (CMT-HI), an important
patient-reported outcome measure of disease severity and well-being and secondary endpoint
in the study. Aspects of the CMT-HI that demonstrated a treatment effect included lower limb
function, mobility, fatigue, pain, sensory function, and upper limb function. Govorestat
continues to be safe and well tolerated to-date. The Company believes the results from the
12-month interim analysis of the ongoing INSPIRE Phase 3 trial confirm the role of sorbitol
as a key driver of disease severity and progression over time. Clinical outcomes of the ongoing
INSPIRE trial are expected to be assessed again at 24 months, where the 10-meter walk run
test serves as the primary clinical efficacy endpoint. The Company plans to discuss a potential
NDA submission with the FDA based on the clinical data to date. The ongoing INSPIRE trial
is a Phase 3 double-blind placebo-controlled registrational study evaluating the effect of
once-daily oral govorestat in approximately 50 patients aged 16-55 with SORD Deficiency in
the US and Europe. |
| · | Announced
Topline Results from ARISE-HF Phase 3 Study of AT-001 (caficrestat) in Diabetic Cardiomyopathy.
In January 2024, the Company announced topline data from its Phase 3 Study of AT-001
in patients with diabetic cardiomyopathy (DbCM). AT-001 1500mg twice daily (BID) was generally
safe and well tolerated, and demonstrated a strong trend in stabilizing cardiac functional
capacity. In a pre-specified subgroup analysis of patients not concomitantly treated with
SGLT2 or GLP-1 therapies, active treatment with AT-001 resulted in a statistically significant
difference in the primary endpoint, and also resulted in a substantially lower rate of clinically
significant worsening in cardiac functional capacity of 6% or more as compared to placebo.
Full study results will be presented at an upcoming medical conference, along with results
of the Diabetic Peripheral Neuropathy sub-study, which are still being analyzed. As a result
of the encouraging ARISE-HF Phase 3 data, the Company plans to focus on identifying an appropriate
path forward in order to bring AT-001 to DbCM patients. |
Financial Results
| · | Cash
and cash equivalents and short-term investments totaled $49.9 million as of December 31,
2023, compared to $30.6 million as of December 31, 2022. On March 1, 2024, the
Company completed the private placement of shares and pre-funded warrants to purchase common
stock for gross proceeds of approximately $100 million (before deducing placement agent commissions
and other offering expenses). |
| · | Research
and development expenses for the year ended December 31, 2023 were $53.9 million,
compared to $55.6 million for the year ended December 31, 2022. The decrease of approximately
$1.7 million was primarily related to decreased expenses related to contract research
organization (CRO) costs, partially offset by an increase in drug manufacturing and formulation
costs. |
| · | General
and administrative expenses were $20.6 million for the year ended December 31, 2023,
compared to $27.3 million for the year ended December 31, 2022. The decrease of approximately
$6.7 million was primarily related to a decrease in commercial expense of $2.1 million,
an overall decrease in headcount resulting in a $3.0 million decrease in expense and reduced
insurance expense of $1.4 million. |
| · | Net
loss for the year ended December 31, 2023 was $119.8 million, or $1.42 per basic
and diluted common share, compared to a net loss of $82.5 million, or $2.18 per basic and
diluted common share, for the year ended December 31, 2022. |
| · | Cash
runway: The Company expects that its cash and cash equivalents, combined with the proceeds from the February 2024 Private Placement
and potential milestones expected from its Advanz European licensing partnership, will fund the business into 2026. Additionally, the
sale of the PRV, which would be granted upon a potential Galactosemia NDA approval could substantially extend the Company’s cash
runway. |
About Applied Therapeutics
Applied Therapeutics is a clinical-stage biopharmaceutical company
developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need. The Company’s
lead drug candidate, govorestat, is a novel central nervous system penetrant Aldose Reductase Inhibitor (ARI) for the treatment of CNS
rare metabolic diseases, including Galactosemia, SORD Deficiency, and PMM2-CDG. The Company is also developing AT-001, a novel potent
ARI, for the treatment of Diabetic Cardiomyopathy, or DbCM, a fatal fibrosis of the heart. The preclinical pipeline also includes AT-003,
an ARI designed to cross through the back of the eye when dosed orally, for the treatment of Diabetic retinopathy.
To learn more, please visit www.appliedtherapeutics.com
and follow the company on Twitter @Applied_Tx.
Forward-Looking Statements
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 the strategy, future
operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,”
“anticipate,” “plan,” “intend,” “predicts” 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 the (i) Company’s expectation that its cash and cash equivalents will extend into 2026; (ii) Company’s
plans to request a pre-NDA meeting with the FDA; and (iii) the likelihood that the Company’s ongoing NDA and MMA submissions
will be approved and the timing of any approval decision. 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, market 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 and advance product candidates into, and successfully complete, clinical studies, (vi) our ability to maintain
and establish collaborations or obtain additional funding, (vii) our ability to obtain and timing of regulatory approval of our
current and future product candidates, (viii) the anticipated indications for our product candidates, if approved, (ix) our
expectations regarding the potential market size and the rate and degree of market acceptance of such product candidates, (x) our
ability to fund our working capital requirements and expectations regarding the sufficiency of our capital resources, (xi) the implementation
of our business model and strategic plans for our business and product candidates, (xii) our intellectual property position and
the duration of our patent rights, (xiii) developments or disputes concerning our intellectual property or other proprietary rights,
(xiv) our expectations regarding government and third-party payor coverage and reimbursement, (xv) our ability to compete in
the markets we serve, (xvi) the impact of government laws and regulations and liabilities thereunder, (xvii) developments relating
to our competitors and our industry, (xviii) our ability to achieve the anticipated benefits from the agreements entered into in
connection with our partnership with Advanz Pharma and (xiv) 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 U.S. Securities and Exchange Commission, including the “Risk
Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any
forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or
circumstances or otherwise.
Contacts
Investors:
Maeve Conneighton
(212) 600-1902 or
appliedtherapeutics@argotpartners.com
Media:
media@appliedtherapeutics.com
Applied Therapeutics, Inc.
Balance Sheets
(in thousands except share and per share data)
| |
As of | | |
As of | |
| |
December 31, | | |
December 31, | |
| |
2023 | | |
2022 | |
| |
(Unaudited) | | |
| |
ASSETS | |
| | | |
| | |
CURRENT ASSETS: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 49,898 | | |
$ | 16,657 | |
Investments | |
| — | | |
| 13,923 | |
Current portion of security deposits and
leasehold improvements | |
| 254 | | |
| 57 | |
Prepaid expenses and
other current assets | |
| 4,234 | | |
| 6,671 | |
Total current assets | |
| 54,386 | | |
| 37,308 | |
Noncurrent portion of security deposits
and leasehold improvements | |
| — | | |
| 198 | |
Operating lease right-of-use
asset | |
| 447 | | |
| 857 | |
TOTAL ASSETS | |
$ | 54,833 | | |
$ | 38,363 | |
LIABILITIES AND STOCKHOLDERS’ (DEFICIT)/EQUITY | |
| | | |
| | |
CURRENT LIABILITIES: | |
| | | |
| | |
Current portion of operating lease liabilities | |
$ | 429 | | |
$ | 477 | |
Accounts payable | |
| 1,742 | | |
| 4,534 | |
Accrued expenses and other current liabilities | |
| 15,286 | | |
| 14,756 | |
Warrant liabilities | |
| 53,725 | | |
| 13,657 | |
Total current liabilities | |
| 71,182 | | |
| 33,424 | |
NONCURRENT LIABILITIES: | |
| | | |
| | |
Noncurrent portion of operating lease liabilities | |
| 38 | | |
| 414 | |
Clinical holdback
- long-term portion | |
| 759 | | |
| 464 | |
Total noncurrent
liabilities | |
| 797 | | |
| 878 | |
Total liabilities | |
| 71,979 | | |
| 34,302 | |
STOCKHOLDERS’ (DEFICIT)/EQUITY: | |
| | | |
| | |
Common stock, $0.0001 par value; 200,000,000 shares authorized
as of December 31, 2023 and December 31, 2022; 84,869,832 shares issued and outstanding as of December 31, 2023
and 48,063,358 shares issued and outstanding as of December 31, 2022 | |
| 8 | | |
| 5 | |
Preferred stock, par value $0.0001; 10,000,000 shares authorized
as of December 31, 2023 and December 31, 2022; 0 shares issued and outstanding as of December 31, 2023
and December 31, 2022 | |
| — | | |
| — | |
Additional paid-in capital | |
| 451,432 | | |
| 352,828 | |
Accumulated other comprehensive income | |
| — | | |
| 51 | |
Accumulated deficit | |
| (468,586 | ) | |
| (348,823 | ) |
Total stockholders'
(deficit)/equity | |
| (17,146 | ) | |
| 4,061 | |
TOTAL LIABILITIES
AND STOCKHOLDERS’ (DEFICIT)/EQUITY | |
$ | 54,833 | | |
$ | 38,363 | |
Applied Therapeutics, Inc.
Statements of Operations
(in thousands except share and per share data)
(Unaudited)
| |
Year Ended | |
| |
December 31, | |
| |
2023 | | |
2022 | |
REVENUE: | |
| | | |
| | |
License revenue | |
$ | 9,219 | | |
$ | — | |
Research and development
services revenue | |
| 774 | | |
| — | |
Total revenue | |
| 9,993 | | |
| — | |
COSTS AND EXPENSES | |
| | | |
| | |
Research and development | |
| 53,905 | | |
| 55,634 | |
General and administrative | |
| 20,623 | | |
| 27,316 | |
Total operating expenses | |
| 74,528 | | |
| 82,950 | |
LOSS FROM OPERATIONS | |
| (64,535 | ) | |
| (82,950 | ) |
OTHER INCOME (EXPENSE), NET: | |
| | | |
| | |
Interest income | |
| 1,372 | | |
| 685 | |
Change in fair value of warrant liabilities | |
| (56,573 | ) | |
| (66 | ) |
Other expense | |
| (27 | ) | |
| (177 | ) |
Total other income
(expense), net | |
| (55,228 | ) | |
| 442 | |
Net loss | |
$ | (119,763 | ) | |
$ | (82,508 | ) |
Net loss per share attributable to
common stockholders—basic and diluted | |
$ | (1.42 | ) | |
$ | (2.18 | ) |
Weighted-average common stock outstanding—basic
and diluted | |
| 84,244,494 | | |
| 37,825,431 | |
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Applied Therapeutics (NASDAQ:APLT)
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