Delaware

001-37581

46-0571712

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

Title of Each Class:

Trading Symbol(s)

Name of Each Exchange on which Registered

Common Stock, $0.00001 par value

ACRS

The Nasdaq Stock Market, LLC

Exhibit

Number

Exhibit Description

99.1

Press Release, dated February 25, 2020.

ACLARIS THERAPEUTICS, INC.

By:  

/s/ Frank Ruffo

Date:  February 25, 2020

Frank Ruffo
Chief Financial Officer

  

Positive Preliminary Results from Phase 1 Single and Multiple Ascending Dose Trial of ATI-450, an Investigational Oral MK2 Inhibitor



Projected Cash Runway into the Third Quarter of 2021

  

Management to Host Conference Call at 5:00 PM ET today

·

ATI-450:  

o

ATI-450 is an investigational oral small molecule MK2 inhibitor.

o

ATI-450-PKPD-101:  A  Phase 1 single and multiple ascending dose  (SAD/MAD) trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered ATI-450 in 77 healthy subjects.

§

Preliminary  data from this trial demonstrated that ATI-450:

·

resulted in marked inhibition of TNFα, IL1β, IL8, and IL6;

·

was generally well-tolerated at all doses tested in the trial. The most common adverse events (reported by 2 or more subjects who received ATI-450) observed during the trial were dizziness, headache, upper respiratory tract infection, constipation, abdominal pain, and nausea;

·

had dose-proportional pharmacokinetics (PK) with a terminal half-life of 9-12 hours in the MAD cohort; and

·

had no meaningful food effect or drug-drug interaction with methotrexate.

o

ATI-450-RA-201:  Aclaris intends to initiate a Phase 2a clinical trial for ATI-450 in subjects with rheumatoid arthritis in the first half of 2020.  

o

Aclaris is also planning to initiate a Phase 2a clinical trial of ATI-450 for an additional immuno-inflammatory indication.

·

ATI-1777:

o

ATI-1777 is an investigational topical soft-Janus Kinase (JAK)  inhibitor compound that Aclaris is developing as a potential treatment for moderate-to-severe atopic dermatitis.

o

Aclaris expects to submit an IND for ATI-1777 for the treatment of atopic dermatitis in mid-2020.  

o

If the IND is allowed, Aclaris expects to initiate a Phase 1/2 clinical trial in both healthy subjects and subjects with atopic dermatitis in the second half of 2020 evaluating ATI-1777 as a potential topical treatment for moderate-to-severe atopic dermatitis.  

·

ATI-2138:

o

ATI-2138 is an investigational oral ITK/TXK/JAK3  (ITJ) inhibitor compound that Aclaris is developing as a potential treatment for psoriasis and/or inflammatory bowel disease.

o

Aclaris expects to submit an IND for ATI-2138 in the fourth quarter of 2020 or the first quarter of 2021.

·

Divested RHOFADE (oxymetazoline hydrochloride) cream, 1% to EPI Health, LLC and repaid in full $30 million term loan with Oxford Finance LLC, in October 2019.

·

Appointed Vincent Milano to the Board in January 2020.

·

Aclaris continues to pursue strategic alternatives, including seeking partners for:

o

A-101 45% Topical Solution: to obtain regulatory approval and commercialize A-101 45% Topical Solution, an investigational compound, as a potential treatment for common warts (verruca vulgaris);

o

ATI-501 & ATI-502: to further develop, obtain regulatory approval and commercialize ATI-501 (oral) and ATI-502 (topical), investigational JAK 1/3 inhibitor compounds, as potential treatments for alopecia; and

o

ESKATA:  to commercialize ESKATA® (hydrogen peroxide) topical solution, 40% (w/w).

·

The accompanying consolidated statements of operations and selected consolidated balance sheet data have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to Aclaris’ commercial products as discontinued operations. The accompanying financial statement data are generally presented in conformity with Aclaris’ historical format.  Aclaris believes this format provides comparability with its previously filed financial statements. 

·

Total costs and expenses from continuing operations for the fourth quarter of 2019 were $18.4 million, compared to $26.9 million for the fourth quarter of 2018. For the year ended December 31, 2019, total costs and expenses were $115.3 million, compared to $90.9 million in 2018.

o

These amounts included non-cash stock-based compensation expenses of $3.2 million and $16.1 million for the quarter and year ended December 31, 2019, respectively, compared to $4.2 million and $16.6 million for the prior year periods, respectively.

o

For the year ended December 31, 2019, there was also a $18.5 million non-cash charge for the impairment of goodwill. There was no such charge in the prior year.

·

R&D expenses were $11.5 million and $64.9 million for the quarter and year ended December 31, 2019, respectively, compared to $19.0 million and $60.8 million for the quarter and year ended December 31, 2018, respectively.

o

The year-over-year fourth quarter decrease of $7.5 million was mainly the result of Aclaris’ Phase 2 clinical trials of ATI-501 and ATI-502 and two pivotal Phase 3 clinical trials of A-101 45% Topical Solution, which were at or near completion in the third quarter of 2019, as well as a reduction in personnel-related costs.

o

These reductions were offset by increased expenses related to Aclaris’ preclinical development programs and the Phase 1 clinical trial for ATI-450 which was initiated in 2019, and by a milestone expense related to one of Aclaris’ licensing agreements.

·

General and administrative expenses were $5.8 million and $27.2 million for the quarter and year ended December 31, 2019, respectively, compared to $6.6 million and $25.6 million for the quarter and year ended December 31, 2018, respectively.

·

Loss from continuing operations was $19.2 million for the fourth quarter of 2019, compared to $24.7 million for the fourth quarter of 2018. Loss from continuing operations was $113.5 million for the year ended December 31, 2019, compared to $82.1 million for the year ended December 31, 2018.

·

The gain from discontinued operations was $0.6 million for the fourth quarter of 2019, compared to a loss of $13.9 million for the fourth quarter of 2018. The loss from discontinued operations was $47.8 million for the year ended December 31, 2019, compared to $50.6 million for the year ended December 31, 2018.

·

Net loss was $18.6 million for the fourth quarter of 2019, compared to net loss of $38.6 million for the fourth quarter of 2018, and was $161.4 million for the year ended December 31, 2019, compared to $132.7 million for the year ended December 31, 2018.

Three Months Ended

Year Ended

December 31,

December 31,

2019

2018

2019

2018

Revenues:

Product sales, net

$

—

$

—

$

—

$

—

Contract research

Other revenue

—

—

Total revenue, net

Costs and expenses:

Cost of revenue (1)

Research and development (1)

Sales and marketing (1)

General and administrative (1)

Goodwill impairment

—

—

—

Amortization of definite-lived intangible

—

—

—

—

Total costs and expenses

Loss from operations

Other (expense) income, net

Loss from continuing operations

Gain / (loss) from discontinued operations (1)

Net loss

$

$

$

$

Net loss per share, basic and diluted

$

$

$

$

Weighted average common shares outstanding, basic and diluted

(1) Amounts include stock-based compensation expense as follows:

Cost of revenue

$

$

$

$

Research and development

Sales and marketing

—

—

—

—

General and administrative

Gain / (loss) from discontinued operations

Total stock-based compensation expense

$

$

$

$

December 31, 2019

December 31, 2018

Cash, cash equivalents and marketable securities

$

$

Total assets

98,297

275,566

Total current liabilities

22,432

27,342

Total liabilities

28,385

60,442

Total stockholders' equity

69,912

215,124