Concert Pharmaceuticals Reports Third Quarter 2022 Financial Results

Concert Pharmaceuticals Reports Third Quarter 2022 Financial Results

LEXINGTON, Mass.–()–Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today reported financial results for the third quarter of 2022.

“With the THRIVE-AA clinical program completed and the positive Phase 3 results available for deuruxolitinib in alopecia areata, we are well on track to meet our goal of submitting the NDA in the first half of 2023,” said Roger Tung, Ph. D., Chairman and CEO of Concert Pharmaceuticals. “Given the promising clinical properties and potential best-in-class profile shown by deuruxolitinib and the great needs of the alopecia areata patient community, we are well positioned to emerge as leaders in the field of autoimmune dermatology. All of our development and pre-commercial efforts are strongly positioning us to transition to being a commercially focused organization.”

Recent highlights and upcoming milestones

Deuruxolitinib (CTP-543): An Investigational Treatment for Moderate to Severe Alopecia Areata

  • Deuruxolitinib EADV breaking presentation: In September 2022, Brett King, MD, Department of Dermatology, Yale University School of Medicine, presented the results of Phase 3 of THRIVE-AA1 in alopecia areata during the 31st Congress breaking news session of the European Academy of Dermatology and Venereology (EADV). To access the full presentation of safety and efficacy findings from the THRIVE-AA1 study, visit Concert’s Scientific Presentation page on your website. Presentation details include:

    • SALT scores for scalp regrowth. Data from the THRIVE-AA1 study showed the ability of deuruxolitinib to achieve more stringent criteria for hair regrowth than those measured by the primary study endpoint of a Severity of Alopecia Tool (SALT) score of 20 or less. (meaning 20 percent or less hair on the scalp). loss) at week 24. Specifically, 21 percent and 35 percent of patients in the deuruxolitinib 8 mg twice daily and 12 mg twice daily dose groups, respectively, achieved a SALT score of 10 or less at week 24, compared to 0 percent of patients in the placebo group (p<0.0001). In addition, the relative improvement in SALT score from baseline was significantly different for the 12 mg twice daily dose group compared to placebo (p<0.001) as early as week 4.
    • Regrowth of eyebrows or eyelashes. New data was presented showing that patients in the THRIVE-AA1 study with baseline eyebrow or eyelash hair loss who were treated with deuruxolitinib had significant improvement compared to placebo from 12 weeks, which was the first time point measured, and continued through the 24-week treatment period (p<0.001).
  • Positive phase 3 results reported for the THRIVE-AA2 study of deuruxolitinib. In August 2022, the Company reported positive top-line results for its second Phase 3 clinical trial of deuruxolitinib, THRIVE‑AA2. A statistically significant proportion of patients treated with deuruxolitinib 8 mg twice daily or 12 mg twice daily in the THRIVE-AA2 study experienced increased scalp growth compared to placebo. The proportion of patients achieving a SALT score of 20 or less at Week 24 was 33% in the 8 mg twice daily dose group and 38% in the 12 mg twice daily dose group, compared to 1% of patients in the placebo group. The treatment difference for both dose groups relative to placebo was statistically significant (p<0.0001). The safety profile observed with deuruxolitinib in THRIVE-AA2 was consistent with previous studies of CTP-543.
  • Presentation of Deuruxolitinib Phase 3 in Alopecia Areata at the World Congress for Hair Research. Dr. King will present additional results from the THRIVE-AA1 study at the 12th World Congress of Hair Research taking place November 18-21, 2022 in Melbourne, Australia. The presentation will include additional analyzes of hair regrowth based on disease severity and disease time course.

Financial results for the third quarter of 2022

  • Cash and investment position. Cash, cash equivalents and investments as of September 30, 2022 totaled $148.9 million, compared to $141.6 million as of December 31, 2021. Under its current operating plan, the Company expects its cash, cash equivalents and investments finance the Company through the second quarter of 2023.
  • R&D expenses. Research and development expenses were $24.4 million for the quarter ended September 30, 2022, compared to $21.9 million for the same period in 2021. The increase in research and development expenses is primarily related to the deuruxolitinib clinical development program.
  • General and adminsitrative expenses. General and administrative expenses were $5.3 million for the quarter ended September 30, 2022, compared to $5.5 million for the same period in 2021. The decrease in general and administrative expenses is primarily related to the decrease non-monetary share-based compensation and outside professional services.
  • Net loss. For the quarter ended September 30, 2022, net loss attributable to common stockholders was $28.9 million, or $0.58 per share, compared to net loss attributable to common stockholders of $26.7 million, or $0.78 per share, for the quarter ended September 30, 2021.

Conference call and webcast

The company will hold a conference call and webcast today at 8:30 am ET to provide an update on the company and discuss third quarter financial results. To join the live call, please register here. A unique PIN and dial-in number will be provided to join the call.

An audio-only webcast of the call can be accessed at investors section of the Company’s website at www.concertpharma.com. A replay of the webcast will be available on the Concert website for three months.

– Financial tables to follow –

Concert Pharmaceuticals, Inc.

Summarized Consolidated Statements of Operations

(in thousands, except amounts per share)

(unaudited)

three months done

September 30th,

Nine months done

September 30th,

2022

2021

2022

2021

Income:

Licensing and research and development revenue

$

8

$

4

$

29

$

26

Other income

539

32,539

total income

8

543

29

32,565

Operating expenses:

Investigation and development

24,364

21,876

75,708

60,560

General and administrative

5,250

5,462

15,639

16,561

Total operating expenses

29,614

27,338

91,347

77,121

loss of operations

(29,606

)

(26,795

)

(91,318

)

(44,556

)

investment income

785

4

951

44

Unrealized gain (loss) on marketable equity securities

(164

)

113

(788

)

590

Unrealized gain on warrant liabilities

81

975

Net loss

$

(28,904

)

$

(26,678

)

$

(90,180

)

$

(43,922

)

Net loss attributable to common shareholders: basic and diluted

(28,904

)

(26,678

)

(90,553

)

(43,922

)

Net loss per share attributable to common shareholders: basic and diluted

$

(0.58

)

$

(0.78

)

$

(2.13

)

$

(1.29

)

Weighted average number of common shares used in net loss per share attributable to common shareholders: basic and diluted

49,731

34,090

42,535

33,987

Concert Pharmaceuticals, Inc.

Summary of balance sheet data

(in thousands)

(unaudited)

September 30, 2022

December 31, 2021

Cash and cash equivalents

$

95,189

$

141,636

Investments available for sale

53,669

working capital

139,797

134,209

total assets

171,134

165,316

deferred income

7,595

7,595

Equity of total shareholders

133,272

112,225

about the concert

concert pharmacists is a late-stage clinical biopharmaceutical company developing deuruxolitinib (CTP-543), a new oral deuterated JAK1/2 inhibitor. Concert has successfully completed two Phase 3 trials with deuruxolitinib in adults with alopecia areata, a serious autoimmune skin disease. The Company is also evaluating the use of deuruxolitinib in other indications and evaluating a number of early-stage candidates. For more information please visit www.concertpharma.com or follow us on Twitter, Instagram either LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

Any statements in this press release about our future expectations, plans and prospects, including, but not limited to, statements about our expectations regarding the development of deuruxolitinib, the potential of deuruxolitinib to be a best-in-class treatment for the treatment of alopecia areata, the anticipated timing of filing a New Drug Application (NDA) for deuruxolitinib and the adequacy of our cash, cash equivalents and investments to fund our operations, and any other statements containing the words “anticipate”, “believe”, “continue”, “could”, “estimate”, “expect”, “intend”, “may”, “plan”, “potential”, “predict”, “project”, “should”, “target”, “will ”, “would be” and similar expressions constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by r such forward-looking statements as a result of several important factors, including: the uncertainties inherent in the initiation, timing, and design of future clinical trials, the availability and timing of data from ongoing and future clinical trials, and the results of such trials, whether the preliminary results, including safety profiles, of a clinical trial will be predictive of the final results of that trial or whether the results of the first clinical trials will be indicative of the results of subsequent clinical trials, expectations about the timing of the filing of an NDA, the availability of regulatory approvals, the availability of sufficient funds for our foreseeable capital and operating expenses and unforeseeable spending requirements, expectations regarding the protection of our intellectual property provided by our patents, and other factors discussed in the “Risk Factors” section of n Our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission and in other filings we make with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent our opinion only as of the date of this release and should not be relied upon to represent our opinion as of any later date. We specifically disclaim any obligation to update any forward-looking statements contained in this press release.

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