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Deciphera Pharmaceuticals, Inc. Announces First Quarter 2022 Financial Results

May 4, 2022 7:00 AM

– First Quarter 2022 Revenue of $29.2 Million –

– Net Proceeds of $163.4 Million from Public Offering in April, Enabling the Company to Fund Operating and Capital Expenditures into 2025 –

– Pivotal Phase 3 MOTION Study of Vimseltinib in TGCT Patients Underway; Updated Phase 1/2 Results Expected in 2H 2022 –

– Preclinical Data for DCC-3116 in Combination with KRASG12C Inhibitors Presented at the AACR Annual Meeting Demonstrating Deeper and Longer Tumor Regressions in Mutant KRASG12C NSCLC Models In Vivo –

– Phase 1 Single Agent Dose Escalation Data for DCC-3116 Expected in 2H 2022 –

– New Development Candidate from Pan-RAF Research Program Expected in 2022 –

WALTHAM, Mass.--(BUSINESS WIRE)-- Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH) today announced financial results for the first quarter ended March 31, 2022, and provided a corporate update.

“We have made significant progress on our 2022 goals so far this year, demonstrating our commercial success with QINLOCK®, strengthening our balance sheet, and rapidly advancing our potential best-in-class and first-in-class clinical-stage pipeline,” said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. “The strong commercial launch of QINLOCK in Germany underscores the long-term potential for this medicine to benefit patients with GIST around the world. The pivotal Phase 3 MOTION study of vimseltinib, which we are developing for the treatment of tenosynovial giant cell tumor, or TGCT, is now enrolling patients and we expect to present updated results from the Phase 1/2 study in patients with TGCT in the second half of this year.”

Mr. Hoerter continued, “We are very excited about our potential first-in-class autophagy pathway inhibitor, DCC-3116. At this year’s AACR Annual Meeting, we presented encouraging preclinical data for DCC-3116 in combination with KRASG12C inhibitors highlighting the broad potential of this product candidate to benefit patients. We expect to present initial data from the single agent dose escalation portion of the Phase 1 study later this year.”

First Quarter 2022 Highlights and Upcoming Milestones

QINLOCK® (ripretinib)

Vimseltinib

DCC-3116

Proprietary Drug Discovery Platform

Corporate Updates

First Quarter 2022 Financial Results

Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, May 4, 2022 at 8:00 AM ET. The conference call may be accessed by dialing (877) 270-2148 (domestic) or (412) 902-6510 (international). A webcast of the conference call will be available in the “Events and Presentations” page in the “Investors” section of the Company’s website at https://investors.deciphera.com/events-presentations. The archived webcast will be available on the Company's website approximately two hours after the conference call and will be available for 30 days following the call.

About Deciphera Pharmaceuticals

Deciphera is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. In addition to advancing multiple product candidates from our platform in clinical studies, QINLOCK® is Deciphera’s switch control inhibitor for the treatment of fourth-line GIST. QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Switzerland, Taiwan, the United Kingdom, and the United States. For more information, visit www.deciphera.com and follow us on LinkedIn and Twitter (@Deciphera).

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, our expectations and timing regarding the long-term potential of QINLOCK to benefit GIST patients globally, vimseltinib for the pivotal Phase 3 MOTION study in TGCT patients, the potential for our clinical stage pipeline assets to be first-in-class and/or best-in-class treatments, presenting updated vimseltinib data from our Phase 1/2 study in TGCT patients, initial data from the single agent dose escalation phase of the Phase 1 study of DCC-3116, plans to initiate three combination dose escalations in the Phase 1 study of DCC-3116, subject to feedback from regulatory authorities, plans to present additional pre-clinical data for DCC-3116, exploration of additional preclinical combinations of DCC-3116, the potential for DCC-3116 to be a first-in-class agent with broad potential applicability, nominating a development candidate for our pan-RAF research program, and cash guidance. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “seek,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to our ability to provide access to QINLOCK in European countries other than Germany and France through other channels, the severity and duration of the impact of COVID-19 on our business and operations, our ability to successfully demonstrate the efficacy and safety of our drug or drug candidates, the preclinical or clinical results for our product candidates, which may not support further development of such product candidates, comments, feedback and actions of regulatory agencies, our ability to commercialize QINLOCK and execute on our marketing plans for any drugs or indications that may be approved in the future, the inherent uncertainty in estimates of patient populations, competition from other products, our ability to obtain and maintain reimbursement for any approved product and the extent to which patient assistance programs are utilized and other risks identified in our Securities and Exchange Commission (SEC) filings, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 , and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Deciphera, the Deciphera logo, QINLOCK, and the QINLOCK logo are registered trademarks of Deciphera Pharmaceuticals, LLC.

Deciphera Pharmaceuticals, Inc.

Consolidated Balance Sheets

(Unaudited, in thousands, except share and per share amounts)

March 31, 2022

December 31,
2021

Assets

Current assets:

Cash and cash equivalents

$

95,332

$

87,063

Short-term marketable securities

161,221

198,571

Accounts receivable, net

23,151

20,595

Inventory

19,627

14,125

Prepaid expenses and other current assets

20,504

18,660

Total current assets

319,835

339,014

Long-term marketable securities

18,853

41,950

Long-term investments—restricted

3,109

3,110

Property and equipment, net

7,821

8,610

Operating lease assets

35,846

36,800

Total assets

$

385,464

$

429,484

Liabilities and Stockholders' Equity

Current liabilities:

Accounts payable

$

17,801

$

13,130

Accrued expenses and other current liabilities

65,938

80,773

Operating lease liabilities

2,931

2,870

Total current liabilities

86,670

96,773

Operating lease liabilities, net of current portion

27,229

27,991

Total liabilities

113,899

124,764

Commitments and contingencies

Stockholders' equity:

Preferred stock, $0.01 par value per share; 5,000,000 shares authorized; no shares issued or outstanding

Common stock, $0.01 par value per share; 125,000,000 shares authorized; 58,697,263 shares and 58,549,644 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively

586

585

Additional paid-in capital

1,372,866

1,358,516

Accumulated other comprehensive income (loss)

(563

)

51

Accumulated deficit

(1,101,324

)

(1,054,432

)

Total stockholders' equity

271,565

304,720

Total liabilities and stockholders' equity

$

385,464

$

429,484

Deciphera Pharmaceuticals, Inc.

Consolidated Statements of Operations

(Unaudited, in thousands, except share and per share amounts)

Three Months Ended March 31,

2022

2021

Revenues:

Product revenues, net

$

28,809

$

19,962

Collaboration revenues

414

5,194

Total revenues

29,223

25,156

Cost and operating expenses:

Cost of sales

382

222

Research and development

47,412

55,681

Selling, general, and administrative

28,321

30,747

Total cost and operating expenses

76,115

86,650

Loss from operations

(46,892

)

(61,494

)

Other income (expense):

Interest and other income, net

196

Total other income (expense), net

196

Net loss

$(46,892) (46,892)

$(61,298) (61,298)

Net loss per share—basic and diluted

$

(0.80

)

$

(1.06

)

Weighted average common shares outstanding—basic and diluted

58,616,458

57,747,168

Investor Relations:

Maghan Meyers

Argot Partners

[email protected]

212-600-1902

Media:

David Rosen

Argot Partners

[email protected]

212-600-1902

Source: Deciphera Pharmaceuticals, Inc.

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