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Deciphera Pharmaceuticals, Inc. Announces Second Quarter 2021 Financial Results

August 3, 2021 4:01 PM

- Second Quarter 2021 QINLOCK® Net Product Revenue of $22.0 Million -

- Top-line Results from INTRIGUE Phase 3 Study of QINLOCK in Patients with Second-line Gastrointestinal Stromal Tumor (GIST) Expected in the Fourth Quarter of 2021 -

- First Patient Treated in Phase 1 Study of ULK Kinase Inhibitor DCC-3116 -

- Data from Vimseltinib in Patients with Tenosynovial Giant Cell Tumor (TGCT) and Rebastinib in Combination with Paclitaxel in Platinum-Resistant Ovarian Cancer to be Presented at the ESMO Congress 2021; Finalization of Pivotal Development Plans for both Programs Expected in the Second Half of 2021 -

WALTHAM, Mass.--(BUSINESS WIRE)-- Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH) today announced financial results for the first quarter ended June 30, 2021 and provided a corporate update.

“We made significant progress against our goals in the first half of the year and we look forward to carrying this momentum through the rest of 2021,” said Steve Hoerter, President and Chief Executive Officer of Deciphera. “Building on the successful launch of QINLOCK for fourth-line GIST in the U.S., this best-in-class medicine has now been approved in China and Hong Kong and we expect approval from the European Medicines Agency later this year. In the fourth quarter, we look forward to reporting top-line data from the INTRIGUE Phase 3 study in second-line GIST. In addition, we expect to report updated data from the vimseltinib and rebastinib programs at the upcoming ESMO congress as well as finalize pivotal development plans for both programs later this year.”

Mr. Hoerter continued, “We also recently achieved a key milestone treating the first patient in our Phase 1 trial of DCC-3116, a first-in-class ULK kinase inhibitor designed to address mutant RAS and RAF cancers through the inhibition of autophagy.”

Second Quarter 2021 Highlights and Upcoming Milestones

Recent Corporate Updates

Upcoming Scientific Congress Presentations

Second Quarter Financial Results

Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, August 3, 2021 at 4:30 PM ET. To access the live call by phone please dial (866) 930-5479 (domestic) or (409) 216-0603 (international); the conference ID is 9943767. A live audio webcast of the event may also be accessed through the “Investors” section of Deciphera’s website at www.deciphera.com. A replay of the webcast will be available for 30 days following the event.

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 FDA-approved switch-control kinase inhibitor for the treatment of fourth-line gastrointestinal stromal tumor (GIST). QINLOCK is also approved for fourth-line GIST in Australia, Canada, China, and Hong Kong. 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 top-line data from our Phase 3 INTRIGUE study in second-line GIST, plans to initiate a phase 1b/2 study of QINLOCK with a MEK inhibitor in post-imatinib GIST patients, potential EMA approval of QINLOCK for the treatment of fourth-line GIST, finalizing pivotal study plans for vimseltinib in TGCT patients and for the rebastinib/paclitaxel combination, subject to favorable data and discussions with regulators, presenting updated data at ESMO 2021 from the Phase 1/2 study of vimseltinib in TGCT patients and from the Phase 1b/2 study of rebastinib in combination with paclitaxel for patients with platinum-resistant ovarian cancer, presenting e-posters at ESMO 2021 on several other programs, presenting preclinical data on DCC-3116 in combination with approved agents in multiple tumor models, planned expansion of our phase 1 study of DCC-3116 in patients with cancers driven by mutant RAS/RAF genes; the company’s leading position in the development of regulators of autophagy for the potential treatment of cancer and our belief that targeting VPS34 may provide an additional approach to regulating autophagy that is complementary to inhibition of ULK kinase by blocking VPS34-mediated immunosuppression in tumors, and cash runway expectations. 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 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 candidates and in additional indications for our existing drug, the preclinical or clinical results for our product candidates, which may not support further development of such product candidates, our ability to manage our reliance on sole-source third parties such as our third party drug substance and drug product contract manufacturers, 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, our ability to build and scale our operations to support growth in additional geographies, 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, our ability to comply with healthcare regulations and laws, our ability to obtain, maintain and enforce our intellectual property rights, any or all of which may affect the initiation, timing and progress of clinical studies and the timing of and our ability to obtain additional regulatory approvals, and other risks identified in our Securities and Exchange Commission (SEC) filings, including our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, 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. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

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

Deciphera Pharmaceuticals, Inc.

Consolidated Balance Sheets

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

June 30, 2021

December 31,
2020

Assets

Current assets:

Cash and cash equivalents

$

90,947

$

135,897

Short-term marketable securities

304,405

416,033

Accounts receivable, net

18,608

13,896

Inventory

8,206

5,716

Prepaid expenses and other current assets

14,977

12,489

Total current assets

437,143

584,031

Long-term marketable securities

55,605

9,375

Long-term investments—restricted

3,102

3,102

Property and equipment, net

9,588

9,583

Operating lease assets

35,128

36,341

Total assets

$

540,566

$

642,432

Liabilities and Stockholders' Equity

Current liabilities:

Accounts payable

$

14,022

$

12,308

Accrued expenses and other current liabilities

49,428

55,227

Operating lease liabilities

2,604

2,457

Total current liabilities

66,054

69,992

Operating lease liabilities, net of current portion

27,856

28,764

Total liabilities

93,910

98,756

Commitments and contingencies

Stockholders' equity:

Common stock, $0.01 par value per share; 125,000,000 shares authorized; 58,033,984 shares and 57,596,144 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively

580

576

Additional paid-in capital

1,332,249

1,297,557

Accumulated other comprehensive income (loss)

26

11

Accumulated deficit

(886,199

)

(754,468

)

Total stockholders' equity

446,656

543,676

Total liabilities and stockholders' equity

$

540,566

$

642,432

Deciphera Pharmaceuticals, Inc.

Consolidated Statements of Operations

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

Three Months Ended June 30,

Six Months Ended June 30,

2021

2020

2021

2020

Revenues:

Product revenues, net

$

22,048

$

4,825

$

42,010

$

4,825

Collaboration revenues

1,525

2,265

6,719

2,327

Total revenues

23,573

7,090

48,729

7,152

Cost and operating expenses:

Cost of sales

1,275

8

1,497

8

Research and development

59,984

46,081

115,665

97,469

Selling, general, and administrative

32,828

29,933

63,575

53,869

Total cost and operating expenses

94,087

76,022

180,737

151,346

Loss from operations

(70,514)

(68,932)

(132,008)

(144,194)

Other income (expense):

Interest and other income, net

81

1,691

277

4,146

Total other income (expense), net

81

1,691

277

4,146

Net loss

$

(70,433)

$

(67,241)

$

(131,731)

$

(140,048)

Net loss per share—basic and diluted

$

(1.21)

$

(1.20)

$

(2.28)

$

(2.56)

Weighted average common shares outstanding—basic and diluted

57,987,095

55,920,122

57,867,795

54,743,778

Investor Relations:

Jen Robinson

Deciphera Pharmaceuticals, Inc

[email protected]

781-906-1112

Media:

David Rosen

Argot Partners

[email protected]

212-600-1902

Source: Deciphera Pharmaceuticals, Inc.

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