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Deciphera Pharmaceuticals, Inc. Announces Fourth Quarter and Full Year 2019 Financial Results

March 9, 2020 4:01 PM

- NDA for Ripretinib for the Treatment of Advanced GIST Accepted for Priority Review by U.S. FDA with PDUFA Date of August 13, 2020; Commercial Preparations Underway to Support Potential Approval and Launch -

- INTRIGUE Pivotal Phase 3 Study of Ripretinib in Second-line GIST Expected to Complete Enrollment in the Second Half of 2020 -

- Ended 2019 with Cash, Cash Equivalents and Marketable Securities of $579.6 Million -

- Company to Host Conference Call Today at 4:30 PM ET -

WALTHAM, Mass.--(BUSINESS WIRE)-- Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH) today announced financial results for the fourth quarter and year ended December 31, 2019 and provided an update on clinical and corporate developments.

“2019 was a year of outstanding execution for Deciphera,” said Steve Hoerter, President and Chief Executive Officer. “In 2020, our top priority is preparing for the potential approval and launch of ripretinib now that the NDA has been accepted by the FDA for Priority Review. Patients with GIST are in need of a new treatment option, and we believe ripretinib has the potential to transform the treatment of this disease.”

Mr. Hoerter continued, “Our broad development program for ripretinib is on track, and we look forward to the completion of enrollment in INTRIGUE, our pivotal Phase 3 study of ripretinib in second-line GIST, in the second half of this year. Beyond ripretinib, we remain focused on the balance of our wholly-owned, clinical-stage pipeline, with updated clinical data for both DCC-3014 and rebastinib, as well as an IND submission for DCC-3116, expected later this year.”

Recent Program Highlights

Recent Corporate Updates

Fourth Quarter 2019 Financial Results

Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, March 9, 2020 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 1669368. 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 Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off” or inactivated conformation. These investigational therapies comprise tumor-targeted agents designed to address therapeutic resistance -causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their responses to treatment.

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 regarding our goal of bringing ripretinib to patients with advanced GIST, the potential for ripretinib to transform treatment of advanced GIST, working with the FDA through its review of our NDA application via the FDA’s Real-Time Oncology Review (RTOR) pilot program, working with the FDA, Health Canada and the Therapeutic Goods Administration (TGA) on our Canadian and Australian regulatory approval filings under the Project Orbis initiative, and the possible benefits of those programs and breakthrough therapy designation, receipt of priority review, preparing for the potential commercial launch of ripretinib in the United States, if approved, the progress and potential of our clinical and preclinical development programs for DCC-3014, rebastinib, and DCC-3116, and corporate guidance for 2020, including timing of completion of enrollment in the INTRIGUE Phase 3 study, progress on the pipeline and cash guidance. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “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 delay of any current or planned clinical studies or the development of our product candidates, including ripretinib, our ability to successfully demonstrate the efficacy and safety of our product candidates including in later-stage studies, the preclinical and clinical results for our product candidates, which may not support further development of such product candidates, the possibility that results experienced in early, preliminary, top-line or initial data may not be indicative of the results experienced in final data, our ability to work with the FDA under its RTOR pilot program and our ability to work with the FDA, Health Canada and the TGA under the Project Orbis initiative and timely respond to information requests or requirements in connection with our recently-filed NDAs and marketing approval applications in Canada and Australia for ripretinib in fourth-line GIST, that acceptance into the RTOR and Project Orbis programs does not guarantee or influence approvability of our NDAs for ripretinib in fourth-line GIST, which are subject to the standard benefit-risk evaluation by the FDA, Health Canada and the TGA, and that we may not derive any benefit from inclusion in the RTOR or Project Orbis programs, including, but not limited to, a more efficient review process compared to investigational drugs evaluated without these programs or under standard FDA, Health Canada or TGA procedures, the fact that these programs are being tested by the FDA, are not formal regulatory pathways with regulatory process, regulations or procedures, and may be suspended or halted at any time, including, without limitation, because the FDA decides not to continue these programs, or because the FDA determines that our application no longer meets its criteria for inclusion in one or both of these programs, the fact that receipt of a breakthrough therapy designation for a product candidate, such as ripretinib, may not result in us receiving any of the benefits of such designation such as a faster development process, review or approval compared to drugs considered for approval under conventional FDA procedures, the fact such designation does not assure ultimate approval by the FDA and is subject to the risk the FDA may later decide that the products no longer meet the conditions for qualification or decide that the time period for FDA review or approval will not be shortened, the fact that priority review may not result in any more efficient review or other benefits, our ability to manage and our reliance on sole-source third parties such as our third party drug substance and drug product contract manufacturers, actions of regulatory agencies, our ability to plan for potential commercialization of our product candidates, such as ripretinib, and if approved, execute on our marketing plans, the inherent uncertainty in estimates of patient populations and incidence and prevalence estimates, 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 regulatory approval, if at all, and make our investigational drugs, including ripretinib, available to patients, and, once commercial, to derive revenue from product sales, and other risks identified in our SEC filings, including our Annual Report on Form 10-K for the quarter and year ended December 31, 2019, 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 its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

DECIPHERA PHARMACEUTICALS, INC.

CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share amounts)

December 31,

2019

2018

Assets

Current assets:

Cash and cash equivalents

$

120,320

$

293,764

Marketable securities

459,256

Prepaid expenses and other current assets

13,832

7,273

Total current assets

593,408

301,037

Long-term investment—restricted

1,510

1,069

Property and equipment, net

6,333

13,453

Operating lease assets

21,158

Total assets

$

622,409

$

315,559

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable

$

19,575

$

8,308

Accrued expenses and other current liabilities

38,716

13,709

Operating lease liabilities

1,747

539

Notes payable to related party

187

Total current liabilities

60,038

22,743

Notes payable to related party, net of current portion

1,107

Operating lease liabilities, net of current portion

15,904

11,347

Other long-term liabilities

381

Total liabilities

75,942

35,578

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; 51,617,639 shares and 37,676,760 shares issued and outstanding as of December 31, 2019 and 2018, respectively

516

377

Additional paid-in capital

1,033,819

575,327

Accumulated other comprehensive income (loss)

111

Accumulated deficit

(487,979

)

(295,723

)

Total stockholders’ equity

546,467

279,981

Total liabilities and stockholders’ equity

$

622,409

$

315,559

DECIPHERA PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except share and per share amounts)

Year Ended December 31,

2019

2018

2017

Revenues

$

25,000

$

$

Operating expenses:

Research and development

157,610

82,887

39,514

Selling, general, and administrative

68,116

21,212

11,421

Total operating expenses

225,726

104,099

50,935

Loss from operations

(200,726

)

(104,099

)

(50,935

)

Other income (expense):

Interest and other income, net

8,537

4,329

746

Interest expense

(67

)

(84

)

(95

)

Total other income (expense), net

8,470

4,245

651

Net loss

$

(192,256

)

$

(99,854

)

$

(50,284

)

Net loss per share—basic and diluted

$

(4.48

)

$

(2.82

)

$

(2.99

)

Weighted average common shares outstanding—basic and diluted

42,869,058

35,390,480

16,792,179

DECIPHERA PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

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

Three Months Ended December 31,

2019

2018

Revenues

$

$

Operating expenses:

Research and development

46,636

27,356

Selling, general, and administrative

23,737

6,474

Total operating expenses

70,373

33,830

Loss from operations

(70,373

)

(33,830

)

Other income (expense):

Interest and other income, net

3,169

1,551

Interest expense

(12

)

(20

)

Total other income (expense), net

3,157

1,531

Net loss

$

(67,216

)

$

(32,299

)

Net loss per share—basic and diluted

$

(1.31

)

$

(0.86

)

Weighted average common shares outstanding—basic and diluted

51,260,062

37,665,599

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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