Deciphera Pharmaceuticals, Inc. Announces Fourth Quarter 2017 Financial Results and Corporate Highlights
- Initiated Pivotal Phase 3 Trial of DCC-2618 in 4th Line Plus GIST; 2nd Line GIST Study Expected to Commence Later this Year -
“2017 was a highly productive year for Deciphera marked by significant
progress with our lead program, DCC-2618. Data presented throughout the
year continue to support our belief that DCC-2618 has the potential to
serve as a much-needed therapy across multiple disease indications where
treatment options for patients are limited,” said
Dr. Taylor added, “Following our successful IPO last year, we have a strong balance sheet and believe we are well-positioned for continued success across our full clinical-stage pipeline, including DCC-3014 and rebastinib, and look forward to sharing our progress throughout the coming months.”
Recent Clinical and Corporate Developments
- DCC-2618
-
Announced the initiation of the Phase 3 INVICTUS pivotal study in
January 2018 evaluating the safety and efficacy of DCC-2618, in heavily pretreated patients with advanced gastrointestinal stromal tumors (GIST). The Company expects to report top-line data from the study in 2019. -
Received Orphan Drug Designation from the
European Medicines Agency inNovember 2017 for the treatment of GIST. -
Provided an enrollment update from the ongoing Phase 1 clinical
trial of DCC-2618 at the Annual Meeting of
The Connective Tissue Oncology Society inNovember 2017 . As ofOctober 31, 2017 , a total of 125 patients had been dosed with DCC-2618 of which 109 were GIST patients, including 54 GIST patients in three expansion cohorts of the Phase 1 trial, which are enrolling second-line, third-line, and fourth-to-fifth line GIST patients, respectively. -
Reported data on eight patients with malignant gliomas in the
ongoing Phase 1 clinical trial of DCC-2618 at the 22nd
Annual Scientific Meeting and Education Day of the
Society for Neuro-Oncology inNovember 2017 , including a 94% tumor reduction per RANO after 84 weeks (cycle 23, day 1) from a patient with glioblastoma multiforme (GBM) and amplification of three kinase genes, KIT, PDGFRα and VEGFR2.
-
Announced the initiation of the Phase 3 INVICTUS pivotal study in
- Corporate Updates
-
Completed an initial public offering of 8,166,496 shares of its
common stock in
October 2017 at a public offering price of$17.00 per share, including shares pursuant to the partial exercise by the underwriters of their option to purchase additional shares.Deciphera Pharmaceuticals received net proceeds of approximately$124.6 million from the offering, after deducting underwriting discounts, commissions and offering expenses.
-
Completed an initial public offering of 8,166,496 shares of its
common stock in
Fourth Quarter 2017 Financial Results
Cash Position: As of
R&D Expenses: Research and development expenses for the
fourth quarter of 2017 were
G&A Expenses: General and administrative expenses for the
fourth quarter of 2017 were
Net Loss: For the fourth quarter of 2017, Deciphera reported a
net loss of
About
Availability of
Investors
and others should note that
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, statements regarding the potential for
DCC-2618 to treat GIST; statements regarding the potential benefits to
patients of DCC-2618; statements regarding plans and timelines for the
clinical development of DCC-2618; and Deciphera Pharmaceuticals’
strategy, business plans and focus. 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 trials or the
development of Deciphera Pharmaceuticals’ drug candidates, including
DCC-2618; Deciphera Pharmaceuticals‘ advancement of multiple early-stage
efforts; Deciphera Pharmaceuticals’ ability to utilize the EMA orphan
drug designation to accelerate the clinical development of DCC-2618 for
the treatment of GIST; Deciphera Pharmaceuticals’ ability to
successfully demonstrate the efficacy and safety of its drug candidates;
the preclinical and clinical results for Deciphera Pharmaceuticals’ drug
candidates, which may not support further development of such drug
candidates; and actions of regulatory agencies, which may affect the
initiation, timing and progress of clinical trials; Deciphera
Pharmaceuticals‘ ability to develop and commercialize companion
diagnostic tests for its current and future drug candidates. These and
other risks and uncertainties are described in greater detail in the
section entitled "Risk Factors" in Deciphera Pharmaceuticals’ most
recent annual report on Form 10-K, and other filings that
| Balance Sheets | ||||||||
| (In thousands) | ||||||||
| December 31, | ||||||||
| 2017 | 2016 | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 196,754 | $ | 57,461 | ||||
| Prepaid expenses and other current assets | 1,428 | 791 | ||||||
| Property and equipment, net | 838 | 514 | ||||||
| Other assets | 75 | 179 | ||||||
| Total assets | $ | 199,095 | $ | 58,945 | ||||
| Liabilities, Convertible Preferred Shares and Stockholders’ Equity/Members' Deficit |
||||||||
| Accounts payable | $ | 4,395 | $ | 1,413 | ||||
| Accrued expenses and other liabilities | 9,246 | 2,957 | ||||||
| Debt obligations | 1,481 | 1,668 | ||||||
| Total liabilities | 15,122 | 6,038 | ||||||
| Convertible preferred shares | - | 192,667 | ||||||
| Total stockholders’ equity/(members' deficit) | 183,973 | (139,760) | ||||||
|
Total liabilities, convertible preferred shares and stockholders' equity/members' deficit |
$ | 199,095 | $ | 58,945 | ||||
| STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||||||||||
| (In thousands, except share and per share data) | ||||||||||||||||
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Revenue |
$ |
— |
$ |
— |
$ |
— |
$ |
— | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 15,658 | 6,537 | 39,514 | 20,163 | ||||||||||||
| General and administrative | 4,680 | 1,997 | 11,421 | 5,675 | ||||||||||||
| Total operating expenses | 20,338 | 8,534 | 50,935 | 25,838 | ||||||||||||
| Loss from operations | (20,338) | (8,534) | (50,935) | (25,838) | ||||||||||||
| Other income (expense): | ||||||||||||||||
| Interest expense | (23) | (25) | (95) | (106) | ||||||||||||
| Interest and other income, net | 449 | 2 | 746 | 4 | ||||||||||||
| Total other income (expense), net | 426 | (23) | 651 | (102) | ||||||||||||
| Net loss and comprehensive loss | $ | (19,912) | $ | (8,557) | $ | (50,284) | $ | (25,940) | ||||||||
| Net loss per share —basic and diluted | $ | (0.62) | $ | (0.74) | $ | (2.99) | $ | (2.23) | ||||||||
|
Weighted average common shares outstanding—basic and diluted (1) |
32,121,428 | 11,626,287 | 16,792,179 | 11,626,287 | ||||||||||||
|
(1)The Company did not have any common shares outstanding prior to the closing of the IPO on October 2, 2017. To determine the weighted average shares outstanding for purposes of calculating net loss per share during those periods, the Company used the weighted average number of Series A convertible preferred shares outstanding because such shares represented the most subordinated share class outstanding during those periods. Share amounts for periods prior to the IPO have been retrospectively adjusted to give effect to the exchange of Series A convertible preferred shares into shares of common stock upon the Conversion on a one-for-5.65 basis. |
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Investor
Relations:
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or
Company:
Deciphera
Pharmaceuticals, Inc.
Christopher J. Morl, 781-209-6418
Chief
Business Officer
cmorl@deciphera.com