8-K
false 0001654151 0001654151 2023-10-30 2023-10-30

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): October 30, 2023

 

 

Deciphera Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-38219   30-1003521

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

200 Smith Street, Waltham, Massachusetts   02451
(Address of principal executive offices)   (Zip code)

Registrant’s telephone number, including area code: (781) 209-6400

(Former name or former address, if changed from last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 203.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Exchange Act:

 

Title of each class

 

Trading

Symbol

 

Name of exchange

on which registered

Common Stock, $0.01 Par Value   DCPH   Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 


Item 2.02

Results of Operations and Financial Condition.

On October 30, 2023, Deciphera Pharmaceuticals, Inc. (the “Company” or “we”) announced its financial results for the quarter ended September 30, 2023 and provided a corporate update. A copy of the press release in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 8.01

Other Events

On October 30, 2023, the Company announced positive top-line data from its pivotal Phase 3 MOTION study of vimseltinib, an investigational, orally administered, potent, and highly-selective switch-control kinase inhibitor of the colony stimulating factor 1 receptor (CSF1R) in patients with tenosynovial giant cell tumor (TGCT). The Company also announced positive updated interim data from TGCT patients in its ongoing Phase 1/2 study of vimseltinib.

Top-line Data from Phase 3 MOTION Study of Vimseltinib in TGCT Patients

The MOTION study is a two-part, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of vimseltinib in patients with TGCT not amenable to surgery with no prior anti-CSF1/CSF1R therapy (prior therapy with imatinib or nilotinib allowed). In Part 1, patients (n=123) were randomized two-to-one to receive either 30 mg twice weekly of vimseltinib (n=83) or placebo (n=40) for 24 weeks. The primary endpoint of the study is Objective Response Rate (ORR) at Week 25 as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent radiologic review (IRR). The open-label Part 2 portion of MOTION, in which patients from both the vimseltinib and placebo arms may receive treatment with vimseltinib, remains ongoing. The results for Part 1 of the study are based on a data cutoff date of August 22, 2023.

On October 30, 2023, we announced that the MOTION study met its primary endpoint in the intent-to-treat (ITT) population demonstrating statistically significant and clinically meaningful improvement versus placebo in ORR at Week 25 based on IRR per RECIST v1.1. In the ITT population, the ORR at Week 25 was 40% (95% CI: 29%, 51%) for the vimseltinib arm and 0% (95% CI: 0%, 9%) for the placebo arm resulting in a response difference (vimseltinib vs. placebo) of 40% (95% CI: 29%, 51%) (p<0.0001).

In addition to meeting the primary endpoint, the study also achieved statistically significant and clinically meaningful improvements versus placebo for all key secondary endpoints assessed at Week 25 including ORR per tumor volume score (TVS), active range of motion (ROM), physical function, stiffness, quality of life, and pain.

In the ITT population, the ORR at Week 25 based on IRR per TVS was 67% (95% CI: 56%, 77%) for the vimseltinib arm and 0% (95% CI: 0%, 9%) for the placebo arm (p<0.0001). Treatment with vimseltinib also demonstrated an improvement in mean change from baseline in active ROM at Week 25 of 18.4% vs. a 3.8% improvement for placebo (p=0.0077).


Vimseltinib was well tolerated and the observed adverse events in the MOTION study were consistent with previously disclosed data from the Phase 1/2 study. There was no evidence of cholestatic hepatotoxicity in patients treated with vimseltinib. In the vimseltinib arm, six percent of patients (n=5) experienced treatment emergent adverse event (TEAEs) leading to study treatment discontinuation, 42% of patients (n=35) experienced TEAEs leading to dose reduction and 53% of patients (n=44) had TEAEs leading to dose interruption. The below table lists all TEAEs in greater than or equal to 15% of patients in either arm during Part 1 of the MOTION study:

 

Preferred Term n (%)

   Vimseltinib
(n=83)
   Placebo
(n=39)1
   All Grades    Grade 3/4    All Grades    Grade 3/4

Periorbital edema^

   37 (45%)    3 (4%)    5 (13%)    0

Fatigue ^

   27 (33%)    0    6 (15%)    0

Face edema^

   26 (31%)    1 (1%)    3 (8%)    0

Pruritus^

   24 (29%)    2(2%)    3 (8%)    0

Headache^

   23 (28%)    1(1%)    10 (26%)    0

Asthenia^

   22 (27%)    1(1%)    9 (23%)    1 (3%)

Nausea ^

   21 (25%)    0    8 (21%)    1 (3%)

CPK increased

   20 (24%)    8 (10%)    0    0

AST increased

   19 (23%)    0    1 (3%)    0

Arthralgia ^

   16 (19%)    0    6 (15%)    1 (3%)

Rash ^

   16 (19%)    0    2 (5%)    0

Rash maculo-papular^

   16 (19%)    1 (1%)    0    0

Edema peripheral ^

   15 (18%)    0    3 (8%)    0

Hypertension

   14 (17%)    4 (5%)    4 (10%)    1 (3%)

Diarrhea

   10 (12%)    0    8 (21%)    1 (3%)

 

(1)

Does not include one patient randomized to placebo that did not receive study drug.

Notes: TEAE incidence is based on maximum grade per CTCAE v5.0. The only Grade 4 adverse events were CPK Increased observed in two patients. ^ Denotes adverse events without Grade 4 criteria per CTCAE v5.0.

Based on our internal analysis of U.S. claims data, we estimate there are approximately 1,400 incident and 9,000 prevalent TGCT patients in the U.S. meeting the following criteria: (i) diagnosed, (ii) drug treated, (iii) may or may not have undergone surgery, and (iv) recently engaged with an oncologist. We estimate that the total addressable market opportunity in the U.S. based on the incident population alone is approximately $500 million; for this purpose, we assume 18 months of treatment duration and the current pexidartinib wholesale acquisition cost. Further, we estimate an additional opportunity exists for the approximately 1,300 incident TGCT patients in the U.S. who meet the following criteria: (i) diagnosed, (ii) drug-treated, (iii) may or may not have undergone surgery, and (iv) have not recently engaged with an oncologist but who have engaged with a surgeon. We believe a further opportunity exists in Europe, which we estimate has a comparable epidemiology to the U.S. Estimates are inherently uncertain.

The Company plans to engage with regulatory authorities and expects to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vimseltinib for the treatment of patients with TGCT in the second quarter of 2024 and a Marketing Authorisation Application to the European Medicines Agency (EMA) in the third quarter of 2024.

Additional results from the MOTION Phase 3 study are expected to be presented at an upcoming medical meeting.

Updated Interim Data from Ongoing Phase 1/2 Study of Vimseltinib in TGCT Patients

We are studying vimseltinib in an ongoing open-label Phase 1/2 study designed to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of vimseltinib in patients with solid tumors and TGCT. In the Phase 2 expansion, Cohort A includes TGCT patients with no prior anti-CSF1/CSF1R (previous therapy with imatinib or nilotinib is allowed) and Cohort B includes TGCT patients with prior anti-CSF1/CSF1R (previous therapy with imatinib or nilotinib alone is not allowed).

As of a June 27, 2023 cut-off date, 32 TGCT patients enrolled in the Phase 1 dose escalation portion of the study and 65 TGCT patients enrolled in the two Phase 2 Cohorts (Cohort A and B) in the expansion portion of the study as follows: Phase 1 cohort 5 (n=8): 30 mg loading dose daily for five days followed by a maintenance dose of 30 mg twice a week; Phase 1 cohort 8 (n=12): 30 mg loading dose daily for three days followed by a maintenance dose of 10 mg daily; Phase 1 cohort 9 (n=12): 20 mg loading dose daily for three days followed by a maintenance dose of six mg daily; and Phase 2 Cohorts A (n= 46) and B (n=19): recommended Phase 2 dose of 30 mg twice weekly (no loading dose).

 


On October 30, 2023, we announced an update to the results from our ongoing Phase 1/2 study of vimseltinib in 97 TGCT patients with a cut-off date of June 27, 2023. We observed a best ORR of 72% in Phase 1, 64% in Phase 2 Cohort A, and 44% in Phase 2 Cohort B, as measured by RECIST version v1.1 by blinded IRR.

Updated interim results for the 93 efficacy evaluable patients are summarized in the below table.

 

    

Phase 1

(n=32)

  

Phase 2 Cohort A

(n=45)

  

Phase 2 Cohort B

(n=16)

Best ORR per RECIST v1.1 by IRR (%)

   72%   

64%

(38% at Week 25)

   44%

Median Duration of Response

(months) (Range)

   NR (3.8+, 45.2+)    NR (0.03+, 25.4+)    NR (4.0+, 21.0+)

Median Treatment Duration

(months) (Range)

   25.1 (0.7, 46.9)    21.0 (0.2, 30.3)    7.3 (0.7, 27.4)

Patients Active on Treatment at Cutoff Date (%)

   47%    48%    74%

Notes: NR: Not Reached by Kaplan-Meier analysis.

In addition, updated data from Cohorts A and B of the Phase 2 study demonstrated that patients achieved clinically meaningful symptomatic benefit at Week 25 across multiple secondary efficacy measures including best ORR per TVS (Cohort A), active range of motion, physical function, stiffness, and pain.

In the Phase 1/2 study, vimseltinib was well tolerated and the observed adverse events were consistent with previously presented Phase 1/2 data in patients with TGCT. There was no evidence of cholestatic hepatotoxicity in patients treated with vimseltinib. In Phase 2 Cohort A, nine percent of patients (n=4) experienced TEAEs leading to study treatment discontinuation, 52% of patients (n=24) experienced TEAEs leading to dose reduction and 70% of patients (n=32) had TEAEs leading to dose interruption. There were no treatment-related serious adverse events in Phase 2 Cohort A. The TEAEs across all cohorts in the Phase 1/2 study greater than or equal to 15% of TGCT patients (n=95) by all Grades, and the corresponding TEAEs across all cohorts in Grades 3/4, are summarized in the table below.

 

Preferred Term n (%)   

Phase 1/2 Combined: All
Patients 

(n=95)

     All Grades    Grade 3/4

Blood CPK increased

   63 (66%)    39 (41%)

Periorbital edema^

   45 (47%)    0

Headache^

   37 (39%)    0

Fatigue^

   35 (37%)    2 (2%)

Myalgia^

   28 (29%)    3 (3%)

Nausea^

   28 (29%)    0

AST increased

   27 (28%)    4 (4%)

Arthralgia^

   27 (28%)    2 (2%)

Asthenia^

   23 (24%)    1 (1%)

Edema peripheral^

   23 (24%)    0

Rash maculopapular^

   21 (22%)    1 (1%)

Face edema^

   21 (22%)    0


Pruritus^

   20 (21%)    0

Diarrhea

   19 (20%)    1 (1%)

Rash^

   18 (19%)    0

COVID-19

   18 (19%)    0

Hypertension

   15 (16%)    6 (6%)

Lipase increased

   15 (16%)    4 (4%)

Amylase increased

   15 (16%)    3 (3%)

ALT increased

   15 (16%)    1 (1%)

Notes: Results are reported for patients with TGCT with a data cutoff of June 27, 2023. TEAE incidence is based on maximum grade per CTCAE v4.03. TEAEs were summarized in n=95 patients with TGCT across all cohorts in the Phase 1/2 study. One patient from Phase 1 and one patient from Cohort A discontinued and enrolled into Cohort B. The only Grade 4 adverse events were CPK increased. ^ Denotes adverse events without Grade 4 criteria per CTCAE v4.03.

Additional interim data from the Phase 1/2 study of vimseltinib are expected to be presented at an upcoming medical meeting.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This Current Report on Form 8-K 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 potential for our preclinical and/or clinical stage pipeline assets to be first-in-class and/or best-in-class treatments; the potential for vimseltinib to become our second approved medicine, the potential for vimseltinib to become a new treatment option for patients with TGCT, plans to submit an NDA for vimseltinib in the second quarter of 2024 and an MAA in the third quarter of 2024, and plans for upcoming presentations of the study of vimseltinib and plans to present additional data at upcoming medical congresses . 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 Current Report on Form 8-K 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 Current Report on Form 8-K, including, without limitation, 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, including the FDA and the EMA, 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 and total addressable markets, 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 September 30, 2023, 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.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits.

 

99.1    Press Release issued by Deciphera Pharmaceuticals, Inc. on October 30, 2023
104    Cover Page Interactive Data File (embedded within the Inline XBRL document)


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: October 30, 2023     DECIPHERA PHARMACEUTICALS, INC.
    By:  

/s/ Steven L. Hoerter

    Name:   Steven L. Hoerter
    Title:   President and Chief Executive Officer
EX-99.1

Exhibit 99.1

Deciphera Pharmaceuticals Announces Third Quarter 2023 Financial Results

– Third Quarter 2023 Total Revenue of $43.3 Million; Net Product Revenue for QINLOCK® (ripretinib)

Increased 29% to $41.8 Million Compared to Third Quarter 2022 –

– Announced Positive Top-line Results for MOTION Pivotal Phase 3 Study of Vimseltinib for TGCT and Updated Results from Phase 1/2 Study; NDA Submission Expected in Second Quarter of 2024 –

– QINLOCK Successfully Launched in Italy –

– Conference Call to be Held Today at 8:00 AM ET –

WALTHAM, Mass.— (BUSINESS WIRE)—October 30, 2023—Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced financial results for the third quarter ended September 30, 2023 and provided a corporate update.

“QINLOCK achieved another record quarter of product revenue with continued strength in commercial demand,” said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. “With the positive results of the MOTION Phase 3 study of vimseltinib we reported earlier today, we are now one step closer to becoming a company with multiple approved products. We look forward to engaging with regulatory authorities to advance vimseltinib toward approval and deliver it to the TGCT patients in need of an effective and well tolerated treatment option.”

Third Quarter 2023 Highlights and Upcoming Milestones

QINLOCK® (ripretinib)

 

   

Recorded $41.8 million in QINLOCK net product revenue in the third quarter of 2023, including $32.7 million in U.S. net product revenue and $9.1 million in international net product revenue, an increase of 29% compared to net product revenue of $32.3 million in the third quarter of 2022. In addition, QINLOCK generated $1.5 million in collaboration revenue including royalties and supply revenue with Zai Lab, the Company’s partner in Greater China.

 

   

Successfully launched QINLOCK in Italy for the treatment of fourth-line gastrointestinal stromal tumor (GIST).

 

   

Initiated the INSIGHT Phase 3 study by opening the first sites for enrollment comparing QINLOCK versus sunitinib in second-line GIST patients with mutations in KIT exon 11 and 17/18.

Vimseltinib

 

   

Announced positive top-line results from the MOTION pivotal Phase 3 study of vimseltinib, an investigational, orally administered, potent, and highly selective switch-control kinase inhibitor of CSF1R for the potential treatment of tenosynovial giant cell tumor (TGCT). The study met its primary endpoint in the intent-to-treat (ITT) population demonstrating statistically significant and clinically meaningful improvements in objective response rate (ORR) at Week 25 compared to placebo. In the ITT population, the ORR at Week 25 was 40% for the vimseltinib arm and 0% for the placebo arm (p-value <0.0001). In addition, the study met all key secondary endpoints demonstrating statistically significant and clinically meaningful improvements in tumor volume


 

score (TVS), range of motion (ROM), physical function, stiffness, quality of life, and pain compared to placebo. In the ITT population, the ORR by TVS at Week 25 was 67% for the vimseltinib arm and 0% for the placebo arm (p<0.0001). Treatment with vimseltinib also demonstrated an improvement in ROM at Week 25 of 18.4% vs. a 3.8% improvement for placebo (p=0.0077). Treatment with vimseltinib was well-tolerated in patients with TGCT and the safety profile was consistent with previously disclosed data. There was no evidence of cholestatic hepatotoxicity.

 

   

Announced updated results from the Phase 1/2 study of vimseltinib as of a June 27, 2023 cutoff date demonstrating strong clinical benefit with best overall response rates of 72% (Phase 1) and 64% (Phase 2 Cohort A), a favorable long-term safety profile with no evidence of cholestatic hepatotoxicity and increasing median treatment duration of 25.1 months (Phase 1) and 21.0 months (Phase 2 Cohort A). Results from the Phase 1 portion of the study are being presented in an oral presentation and results from Cohorts A and B of the Phase 2 portion of the study are being presented in two poster presentations at the Connective Tissue Oncology Society 2023 Annual Meeting in Dublin, Ireland on November 1-4, 2023.

 

   

Expects to submit a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in the second quarter of 2024 and a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) in the third quarter of 2024.

DCC-3116

 

   

Enrollment is ongoing in combination escalation cohorts evaluating the potential first-in-class ULK inhibitor, DCC-3116, in combination with binimetinib, trametinib, sotorasib, encorafenib/cetuximab, and QINLOCK, designed to select recommended Phase 2 combination dosing for potential expansion cohorts.

DCC-3084

 

   

Expects to submit an Investigational New Drug (IND) application to the FDA for its pan-RAF inhibitor, DCC-3084, by year end 2023.

DCC-3009

 

   

Expects to submit an IND application to the FDA for its pan-KIT inhibitor, DCC-3009, in the first half of 2024.

Third Quarter 2023 Financial Results

 

   

Revenue: Total revenue for the third quarter of 2023 was $43.3 million, which includes $41.8 million of net product revenue of QINLOCK and $1.5 million of collaboration revenue compared to $36.0 million of total revenue, including $32.3 million of net product revenue of QINLOCK and $3.7 million of collaboration revenue, for the same period in 2022.

 

   

Cost of Sales: Cost of sales were $1.3 million in the third quarter of 2023 compared to cost of sales of $3.3 million for the third quarter of 2022. In the third quarter of 2022, Deciphera completed the sale of zero cost inventories of QINLOCK that had been expensed prior to FDA approval.

 

   

R&D Expenses: Research and development expenses for the third quarter of 2023 were $62.5 million, compared to $47.5 million for the same period in 2022. The increase was primarily due to an increase in clinical study costs for QINLOCK and clinical study costs related to the Phase 1/2 study of DCC-3116. Non-cash, stock-based compensation was $5.0 million and $5.3 million for the third quarters of 2023 and 2022, respectively.


   

SG&A Expenses: Selling, general, and administrative expenses for the third quarter of 2023 were $33.3 million, compared to $30.0 million for the same period in 2022. The increase was primarily due to an increase in professional, consulting, and other expenses as well as personnel-related costs. Non-cash, stock-based compensation was $6.1 million and $7.1 million for the third quarters of 2023 and 2022, respectively.

 

   

Net Loss: For the third quarter of 2023, Deciphera reported a net loss of $49.6 million, or $0.58 per share, compared with a net loss of $43.0 million, or $0.55 per share, for the same period in 2022.

 

   

Cash Position: As of September 30, 2023, cash, cash equivalents, and marketable securities were $376.9 million, compared to $389.4 million as of June 30, 2023. Based on its current operating plans, Deciphera expects its current cash, cash equivalents, and marketable securities together with anticipated product, royalty, and supply revenues, but excluding any potential future milestones received under its collaboration or license agreements, will enable the Company to fund its operating and capital expenditures into 2026.

Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, October 30, 2023, at 8:00 AM ET. The conference call may be accessed via this link: https://register.vevent.com/register/BIc2885b197da74145bfc30deb5fb11858. A live webcast of the conference call will be available in the “Events and Presentations” page in the “Investors & News” section of the Company’s website at https://investors.deciphera.com/events-presentations. A replay 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, Israel, Macau, New Zealand, Singapore, 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 potential for our preclinical and/or clinical stage pipeline assets to be first-in-class and/or best-in-class treatments; our Phase 3 INSIGHT study of QINLOCK versus sunitinib in second-line GIST patients with mutations in KIT exon 11 and 17/18; the potential for vimseltinib to become our second approved medicine, plans to submit an NDA for vimseltinib in the second quarter of 2024 and an MAA in the third quarter of 2024, and plans to present additional data at upcoming medical congresses; plans for our ongoing Phase 1/2 studies of DCC-3116; plans to submit an IND application to the FDA for DCC-3084 by the end of 2023; plans to submit an IND application to the FDA for DCC-3009 in the first half of 2024; 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, 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 September 30, 2023, 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.

The Deciphera logo, QINLOCK, and the QINLOCK logo are registered trademarks and Deciphera is a trademark of Deciphera Pharmaceuticals, LLC.


Deciphera Pharmaceuticals, Inc.

Consolidated Balance Sheets

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

 

     September 30,
2023
    December 31,
2022
 

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 108,087     $ 64,741  

Short-term marketable securities

     230,988       259,745  

Accounts receivable, net

     27,549       22,429  

Inventory

     27,105       20,561  

Prepaid expenses and other current assets

     23,847       25,482  
  

 

 

   

 

 

 

Total current assets

     417,576       392,958  

Long-term marketable securities

     37,850       14,550  

Long-term investments—restricted and other long-term assets

     3,337       3,277  

Property and equipment, net

     5,864       6,707  

Operating lease assets

     33,209       36,547  
  

 

 

   

 

 

 

Total assets

   $ 497,836     $ 454,039  
  

 

 

   

 

 

 

Liabilities and Stockholders’ Equity

    

Current liabilities:

    

Accounts payable

   $ 21,453     $ 18,612  

Accrued expenses and other current liabilities

     68,005       64,622  

Operating lease liabilities

     3,436       3,235  
  

 

 

   

 

 

 

Total current liabilities

     92,894       86,469  

Operating lease liabilities, net of current portion

     23,272       25,879  
  

 

 

   

 

 

 

Total liabilities

     116,166       112,348  
  

 

 

   

 

 

 

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; 79,975,625 shares and 67,637,351 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively

     799       676  

Additional paid-in capital

     1,762,882       1,575,361  

Accumulated other comprehensive income (loss)

     (896     (983

Accumulated deficit

     (1,381,115     (1,233,363
  

 

 

   

 

 

 

Total stockholders’ equity

     381,670       341,691  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 497,836     $ 454,039  
  

 

 

   

 

 

 


Deciphera Pharmaceuticals, Inc.

Consolidated Statements of Operations

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

 

     Three Months Ended September 30,     Nine Months Ended September 30,  
     2023     2022     2023     2022  

Revenues:

        

Product revenues, net

   $ 41,820     $ 32,318     $ 112,362     $ 92,624  

Collaboration revenues

     1,493       3,656       2,700       5,067  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenues

     43,313       35,974       115,062       97,691  
  

 

 

   

 

 

   

 

 

   

 

 

 

Cost and operating expenses:

        

Cost of sales

     1,286       3,344       1,947       5,525  

Research and development

     62,463       47,485       175,524       139,755  

Selling, general, and administrative

     33,252       30,026       97,311       87,972  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total cost and operating expenses

     97,001       80,855       274,782       233,252  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (53,688     (44,881     (159,720     (135,561
  

 

 

   

 

 

   

 

 

   

 

 

 

Other income (expense):

        

Interest and other income, net

     4,107       1,838       11,968       2,565  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other income (expense), net

     4,107       1,838       11,968       2,565  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (49,581   $ (43,043   $ (147,752   $ (132,996
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share—basic and diluted

   $ (0.58   $ (0.55   $ (1.75   $ (1.82
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average common shares outstanding—basic and diluted

     85,788,613       78,206,647       84,506,593       73,129,804  
  

 

 

   

 

 

   

 

 

   

 

 

 

Investor Relations:

Maghan Meyers

Argot Partners

Deciphera@argotpartners.com

212-600-1902

Media:

David Rosen

Argot Partners

david.rosen@argotpartners.com

212-600-1902