Recorded $28.8 million in QINLOCK net product revenue in the first quarter of 2022, including $23.4 million in U.S. net product revenue and $5.4 million in international net product revenue.

Launched in Germany and received authorization for the post-approval paid access program in France.

Received a favorable ASMR III rating for QINLOCK from the Transparency Commission of the French National Authority for Health.

Continued enrollment and site activation in the pivotal Phase 3 MOTION study of vimseltinib for the treatment of TGCT. MOTION is a two-part, randomized, double-blind, placebo-controlled study of vimseltinib to assess the efficacy and safety in patients with TGCT who are not amenable to surgery. The primary endpoint of the study is objective response rate at week 25 as measured by RECIST v1.1 by blinded independent central review.

Expects to present updated results from the ongoing Phase 1/2 study in TGCT patients in the second half of 2022.

Presented preclinical data at the American Association for Cancer Research (AACR) Annual Meeting 2022.

The results showed that treatment of mutant KRAS^G12C NSCLC cell lines with KRAS^G12C inhibitors sotorasib and adagrasib induced autophagy via activation of ULK1/2 kinases as measured by an increase in ULK-mediated phosphorylation of the key ULK autophagy substrate ATG13 and resulting increase in autophagic flux.

DCC-3116 in combination with KRAS^G12C inhibitors translated to deeper and longer tumor regressions in mutant KRAS^G12C NSCLC models in vivo than with KRAS^G12C inhibitors alone.

Expects to present data in the second half of 2022 from the single agent dose escalation portion of the Phase 1 study of DCC-3116 in patients with advanced or metastatic tumors with a mutant RAS or RAF gene.

Expects to initiate three Phase 1b study combination dose escalation cohorts in the second half of 2022:

In combination with trametinib, an FDA-approved MEK inhibitor, in patients with advanced or metastatic solid tumors with RAS, NF1 or RAF mutations.

In combination with binimetinib, an FDA-approved MEK inhibitor, in patients with advanced or metastatic solid tumors with RAS, NF1 or RAF mutations, subject to feedback from regulatory authorities.

In combination with sotorasib, an FDA- approved KRAS^G12C inhibitor, in patients with advanced or metastatic solid tumors with KRAS^G12C mutations, subject to feedback from regulatory authorities.

Expects to present additional preclinical data for DCC-3116 in the second half of 2022 and continue to explore preclinical combinations with multiple additional anti-cancer agents with diverse mechanisms of action.

Expects to nominate a development candidate in 2022 from the pan-RAF inhibitor research program discovered using the Company’s novel switch-control inhibitor platform.

Announced the closing in April 2022 of an underwritten public offering of 7,501,239 shares of the Company’s common stock at a public offering price of $10.00 per share and, in lieu of common stock to certain investors, the Company issued pre-funded warrants to purchase 9,748,761 shares of its common stock at a purchase price of $9.99 per pre-funded warrant, which equals the public offering price per share of the common stock less the $0.01 exercise price per share of each pre-funded warrant. The shares of common stock sold include 2,250,000 shares pursuant to the option granted by the Company to the underwriters, which option was exercised in full. This offering resulted in net proceeds of $163.4 million after deducting underwriting discounts and commissions and other offering expenses.

Revenue: Total revenue for the first quarter was $29.2 million, which includes $28.8 million of net product revenue of QINLOCK and $0.4 million of collaboration revenue compared to $25.2 million of total revenue, including $20.0 million of net product revenue of QINLOCK and $5.2 million of collaboration revenue, for the same period in 2021.

Cost of Sales: Cost of sales were $0.4 million in the first quarter ended March 31, 2022 compared to $0.2 million in the same period in 2021. Cost of sales for newly launched products will not include the full cost of manufacturing until the initial pre-launch inventory is depleted, and additional inventory is manufactured and sold. Deciphera does not expect the cost of sales as a percentage of net sales of QINLOCK to increase significantly after the Company has sold all zero cost inventories and commenced the sales of inventories that will reflect the full cost of manufacturing. The Company expects to continue to sell zero cost inventories of QINLOCK in the U.S. during 2022.

R&D Expenses: Research and development expenses for the first quarter of 2022 were $47.4 million, compared to $55.7 million for the same period in 2021. The decrease was primarily due to lower clinical trial costs related to QINLOCK, including INTRIGUE, our Phase 3 study for the treatment of second-line GIST for which top-line results were announced in November 2021, and the discontinuation of our rebastinib program following the corporate restructuring implemented in the fourth quarter of 2021, partially offset by an increase in clinical trial costs related to our Phase 1 study of DCC-3116, preclinical costs, and personnel costs. Non-cash, stock-based compensation was $6.3 million and $5.0 million for the first quarters of 2022 and 2021, respectively.

SG&A Expenses: Selling, general, and administrative expenses for the first quarter of 2022 were $28.3 million, compared to $30.7 million for the same period in 2021. The decrease was primarily due to a decrease in professional and consultant fees. Non-cash, stock-based compensation was $8.0 million and $6.2 million for the first quarters of 2022 and 2021, respectively.

Net Loss: For the first quarter of 2022, Deciphera reported a net loss of $46.9 million, or $0.80 per share, compared with a net loss of $61.3 million, or $1.06 per share, for the same period in 2021.

Cash Position: As of March 31, 2022, cash, cash equivalents, and marketable securities were $275.4 million, compared to $327.6 million as of December 31, 2021. In April 2022, the Company completed an underwritten public offering that resulted in aggregate net proceeds of $163.4 million. 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 milestone payments under its collaboration or license agreements, will enable the Company to fund its operating and capital expenditures into 2025.

Assets

Current assets:

Cash and cash equivalents

Short-term marketable securities

Accounts receivable, net

Inventory

Prepaid expenses and other current assets

Total current assets

Long-term marketable securities

Long-term investments - restricted

Property and equipment, net

Operating lease assets

Total assets

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable

Accrued expenses and other current liabilities

Operating lease liabilities

Total current liabilities

Operating lease liabilities, net of current portion

Total liabilities

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

Additional paid-in capital

Accumulated other comprehensive income (loss)

Accumulated deficit

Total stockholders’ equity

Total liabilities and stockholders’ equity

Revenues:

Product revenues, net

Collaboration revenues

Total revenues

Cost and operating expenses:

Cost of sales

Research and development

Selling, general, and administrative

Total cost and operating expenses

Loss from operations

Other income (expense):

Interest and other income, net

Total other income (expense), net

Net loss

Net loss per share—basic and diluted

Weighted average common shares outstanding—basic and diluted