On May 3, 2023 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported a corporate and financial update for the first quarter ended March 31, 2023 (Press release, G1 Therapeutics, MAY 3, 2023, View Source [SID1234630914]).

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"Since the start of 2023, we’ve focused efforts on our three core priorities of driving significant growth in sales of COSELA, executing on our four ongoing clinical trials of trilaciclib, and efficiently managing our cash runway through each of our data readouts," said Jack Bailey, Chief Executive Officer of G1 Therapeutics. "We made good progress on all fronts during the first quarter of this year. The commercial team executed well, driving net COSELA sales growth of 18% quarter-over-quarter, and vial volume growth of 21%, as we work towards our guidance of between $50 million and $60 million in product revenue this year. Regarding the clinical pipeline, we’ve continued to move each of our trials forward, including our two Phase 2 trials in TNBC from which data are expected later this quarter, followed by results from our pivotal Phase 3 trial in TNBC which are now expected in the first quarter of next year."

First Quarter 2023 and Recent Highlights

Financial

Recognized $10.5 million in Net COSELA Revenue: Results represent an 18% increase in net sales over the fourth quarter of 2022. G1 recognized total revenues of $12.9 million for the first quarter of 2023.

Achieved 21% COSELA Vial Volume Growth Over the Fourth Quarter of 2022.

Ended the First Quarter 2023 with Cash, Cash Equivalents, and Marketable Securities of $116.3 million.

Strengthened Balance Sheet Through Non-Equity Dilutive Monetization of Simcere Milestones and Royalties: In the second quarter of 2023, G1 and Simcere reached agreement whereby Simcere will buy out the remaining milestones and royalties on sales of COSELA (trilaciclib hydrochloride for injection) in Greater China for up to $48 million, with $30 million received within the second quarter of 2023, providing additional non-equity dilutive financing that secures G1’s cash runway beyond its clinical trial readouts. All other aspects of the strategic collaboration remain in place including participation and cost-sharing in global clinical trials. G1 retains the rights to trilaciclib throughout the rest of the world, other than Greater China.
Clinical

Provided Updated Timing for Initial Results from Pivotal Phase 3 Clinical Trial of Trilaciclib in Patients with mTNBC; Interim OS Analysis Now Expected in the First Quarter of 2024: The primary endpoint of PRESERVE 2 is to evaluate the effect of trilaciclib on OS compared with placebo in patients receiving first-line gemcitabine/carboplatin. G1 now expects the interim OS analysis to be conducted by its data monitoring committee at 70% of events in the first quarter of 2024. If the trial meets the interim analysis stopping rule, it will terminate, and G1 will report the top line results. If it does not, the trial will continue to the final analysis.

Completed Enrollment in Phase 2 Trial of Trilaciclib in Combination with the ADC Sacituzumab Govitecan-Hziy: Enrollment is complete at 30 patients in this exploratory Phase 2, multicenter, open-label, single arm study evaluating the safety and efficacy of trilaciclib administered prior to sacituzumab in patients with unresectable, locally advanced or metastatic TNBC.

Announced Upcoming Poster Presentation of Results from Trilaciclib Phase 2 ADC Combination Trial: Additional results from this trial in metastatic TNBC have been accepted for poster presentation during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer 2023 Annual Congress. The abstract (201P) will be presented during the poster session on May 12, 2023 from 12:15PM to 1:00PM Central European Summer Time (CEST). G1 currently expects to reach the OS endpoints for this study in the first quarter of 2024. Initial Phase 2 safety data presented in November 2022 suggested an on-target effect of trilaciclib to reduce the rates of adverse events associated with sacituzumab govitecan (SG), including myelosuppression and diarrhea, relative to the previously published SG single agent safety profile. (Press release here)

Announced Upcoming Poster Presentation of Results from Phase 2 Mechanism of Action Trial of Trilaciclib in Patients with Neoadjuvant TNBC: Additional results from this trial have been accepted for poster presentation during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting. The abstract (603) will be presented during the poster session on June 4, 2023 from 8:00AM to 11:00AM CDT. Initial Phase 2 safety data showed favorable alterations in the tumor microenvironment from a single dose of trilaciclib monotherapy as measured by increases in the proportions of CD8+ T cells compared to T regulatory cells (Tregs) in patients with early-stage triple negative breast cancer (TNBC). (Press release here)

Confirmed that Initial Results Including the Primary Endpoint of Progression Free Survival from the Phase 2 Bladder Cancer Trial of Trilaciclib (PRESERVE 3) Are Anticipated Midyear 2023: G1 has reiterated that additional safety and efficacy results, including results from the primary endpoint of Progression Free Survival, are expected from PRESERVE 3 midyear 2023. The Company currently expects to reach the OS endpoints for this study in the first quarter of 2024.
First Quarter 2023 Financial Results

As of March 31, 2023, cash and cash equivalents and marketable securities totaled $116.3 million, compared to $145.1 million as of December 31, 2022. This includes $52.0 million in net proceeds from a fourth quarter 2022 underwritten public offering of its common stock at a public offering price of $6.50 per share. Cowen and Raymond James acted as joint book-running managers for the offering. Needham & Company and Wedbush PacGrow acted as lead managers for the offering.

Total revenues for the first quarter of 2023 were $12.9 million, including $10.5 million in net product sales of COSELA and license revenue of $2.5 million, related to supply and manufacturing services with Simcere, royalty revenue from Simcere, and clinical trial reimbursements from EQRx and Simcere, compared to $6.9 million in total revenues in the first quarter of 2022.

Operating expenses for the first quarter of 2023 were $38.7 million, compared to $53.7 million for the first quarter of 2022. GAAP operating expenses include stock-based compensation expense of $3.8 million for the first quarter of 2023, compared to $5.8 million for the first quarter of 2022.

Cost of goods sold expense for the first quarter of 2023 was $1.5 million compared to $0.7 million for the first quarter of 2022, primarily due to an increase in product sales.

Research and development (R&D) expenses for the first quarter of 2023 were $15.5 million, compared to $26.3 million for the first quarter of 2022. The decrease in R&D expenses was primarily due to a decrease in the Company’s clinical program costs.

Selling, general, and administrative (SG&A) expenses for the first quarter of 2023 were $21.8 million, compared to $26.7 million for the first quarter of 2022. The decrease in SG&A expenses was primarily due to decreases in commercialization activities, personnel costs, and professional fees.

The net loss for the first quarter of 2023 was $27.6 million, compared to $49.2 million for the first quarter of 2022. The basic and diluted net loss per share for the first quarter of 2023 was $(0.53) compared to $(1.15) for the first quarter of 2022.

2023 Financial Guidance

G1 today reiterated its full year 2023 net revenue guidance. The Company expects to generate between $50 million and $60 million in COSELA net revenue in 2023. G1’s product revenue guidance was initially provided in its fourth quarter and full year 2022 financial results and business update, and is based on expectations for continued acceleration of sales performance of COSELA in the U.S.

Webcast and Conference Call

G1 will host a webcast and conference call at 8:30 a.m. ET today to provide a corporate and financial update for the first quarter ended March 31, 2023.

Please note that there is a new process to access the call via telephone. To register and receive a dial in number and unique PIN to access the live conference call, please follow this link to register online. While not required, it is recommended that you join 10 minutes prior to the start of the event. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

About COSELA (trilaciclib) for Injection

COSELA (trilaciclib) was approved by the U.S. Food and Drug Administration on February 12, 2021.

Indication

COSELA (trilaciclib) is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.

Important Safety Information

COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.

Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity.

The most common adverse reactions (>10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

This information is not comprehensive. Please click here for full Prescribing Information. View Source

To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or call FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

On May 3, 2023 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, reported business highlights and financial results for the first quarter ended March 31, 2023 (Press release, Fate Therapeutics, MAY 3, 2023, View Source [SID1234630913]).

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"Over the first months of 2023, we have sharpened our clinical focus and significantly reduced our operating expenses, creating the necessary cash runway to achieve key milestones across our multiplexed-engineered CAR NK and CAR T-cell pipeline. We sincerely thank our employees whose patience and perseverance have allowed us to emerge through this transition period with a renewed sense of energy, commitment, and drive to bring first-in-class, iPSC-derived cellular immunotherapies to patients with cancer and autoimmune disorders," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "We are now well-positioned to clinically assess higher therapeutic exposures for our FT576 BCMA-targeted CAR NK cell program in multiple myeloma and our FT819 CD19-targeted CAR T-cell program in B-cell malignancies. In addition, we aim to bring our FT522 CD19-targeted CAR NK cell program, which incorporates our proprietary ADR technology designed to enhance NK cell potency, extend functional persistence, and resist host immune cell rejection, into clinical development in the second half of 2023 for B-cell lymphoma, and intend to expand its clinical reach to include severe autoimmune disorders. Finally, we are excited to be jointly developing our clinical strategy with ONO Pharmaceutical for FT825/ONO-8250, our HER2-targeted CAR T-cell collaboration program for solid tumors for which we plan to submit an IND application in the second half of 2023."

NK Cell Programs

FT576 BCMA-targeted CAR NK Cell Program Accruing Patients in Multi-dose Escalation Cohorts for Multiple Myeloma. The Company’s Phase 1 study of FT576, its multiplexed-engineered, BCMA-targeted chimeric antigen receptor (CAR) NK cell product candidate for relapsed / refractory multiple myeloma, is currently enrolling two-dose treatment cohorts as monotherapy and in combination with CD38-targeted monoclonal antibody (mAb) therapy at 300 million cells per dose. Upon clearance of the current treatment cohorts, the Company plans to open and assess three-dose treatment cohorts starting at 1 billion cells per dose. At the 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December, the Company presented interim Phase 1 clinical data from nine heavily pre-treated patients in the single-dose cohorts, which showed encouraging clinical evidence of BCMA-targeted activity and a favorable safety profile indicating the potential for administration in the outpatient setting. Translational data from the CD38-targeted mAb combination regimen showed rapid and selective depletion of CD38-positive patient immune cells in the peripheral blood and bone marrow that extended through the first month of therapy, indicating that the regimen may uniquely serve to attenuate reconstitution of activated T cells, extend functional persistence of FT576, and enable dual-antigen targeting of myeloma cells.

Initiation of Clinical Assessment of FT522 ADR-armed, CD19-targeted CAR NK Cell Program Anticipated in 2H23. FT522 is the Company’s first product candidate to incorporate its proprietary alloimmune defense receptor (ADR) technology, which has been shown in preclinical studies to increase NK cell potency, enhance functional persistence, and confer resistance to host immune cell allo-reactivity. The Company has recently submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to investigate the safety and activity of FT522 in combination with CD20-targeted mAb therapy in patients with B-cell lymphoma, including without prior administration of intensive conditioning chemotherapy. In addition, the Company is currently conducting preclinical studies to support clinical assessment of FT522 in autoimmune disease, including in combination with CD20- and CD38-targeted mAb therapy, to selectively target and durably deplete pathogenic B cells, plasma cells, and auto-reactive T cells.
T-cell Programs

First-of-kind FT819 Program Advancing in Single-dose Escalation Cohorts for B-cell Malignancies. The Company’s landmark Phase 1 clinical trial of FT819, which is the first-ever clinical investigation of a T-cell product candidate manufactured from a clonal master iPSC line, is currently enrolling patients in single-dose escalation cohorts at 540 million cells in B-cell lymphoma and at 180 million cells in chronic lymphocytic leukemia. At the 2022 ASH (Free ASH Whitepaper) Annual Meeting, the Company presented interim Phase 1 clinical data from eight patients with relapsed / refractory aggressive large B-cell lymphoma treated with a single dose of FT819 ranging from 90 million cells to 360 million cells, which demonstrated a favorable safety profile and objective responses including in patients who were not eligible for or had previously failed autologous CD19-targeted CAR T-cell therapy. FT819 incorporates several novel features including the integration of a novel CD19-targeted 1XX CAR construct into the T-cell receptor alpha constant (TRAC) locus, which is intended to promote uniform CAR expression, enhance T-cell potency, and prevent graft-versus-host disease.

2023 IND Submission Planned for HER2-targeted CAR T-cell Program for Solid Tumors. Under the Company’s collaboration with ONO Pharmaceutical Co., Ltd. (ONO), the companies are co-developing FT825/ONO-8250, an iPSC-derived CAR T-cell product candidate targeting human epidermal growth factor receptor 2 (HER2)-expressing solid tumors. IND-enabling activities for FT825/ONO-8250 are currently ongoing, and the Company plans to submit an IND application to the FDA in 2023 to jointly conduct with ONO a Phase 1 study for the treatment of patients with HER2-positive solid tumors. The multiplexed-engineered, iPSC-derived CAR T-cell product candidate incorporates seven novel synthetic controls designed to enhance effector cell function and overcome unique challenges in treating solid tumors, including a novel HER2-targeted binding domain with a differentiated targeting profile, a synthetic CXCR2 receptor to promote cell trafficking, a synthetic TGFβ receptor to redirect immunosuppressive signals in the tumor microenvironment, and a synthetic interleukin-7 receptor fusion protein to induce T-cell activation.

Strategic Pipeline Prioritization & Corporate Restructuring
During the first quarter of 2023, in connection with the termination of its collaboration with Janssen Biotech, Inc. (Janssen), the Company discontinued all collaboration activities, including withdrawing an IND application previously allowed by the FDA for a first collaboration product for the treatment of B-cell lymphoma. In addition, following a strategic review of its wholly-owned iPSC-derived NK cell and T-cell programs, the Company focused its operations on advancing its most innovative and differentiated programs and initiated the discontinuation of its FT516, FT596, FT538, and FT536 NK cell product candidates. As part of its corporate restructuring, the Company reduced its workforce to approximately 220 employees.

First Quarter 2023 Financial Results & 2023 Guidance

Cash & Investment Position: Cash, cash equivalents and investments as of March 31, 2023 were $412.8 million. In addition, as of March 31, 2023, cash receivables from collaborations were $13.5 million. The Company expects its cash, cash equivalents, and investments to exceed $300 million at year-end 2023.
Total Revenue: Revenue was $59.0 million for the first quarter of 2023, of which $52.3 million was associated with the termination of its collaboration with Janssen and $6.7 million was derived from its ongoing collaboration with ONO. Under the ONO collaboration, a one-time amount of $6.2 million was recorded as revenue for the first quarter of 2023 associated with the Company’s conduct of IND-enabling activities for FT825/ONO-8250, for which ONO exercised its development and commercialization option in November 2022. For each of the remaining three quarters of 2023, the Company expects to recognize approximately $0.8 million in revenue under the ONO collaboration in connection with its conduct of preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen.
Total Operating Expenses: For the first quarter of 2023, GAAP operating expenses were $87.6 million, including research and development expenses of $65.6 million and general and administrative expenses of $21.9 million. Such amounts included $11.0 million of non-cash stock-based compensation expense and a one-time charge of $12.9 million for severance and other employee termination-related costs associated with the Company’s corporate restructuring. For the full year ending December 31, 2023, the Company expects its GAAP operating expenses to be between $265 million to $285 million.
Shares Outstanding: Common shares outstanding were 98.2 million, and preferred shares outstanding were 2.8 million, as of March 31, 2023. Each preferred share is convertible into five common shares.

Today’s Conference Call and Webcast

The Company will conduct a conference call today, Wednesday, May 3, 2023 at 5:00 p.m. ET to review financial and operating results for the quarter ended March 31, 2023. In order to participate in the conference call, please register using the conference link here. The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

On May 3, 2023 Exelixis, Inc. (Nasdaq: EXEL) reported that company management will participate in a fireside chat at the BofA Securities 2023 Healthcare Conference on Wednesday, May 10 at 1:40 p.m. ET / 10:40 a.m. PT (Press release, Exelixis, MAY 3, 2023, View Source [SID1234630912]).

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcasts. A replay will also be available at the same location for at least 30 days.

On May 3, 2023 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the Bank of America Securities 2023 Healthcare Conference, May 9-11, 2023 (Press release, Eli Lilly, MAY 3, 2023, View Source [SID1234630911]). Patrik Jonsson, executive vice president, president of Lilly Immunology and Lilly USA, and chief customer officer, will participate in a fireside chat on Wednesday, May 10 at 1 p.m., Eastern time.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

On May 3, 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, reported financial results for the first quarter ended March 31, 2023 and provided a corporate update (Press release, Deciphera Pharmaceuticals, MAY 3, 2023, View Source [SID1234630910]).

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"We have had a very strong start to 2023, achieving significant milestones including the completion of enrollment for the MOTION pivotal Phase 3 study of vimseltinib in TCGT patients, presentation of the ctDNA data for QINLOCK in second-line GIST patients with mutations in KIT Exon 11 and 17/18, and receiving Breakthrough Therapy Designation from the FDA for QINLOCK in this patient population," said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. "These advancements in our late-stage pipeline position us for a catalyst-rich remainder of 2023, in which we expect top-line results from the MOTION study and plan to initiate INSIGHT, the pivotal Phase 3 study of QINLOCK versus sunitinib in second-line GIST patients with mutations in KIT exon 11 and 17/18."

Mr. Hoerter continued, "We continue to complement this impressive momentum with progress in our early-stage programs, including the recent presentations at AACR (Free AACR Whitepaper), which highlighted the productivity of our kinase switch-control research engine. We were excited to present the preclinical data for DCC-3084, a potential best-in-class pan-RAF inhibitor, and announce the nomination of our newest development candidate, DCC-3009, a potential best-in-class pan-KIT inhibitor. We also presented preclinical data supporting the study of DCC-3116 in combination with QINLOCK in GIST and with encorafenib and cetuximab in colorectal cancer. This encouraging progress demonstrates that, as we work toward becoming a company with multiple approved medicines, our proprietary drug discovery platform continues to fuel our pipeline with innovative, potential first- and best-in-class kinase inhibitors."

First Quarter 2023 Highlights and Upcoming Milestones

QINLOCK (ripretinib)

Recorded $33.2 million in QINLOCK net product revenue in the first quarter of 2023, including $24.6 million in U.S. net product revenue and $8.6 million in international net product revenue, an increase of 15% compared to net product revenue of $28.8 million in the first quarter of 2022.
Granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) who received prior treatment with imatinib, and who harbor a KIT exon 11 mutation and co-occurring KIT exon 17 and/or 18 mutations. The Company expects to initiate the INSIGHT study in the second half of 2023.
Included in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as a preferred regimen for second-line GIST patients intolerant to sunitinib.
Will present posters at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting featuring updated overall survival (OS) and outcome data on patients without circulating tumor DNA (ctDNA) at baseline from the INTRIGUE Phase 3 study of QINLOCK in patients with advanced GIST previously treated with imatinib, along with information on the upcoming INSIGHT pivotal Phase 3 study of QINLOCK versus sunitinib in second-line GIST patients with KIT exon 11 and 17/18 mutations.
Concluded successful price negotiations in Germany. In 2022, QINLOCK received a "major additional benefit" rating from Germany’s Federal Joint Committee (G-BA). QINLOCK is the first orphan oncology treatment in Germany to receive this rating for its lead indication and the only GIST treatment awarded with this recognition.
Vimseltinib

Completed enrollment for 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) and expects to announce top-line results from the study in the fourth quarter of 2023.
Expects to present updated data from the Phase 1/2 study of vimseltinib in the second half of 2023.
DCC-3116

Presented preclinical data on combinations with DCC-3116, an investigational, orally administered, selective, and potent switch-control kinase inhibitor of ULK1/2-mediated autophagy, at the American Association for Cancer (AACR) (Free AACR Whitepaper) Annual Meeting 2023, including preclinical models in combination with ripretinib in GIST models and with encorafenib and cetuximab in colorectal cancer (CRC) models.
Expects to initiate new combination escalation studies evaluating DCC-3116 in combination with ripretinib in patients with GIST and in combination with encorafenib and cetuximab in patients with CRC in the second half of 2023. Under the terms of the clinical trial collaboration and supply agreement with Pfizer, Inc., Deciphera will sponsor the study and Pfizer will supply encorafenib at no cost.
Expects to initiate one or more expansion cohorts in the ongoing Phase 1/2 study of DCC-3116 in the second half of 2023 in combination with the MEK inhibitors trametinib or binimetinib, or the KRAS G12C inhibitor sotorasib.
DCC-3084

Presented preclinical data for DCC-3084, a pan-RAF inhibitor, at the AACR (Free AACR Whitepaper) Annual Meeting 2023, which demonstrated a potential best-in-class profile based on its inhibition of Class I, II, and III BRAF mutations, BRAF fusions, and BRAF/CRAF heterodimers, and optimized pharmaceutical properties.
Expects to submit an investigational new drug (IND) application to the FDA for DCC-3084 in the second half of 2023.
DCC-3009

Presented preclinical data for DCC-3009, a potential best-in-class pan-KIT inhibitor, at the AACR (Free AACR Whitepaper) Annual Meeting 2023, which demonstrated its ability to potently and selectively inhibit the broad spectrum of known primary and secondary drug-resistant mutations in GIST models, spanning KIT exons 9, 11, 13, 14, 17, and 18.
Expects to submit an IND to the FDA for DCC-3009 in the first half of 2024.
Kinase Switch-Control Research Engine

Presented new preclinical data from research programs focused on GCN2 and PERK, novel targets in the integrated stress response pathway, at the AACR (Free AACR Whitepaper) Annual Meeting 2023.
Corporate Update

Announced the closing in January 2023 of its underwritten public offering of 7,986,111 shares of its common stock at a public offering price of $18.00. The aggregate gross proceeds to Deciphera from this offering were approximately $143.7 million, before deducting underwriting discounts and commissions and other estimated offering expenses.
First Quarter 2023 Financial Results

Revenue: Total revenue for the first quarter of 2023 was $33.4 million, which includes $33.2 million of net product revenue of QINLOCK and $0.2 million of collaboration revenue compared to $29.2 million of total revenue, including $28.8 million of net product revenue of QINLOCK and $0.4 million of collaboration revenue, for the same period in 2022.
Cost of Sales: Cost of sales were $0.5 million in the first quarter of 2023, which includes $0.4 million in cost of product sales, compared to cost of sales of $0.4 million for the first 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 first quarter of 2023 were $54.8 million, compared to $47.4 million for the same period in 2022. The increase was primarily due to an increase in clinical study costs related to the MOTION Phase 3 study of vimseltinib, the Phase 1/2 study of DCC-3116, and clinical study costs for QINLOCK, including the Phase 3 INTRIGUE study. Non-cash, stock-based compensation was $5.4 million and $6.3 million for the first quarters of 2023 and 2022, respectively.
SG&A Expenses: Selling, general, and administrative expenses for the first quarter of 2023 were $31.4 million, compared to $28.3 million for the same period in 2022. The increase was primarily due to an increase in professional, consulting, and other expenses, partially offset by a decrease in personnel-related costs. Non-cash, stock-based compensation was $7.0 million and $8.0 million for the first quarters of 2023 and 2022, respectively.
Net Loss: For the first quarter of 2023, Deciphera reported a net loss of $49.6 million, or $0.60 per share, compared with a net loss of $46.9 million, or $0.80 per share, for the same period in 2022.
Cash Position: As of March 31, 2023, cash, cash equivalents, and marketable securities were $426.3 million, compared to $339.0 million as of December 31, 2022. 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 2026.
Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, May 3, 2023, at 8:00 AM ET. The conference call may be accessed via this link: https://register.vevent.com/register/BI75fb53c225a648b486e50d922b166468. 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 View Source 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.