On May 7, 2026 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported a business update and announced financial results for the first quarter ended March 31, 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We started the year with strong momentum for soquelitinib, our selective ITK inhibitor that we believe is well positioned to improve therapy for a broad range of patients with atopic dermatitis, other immune diseases and cancers," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "The data generated from our clinical and preclinical work support soquelitinib’s potential to provide a new treatment paradigm for these diseases based on a rebalancing of the immune system. We will share additional data supporting this mechanism at the upcoming annual meeting of the Society for Investigative Dermatology, where we are reviewing data from our Phase 1 atopic dermatitis trial in two oral presentations. Looking forward, we are focused on our ongoing and planned soquelitinib clinical trials, including the initiation of new Phase 2 studies in hidradenitis suppurativa and asthma anticipated later this year."

Business Update and Strategy

Soquelitinib for Immune Diseases

In January 2026, Corvus reported data from cohort 4 of the randomized, blinded, placebo-controlled Phase 1 trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis (data as of January 15, 2026). Cohort 4 data demonstrated positive safety and efficacy results, including additional clinical benefit observed following longer 8-week treatment.
Final data from the randomized, blinded, placebo-controlled Phase 1 trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis will be presented in two oral sessions at the Society for Investigative Dermatology (SID) Annual Meeting, which is taking place May 13-16, 2026 in Chicago. The Company will host an in-person and virtual investor and analyst meeting on May 14, 2026 to review soquelitinib data being presented at SID, including new immunologic and biomarker data that focus on the drug’s mechanism of action and potential for drug-free remissions.
Corvus initiated its Phase 2 randomized placebo-controlled atopic dermatitis clinical trial during the first quarter 2026. The trial is anticipated to enroll approximately 200 patients with moderate-to-severe atopic dermatitis that have failed at least one prior topical or systemic therapy. This includes four cohorts of 50 patients each, with soquelitinib doses of 200 mg once per day, 200 mg twice per day and 400 mg once per day, along with a placebo group. The treatment period is 12 weeks with a 90-day follow-up period with no treatment.
Angel Pharmaceuticals, Corvus’ partner in China, is enrolling a Phase 1b/2 clinical trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis. This is a blinded, placebo-controlled trial that is planned to evaluate a 12-week treatment regimen in 48 patients utilizing soquelitinib doses of 100 mg twice per day, 200 mg once per day, 200 mg twice per day and 400 mg once per day. The patient eligibility and endpoints are similar to those used previously by Corvus. Depending on the results from the Phase 1b portion of the study, an additional 60-90 patients will be enrolled in the Phase 2 portion of the study. The trial is open at several leading dermatology centers in China who have been involved in global registration trials. The study is conducted in close collaboration with Corvus. Results from the initial cohorts are anticipated late this year.
Corvus plans to initiate two additional Phase 2 clinical trials evaluating soquelitinib in patients with hidradenitis suppurativa and asthma.
Corvus also continues to advance its next-generation ITK inhibitor preclinical product candidates, which are designed to deliver precise T-cell modulation for specific immunology and oncology indications.

Collaboration with National Institute of Allergy and Infectious Diseases (NIAID)

The Autoimmune Lymphoproliferative Syndrome (ALPS) Phase 2 clinical trial continues to advance. This trial is being conducted under a clinical research and development agreement with NIAID. The Phase 2 clinical trial (NCT06730126) is anticipated to enroll up to 30 patients aged 16 or older with confirmed ALPS based on genetic testing.

Soquelitinib for T Cell Lymphoma

Corvus continues to enroll patients in a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed/refractory PTCL at multiple clinical sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed/refractory PTCL and is evaluating soquelitinib versus physicians’ choice of either belinostat or pralatrexate chemotherapies. The primary endpoint of the trial is progression free survival. There are no FDA fully approved agents for the treatment of relapsed/refractory PTCL, and the FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for treatment of adult patients with relapsed or refractory PTCL after at least two lines of systemic therapy.

Financial Results
As of March 31, 2026, Corvus had cash, cash equivalents and marketable securities of $236.7 million compared to $56.8 million as of December 31, 2025. Cash, cash equivalents and marketable securities as of March 31, 2026 included approximately $189.4 million in net proceeds received in a financing completed on January 23, 2026. Based on its current plans, Corvus expects its cash, cash equivalents and marketable securities to fund operations into the second quarter of 2028.

Research and development expenses for the three months ended March 31, 2026 totaled $11.2 million compared to $7.5 million for the same period in 2025. The increase in research and development expenses of $3.7 million was primarily due to higher clinical trial costs associated with the development of soquelitinib as well as an increase in personnel related costs.

Net loss for the three months ended March 31, 2026 was $13.7 million compared to net income of $15.2 million for the same period in 2025. Included in net loss for the three months ended March 31, 2026 and net income for the three months ended March 31, 2025 were non-cash losses of $0.6 million and $0.5 million, respectively, from Corvus’ investment in Angel Pharmaceuticals and non-cash income of $25.1 million in the three months ended March 31, 2025 associated with a change in fair value of the Company’s warrant liability. Total stock compensation expense for the three months ended March 31, 2026 was $2.7 million compared to $1.3 million for the same period in 2025.

(Press release, Corvus Pharmaceuticals, MAY 7, 2026, View Source [SID1234665316])

On May 7, 2026 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies, reported financial results for the quarter ended March 31, 2026, and provided a business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Our commitment to advancing a prostate cancer franchise is demonstrated by our continued progress with JANX007, clinical initiation of JANX014, and advancement of JANX013 toward the clinic," said David Campbell, Ph.D., President and CEO of Janux. "Our ongoing clinical study with JANX011 has been designed to support our emerging autoimmune disease opportunity."

BUSINESS HIGHLIGHTS AND RECENT DEVELOPMENTS:

Clinical & Pipeline Progress

•
JANX007 (PSMA-TRACTr) continues to enroll in its Phase 1b trial in metastatic castration-resistant prostate cancer (mCRPC), with ongoing dose optimization and expansion in taxane-naïve patients.
•
An expansion cohort evaluating JANX007 in combination with darolutamide, an androgen receptor pathway inhibitor, is actively enrolling in taxane-naïve mCRPC.
•
JANX014 (PSMA-TRACTr), a double masked tumor-activated T cell engager, has initiated clinical evaluation.
•
Following the completion of the Phase 1a portion of the study and internal review of the data, the Company has discontinued further clinical development of JANX008 (EGFR-TRACTr) and is prioritizing resources toward other pipeline opportunities.
•
JANX011 (CD19-ARM) is actively enrolling in its Phase 1 clinical trial in healthy volunteers.
•
The Company continues to advance additional TRACTr, TRACIr and ARM programs for potential future development.

Strategic Collaborations

•
Janux announced a collaboration and exclusive worldwide license agreement with Bristol Myers Squibb to develop a novel tumor-activated therapeutic targeting a validated solid tumor antigen, utilizing Janux’s TRACTr platform.
•
Recently announced development candidate nomination, triggering a $35 million milestone payment.

Corporate & Leadership

•
Janux announced the appointment of William Go, M.D., Ph.D. as Chief Medical Officer, supporting the Company’s continued clinical advancement as additional programs enter the clinic in 2026.

Upcoming Milestones

•
Janux expects to provide additional clinical data for JANX007 at a future medical congress in the first half of 2027.
•
Janux plans to announce an initial clinical update from the Phase 1 study of JANX011 in healthy volunteers in the second half of 2026.
•
Janux plans to initiate clinical development of JANX013, a PSMA-targeted CD28 costimulatory TRACIr, in the second half of 2026.

FIRST QUARTER 2026 FINANCIAL RESULTS:

•
Cash and cash equivalents and short-term investments: As of March 31, 2026, Janux reported cash and cash equivalents and short-term investments of $956.4 million, compared to $966.6 million on December 31, 2025.
•
Research and development expenses: Research and development expenses were $26.8 million for the quarter ended March 31, 2026, compared to $25.1 million for the comparable period in 2025. The change was primarily driven by manufacturing.
•
General and administrative expenses: General and administrative expenses were $11.1 million for the quarter ended March 31, 2026, compared to $9.8 million for the comparable period in 2025.
•
Net loss: Net loss was $24.4 million for the quarter ended March 31, 2026, compared to $23.5 million for the comparable period in 2025.

(Press release, Janux Therapeutics, MAY 7, 2026, View Source [SID1234665332])

On May 7, 2026 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported financial results for the first quarter ended March 31, 2026, and highlighted recent business progress.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"As we mark the one-year anniversary of the FDA-approval of AVMAPKI FAKZYNJA CO-PACK for KRAS-mutated recurrent low-grade serous ovarian cancer, I am incredibly proud of the progress we have made to deliver a meaningful impact for people living with this rare cancer," said Dan Paterson, president and chief executive officer at Verastem Oncology. "As we build on the foundation we have established with the commercial launch, we also look to continue accelerating VS-7375, our potential best-in-class oral, KRAS G12D (ON/OFF) inhibitor, and are pleased to announce the initiation of three Phase 2 registration-directed trials in pancreatic, non-small cell lung, and colorectal cancers. In an evolving competitive landscape, we remain encouraged by the efficacy data generated by our partner and emerging in the U.S., along with the safety and tolerability profile we are seeing across multiple solid tumor cancers and look forward to sharing data updates throughout this year. Altogether, we believe we are well-positioned to drive strong execution across our commercial launch and expedite VS-7375 development while maintaining disciplined capital management."

First Quarter 2026 and Recent Updates

AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets) U.S. Commercial Performance

AVMAPKI FAKZYNJA CO-PACK generated net product revenue of $18.7 million for the first quarter of 2026.
In April, the Company announced the launch of a new healthcare professional and patient marketing campaign, Reimagine Recurrent Low-Grade Serous Ovarian Cancer (LGSOC), to drive awareness of AVMAPKI FAKZYNJA CO-PACK.
In April, the Company announced new two-year median follow up data from the Phase 2 RAMP 201 trial that demonstrated durable benefit of avutometinib plus defactinib across both KRAS mutant and KRAS wild-type recurrent LGSOC patients, with discontinuation rates consistent with the primary analysis, presented at the Society of Gynecologic Oncology 2026 Annual Meeting on Women’s Cancers. A new exposure-response analysis further demonstrated that the approved dose and schedule of avutometinib plus defactinib achieve the optimal therapeutic effect.
In February, the Company announced updated data for RAMP 201J in Japan evaluating the combination in patients with LGSOC with or without a KRAS mutation. As of a data cutoff of January 30, 2026, a confirmed overall response rate (ORR) of 38% (6/16) was achieved. Patients with a KRAS mutation achieved a confirmed ORR of 57% (4/7) and KRAS wild-type patients achieved a confirmed ORR of 22% (2/9). The safety profile was consistent with previously reported data outside of Japan.
Expected Key Milestones:

Report a topline readout of the primary endpoint in the RAMP 301 trial in mid-2027.
Continue to pursue regulatory paths for potential expansion into Europe and Japan.
VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor in Advanced Solid Tumors

Today, the Company provided an update on its ongoing VS-7375 clinical trials, including branding the trials as the VS-7375 TARGET-D Clinical Trial Program. In the ongoing TARGET-D 101 (VS-7375-101) Phase 1/2 dose escalation, dose expansion and combination-evaluation trial, the Company is now evaluating the 1200 mg daily dose (QD). The Company is also evaluating VS-7375 900 mg QD in combination with cetuximab. The Company expects to finish enrollment across the various expansion cohorts and combination cohorts with chemotherapies in the near term.
In addition, the Company shared updated pharmacokinetic (PK) data that showed the 900 mg QD dose achieves target plasma levels of VS-7375 and provides clear separation from the 600 mg QD dose.
The Company has initiated three Phase 2 registration-directed trials, including:
TARGET-D 201 to evaluate VS-7375 at 900 mg QD both as monotherapy and in combination with cetuximab in patients with second-line pancreatic ductal carcinoma (PDAC). The study is also evaluating VS-7375 and cetuximab in the first-line PDAC setting.
TARGET-D 202 to evaluate VS-7375 at 900 mg QD in patients with advanced non-small cell lung cancer (NSCLC) who have received one to two prior lines of therapy. The study is also evaluating VS-7375 in NSCLC patients with asymptomatic untreated brain metastases.
TARGET-D 203 to evaluate VS-7375 at 900 mg QD as both monotherapy and in combination with EGFR inhibitors, including cetuximab or panitumumab, in previously treated colorectal cancer (CRC). The study will also evaluate VS-7375 in combination with chemotherapy in the first-line setting in patients with metastatic CRC.
In March, the Company announced that several late-breaking and regular abstracts were selected for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The abstracts included preclinical data demonstrating sustained tumor regressions with VS-7375 in combination with PRMT5 inhibitors in MTAP-deleted KRAS G12D mutant pancreatic cancer and improved efficacy in comparison to ON-only KRAS G12D or pan-RAS inhibitors.
In March, the Company reported an update on its progress with VS-7375, highlighting progress with its dose-escalation and dose-expansion trial, TARGET-D 101, a PK analysis, and a safety update, which demonstrated VS-7375 was generally well-tolerated across all monotherapy dose levels evaluated to date. Patients (n=23) receiving VS-7375 at either 400 mg QD, 600 mg QD or 900 mg QD with a mean duration of therapy of 1.6 months (0.7-5.6), reported no drug related liver function test abnormalities. As of the January 30, 2026 data cutoff, there was no drug-related neutropenia greater than Grade 2 and rates of nausea, vomiting and diarrhea remained lower than those reported by the Company’s partner in China. The Company also reported that the U.S. Food and Drug Administration (FDA) requested the Company develop separate Phase 2 trial protocols for their trials in PDAC, NSCLC and CRC.
In January, the Company reported progress from its ongoing TARGET-D 101 trial, with multiple dose levels cleared without dose-limiting toxicities or major toxicities. At that time, monotherapy cohorts and dose escalation combination cohorts were initiated across various KRAS G12D-mutated solid tumors.
The Company shared multiple updates from GenFleet Therapeutics, its partner developing VS-7375, known as GFH375 in China.

In April, GenFleet announced that GFH375 was granted Breakthrough Therapy Designation (BTD) in China for patients with KRAS G12D-mutated metastatic pancreatic cancer who have received at least one prior systemic therapy.
In March, GenFleet announced that GFH375 was granted BTD in China for patients with KRAS G12D-mutated NSCLC who have received prior systemic therapy.
Expected Key Milestones:

Report early data from the TARGET-D 101 trial in 1H 2026.
Report an update on the TARGET-D 101 trial in 2H 2026.
Announce first patient initiated in the TARGET-D 201, TARGET-D 202, and TARGET-D 203 clinical trials in mid-2026.
RAMP 205: Avutometinib Plus Defactinib in Combination with Chemotherapy in 1L Metastatic Pancreatic Cancer

Expected Key Milestone:

Report an update on the safety and efficacy of the RAMP 205 expansion cohort with at least six months of follow-up on all patients in Q2 2026.
Corporate Updates

The Company announced today the appointment of Daniel Lyons as chief commercial officer. Prior to joining, Mr. Lyons served as the Senior Vice President, Head of Rare Tumors International and Global Head of Market Access at SpringWorks Therapeutics.
First Quarter 2026 Financial Results

Verastem Oncology ended the first quarter of 2026 with cash, cash equivalents, and investments of $181.7 million.

Net product revenue for the three months ended March 31, 2026 (the "2026 Quarter") was $18.7 million, compared to no revenue recognized for the three months ended March 31, 2025 (the "2025 Quarter"). The Company began commercial sales of the AVMAPKI FAKZYNJA CO-PACK within the U.S. following receipt of FDA approval in May 2025.

Total operating expenses for the 2026 Quarter were $63.6 million, compared to $44.2 million for the 2025 Quarter. Cost of sales was $3.1 million for the 2026 Quarter, compared to no cost of sales recognized for the 2025 Quarter.

Research & development expenses for the 2026 Quarter were $38.2 million, compared to $29.2 million for the 2025 Quarter. The increase of $9.0 million, or 31%, was primarily due to higher costs for investigator fees, drug substance manufacturing, drug product manufacturing, clinical supply, and contract research organizations partially offset by the VS-7375 program option exercise fee paid to GenFleet in the 2025 Quarter.

Selling, general & administrative expenses for the 2026 Quarter were $22.3 million, compared to $15.0 million for the 2025 Quarter. The increase of $7.3 million, or 48%, was primarily due to higher costs for personnel and commercial operations.

Net loss (GAAP basis) for the 2026 Quarter was $36.6 million, or $0.37 per share (basic), compared to $52.1 million, or $0.96 per share (basic and diluted) for the 2025 Quarter.

Non-GAAP adjusted net loss for the 2026 Quarter was $42.7 million, or $0.43 per share (basic) compared to non-GAAP adjusted net loss of $42.9 million, or $0.79 per share (basic), for the 2025 Quarter. Please refer to the GAAP to non-GAAP Reconciliation attached to this press release.

Conference Call and Webcast

Verastem will host a conference call and webcast today at 4:30 p.m. ET to review the first quarter 2026 financial results and recent business updates. To access the live audio webcast of the call, along with accompanying slides, please visit the "Events & Presentations" page in the Investor section of the Company’s website, View Source A replay of the webcast will be archived and available following the event.

(Press release, Verastem, MAY 7, 2026, View Source [SID1234665350])

On May 7, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care reported the addition of NYU Langone Health’s Laura and Isaac Perlmutter Cancer Center, a renowned cancer center in New York City, as a clinical trial site in its ongoing pivotal Phase 3 clinical study (Bria-ABC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

BriaCell has enjoyed a marked uptick in interest from premier cancer centers and patient enrollment numbers following the prominent independent feature of its Phase 3 clinical trial in Nature Medicine’s publication, "Eleven clinical trials that will shape medicine in 2026", linked here.

BriaCell’s pivotal Phase 3 clinical study in Advanced Breast Cancer (Bria-ABC) is evaluating BriaCell’s lead clinical candidate, Bria-IMT, plus an immune check point inhibitor versus treatment of physician’s choice in advanced metastatic breast cancer.

"At NYU Langone Health’s Perlmutter Cancer Center, we are dedicated to offering state-of-the-art treatments to patients with difficult-to-treat cancers," stated Nancy Chan MD, Director, Breast Cancer Clinical Research, NYU Langone Health’s Perlmutter Cancer Center. "We look forward to helping accelerate the development of Bria-IMT, a novel immunotherapy with the potential to improve outcomes for patients with advanced metastatic breast cancer."

"We are thrilled to partner with clinical experts at the renowned NYU Langone Health’s Perlmutter Cancer Center, a patient-focused, NCI-designated Comprehensive Cancer Center, to further expand patient access to our novel immunotherapy treatment," said Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. "We continue to advance the study and look forward to sharing interim data in the coming months."

Interim analysis of the pivotal Phase 3 study will be conducted after 144 patient events (deaths) have occurred, with overall survival (OS) as the primary endpoint. The study compares the Bria-IMT combination regimen with immune checkpoint inhibitor versus physician’s choice in patients with advanced metastatic breast cancer. Importantly, the Bria-IMT combination regimen has been granted FDA Fast Track designation, underscoring its potential to address a serious unmet medical need.

For additional information on BriaCell’s pivotal Phase 3 study, please visit ClinicalTrials.gov NCT06072612.

(Press release, BriaCell Therapeutics, MAY 7, 2026, View Source [SID1234665366])

On May 7, 2026 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a global pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, reported financial results for the first quarter ended March 31, 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are extremely pleased with the significant impact that Palsonify is making across the community. This is illustrated by the strong adoption of Palsonify by healthcare providers and the positive patient response to treatment," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "The significant growth in our unique prescriber base reflects a growing confidence among endocrinologists in the compelling clinical data and proven efficacy of Palsonify. Expanding clinical adoption is fueling sustained demand, evidenced by the steady growth trend in new patient start forms. We are seeing an increasingly efficient path to treatment for patients as the reimbursement environment matures. These results reinforce our confidence in the long-term commercial trajectory of Palsonify and our ability to deliver transformative therapies at scale."

First Quarter 2026 and Recent Highlights:
•Reported $10.3 million in net product revenue, reflecting the rapid adoption of PALSONIFY as the preferred choice for the acromegaly community.
•Received 232 enrollment forms1 during the first quarter of 2026. Breadth and depth of PALSONIFY prescribers continued to grow, with 263 unique healthcare providers (HCPs) having prescribed PALSONIFY within the first two quarters of launch. Approximately 70% of patients treated with PALSONIFY at the end of the first quarter of 2026 were on reimbursed therapy, as payers have increasingly provided coverage.
•In January 2026, we initiated the BALANCE-CAH Phase 2/3 trial addressing the critical unmet need in pediatric CAH patients.
•In February 2026, the CHMP of the EMA adopted a positive opinion, recommending the marketing authorization of PALSONIFY for the medical treatment of adult patients with acromegaly. In April 2026, the European Commission approved PALSONIFY, the first once-daily oral, selectively targeted somatostatin receptor type 2 nonpeptide agonist, for the medical treatment of adults with acromegaly.
•In March 2026, Crinetics submitted a Marketing Authorization Application (MAA) to Brazil’s National Health Surveillance Agency (ANVISA) for PALSONIFY for the treatment of acromegaly in adults. In April 2026, SKK submitted a New Drug Application (NDA) in Japan for paltusotine for the treatment of acromegaly.
•In May 2026, Crinetics entered into an exclusive license agreement with Ohio University to develop an early preclinical growth hormone receptor antagonist for the treatment of acromegaly.
•We remain on schedule to initiate, in the second quarter of 2026, the pivotal, seamless Phase 2/3 trial evaluating atumelnant for the treatment of ACTH-dependent Cushing’s syndrome. The study will assess the efficacy and safety of our once-daily, oral ACTH antagonist, atumelnant, in a broad population including patients with both Cushing’s disease and ectopic ACTH syndrome.

First Quarter 2026 Financial Results:
•Revenue was $10.7 million for the quarter ended March 31, 2026, compared to $0.4 million for the same period in 2025. Revenue for the quarter ended March 31, 2026 includes $10.3 million in net product revenue from the U.S. commercial launch of PALSONIFY, up from $5.4 million in net product revenue reported in the fourth quarter of 2025.
•Cost of product revenue was $0.2 million for the quarter ended March 31, 2026, primarily related to distribution, packaging, and fulfillment of PALSONIFY.
•Research and development expenses were $100.1 million for the quarter ended March 31, 2026, compared to $76.2 million for the same period in 2025, and compared to $85.1 million in the quarter ended December 31, 2025. The increase compared to the prior year period reflects the advancement of our clinical and preclinical programs. The sequential increase compared to the prior quarter was primarily due to the ramp-up of ongoing Phase 3 trials, as well as the initiation of the Phase 2/3 pediatric study of atumelnant in CAH.
•Selling, general and administrative expenses were $50.8 million for the quarter ended March 31, 2026, compared to $35.5 million for the same period in 2025, and compared to $53.7 million in the quarter ended December 31, 2025. The increase compared to the prior year period is related to investments in our corporate infrastructure as we transition into a commercial-stage company. The fluctuation compared to the prior quarter reflects timing of commercial investment.
•Net loss was $127.8 million for the quarter ended March 31, 2026, compared to net loss of $96.8 million for the same period in 2025.
•Cash, cash equivalents, and investment securities totaled $1.3 billion as of March 31, 2026, compared to $1.0 billion as of December 31, 2025. The March 31, 2026 total includes net proceeds of $380 million from our January 2026 public equity offering.

Guidance and Outlook:
•Crinetics continues to expect 2026 operating expenses presented in accordance with U.S. generally accepted accounting principles ("GAAP") to be between $600 million to $650 million and non-GAAP operating expenses – which exclude cost of product revenue, stock-based compensation, depreciation and amortization – to be between $480 million to $520 million.
•Crinetics is unable to reconcile forward-looking non-GAAP operating expenses to the most directly comparable GAAP measure without unreasonable effort because the items that are being excluded are difficult to predict or a range of results could lead to disclosure that would be imprecise or potentially misleading. Material changes to any one of the exclusions could have a significant effect on our forward-looking estimates and GAAP results. Such items include cost of product revenue, stock-based compensation, depreciation and amortization. See "Use of Non-GAAP Financial Measures".

Conference Call and Webcast Details
Management will hold a live conference call and webcast today, Thursday, May 7, 2026 at 4:30 p.m. ET. To participate, please dial 1-833-461-5787 (domestic) or 1-585-542-9983 (international) and refer to Meeting ID 173777518. To access the webcast, the direct link (here) or visit the Events page of the Crinetics website. Following the live event, the webcast will be archived on the Investor Relations section of www.crinetics.com.

(Press release, Crinetics Pharmaceuticals, MAY 7, 2026, View Source [SID1234665317])