Crinetics Pharmaceuticals Q1 2025 Earnings Report

Crinetics Pharmaceuticals EPS Results

• Actual EPS: -$1.04
• Consensus EPS: -$0.99
• Beat/Miss: Missed by -$0.05
• One Year Ago EPS: -$0.93

Crinetics Pharmaceuticals Revenue Results

• Actual Revenue: $0.36 million
• Expected Revenue: $0.10 million
• Beat/Miss: Beat by +$261.00 thousand
• YoY Revenue Growth: -43.60%

Crinetics Pharmaceuticals Announcement Details

• Quarter: Q1 2025
• Date: 5/8/2025
• Time: Before Market Opens
• Conference Call Date: Thursday, May 8, 2025
• Conference Call Time: 4:30PM ET

Crinetics Pharmaceuticals (NASDAQ:CRNX), a clinical-stage pharmaceutical company, focuses on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. The company's lead product candidate is paltusotine, an oral selective nonpeptide somatostatin receptor type 2 agonist, which is in Phase 3 trial for the treatment of acromegaly; and Phase 2 trial for treating carcinoid syndrome associated with neuroendocrine tumors. It is also developing CRN04894, an investigational oral nonpeptide product candidate to antagonize the adrenocorticotrophic hormone (ACTH) receptor that has completed a Phase 1 study for the treatment of diseases caused by excess ACTH, including congenital adrenal hyperplasia and Cushing's disease. In addition, the company is developing antagonists of the parathyroid hormone (PTH) receptor for the treatment of primary hyperparathyroidism and humoral hypercalcemia of malignancy, and other diseases of excess PTH; identified investigational orally available somatostatin receptor type 3 targeted nonpeptide agonists for the treatment of autosomal dominant polycystic kidney disease; and developing thyroid-stimulating hormone receptor antagonists for the treatment of graves' disease and thyroid eye disease, as well as Oral GLP-1 and GIP nonpeptides for the treatment of diabetes and obesity. Crinetics Pharmaceuticals, Inc. was incorporated in 2008 and is headquartered in San Diego, California.

Crinetics Pharmaceuticals Q1 2025 Earnings Call Transcript

Key Takeaways

• The company is preparing for the U.S. commercial launch of paltusotine in September 2025, building a ~30-rep sales force, engaging payers on favorable prior authorization using label alignment, and launching a patient support platform “Kineticare.”
• The pivotal Phase III trial of adomelant in adult congenital adrenal hyperplasia uses a composite primary endpoint of normalized A4 levels and physiologic glucocorticoid dosing, enrolling 150 patients to establish a new standard of care.
• The pipeline remains robust with IND clearance for first NDC candidate (9682) targeting SST2-positive tumors, CARCINOID syndrome Phase III planned H2 2025, and advancing TSH antagonists, SST3 agonists, and PTH antagonists toward IND enabling studies.
• Financially, Kinetics ended Q1 with $1.3 billion in cash to fund operations into 2029, saw R&D expenses rise 43% and SG&A 71% YoY, and expects $340–380 million cash burn for 2025 ahead of product launches.
• Paltusotine’s NDA is on track for an FDA decision by September 25, 2025 without an advisory committee, and its European MAA has been validated with orphan drug designation.

Presentation

[Operator]

Welcome to the Kinetics Pharmaceuticals First Quarter twenty twenty five Financial Results Conference Call. At this time, all participants are in listen only mode. Following the management's prepared remarks, we will hold a question and answer session. I would now like to turn the call over to Gayatri Tewakkar, Head of Investor Relations. Please go ahead.

[Gayathri Diwakar, Head of IR at Crinetics Pharmaceuticals]

Thank you, operator. Good afternoon, everyone, and thank you for joining us to discuss the first quarter twenty twenty five results. Today on the call, we have Doctor. Scott Struthers, Founder and Chief Executive Officer Doctor. Dana Pizzuti, Chief Medical and Development Officer Isabelle Tralfonos, Chief Commercial Officer and Toby Schulke, Chief Financial Officer.

[Gayathri Diwakar, Head of IR at Crinetics Pharmaceuticals]

Doctor. Alan Krasner, Chief Endocrinologist, will also be joining for the Q and A portion. Please note there is a slide deck for today's presentation, which is in the Events and Presentations section of the Investors page on the Kinetics website. In addition, a press release was issued earlier today and is also available on the corporate website. Slide two.

[Gayathri Diwakar, Head of IR at Crinetics Pharmaceuticals]

As a reminder, we will be making forward looking statements, and I invite you to learn more about the risks and uncertainties associated with these statements as disclosed in our SEC filings. Such forward looking statements are not a guarantee of performance, and the company's actual results could differ materially from those stated or implied in such statements due to risks and uncertainties associated with the company's business. These forward looking statements are qualified in their entirety by the cautionary statements contained in today's news release, the company's other news releases and Kinetics' SEC filings, including its annual report on Form 10 ks and quarterly reports on Form 10 Q. I would also like to specify that the content of this conference call contains time sensitive information that is accurate only as of the date of this live broadcast, 05/08/2025. Kinetics takes no obligation to revise or update any forward looking statements to reflect events or circumstances after the date of this conference call.

[Gayathri Diwakar, Head of IR at Crinetics Pharmaceuticals]

With that, I'll hand the call over to Scott.

[R. Scott Struthers, Founder & CEO at Crinetics Pharmaceuticals]

Thank you, Deathri, and good afternoon to everyone joining in today's call. We're pleased to share our first quarter results and highlight the great progress we're making towards our mission of transforming the lives of patients with serious endocrine and endocrine adjacent diseases. Turning to Slide three, Kinetics has never been stronger and I want to emphasize that. We're strategically positioned for long term sustainable growth. Our immediate focus is on the anticipated commercial launch

[R. Scott Struthers, Founder & CEO at Crinetics Pharmaceuticals]

of our

[R. Scott Struthers, Founder & CEO at Crinetics Pharmaceuticals]

first product this year. This is a pivotal milestone for the company. We believe paltusotine has the potential to deliver meaningful improvements for people living with acromegaly. Stacked by an experienced team deeply embedded in the endocrinology community and driven by a strong commitment to patients and science, we're well on our way to becoming a fully integrated global commercial organization. We're advancing a robust pipeline in parallel including two late stage candidates, one recently clearing IND and three additional candidates in preclinical studies.

[R. Scott Struthers, Founder & CEO at Crinetics Pharmaceuticals]

With $1,300,000,000 on the balance sheet, we're able to continue to invest in our pipeline, support prospective launches and thoughtfully pursue opportunities and enhance value across our portfolio. We have never been stronger. I'd like to take a moment to welcome Toby Schulke, who you'll be hearing from towards the end of today's call. Toby recently joined as Chief Financial Officer, and he brings over twenty five years of global experience with a proven track record of guiding companies through the transition from R and D focused ventures into fully integrated commercial organizations. Toby's extensive financial and operational experience will be invaluable as we accelerate our growth trajectory and position Kinetics for long term success.

[R. Scott Struthers, Founder & CEO at Crinetics Pharmaceuticals]

I also wanted to reassure you that regulatory engagement with the FDA on the altusatine NDA for acromegaly as well as our other clinical development activities have been proceeding on track. We're grateful for the ongoing professionalism and commitment of the staff at FDA with whom we interact. We remain proactive in monitoring the evolving regulatory environment and maintaining active dialogue with key stakeholders both in the administration and on Capitol Hill. As you'll hear from Isabelle, we're laser focused on preparing for the anticipated launch of paltusotine in September. This will be our first product approval and a defining milestone for our ambition to become a fully integrated pharmaceutical company.

[R. Scott Struthers, Founder & CEO at Crinetics Pharmaceuticals]

On today's call, we'll walk through some of the launch initiatives we are executing and reflect on the progress the team has made to date. Turning to Asmelanin, we remain very encouraged by its potential to establish an uncompromising treatment goal for people living with congenital adrenal hyperplasia. We're moving forward to the Phase three study for adults with CAH that Dana will describe in some detail. At a high level, this study is designed to redefine the standard of care as the achievement of normal adrenal androgen levels with only physiologic levels of glucocorticoid replacement. We believe that tamellant should be used to treat the disease and glucocorticoid should only be used for physiologic replacement, not treatment.

[R. Scott Struthers, Founder & CEO at Crinetics Pharmaceuticals]

With that, I'll hand the call over to Isabel to update our acromegaly launch preparations. Isabel?

[Isabel Kalofonos, Chief Commercial Officer at Crinetics Pharmaceuticals]

Thanks, Scott. As described on the Slide four, our mission with participants is to provide the next generation of care for people living with acromegaly. While we have a long term global vision and we are building out our infrastructure to support commercialization of our whole pipeline, we are constantly focused on executing on the anticipated U. S. Launch.

[Isabel Kalofonos, Chief Commercial Officer at Crinetics Pharmaceuticals]

We are making significant progress in building our infrastructure, educating and driving awareness among healthcare professionals and patients and engaging with payers. We also have a strong long standing patient advocacy partnerships in place as we continue to engage with the broader acromegaly community. On the healthcare professional side, we have held advisory boards with nurses and endocrinologists, and they have provided positive feedback on the potential value proposition of Baltusotine in both biochemical control of IGF-one and symptom control. We are working on the final sales force mapping and we expect to have approximately 30 reps in place over the summer. We will cover healthcare professionals in pituitary treatment centers, academic centers of excellence and in community endocrinology practices.

[Isabel Kalofonos, Chief Commercial Officer at Crinetics Pharmaceuticals]

We're making powerful strides in advancing awareness and visibility for paltusotine and our broader pipeline at conference attended by academic endocrinologists like ENDO and by community endocrinologists like ACE. We will share exciting new scientific data that reinforce the long term value of paltusotine and the need for innovation in acromegaly treatment. Notably, we present data from our four year acrobat open label extension or OLE study, demonstrating that patients on paltusotine maintained biochemical control in IGES-one over a ninety six week period. Equally important, eighty seven percent of patients preferred partucetine over prior injectable SRL therapy, highlighting the patient centric benefits of our once daily oral treatment. We will also share real world evidence that current SRL therapies are associated with persistent breakthrough symptoms and low compliance and adherence.

[Isabel Kalofonos, Chief Commercial Officer at Crinetics Pharmaceuticals]

Patients experience symptom exacerbations more than one set of days each month, and those days are not always concentrated in the week leading up to the next injection. Data from BILEFINDER-one demonstrate that patients treated with paltusotine experienced decreased symptoms exacerbation rates over time. Additionally, based on real world data compiled over a four year period, eighty percent of patients with acromegaly who are newly treated either discontinue or switch from their initial treatment within their first year. This data highlights paltusotine's scientific and clinical relevance in an area of significant unmet need to improve the lives of patients living with acromegaly. In Slide five, education and awareness are critical elements of our plan to reach patients as part of our ACTIVATE, ADOPT, ACCESS, ADHERE launch strategy.

[Isabel Kalofonos, Chief Commercial Officer at Crinetics Pharmaceuticals]

We are focused on elevating awareness of the burden of disease experienced by patients, even those currently being treated. Our insights consistently show that while patients might achieve biochemical control, they often continue to experience persistent symptoms that impact quality of life. Our educational initiatives are designed to address both aspects of disease control to ensure patients are better informed, more empowered and fully activated to advocate for treatment that addresses the unmet need of the current standard of care. We recently launched our Kineticare patient support service platform to act as a partner to patients on their treatment journey from the very beginning. We opened our hub before the anticipated approval because the acromegaly community faces significant unmet need in patient support.

[Isabel Kalofonos, Chief Commercial Officer at Crinetics Pharmaceuticals]

Clinetic Care connects patients with nurses to discuss their symptoms and offers interactive tools to help them experience healthcare providers. The Clinetic Care platform will serve as a continuous connection between us and the patients we serve. Once paltusotine is approved, KrinesiCare will provide a wide globe experience for patients from the time they receive prescriptions to initiation of therapy all the way to long term maintenance. We also recently revealed our unbranded diseases stay education campaign. This campaign leverage our learnings from our ongoing engagement with health care professionals, patients and acromegaly community partners to amplify patients' voices and provide educational materials.

[Isabel Kalofonos, Chief Commercial Officer at Crinetics Pharmaceuticals]

Turning to Slide six. We continue our pre approval conversations with payers, and we are encouraged by their feedback. In particular, we anticipate that prior authorization for patisiran will reflect the label, which will help us drive the success of reimbursement. Patuxetin value proposition is resonating with payers because their unmet need with injectable SRL, long titration times, incorrect injections and inconsistent symptom control collectively result in higher costs overall. First, patients starting on SRLs typically have their dose titrated every three months.

[Isabel Kalofonos, Chief Commercial Officer at Crinetics Pharmaceuticals]

With three different dose strengths available, it might take patients up to nine months to get to the right dose where the disease is under control. Payers bear the course of treatment for many months before the patient sees a benefit. In contrast, daily dosing ofaltucine will allow titration to the optimal levels within weeks if titration is needed. Second, SRLs are not always correctly delivered, which can lead to higher cost to manage the resulting symptoms and side effects. For context, SRL injections are given with large eighteen, nineteen gauge needle.

[Isabel Kalofonos, Chief Commercial Officer at Crinetics Pharmaceuticals]

The injections are unpleasant to receive and challenging to give. A research study conducted at MD Anderson, one of the leading centers found that half of long acting osteoarthritis injections administered by experienced nurses were not injected into the intramuscular space. The depot of UltraType instead persisted in the subcutaneous layer where they form nodules that sometimes became granular. It is important to note that if the drug is not administered properly, it might not achieve its intended ethics. In addition, payers understand that injectable SRS often do not provide adequate disease control for the duration of an injection cycle.

[Isabel Kalofonos, Chief Commercial Officer at Crinetics Pharmaceuticals]

According to our real world data analysis, one third of acromegaly patients on injectable SRS receive more than the 13 injections per year expected based on an approved dosing, which is every four weeks. Consequently, this increase is caused substantially for payers. Furthermore, ANCONTROLA primarily is associated with comorbidities and additional procedures, which are costly for payers and very burdensome for patients. Lastly, paltusotine once daily oral dosing offers an opportunity to improve patient adherence for more consistent control. In sum, there remains a significant unmet need for safe, highly efficacious, easy to administer treatments that offer daily control and the economic and clinical value that an option like paltusotine could provide to all the stakeholders is clear.

[Isabel Kalofonos, Chief Commercial Officer at Crinetics Pharmaceuticals]

These and other market insights continue to highlight meaningful unmet need in acromegaly and a strong enthusiasm for paltusotine. During early launch, we anticipate major uptake as we educate both healthcare providers and patient communities. As with any new therapy, we expect coverage to build progressively and we will work through the formulary review process with payers over the first six to nine months. Our team is highly prepared and confident in navigating this initial steps to unlock the full opportunity of paltusotine. As the value proposition continues to resonate with patients, healthcare professionals and payers, we are optimistic that over time, pactusotine could become the new standard of care in acromegaly.

[Isabel Kalofonos, Chief Commercial Officer at Crinetics Pharmaceuticals]

And now, Dana will share a regulatory update and additional detail on our CAH late stage development strategy. Dana?

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

Thank you, Isabelle. Starting with Valtuzotine, we continue to make progress in both The U. S. And EU, where our regulatory reviews remain on track. We have not experienced any disruptions with our interactions with the FDA and continue to expect a decision by September 25.

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

And as previously mentioned, we do not anticipate an advisory committee meeting as part of the NDA review. The European Medicines Agency has validated our MAA submission and granted orphan drug designation. We believe the orphan drug designation highlights the unmet need in acromegaly and the potential benefit that baptuzotine can offer patients compared to existing therapies. Our team continues to work with regulatory authorities in The U. S.

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

And EU on all aspects of the review process. In preparation for launch, our growing medical affairs team has been connecting with the endocrinology community. Our experienced endocrinologists at Kinetics have been making warm introductions for our medical science liaisons to all the top KOLs. We've hosted roundtable discussions to deepen our understanding of the patient journey and gaps in treatment. As Isabelle highlighted, we have submitted multiple abstracts to upcoming endocrinology meetings that showcase paltusotine's differentiation.

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

Moving to carcinoid syndrome, we expect to initiate the CARE FINDER Phase III trial in the second half of twenty twenty five. Turning to ADEMELNET on Slide seven. We added a fourth cohort to our Phase two study due to the significant amount of enthusiasm and interest from sites and investigators. Cohort four is just one part of our larger development plan for adomelna in CAH and it is an exploratory analysis in a small group of six to 12 patients to evaluate eighty milligrams with morning dosing as opposed to evening dosing in the prior cohorts and to allow for glucocorticoid reduction. As previously shared, we are also conducting an open label extension study, which will provide real world insights into adomelnant's efficacy and safety over the long term.

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

Investigators will have the opportunity to titrate both the dose of adomelnant and the dose of GCs as they see fit. Study participants from the Phase two study are given the opportunity to enroll in the OLE. This study is ongoing and will eventually also include patients who complete Phase three. Turning to Slide eight. Our Phase III study for adomelmen in adult CAH patients builds on the strong top line results we shared from Cohorts one through three of the Phase II study.

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

It is designed to provide a potential new therapeutic paradigm for patients. As Scott mentioned, there is a significant need for new treatments in CAH that not only allow patients to lower their GC dose to physiologic levels, but also to control their androgens, which account for many of the signs and symptoms of the underlying disease. With this in mind, we are pursuing a novel primary endpoint that combines both goals. The proportion of participants with A four levels less than or equal to the upper limit of normal and who are on physiologic doses of GC replacement at week thirty two. Patients should not have to sacrifice one or the other in treating CAH.

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

In this study, we will enroll 150 participants who will be treated for thirty two weeks. We will offer investigators two periods of time over which they can reduce GCs with four assessment visits in each period. Investigators are given additional flexibility for physician guided reductions. We designed this individualized approach in response to feedback we received from investigators who prefer to use their discretion in titrating GCs as they would in a real world scenario with the goal of reaching physiologic doses. Based on the early and profound decrease in A four seen with animelmet treatment in the Phase two study, we are measuring A four at just two weeks after the study initiation and allowing investigators to assess glucocorticoid reduction immediately thereafter.

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

Midway through the study, participants will be on stable GC doses for several weeks so their A four can be measured. Investigators will then have the option to titrate patients up to one hundred and twenty milligram dose of Adameldin if the patient needs more A four control. Otherwise, participants will continue on eighty milligrams. The key secondary and other endpoints are designed to demonstrate potential benefits beyond what has been achieved with existing standard of care for CAH patients. In addition to reductions in key disease biomarkers such as A four and seventeen OHP and other androgens, we will study improvement in the clinical signs and symptoms of CAH, including, but not limited to, restoration of menses, testicular adrenal breast tumors or TARTs and adrenal size.

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

Our primary endpoint will use morning androgen measurement post GC dosing, consistent with the previous regulatory precedent. However, in our secondary endpoint, measuring these hormone levels pre GC dosing is a rigorous test of efficacy because the androgen levels can be influenced by morning GC administration. Consistent with our patient centric approach to drug development, we will include a novel disease specific patient reported outcomes tool as part of the study design. The last piece of our CAH development program is the combined Phase IIIII study in pediatric patients. We are finalizing our specific plans for integrating each age group into the registrational study, and we have already received helpful feedback from FDA and European authorities on our proposed study design.

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

In summary, as illustrated on Slide nine, we believe ADMELIN has the potential to establish uncompromising treatment goals for people living with CAH by addressing both elevated androgens and reducing the need for supraphysiologic glucocorticoid dosing, which could lead to negative side effects for patients. We believe glucocorticoids should ideally only be used to provide physiologic replacement, not to treat the underlying disease. Our Phase III trial aims to provide a tailored approach to treatment for individual patients, enroll a broad patient population inclusive of patients who could benefit from GC normalization, androgen normalization or both and measure clinical outcomes that are paramount to both HCPs and patients. Our vision is to lower the burden of disease overall and provide a new standard of care for the seventeen thousand plus people living with CAH. Moving to Slide 10.

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

We are making steady progress on the rest of our pipeline, and we are pleased to announce IND clearance for nine thousand six hundred eighty two, the first candidate from our non peptide drug conjugate or NDC platform. Nine thousand six hundred eighty two is being studied for SST2 positive tumors, including neuroendocrine tumors or NETs to complement our carcinoid syndrome indication with paltusotine. Additionally, our discovery team continues to identify new ways to leverage the NDC platform for novel targets to address unmet needs in endocrine oncology. As mentioned in our press release, IND enabling studies for the TSH antagonist are continuing as expected. Also, we continue to progress our SST3 agonist candidate.

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

Based on emerging data from IND enabling studies, our PTH antagonist candidate preclinical development has been substituted with another candidate expected to exhibit an improved profile. This new candidate is in IND enabling studies, which we intend to complete next year. This decision is reflective of the rigorous process we followed with paltusotine and adamelnib and that we apply to all our pipeline programs. We look forward to highlighting our early stage pipeline in more detail at our upcoming R and D Day on June 26. Of note, we will cover NET and beyond with nine thousand six hundred eighty two for SST2 expressing tumors and Valtusotine for carcinoid syndrome.

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

We will also present our TSH antagonist for Graves' thyroid eye disease and our SST3 agonist for ADPKD. These programs represent the next generation of Kinetics innovation and have the potential to positively impact the lives of patients and their caregivers across multiple communities. With that, Toby will now provide the financial update.

[Tobin Schilke, CFO & Principal Accounting Officer at Revance Therapeutics]

Thank you, Dana. Turning to Slide 11. I am pleased to be participating in my first earnings call at Kinetics. It is a privilege to join with a patient centric mission and leading edge science. We are poised for growth and importantly, well capitalized to execute on our ambition.

[Tobin Schilke, CFO & Principal Accounting Officer at Revance Therapeutics]

Now I will present the financial results for the first quarter of twenty twenty five. I will not read aloud the full results as they are available in our press release and on our Form 10 Q filing. Beginning with our income statement, we recognized $400,000 of revenue during the first quarter of twenty twenty five compared to $600,000 during the same period in 2024. As a reminder, this revenue is non cash and is based on amortization of payments we received in connection with our paltusotine licensing arrangement with our Japanese partner SKK. Our research and development expenses in the first quarter of twenty twenty five were $76,200,000 a 43% increase compared to the same period in 2024.

[Tobin Schilke, CFO & Principal Accounting Officer at Revance Therapeutics]

Excluding depreciation, amortization and stock based compensation, R and D expense was $64,400,000 The increase in R and D expenses was primarily due to additional personnel, increased manufacturing costs and higher outside services costs to advance our clinical programs and expand our preclinical portfolio. We expect quarterly R and D spend to increase sequentially through the remainder of the year, primarily driven by Phase three clinical trials for paltusotine and atumelna. Our selling, general and administrative expenses for the first quarter of twenty twenty five were $35,500,000 a 71% increase compared to the same period in 2024. Excluding depreciation, amortization and stock based compensation, SG and A expense was $26,200,000 The increase in SG and A expense was primarily driven by growth to support our ongoing programs and the planned commercial launch of paltusotine. We expect quarterly SG and A investment to increase sequentially through the remainder of the year as we continue to build our commercial infrastructure and prepare for the anticipated launch of paltusidine.

[Tobin Schilke, CFO & Principal Accounting Officer at Revance Therapeutics]

Our cash used in operations for the three months ending 03/31/2025 was $88,500,000 compared to $52,900,000 for the same period in 2024. For 2025, we continue to anticipate our cash used in operations to be between three forty million and $380,000,000 This compares to $226,000,000 of cash used in operations in 2024. Approximately 60% of the increase relative to 2024 is due to R and D investments with the balance due to SG and A. Turning to Slide 12. We ended the first quarter of twenty twenty five on strong financial footing with approximately $1,300,000,000 in cash, cash equivalents and investments, which we continue to expect to fund our operations into 2029.

[Tobin Schilke, CFO & Principal Accounting Officer at Revance Therapeutics]

As a reminder, we could potentially receive up to $250,000,000 if Lilly exercises its option to acquire Radionetics. Kinetics has always been disciplined with capital allocation and we continue to take a prudent approach to execute on the compelling opportunities ahead of us. We believe our strong balance sheet positions us to deliver on our near term milestones, including the anticipated approval and launch of paltusotine and advance our deep enrich pipeline in parallel. I'll now turn it over to Scott for closing remarks. Scott?

[R. Scott Struthers, Founder & CEO at Crinetics Pharmaceuticals]

Thank you, Toby. Moving on to Slide 13. At Kinetics, our core mission is to improve patients' lives and transform the treatment paradigm in areas of serious unmet need like acromegaly. For over ten years, we have partnered with patients for their direct input on our discovery effort, clinical designs and patient resources. We design our therapies to allow patients to live their best lives instead of letting their disease define.

[R. Scott Struthers, Founder & CEO at Crinetics Pharmaceuticals]

With our strong pipeline of late and early stage candidates and the support of our robust balance sheet, we are well positioned to deliver on our clinical regulatory and commercial priorities in 2025 and beyond. With that, I'll hand the call back to the operator to begin the Q and A. Please limit yourselves to one question each in the interest of time. Operator?

[Operator]

Thank you, Scott. First question comes from Yasmeen Rahimi with Piper Sandler. Line is open. Please go ahead.

[Yasmeen Rahimi, Sr. Research Analyst at Piper Sandler Companies]

Good afternoon, team. Thank you so much for all the great updates. Two quick questions. The first question is, could you talk about the powering of your very innovative primary endpoint, which is a co primary? And then short question for Cohort four, have you been able to collect any data from that cohort yet?

[Yasmeen Rahimi, Sr. Research Analyst at Piper Sandler Companies]

And I'll jump back in the queue. Thank you again.

[R. Scott Struthers, Founder & CEO at Crinetics Pharmaceuticals]

Thanks, I'll hand that over to Alan to answer.

[Alan Krasner, Chief Endocrinologist at Crinetics Pharmaceuticals]

Well, hi, Jess. So with regard to the powering of the study, it's, I would say, very highly powered to detect statistically significant differences between the treatment arm and the placebo arm across a range of potential deltas between groups. And I think that acumelmin is well situated to achieve this endpoint that Dana discussed earlier, showing both normalization of A four and physiologic dosing of glucocorticoid.

[Alan Krasner, Chief Endocrinologist at Crinetics Pharmaceuticals]

With regard to cohort four,

[Alan Krasner, Chief Endocrinologist at Crinetics Pharmaceuticals]

this is enrolling and I can't speak yet to the timing of data. I think what we would do, of course, is show new data at scientific meetings. But the timing of that, I can't comment on quite yet. One other lexicon thing I'd like to mention is the kind of primary endpoint we're talking about. I think it's better described as a composite endpoint rather than a co primary endpoint.

[Alan Krasner, Chief Endocrinologist at Crinetics Pharmaceuticals]

There are two components to the endpoint. A co primary though is something else where you kind of have to each component has to statistically stand by itself. Whereas a co primary is basically a responder analysis where a responder is defined as having both normal glucocorticoid doses and normal A four levels.

[Operator]

Our next question comes from Jessica Fye with JPMorgan. Your line is open. Please go ahead.

[Jessica Fye, Managing Director & Equity Research Analyst - Biotechnology at JP Morgan]

Hey guys, good afternoon. Is the CALM CAH study design fully signed off on by FDA as a trial that could support registration? And what indication statement would you hope to secure assuming the trial is successful? Do you think you'd need one or two trials to get approved for CAH? Thank you.

[R. Scott Struthers, Founder & CEO at Crinetics Pharmaceuticals]

Thanks, Jess. I'll let Dana answer that one.

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

Yes, sure, Jess. Thanks for the question. The protocol was put together based upon input from FDA as well as other health authorities, and they are aware of the final study design. I think that the other parts of your question were About the indication statement. Yes.

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

It's hard to say right now an indication, but I think what and the data, of course, will define what we can talk with the agency about. But the basic difference that we have is what we are trying to develop here is a drug that will treat the disease, the CAH, right, and will only need glucocorticoids for the prevention of adrenal insufficiency, right? So if you look at the Cranesiti indication, it's as an adjunct to glucocorticoids for the control of androgens. So that implies that glucocorticoids are necessary to control the androgens. In our situation, based upon our Phase II data, it's the added element that's really going to drive the production in androgens, and therefore, you don't need glucocorticoids to treat that part of the disease.

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

And as I mentioned when we did the call, we really only expect that the glucocorticoids will be used for physiologic replacement. We expect that that could result in a slight difference in how the indication is granted.

[Operator]

Our next question comes from Gavin Clark Gardner with Evercore ISI. Your line is open. Please go ahead.

[Gavin Clark-Gartner, Director - Biotechnology Equity Research at Evercore ISI]

Hey, guys. Thanks for taking the questions. First, just on the primary endpoint for the Phase III, what's the rationale to test the endpoint at a single point in time at thirty two weeks as opposed to averaging across multiple time points? Is there any risk that A four variability may lead to some non responders who maybe shouldn't be non responders?

[Alan Krasner, Chief Endocrinologist at Crinetics Pharmaceuticals]

Thanks for the question, Gavin. I think generally responder analyses are conducted at single points in time rather than averages. There is always variability with biochemical markers. Before, I think, of all the choices in this disease state is one of the least variable. And again, there's a lot of confidence that this compound can achieve both components of the composite primary endpoint.

[Alan Krasner, Chief Endocrinologist at Crinetics Pharmaceuticals]

And therefore, the odds that variability would variability might explain one of these endpoints hitting it once in a while on an occasional occasion, but hitting both is quite, I think, specific. And I would anticipate pretty strong results that are clearly delineated from placebo.

[Operator]

Our next question comes from Tyler Van Buren with TD Securities. Your line is open. Please go ahead.

[Frances Dovell, Biotech Equity Research Analyst at TD Cowen]

Hi, this is Francis on for Tyler. So just one question about the fourth atenolment cohort. So what is the rationale for looking at the morning dosing versus the evening dosing?

[R. Scott Struthers, Founder & CEO at Crinetics Pharmaceuticals]

Yes. Thanks for the question. This is Scott. I think for many of us, it'd be more convenient to perhaps take the drug in the morning rather than in the evening. We just wanted to explore that to provide future optionality for patients.

[R. Scott Struthers, Founder & CEO at Crinetics Pharmaceuticals]

Maybe just to clarify a little bit, reminder that there's a strong diurnal rhythm in this axis, including in the CAH patients. So you just want to be sure that the timing of the drug in respect to the diurnal rhythm doesn't have a significant effect.

[Operator]

Our next question comes from Cory Chauvinville with LifeSci Capital. Your line is open. Please go ahead.

[Cory Jubinville, Managing Director & Research Analyst at LifeSci Capital, LLC]

Good afternoon. Thanks for taking our questions. So you folks have recently received acceptance for your marketing application for paltusotine in Europe. Curious how you're thinking about launch strategy in these different geographies. You previously discussed patient concentration in The U.

[Cory Jubinville, Managing Director & Research Analyst at LifeSci Capital, LLC]

S. Is largely at these pituitary centers of excellence. Is patient concentration similar to those in Europe and or Latin America? And what, if any, are some of the material differences in the way that acromegaly patients might be treated in those geographies that might be important to consider for a launch?

[Alan Krasner, Chief Endocrinologist at Crinetics Pharmaceuticals]

That's a great question.

[Isabel Kalofonos, Chief Commercial Officer at Crinetics Pharmaceuticals]

Yes, I

[R. Scott Struthers, Founder & CEO at Crinetics Pharmaceuticals]

was going to hand that off to Isabelle who's on the line here. Go ahead, Isabelle. Sorry.

[Isabel Kalofonos, Chief Commercial Officer at Crinetics Pharmaceuticals]

Sure, no problem. Hi, Curie. Yes, so we are very excited to have the filing approved and we are preparing for the launch in Germany where also there is a significant unmet need for patients with acromegaly. So to your question, the European markets tend to be more concentrated in terms of even more patients are part of the centers of excellence. There is a little bit more of community in Germany than the rest of the markets, but still a ratio of about 70% to 30%, seventy % on key centers.

[Isabel Kalofonos, Chief Commercial Officer at Crinetics Pharmaceuticals]

We continue to research to confirm that. And so highly concentrated, we are working extensively in our market access strategy and in our discussions with TBA and the different markets. And we are going to be very progressive, be very thoughtful about how we continue to expand there. So right now, we have a footprint in Zug. We have our team in place in Germany.

[Isabel Kalofonos, Chief Commercial Officer at Crinetics Pharmaceuticals]

And it's a very small group of resources that we think will help us maximize the opportunity there and help as many patients as possible. Regarding Latin America, you have seen also that there is a high unmet need and a low patient that has been identified. So the one country that we have considered as a country for expansion is Brazil. As you have seen in our clinical trials, 30 patients in our acromegaly studies were recruited there. We have very good relationships with the different centers and it's also concentrated.

[Isabel Kalofonos, Chief Commercial Officer at Crinetics Pharmaceuticals]

So we see the opportunity there to also serve the patients beyond The United States. So it's a commitment for Kinetics to actually serve patients, not only in The U. S. But in as many countries as possible, but we will be very gradual about our geographic expansion.

[Operator]

Our next question comes from John Wallovan with Citizens. Your line is open. Please go ahead.

[Analyst]

Hi. This is Catherine on for John. I had a

[Analyst]

quick question about the 09/1982 program and the Phase onetwo trial which was about to, I guess, speak that you're planning to begin soon. Any details you could share on the trial design and kind of what you want to learn? And also any particular safety kind of issues that you're going be looking out for in this trial?

[Analyst]

Thank you.

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

Yes. This is Dana. And we look forward to actually sharing a little bit more about this at the R and D Day that we're going to have in June. And so that'll be sort of front and center for those discussions. But our general approach is that it's fairly going to be a fairly standard dose escalation design protocol for oncology.

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

And obviously, when you're treating patients as opposed to healthy volunteers in your Phase I, you have additional safeguards and sort of parameters that you're looking at, particularly around safety. But we'll be very excited to share more details on that later.

[Operator]

Our next question comes from Alex Thompson with Stifel.

[Alex Thompson, Managing Director at Stifel Institutional]

Another

[Alex Thompson, Managing Director at Stifel Institutional]

on the CAH Phase III. Just wondering if you could talk a little about your design here in the context of the glucocorticoid reduction and investigator discretion. Are there any overall guidelines for how to

[Alex Thompson, Managing Director at Stifel Institutional]

do this? Or how confident are you that you're not going to

[Alex Thompson, Managing Director at Stifel Institutional]

see a significant amount of variability here in the study? Thanks.

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

Well, I think part of

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

the sort of overall sort of mindset that we're trying to convey in the trial conduct here was that we wanted it to be as similar as possible to the real world in what investigators would want to do in terms of reducing glucocorticoids. Obviously, patients can come in with quite a lot of differences in what their glucocorticoid levels are and some may have very, very high levels. And so what we wanted to do was allow enough time in the first part and the second part of the trial so that that could be done judiciously and carefully with the investigator deciding what increments they want to use in decreasing that. We have some general guidances that we put in the protocol about what the limits on those increments should be. But in general, we'd like to leave it up to the PIs to decide what's best for their patients that are in the trial.

[Operator]

Our next question comes from Maxwell Skor with Morgan Stanley. Your line is open. Please go ahead.

[Maxwell Skor, Analyst at Morgan Stanley]

Great. Thank you for taking my question. I was just wondering, I recognize you're not interacting directly with CBER for palatuzumab. But I was wondering if you'd comment on the evolving regulatory environment overall and how you're thinking about any potential implications for the rare disease space?

[Maxwell Skor, Analyst at Morgan Stanley]

Thank you.

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

Yes. As you know, we're working with the CDER part of FDA. And so far, we really haven't seen much of a difference in terms of how things are progressing and across all of the programs, not just with paltusotine. So it's right now, it seems like regular order for the way that FDA is working, particularly with programs like ours.

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

And most of our programs are rare disease programs. We don't really see any differences at this point.

[Operator]

Our next question comes from Joseph Schwartz with Leerink Partners. Your line is open. Please go ahead.

[Will Soghikian, Vice President - Equity Research at Leerink Partners]

Hey, all. This is Will on for Joe. Thanks for taking our question. Congrats on the progress this quarter. So one on paltusotine.

[Will Soghikian, Vice President - Equity Research at Leerink Partners]

Now that we're getting closer to the eventual commercial launch, could you provide any preliminary comments on how you might be thinking about pricing? And then with the recent MFN pricing headlines, does this change your thinking around the general strategy at all? And finally, can you just remind us of where the drug is manufactured? Thanks so much.

[R. Scott Struthers, Founder & CEO at Crinetics Pharmaceuticals]

I'll answer the manufacturing and then leave it to Isabelle to not answer your question on pricing directly, but give you some thoughts about how we're thinking. In terms of manufacturing, the final tablets are made here in The U. S. And packaging here in The U. S, although we get precursors and final API from Europe and originally in India.

[R. Scott Struthers, Founder & CEO at Crinetics Pharmaceuticals]

So that answers that part. But maybe, Isabel, can you talk just a little bit about the value we're hoping to deliver?

[Isabel Kalofonos, Chief Commercial Officer at Crinetics Pharmaceuticals]

Yes, of course. As I mentioned it before, the value proposition of participating is resonating really well with payers, you know, fast onset of action, durable effect, easy to use, one daily dosage for patients. And also the fact that they don't have to deal with the breakthrough symptoms and the wastes currently associated with injectables. At this time, we are not commenting on price. Of course, it's something that we are looking at very closely.

[Isabel Kalofonos, Chief Commercial Officer at Crinetics Pharmaceuticals]

We are conducting market research, advisory boards with payers. And as I mentioned, what is very positive for us is that the value proposition is resonating very well and we are tracking on that. We don't see at this point answering your second question any impact in our strategy based on the recent dynamics, but of course we're closely monitoring that with our government affairs group as well and we'll continue to do so considering that about 40% of the population is in Medicare Medicaid, 30% Medicare, 10% Medicaid and we want to continue to monitor the potential impact in the But for now, there are no dynamics.

[Operator]

Our next question is from Dennis Ding with Jefferies. Your line is open. Please go ahead.

[Analyst]

Hi. This is Anthea on for Dennis. Thank you for taking our questions. On CAH, the long term extension, can you give an update on enrollment and follow-up there? And what is the critical mass that you need to give another update to investors?

[Analyst]

Thank you.

[Alan Krasner, Chief Endocrinologist at Crinetics Pharmaceuticals]

Well, enrollment is proceeding and we will of course, once we have a critical mass, we would present to the scientific meeting. I can't really comment on numbers and exact timing at this time. But again, the OLE is another way for us to assess how the compound performs in sort of a more real world setting, which the doctors have control over the dosing of the compound as well as over the dosing of the glucocorticoids. It's always very valuable data for us and we look forward to reporting that when we can.

[Operator]

Our next question is from David Lebowitz with Citi.

[David Lebowitz, Analyst at Citigroup]

The new primary endpoint seems to be a higher bar. And I am curious, do you reserve the ability to maintain also the same primary endpoint as clinecerfont to potentially use if needed for FDA approval? So, I think you're right, it is

[R. Scott Struthers, Founder & CEO at Crinetics Pharmaceuticals]

a higher bar. We're asking the study to see if axiomala can really be the treatment for CAH and give patients an option so that they don't have to compromise on either glucocorticoid levels or the adrenal precursors that are being produced. And so it's intentionally a high bar, but I think it's designed specifically for Afinoma because that's the type of study that this drug deserves. Maybe I'll let Dana talk about the endpoint cascade.

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

I think

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

just along the lines

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

of what Scott was just saying, the patient population is also different from what Cranesity studied in that we have a broader patient population. As you recall in their study, basically what they were looking at was trying to reduce GCs and day four was sort of a side issue. It had to be roughly where it started, which could have been normal, could have been sort of above normal. And so what we like to do is be able to address the full population of patients who have CAH, who may have high A4s and not so high GCs, high GCs and normal A four and high both. And so in order to do that, you really can't have the same endpoint as quinesity had.

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

Okay, so now we also have a cascade, as I mentioned in the call, of secondary endpoints. And some of those are looking at certain aspects of how quickly we work and then sort of other combinations of particular endpoints of interest. But we also will look in the same way that they did at somewhat similar endpoint for theirs too, but that's not what we intend to use for the FDA. You can't sorry, if we make the primary endpoint this broader endpoint, that's what it is required

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

to have to get approved.

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

So we can't change the endpoint.

[R. Scott Struthers, Founder & CEO at Crinetics Pharmaceuticals]

And I

[R. Scott Struthers, Founder & CEO at Crinetics Pharmaceuticals]

think it's maybe important to remind all of us that we're building a study that measures a variety of different parameters of the impact of SMLN on the lives of CAH patients. And it's that whole package that will be the basis for guiding physicians about how this might be used, should it be approved. And so we're interested in developing a broad profile, and that's the primary endpoint is one thing, and I know we'll all focus on that, but also getting to how much do we reduce the A four levels or 17 OHP, which are a couple of our first secondary endpoints, because those lowering is important too, even if you only get slightly above the upper limit of normal. So the goal of the study is to capture all of this to provide the ability to guide physicians and then eventually to use in our commercialization efforts.

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

And we also intend to look closely at the other clinical endpoints and adrenal size as well.

[Operator]

Our next question comes from Brian Skorney with Baird. Your line is open. Please go ahead.

[Brian Skorney, Senior Research Analyst at Baird]

Good afternoon. Thanks for taking the question.

[Brian Skorney, Senior Research Analyst at Baird]

Just also on CAH study, in terms of enrollment criteria, how do you kind of compare exclusion inclusion criteria to the CANALYST study? Are there differences and criteria around GC dose A four, seventeen, OHP to consider? And the pediatric plan you have billed as a Phase twothree, is this just nomenclature? Is there a dose finding portion for the PED study that proceeds full Phase three enrollment?

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

Okay. Just to make sure that I understand, like the you asked about the entry criteria for our trial, right, first for the adult trial. And I think that, as I mentioned before, what we're trying to do is to capture a broader population than the previous trial from PrinectaPlan. Now in terms of our pediatric program, we've also received feedback from health authorities on that. We're going to try to achieve the same things that we're doing for the adult program and we just need to make sure that we have the doses right for the right size kits.

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

We'll be gradually working through that. We don't plan to do it differently. As you recall in the clonestrophon trial, they didn't they held the GC's constant in that one. So there was no GC reduction. So that's sort of one of the big differences.

[Operator]

Our next question comes from Douglas Tsao with H. C. Wainwright. Your line is open. Please go ahead.

[Douglas Tsao, Managing Director at H.C. Wainwright & Co.]

Hi, good afternoon. Thanks for taking the questions and welcome to Toby to the Cranex call. It's real hearing him on on a recent call, but maybe just as a follow-up on CAH and the pediatric study. I'm just curious how you think about that program moving forward? Do you anticipate sort of Dana, you referred to sort of need to do some dose exploration.

[Douglas Tsao, Managing Director at H.C. Wainwright & Co.]

Would you anticipate needing potentially to do two studies there? Or do you think there's an opportunity to do an adaptive design, which would enable you to only run one study? And again, would you anticipate you just said that you anticipate sort of having the same goal as with the CALM CAH study. Is that implied that you would think about the same endpoint in terms of normalization A four and physiologic GC? Or is there some other potential sort of similar endpoint, but perhaps a slightly different one sort of targeted for the pediatric population?

[Dana Pizzuti, Chief Medical & Development Officer at Crinetics Pharmaceuticals]

Well, I think to answer your first part of your question, and maybe Alan can comment on the treatment objectives. But as far as the first question, the way we've designed this study is to be sort of a seamless design, right, as opposed to two separate trials. And so the way that it will work is the Phase II part will guide the Phase III part. And so we don't plan on doing separate trials on that. But I think maybe Alan can comment on the treatment objectives for the pediatricians on this.

[Alan Krasner, Chief Endocrinologist at Crinetics Pharmaceuticals]

Yes. Second, the reason I'm really excited and very supportive of this endpoint that we're talking about, normal GCs and normal A4s, is because this really is treatment goal for this disease. And by the way, it's the same for pediatric patients and adult patients. This is what you want to achieve in clinic. It's very hard to do that these days with available treatments.

[Alan Krasner, Chief Endocrinologist at Crinetics Pharmaceuticals]

I really think Ethamelin has a lot to offer here to achieve that two part goal. So yes, I think it would be very similar in pediatric patients ultimately.

[Operator]

Our next question comes from Andy Chen with Wolfe Research. Your line is open. Please go ahead.

[Andy Chen, Director, Senior Equity Research Analyst at Wolfe Research]

Hey, thank you for taking the question. And back to your Phase III trial design. So I understand that the speed of reduction is individualized, but is it mandatory reduction at each stage of GC reduction? Or is it optional reduction for patients? If it's optional, does that make the primary endpoint very wonky and highly dependent on baseline characteristics of patients?

[Andy Chen, Director, Senior Equity Research Analyst at Wolfe Research]

Is that a worry here or no? Thank you.

[R. Scott Struthers, Founder & CEO at Crinetics Pharmaceuticals]

Well, maybe just this is Scott. Just as a quick reminder, we may have patients in who have physiologic replacement, but their A four levels are already high. So they don't need a glucocorticoid reduction. So you have to account for that in the way you design the protocol. But maybe you want to explain a little bit more, Alan?

[Alan Krasner, Chief Endocrinologist at Crinetics Pharmaceuticals]

Right. It's a good point, Scott. And those who do come in on high glucocorticoid doses, I want to be clear that, yes, this is not optional. The protocol requires, particularly at certain predefined visits, glucocorticoid dose reductions. Of course, the investigator has to make the individualized these dose reductions based on toleration and safety.

[Alan Krasner, Chief Endocrinologist at Crinetics Pharmaceuticals]

But these dose reductions are expected and would be very carefully monitored and followed. And I agree, it's important to reduce the doses of glucocorticoid in those who come in on high doses in order to achieve this endpoint and also to achieve the goal in clinic, which is the same. So yes.

[Operator]

Our next question comes from Catherine Novak with Jones. Your line is open. Please go ahead.

[Catherine Novack, Director - Healthcare Equity Research at JonesTrading]

Hi. Afternoon, everyone. I just wanted to ask one question about paltusotine. So based on PATHFINDER two, we know you can go into treatment naive patients, but do you anticipate any possible step through requirements for payers based on price? How are you thinking about that?

[R. Scott Struthers, Founder & CEO at Crinetics Pharmaceuticals]

Isabel?

[Isabel Kalofonos, Chief Commercial Officer at Crinetics Pharmaceuticals]

Thank you. Thank you for the question. Well, as you know, we have a pathfinder to was looking at naive patients, also washout patients and patients that had discontinued continuing therapy. Our current discussions with payers don't anticipate any step therapy. And so far, the feedback is that they will really just hold us to the label in terms of prior authorization, which in general is a very positive sign for us.

[Isabel Kalofonos, Chief Commercial Officer at Crinetics Pharmaceuticals]

And at this point, we don't anticipate that.

[Operator]

We currently have no further questions. I'll now hand back to Scott Strouffers for closing remarks.

[R. Scott Struthers, Founder & CEO at Crinetics Pharmaceuticals]

Thank you, everybody, for being with

[R. Scott Struthers, Founder & CEO at Crinetics Pharmaceuticals]

us today. And maybe I'll just take a brief moment to also thank our colleagues at the FDA for their hard work on multiple different programs we're working on and keeping up the normal course of business, at least as far as we've seen. So thank you all, and have a great afternoon and weekend.

[Operator]

This concludes today's call. Thank you for joining. You may now disconnect your lines.

Participants

Executives

• Gayathri Diwakar, Head of IR
• R. Scott Struthers, Founder & CEO
• Isabel Kalofonos, Chief Commercial Officer
• Dana Pizzuti, Chief Medical & Development Officer
• Alan Krasner, Chief Endocrinologist

Analysts

• Tobin Schilke, CFO & Principal Accounting Officer at Revance Therapeutics
• Yasmeen Rahimi, Sr. Research Analyst at Piper Sandler Companies
• Jessica Fye, Managing Director & Equity Research Analyst - Biotechnology at JP Morgan
• Gavin Clark-Gartner, Director - Biotechnology Equity Research at Evercore ISI
• Frances Dovell, Biotech Equity Research Analyst at TD Cowen
• Cory Jubinville, Managing Director & Research Analyst at LifeSci Capital, LLC
• Analyst
• Alex Thompson, Managing Director at Stifel Institutional
• Maxwell Skor, Analyst at Morgan Stanley
• Will Soghikian, Vice President - Equity Research at Leerink Partners
• David Lebowitz, Analyst at Citigroup
• Brian Skorney, Senior Research Analyst at Baird
• Douglas Tsao, Managing Director at H.C. Wainwright & Co.
• Andy Chen, Director, Senior Equity Research Analyst at Wolfe Research
• Catherine Novack, Director - Healthcare Equity Research at JonesTrading