On November 4, 2025 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, reported its results for the quarter ended September 30, 2025.

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Financial Results

"The third quarter marked another period of robust growth in our hypercortisolism business. Once again, we had a record number of new prescriptions written for Korlym and continued to add to our base of prescribers. Growing recognition among physicians of hypercortisolism’s true prevalence and the necessity of appropriate treatment is driving higher rates of screening and diagnosis. Our financial results don’t fully reflect this surge in demand, given capacity constraints at our previous specialty pharmacy vendor. We have modified our 2025 revenue guidance to $800 – $850 million. We added a new specialty pharmacy on October 1st and will add others in the coming months. We are confident that these additions will allow us to meet the increasing demand that we now see every month," said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer.

Corcept’s third quarter 2025 revenue was $207.6 million, compared to $182.5 million in the third quarter of 2024. Third quarter 2025 operating expenses were $197.4 million, compared to $135.9 million in the same period last year, due to increased spending to prepare for the launches of relacorilant to treat patients with hypercortisolism and platinum-resistant ovarian cancer. Net income per common share (diluted) was $0.16 in the third quarter of 2025, compared to $0.41 in the third quarter of 2024.

Cash and investments were $524.2 million at September 30, 2025, compared to $515.0 million at June 30, 2025. The balance at September 30, 2025 reflects the acquisition of $50.6 million of common stock in the third quarter pursuant to the company’s stock repurchase program as well as shares acquired upon the exercise of employee stock options and the vesting of restricted stock grants.

Clinical Development

"We are approaching important clinical development milestones," said Dr. Belanoff. "Our New Drug Application (NDA) for relacorilant in hypercortisolism has a Prescription Drug User Fee Act (PDUFA) date of December 30, 2025. The PDUFA date for our NDA for relacorilant in platinum-resistant ovarian cancer is July 11, 2026. We believe both deadlines will be met.

"In addition, our clinical studies will soon produce important data. We expect results from MOMENTUM, our trial evaluating the prevalence of hypercortisolism in patients with resistant hypertension, and final overall survival results from our pivotal ROSELLA trial by early next year. Results from our BELLA trial in patients with advanced ovarian cancer should be available by the end of next year, as will results from MONARCH, our Phase 2b trial in patients with metabolic dysfunction-associated steatohepatitis (MASH)."

"We are also about to start important new studies," added Dr. Belanoff. "These include a Phase 3 trial of dazucorilant in patients with ALS, which will seek to replicate the benefit patients exhibited in our DAZALS trial. In addition, we will initiate Phase 2 trials of relacorilant in combination with chemotherapy and a Phase 1b trial of nenocorilant in combination with immunotherapy in patients with a broad range of solid tumors."

Hypercortisolism (Cushing’s Syndrome)

FDA review of our relacorilant NDA continues, with a December 30, 2025 PDUFA date
MOMENTUM – Enrollment continues in 1,000-patient trial examining the prevalence of hypercortisolism in patients with resistant hypertension; results expected by early next year
CATALYST Part 1 – Prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes – Results published in Diabetes Care (Buse et al, April 2025)
CATALYST Part 2 – Randomized, double-blind, placebo-controlled study of Korlym in 136 patients with hypercortisolism and difficult-to-control type 2 diabetes – Results presented at the American Diabetes Association’s 85th Scientific Sessions; published in Diabetes Care (DeFronzo et al, June 2025)
"Relacorilant has the potential to become the new standard of care for patients with hypercortisolism. In its Phase 2 and Phase 3 studies, patients treated with relacorilant showed clinically meaningful and statistically significant improvements in a wide range of hypercortisolism’s signs and symptoms, without off-target effects and toxicities associated with currently available treatments," said Bill Guyer, PharmD, Corcept’s Chief Development Officer.

"Our CATALYST study showed that there are significantly more patients with hypercortisolism than previously assumed and that treatment with a cortisol modulator is highly effective in improving their signs and symptoms. We expect that CATALYST’s findings, along with results from our MOMENTUM study examining the prevalence of hypercortisolism in patients with resistant hypertension, will lead to more screening and treatment of patients with hypercortisolism," added Dr. Guyer.

Oncology

Relacorilant in Combination with Chemotherapy

New Drug Application – FDA reviewing NDA for relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer, with a July 11, 2026 PDUFA date
Marketing Authorization Application (MAA) – European Medicines Agency reviewing MAA for relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer – Approval expected by the end of next year
ROSELLA – Primary endpoint met in pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in 381 patients with platinum-resistant ovarian cancer – Results presented at the ASCO (Free ASCO Whitepaper) (American Society of Clinical Oncology) and ESMO (Free ESMO Whitepaper) (European Society for Medical Oncology) 2025 annual meetings and published in The Lancet (Olawaiye et al, June 2025) – Final overall survival results expected by early next year
BELLA Part A – Enrollment nearly complete in Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab in 90 patients with platinum-resistant ovarian cancer – Results expected by the end of next year
BELLA Part B – Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab in 90 patients with platinum-sensitive ovarian cancer whose disease progressed while on a PARP inhibitor to begin in coming weeks
BELLA Part C – Phase 2 trial of relacorilant plus nab-paclitaxel in 90 patients with endometrial cancer (who have received one or two prior lines of therapy) to begin in coming weeks
Cervical cancer – Phase 2 trial of relacorilant plus nab-paclitaxel in 50 patients with cervical cancer (received one or two prior lines of therapy) to begin in coming weeks, conducted in collaboration with ARCAGY-GINECO, an academic clinical research group specializing in gynecologic cancers
Pancreatic cancer – Phase 2 trial of relacorilant plus nab-paclitaxel and gemcitabine as first-line therapy in 50 patients with pancreatic cancer to begin in coming weeks
Relacorilant in Combination with Androgen Deprivation Therapy

Prostate cancer – Enrollment continues in randomized, placebo-controlled, Phase 2 trial of relacorilant plus enzalutamide in 90 patients with early-stage prostate cancer, conducted in collaboration with the University of Chicago
Nenocorilant in Combination with Immunotherapy

Solid tumors – Phase 1b dose-finding trial of nenocorilant, our proprietary selective glucocorticoid receptor antagonist, plus nivolumab in 30 patients with a variety of solid tumors to begin in coming weeks – nenocorilant’s first study in patients
"We are seeking approval of relacorilant in patients with platinum-resistant ovarian cancer (PROC) in both the United States and Europe based on positive data from our Phase 2 and pivotal Phase 3 ROSELLA trials. These trials’ groundbreaking results, in which relacorilant improved progression-free and overall survival in patients with a highly challenging form of ovarian cancer without increasing the safety burden of the patients who took it, highlight relacorilant’s potential to become the new standard care in PROC," said Dr. Guyer.

"All of our pre-clinical and clinical oncology data point to the potential of glucocorticoid receptor antagonism to benefit patients across a wide variety of solid tumors, beyond PROC," he added. "That is why in the next few weeks, we will start Phase 2 trials in additional gynecologic tumors, including patients with platinum-sensitive ovarian (an earlier stage of ovarian cancer), endometrial and cervical cancers, as well as a Phase 2 study in patients with first-line pancreatic cancer. These National Comprehensive Cancer Network guideline-enabling studies should proceed quickly and will inform our longer-term clinical development priorities," added Dr. Guyer. "We are also excited to advance a new proprietary glucocorticoid receptor antagonist, nenocorilant, in a Phase 1b dose-finding study combining nenocorilant with the PD-1 checkpoint inhibitor nivolumab to see if reducing cortisol-driven immune suppression can enhance immunotherapy."

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

MONARCH – Enrollment completed in randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant in patients with biopsy-confirmed or presumed MASH – Results expected by the end of next year
"In our Phase 1b study, miricorilant was well-tolerated and very rapidly reduced liver fat while improving liver enzymes and other markers of liver health, as well as key metabolic and lipid measures. We look forward to building on these promising results in our Phase 2b MONARCH study. With enrollment completed, we will have topline results by the end of next year," said Dr. Guyer.

Amyotrophic Lateral Sclerosis (ALS)

DAZALS – Exploratory analyses showed that patients who received dazucorilant 300 mg exhibited an 84 percent reduction in risk of death during the study’s first year compared to patients who received placebo (hazard ratio: 0.16, p-value: 0.0009) – Results presented at European Network to Cure ALS (ENCALS) 2025 annual meeting
Phase 3 trial – Expected to begin by the middle of next year
"ALS is a devastating disease linked to elevated cortisol activity. In our DAZALS study, patients who received dazucorilant experienced a profound reduction in early mortality – a time during which many patients with ALS retain significant function and quality of life," said Dr. Guyer. "We aim to replicate these findings in a Phase 3 trial and are working with regulatory authorities and leading ALS clinicians to finalize our study design."

Conference Call

We will hold a conference call on November 4, 2025, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants must register in advance of the conference call by clicking here. Upon registering, each participant will receive a dial-in number and a unique access PIN. Each access PIN will accommodate one caller. A listen-only webcast will be available by clicking here. A replay of the call will be available on the Investors / Events tab of Corcept.com.

(Press release, Corcept Therapeutics, NOV 4, 2025, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-third-quarter-financial-results-4 [SID1234659348])

On November 4, 2025 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a clinical-stage biotechnology company pioneering the development of systemically delivered, targeted genetic medicines, reported that it will hold an investor event at the Society of Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) Annual Meeting centered around the Company’s groundbreaking RedTail platform and its lead candidate, CLD-401.

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The presentation will take place at the SITC (Free SITC Whitepaper) Annual Meeting on Friday, November 7th from 8:30AM to 9:30AM in the National Harbor Room 15 at the Gaylord National Hotel and Convention Center in National Harbor, Maryland.

The presentation will also be live streamed: (View Source).

Speakers at the event will include:

· Dr. Dmitriy Zamarin of the Icahn Genomics Institute and the Precision Immunology Institute at The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai. Dr. Zamarin is a world renowned expert in virotherapy. Dr. Zamarin is a member of Calidi’s Scientific Advisory Board (SAB).

· Dr. Antonio F. Santidrian, Chief Scientific Officer of Calidi, responsible for leading all of the Company’s research and development initiatives.

· Dr. John M. Wrangle, a thoracis medical oncologist at the Medical University of South Carolina (MUSC). Dr Wrangle is an expert on the clinical development of IL-15 superagonist. Dr. Wrangle is also a member of Calidi’s SAB.

· Dr. Travis Clifton, Chief Medical Officer of Calidi and a surgical oncologist with over 17 years of experience in drug development, early phase and translational clinical trials, and cancer immunotherapy.

"We are excited to hold our first investor event," said Eric Poma, PhD, Chief Executive Officer. "We believe CLD-401 and the RedTail platform represent important breakthroughs in the area of genetic medicine, and we look forward to updating the investment community on our progress."

Calidi is currently conducting IND-enabling studies for CLD-401 and anticipates submitting an Investigational New Drug (IND) application by the end of 2026. The company is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

(Press release, Calidi Biotherapeutics, NOV 4, 2025, View Source [SID1234659347])

On November 4, 2025 BullFrog AI Holdings, Inc. (NASDAQ: BFRG; BFRGW) ("BullFrog AI" or the "Company"), a technology-enabled drug development company using artificial intelligence ("AI") and machine learning to enable the successful development of pharmaceuticals and biologics, reported that an abstract submitted in collaboration with Eleison Pharmaceuticals has been accepted for presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI), to be held January 8–10, 2026, in San Francisco, California.

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The abstract, titled "Data-driven subtyping and differential glufosfamide benefit in pancreatic adenocarcinoma," will be featured in Poster Session B on January 9. It will also be published in the ASCO (Free ASCO Whitepaper) GI 2026 online proceedings and subsequently appear in the Journal of Clinical Oncology (JCO) supplement corresponding to the symposium.

Co-authored by Richard Kim, MD, Service Chief of Medical Gastrointestinal Oncology and Senior Member in the Gastrointestinal Oncology Department at Moffitt Cancer Center, Nikolas Naleid, MD, PharmD, Hematology/Oncology Fellow at Moffitt Cancer Center, Eleison Pharmaceuticals and BullFrog AI, the study explores data-driven precision-oncology approaches to identify patient subtypes that may demonstrate enhanced response to glufosfamide, an investigational chemotherapeutic agent for pancreatic cancer. The research leverages BullFrog AI’s bfLEAP and bfPREP platforms to analyze complex clinical datasets and uncover biologically meaningful patient clusters.

"This acceptance by ASCO (Free ASCO Whitepaper) underscores the growing recognition of AI’s ability to transform oncology research," said Vin Singh, CEO of BullFrog AI. "Our collaboration with Eleison Pharmaceuticals clearly demonstrates how causal AI can help reveal critical insights that guide more precise, effective treatment strategies for difficult cancers like pancreatic adenocarcinoma."

Results from the study will be presented during the poster session, and in accordance with ASCO (Free ASCO Whitepaper)’s embargo policy, no additional data will be publicly disclosed until the official embargo lifts prior to the presentation.

(Press release, Bullfrog AI, NOV 4, 2025, View Source [SID1234659346])

On November 4, 2025 Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, reported third quarter 2025 financial results and provided updates across the company’s hematology and genetic disease franchises.

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"As we near the end of 2025, we see broad-based momentum across our growing portfolio of clinical-stage hematology and liver-targeted genetic disease base editing programs," said John Evans, chief executive officer at Beam. "Our alpha-1 antitrypsin deficiency program, the first clinical program to directly correct a disease-causing mutation in vivo, remains a top priority, and we’re pleased with the continued enrollment and dosing progress in the BEAM-302 Phase 1/2 trial. We look forward to providing a broad update on the program in early 2026 with new clinical data and next steps to advance BEAM-302 to patients. In sickle cell disease, we look forward to sharing updated data from the BEACON trial of BEAM-101 at the ASH (Free ASH Whitepaper) meeting in December, where we aim to continue to demonstrate a differentiated manufacturing and clinical profile in these patients with recurrent severe VOCs. We have also initiated dosing of the BEAM-103 antibody from our ESCAPE platform, which we believe can play an important role in next wave therapies for sickle cell disease."

Mr. Evans continued, "In addition, we are thrilled for the Orbital Therapeutics team following its proposed acquisition by Bristol Myers Squibb, indicating the significant potential of Orbital’s platform and pipeline. Beam contributed capabilities and technology in mRNA and targeted lipid nanoparticles to Orbital, and this outcome further validates our innovative platform strategy to unlock additional shareholder value in non-core areas and accelerate the creation of new medicines for patients."

Third Quarter 2025 and Recent Progress

•
Updated data from the BEACON Phase 1/2 clinical trial of BEAM-101 in patients with sickle cell disease (SCD) were accepted for presentation at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place December 6-9, 2025, in Orlando, Fla.
•
The first subject was dosed in a Phase 1 healthy volunteer clinical trial of BEAM-103, an anti-CD117 monoclonal antibody (mAb) developed as part of the company’s ESCAPE (Engineered Stem Cell Antibody Evasion) platform. ESCAPE represents a potential alternative to genotoxic conditioning regimens in stem cell transplantation, potentially avoiding toxicity challenges associated with currently available conditioning regimens for patients with SCD and beta-thalassemia.
•
In the Phase 1/2 study of BEAM-302 in alpha-1 antitrypsin deficiency (AATD), dosing has commenced in the multi-dose cohort evaluating two 60 mg doses administered eight weeks apart in Part A of the trial, designed to evaluate AATD patients with lung disease. In addition, the first patient was dosed in the first cohort in Part B of the trial, designed to evaluate AATD patients with mild to moderate liver disease with or without lung disease.

•
In August, the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to BEAM-101 for the treatment of SCD. The designation is designed to support the development and evaluation of regenerative medicines, with the intention of addressing serious or life-threatening diseases that have unmet medical needs.
•
In October, Bristol Myers Squibb announced a definitive agreement under which they will acquire Beam collaborator Orbital Therapeutics for $1.5 billion in cash. As of the announcement, Beam held 75 million shares of Orbital common stock, which represented a fully diluted ownership stake of approximately 17%.1
Key Anticipated Milestones

Liver-targeted Genetic Disease Franchise

•
Beam expects to report data from the dose-escalation portions of Part A and Part B of the BEAM-302 Phase 1/2 trial and provide a clinical development update in early 2026.
•
Beam plans to continue dosing in the Phase 1/2 clinical trial of BEAM-301 in glycogen storage disease Ia (GSDIa).
Hematology Franchise

•
Beam plans to present updated data from the BEACON Phase 1/2 trial at the ASH (Free ASH Whitepaper) Annual Meeting, taking place December 6-9, 2025.
Third Quarter 2025 Financial Results

•
Cash Position: Cash, cash equivalents and marketable securities were $1.1 billion as of September 30, 2025, compared to $850.7 million as of December 31, 2024.
•
Research & Development (R&D) Expenses: R&D expenses were $109.8 million for the third quarter of 20252, compared to $94.3 million for the third quarter of 2024.
•
General & Administrative (G&A) Expenses: G&A expenses were $26.7 million for the third quarter of 2025, compared to $26.5 million for the third quarter of 2024.
•
Net Income (Loss): Net loss was $112.7 million, or $1.10 per share, for the third quarter of 2025, compared to $96.7 million, or $1.17 per share, for the third quarter of 2024.
Cash Runway

Beam expects that its cash, cash equivalents and marketable securities as of September 30, 2025, will enable the company to fund its anticipated operating expenses and capital expenditure requirements into 2028. This expectation includes funding directed toward reaching each of the key anticipated milestones for BEAM-101, ESCAPE, BEAM-301 and BEAM-302 described above.

(Press release, Beam Therapeutics, NOV 4, 2025, View Source [SID1234659345])

On November 4, 2025 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported financial results for the third quarter ended September 30, 2025, and provided a business update.

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"Our intent to separate our wholly owned biopharma programs from our royalty assets provides investors with the opportunity to realize and enhance the potential value of two distinct sets of assets. Jemperli sales grew to $785 million YTD with GSK indicating dMMR endometrial market share is now ~5% greater than Keytruda1, reflecting Jemperli’s differentiated overall survival data and supporting GSK’s peak sales guidance of far more than $2.7 billion2 in monotherapy indications," said Daniel Faga, president and chief executive officer of Anaptys. "Our biopharma portfolio is strategically positioned with multiple attractive, high-potential assets, including rosnilimab, ANB033 and ANB101. Rosnilimab’s transformational profile was highlighted in a late-breaking presentation of Phase 2b data in RA at ACR Convergence 2025 and we anticipate reporting top-line Phase 2 data through Week 12 in ulcerative colitis in November or December."

INTENT TO SEPARATE BUSINESS

Announced intent to separate biopharma operations from substantial royalty assets by YE 2026
Designed to unlock potential value by creating two independent, publicly traded companies with different business objectives and opportunities
The royalty management company will manage royalties and milestone payments from financial collaborations, including Jemperli with GSK and imsidolimab with Vanda, with a focus on protecting and returning their value to shareholders
The biopharma operations company will focus on development and potential commercialization of innovative immunology therapeutics for autoimmune and inflammatory diseases, including rosnilimab, ANB033 and ANB101
ROYALTY MANAGEMENT CO

GSK Jemperli Financial Collaboration

GSK announced strong commercial performance for Jemperli ($303 million/£230 million in Q3 2025 sales; $785 million/£600 million in YTD 2025 sales) with >16% USD and >17% GBP quarter-over-quarter growth1
In Q4 2025, Anaptys anticipates accruing a one-time $75 million commercial sales milestone from GSK once Jemperli achieves $1 billion in worldwide net sales
>$390 million in annualized Jemperli royalties payable to Anaptys at GSK’s peak sales guidance of >$2.7 billion2, which Anaptys expects to be achieved before 2031
Estimate Sagard will have accrued ~$250 million in royalties and sales milestones through year-end 2025 and now anticipate full paydown of $600 million non-recourse debt monetization between Q2 2027 and Q2 20283
Substantial GSK investment in additional monotherapy and potential combination trials for Jemperli including –
AZUR-1 – pivotal Phase 2 – dostarlimab monotherapy in untreated stage II/III dMMR/MSI-H locally advanced rectal cancer
Top-line data expected in H2 2026; U.S. FDA Breakthrough Therapy Designation
AZUR-2 – pivotal Phase 3 – dostarlimab versus standard of care in untreated TN40 or stage III dMMR/ MSI-H resectable colon cancer
AZUR-4 – Phase 2 – dostarlimab plus chemotherapy versus standard of care (chemotherapy) in untreated stage III MMRp/MSS resectable colon cancer
JADE – pivotal Phase 3 – dostarlimab monotherapy versus placebo in locally advanced unresected head and neck squamous cell carcinoma (PD-L1 high) post chemoradiation
Vanda Imsidolimab Financial Collaboration

Vanda anticipates FDA BLA submission for imsidolimab in generalized pustular psoriasis (GPP) in Q4 2025
BIOPHARMA CO

Rosnilimab (Pathogenic T Cell Depleter)

Presented Phase 2b data for rosnilimab, a pathogenic T cell depleter, in rheumatoid arthritis as a late-breaking oral presentation at American College of Rheumatology (ACR) Convergence 2025
In both the overall and b/tsDMARD-experienced populations, response rates across multiple higher-order endpoints, including ACR50, ACR70, CDAI LDA, CDAI remission, and patient-reported outcomes increased between Week 12 and Week 28 and are maintained off-drug for at least 3-months through Week 38
Regardless of prior therapy, including JAKs, similar responses were observed on more stringent endpoints, such as ACR50, ACR70, CDAI LDA and CDAI remission
Safety data through Week 38 demonstrate rosnilimab was well-tolerated, including no malignancies and no deaths
The presentation is available for download on the Anaptys website here
Top-line data through Week 12 of global Phase 2 trial in moderate-to-severe UC (N=136, ~50% advanced therapy experienced) on track for November/December 2025
Assessing Q2W and Q4W dose levels of subcutaneously administered rosnilimab vs. placebo (randomized 1:1:1)
Will report data on primary statistical analysis at Week 12 on well-established endpoints, including the primary endpoint of change from baseline in modified Mayo Score (mMS) and key secondary endpoints, such as clinical response and remission on mMS
All patients in all three study arms treat-through to Week 24 and remain blinded to treatment arm. Placebo-treated patients who achieved clinical response on partial mMS (pmMS) at Week 12 remain on placebo, while placebo-treated patients who are non-responders are crossed over to the high dose Q2W rosnilimab treatment arm
Patients who are in clinical response on pmMS at Week 24 are eligible for an additional 26-week (50 weeks of total treatment) blinded treatment extension period (TEP)
Blinded surveillance data to date suggest a favorable safety and tolerability profile consistent with prior rosnilimab trials
ANB033 (CD122 antagonist)

Hosted virtual investor event on ANB033 including preclinical and Phase 1a data
Webcast and presentation are available for viewing on the Anaptys website here
Phase 1b cohort in celiac initiated
Top-line Phase 1b data anticipated in Q4 2026
Plan to initiate an additional Phase 1b trial in a second inflammatory disease in 2026
Exploring eosinophilic esophagitis as a potential indication
ANB101 (BDCA2 modulator)

Phase 1 trial ongoing in healthy volunteers
FINANCIAL UPDATES

Stock Repurchase Program and Cash Runway

Company has repurchased a total of 3,344,064 shares of common stock (10.9% shares outstanding) with $65.2 million as of Sept. 30, 2025, from its $75.0 million Stock Repurchase Program
Cash and investments of $256.7 million as of Sept. 30, 2025
Anticipate ending 2025 with approximately $300 million, including an anticipated accrual of a one-time $75 million commercial sales milestone in Q4 2025 from GSK once Jemperli achieves $1 billion in worldwide net sales
Upon completion of the separation, Biopharma Co will launch with adequate capital to fund operations for at least two years through significant potential corporate milestones
Third Quarter 2025 Financial Results

Cash, cash equivalents and investments totaled $256.7 million as of September 30, 2025, compared to $420.8 million as of December 31, 2024, for a decrease of $164.1 million due primarily to $113.9 million used for operating activities and $65.2 million in shares repurchased offset by $15 million upfront payment received from Vanda Pharmaceuticals for the license of imsidolimab.
Collaboration revenue was $76.3 million and $126.4 million for the three and nine months ended September 30, 2025, compared to $30.0 million and $48.2 million for the three and nine months ended September 30, 2024. The increase was due primarily to Jemperli total sales for 2025 exceeding $750 million which earned a $50 million commercial sales milestone in Q3 under the license agreement. Jemperli royalties increased 80% from $13.8 million to $24.9 million and 110% from $30.1 million to $63.2 million for the three and nine months ended September 30, 2025, and $9.7 million in revenue recognized for the Vanda license agreement.
Research and development expenses were $31.4 million and $110.4 million for the three and nine months ended September 30, 2025, compared to $42.2 million and $121.3 million for the three and nine months ended September 30, 2024. The decrease for the three and nine months ended September 30, 2025, was primarily due to lower development costs for ANB032 and imsidolimab, offset by higher costs relating to the Phase 1 trials for ANB033 and ANB101. The R&D non-cash, stock-based compensation expense was $4.5 million and $13.3 million for the three and nine months ended September 30, 2025, as compared to $4.0 million and $10.9 million in the same period in 2024.
General and administrative expenses were $10.2 million and $34.9 million for the three and nine months ended September 30, 2025, compared to $10.6 million and $32.2 million for the three and nine months ended September 30, 2024. The increase was due primarily to transaction costs associated with the Vanda Pharmaceuticals license agreement. The G&A non-cash, stock-based compensation expense was $4.7 million and $14.2 million for the three and nine months ended September 30, 2025, as compared to $4.2 million and $14.9 million in the same period in 2024.
Net income was $15.1 million for the three months ended September 30, 2025, or a net income per share of $0.54 and a net loss of $62.8 million for the nine months ended September 30, 2025, or a net loss per share of $2.16, compared to a net loss of $32.9 million and $123.4 million for the three and nine months ended September 30, 2024, or a net loss per share of $1.14 and $4.46.

(Press release, AnaptysBio, NOV 4, 2025, View Source [SID1234659344])