On August 6, 2025 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported financial results for the second quarter ended June 30, 2025, and provided a business update (Press release, AnaptysBio, AUG 6, 2025, View Source [SID1234654854]).

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"Rosnilimab’s Phase 2b data in rheumatoid arthritis (RA) delivered a compelling safety and tolerability profile and JAK-like efficacy through six months that is durable for at least three months off-drug. The strength of the data, as well as positive feedback from the KOL community, gives us confidence in the transformational potential of rosnilimab. With enrollment completed in the Phase 2 ulcerative colitis (UC) trial, we look forward to reading out top-line data through Week 12 in Q4 2025, as well as potential additional six- and 12-month data from this trial in 2026," said Daniel Faga, president and chief executive officer of Anaptys. "Additionally, we are excited to announce the initial indication for our CD122 antagonist, ANB033, is celiac disease (CeD), a serious autoimmune disease triggered by the ingestion of gluten, affecting more than 2.1 million people in the U.S. but with no approved therapies. We believe ANB033’s MoA, inhibiting both IL-2 and IL-15 signaling, is well-suited to target the multiple pathogenic drivers of CeD. We plan to initiate a Phase 1b cohort by Q4 2025 and will discuss the program in depth at a dedicated R&D event later this year."

PORTFOLIO UPDATES

Rosnilimab (Pathogenic T Cell Depleter)

Announced positive data for rosnilimab from robust, 424-patient Phase 2b RA trial demonstrating –
Best-in-disease profile with JAK-like efficacy and monthly (Q4W) dosing in both three-month placebo-controlled and six-month​ blinded treatment period
Favorable safety and tolerability, particularly when compared to standard of care biologics or JAK inhibitors
Max response rates have not yet been observed; strict continuation criteria at three months in this Phase 2b trial excluded many patients who either achieved or were trending toward LDA and ACR50
Trial now complete with CDAI LDA responders at Week 28 demonstrating durable responses for at least 12-14 weeks off drug through Week 38
Data consistent with previously reported partial data results through Week 34
Supports potential for maintenance dosing with extended dosing intervals (e.g. Q8W or Q12W)
Safety profile remains favorable and consistent with previously reported data
Plan to present complete RA Phase 2b data at a future medical congress
Enrollment complete for global Phase 2 trial in moderate-to-severe UC (N=136, ~50% advanced therapy experienced)
Assessing Q2W and Q4W dose levels of subcutaneously administered rosnilimab vs. placebo (randomized 1:1:1)
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 modified Mayo score (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)
Top-line data through Week 12, including primary and key secondary endpoints, on track for Q4 2025
Blinded surveillance data to date suggest a favorable safety and tolerability profile consistent with prior rosnilimab trials
ANB033 (CD122 antagonist)

Phase 1 trial ongoing in healthy volunteers
Plan to initiate Phase 1b cohort for ANB033 in initial indication, celiac disease, by Q4 2025
Additional information to be disclosed at ANB033-focused R&D event in Q4 2025
ANB101 (BDCA2 modulator)

Phase 1 trial ongoing in healthy volunteers
COLLABORATION UPDATES

GSK Immuno-Oncology Financial Collaboration

GSK announced strong commercial performance for Jemperli ($262 million/£196 million in Q2 2025 sales; $482 million/£370 million in 1H 2025 sales) with >19% USD and >12% GBP quarter-over-quarter growth
Anaptys anticipates triggering a one-time $75 million commercial sales milestone from GSK in 2025 once Jemperli achieves $1 billion in worldwide net sales in a calendar year
Substantial GSK investment in additional indications of Jemperli monotherapy and combinations ongoing –
AZUR-1 pivotal Phase 2 trial of dostarlimab monotherapy in patients with untreated stage II/III dMMR/MSI-H locally advanced rectal cancer
Top-line data in H2 2026
Jemperli received U.S. FDA Breakthrough Therapy Designation for this indication
AZUR-2 pivotal Phase 3 trial of perioperative dostarlimab monotherapy versus standard of care in participants with untreated T4N0 or stage III dMMR/ MSI-H resectable colon cancer ongoing
AZUR-4 Phase 2 trial of neoadjuvant dostarlimab plus capecitabine plus oxaliplatin (CAPEOX) versus CAPEOX alone in previously untreated T4N0 or stage III mismatch repair proficient/microsatellite stable resectable colon cancer ongoing
JADE pivotal Phase 3 trial of dostarlimab versus placebo as sequential therapy after chemoradiation in participants with locally advanced unresected head and neck squamous cell carcinoma (HNSCC) ongoing
GSK announced that COSTAR Lung Phase 3 trial did not meet primary endpoint of overall survival
Vanda Imsidolimab Financial Collaboration

Vanda anticipates FDA BLA submission for generalized pustular psoriasis (GPP) in 2H 2025
Anaptys eligible to receive up to $35 million for future regulatory approval, including a $5 million milestone upon U.S. FDA approval, and sales milestones, in addition to a 10% royalty on net sales
FINANCIAL UPDATES

Stock Repurchase Program and Cash Runway

The Company has repurchased a total of 2,853,836 shares of common stock (9.3% shares outstanding) with $55.5 million as of June 30, 2025 from its $75.0 million Stock Repurchase Program
Cash and investments of $293.7 million as of June 30, 2025, and reiterating cash runway through year-end 2027
Second Quarter 2025 Financial Results

Cash, cash equivalents and investments totaled $293.7 million as of June 30, 2025, compared to $420.8 million as of December 31, 2024, for a decrease of $127.1 million due primarily to operating activities and $55.5 million in shares repurchased, offset by $15.0 million received from Vanda Pharmaceuticals for the license of imsidolimab.
Collaboration revenue was $22.3 million and $50.0 million for the three and six months ended June 30, 2025, compared to $11.0 million and $18.2 million for the three and six months ended June 30, 2024. This was due primarily to Jemperli royalties increasing $11.0 million and $22.1 million for the three and six months ended June 30, 2025 and $9.7 million in revenue recognized for the Vanda license agreement.
Research and development expenses were $37.8 million and $79.0 million for the three and six months ended June 30, 2025, compared to $42.0 million and $79.0 million for the three and six months ended June 30, 2024. The decrease for the three months ended June 30, 2025, was primarily due to lower development costs for ANB032 and imsidolimab offset by higher costs relating to the Phase 2 trials in RA and UC for rosnilimab and the Phase 1 trials for ANB033 and ANB101. The R&D non-cash, stock-based compensation expense was $4.5 million and $8.9 million for the three and six months ended June 30, 2025 as compared to $3.5 million and $7.0 million in the same period in 2024.
General and administrative expenses were $10.6 million and $24.7 million for the three and six months ended June 30, 2025, compared to $9.3 million and $21.6 million for the three and six months ended June 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 $4.8 million and $9.5 million for the three and six months ended June 30, 2025 as compared to $4.0 million and $10.7 million in the same period in 2024.
Net loss was $38.6 million and $78.0 million for the three and six months ended June 30, 2025, or a net loss per share of $1.34 and $2.62, compared to a net loss of $46.7 million and $90.6 million for the three and six months ended June 30, 2024, or a net loss per share of $1.71 and $3.35.

On August 6, 2025 Aligos Therapeutics, Inc. (Nasdaq: ALGS, "Aligos"), a clinical stage biotechnology company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, reported recent business progress and financial results for the second quarter 2025 (Press release, Aligos Therapeutics, AUG 6, 2025, View Source [SID1234654853]).

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"Initiation of the Phase 2 B-SUPREME study of ALG-000184 is well underway with regulatory approvals across a number of countries, including the US, China, Canada, Taiwan, UK, New Zealand, and Moldova," stated Lawrence Blatt, Ph.D., M.B.A., Chairman, President, and Chief Executive Officer of Aligos Therapeutics. "Site activations are in progress, subjects are being screened, and we expect dosing to commence in the coming weeks. This pertinent study is the next step in our journey to potentially deliver better therapies for patients living with HBV infection and create value for our stakeholders. The Phase 1 data showcasing 96 weeks of treatment presented at the EASL meeting suggests that ALG-000184 has the potential to replace standard of care treatment for chronic suppression of HBV infection and may become the backbone of treatments aimed at a functional cure. We remain excited about the potential of ALG-000184 and the entirety of our pipeline, including ALG-055009 which remains in discussions with potential partners."

Recent Business Progress

Pipeline Updates

ALG-000184: Potential first-/best-in-class small molecule CAM-E for chronic hepatitis B virus (HBV) infection

The Phase 2 B-SUPREME study (NCT04746183) of ALG-000184 in subjects with chronic HBV infection recently began obtaining regulatory approvals, activating global sites, and screening subjects. Dosing is expected to commence in the coming weeks.
The study is designed as a randomized, double-blind, active-controlled multicenter study evaluating the safety and efficacy of ALG-000184 monotherapy compared with tenofovir disoproxil fumarate in approximately 200 untreated HBeAg+ and HBeAg- adult subjects with chronic HBV infection for 48 weeks. The primary endpoint in the HBeAg+ part will be HBV DNA 96-week dosing recently completed in the Phase 1 study and data readouts, including post-treatment data, are planned for scientific conferences this year. Interim data from up to 96 weeks following an oral daily dose of 300 mg ALG-000184 in both HBeAg+ and HBeAg- subjects with chronic HBV infection were presented at the European Association for the Study of the Liver (EASL) Congress 2025.
ALG-000184 administered for up to 96 weeks was well tolerated by study participants, exhibited a favorable PK profile, and suggested potentially best-in-class antiviral activity.
In HBeAg+ subjects with a very high mean HBV DNA level of 8.0 log10 IU/mL at baseline, all experienced profound and persistent HBV DNA reductions after receiving an oral daily dose of 300 mg ALG-000184 monotherapy. At Week 48, 6 of 10 subjects (60%) achieved HBV DNA < LLOQ (10 IU/mL, target detected or target not detected). With treatment extension, this rate increased to 9 of 9 subjects (100%) at Week 96. Additionally, HBV DNA level continuously declined to < LLOQ (10 IU/mL, target not detected) in 5 of 9 subjects at Week 96.
In HBeAg- subjects, all 11 (100%) had rapid decline in HBV DNA levels and achieved sustained HBV DNA suppression (HBV DNA < LLOQ (10 IU/mL, target detected or target not detected)) by Week 24. The HBV DNA suppression level was maintained in the ALG-000184 monotherapy cohort for up to 96 weeks, with further decline in HBV DNA to < LLOQ (10 IU/mL, target not detected), observed in all subjects (8/8) at Week 96.
Multi-log10 reductions in HBsAg, HBeAg, and HBcrAg were observed in HBeAg+ subjects, and HBcrAg decline was observed in HBeAg- subjects.
In both patient populations in this study, ALG-000184 was well tolerated with no viral breakthrough observed and no known CAM resistant mutations identified with monotherapy treatment.
ALG-055009: Potential best-in-class small molecule THR-β agonist for metabolic dysfunction-associated steatohepatitis (MASH)

The Phase 2a HERALD data were presented at EASL 2025, demonstrating that ALG-055009 dose groups met the primary endpoint with statistically significant reductions in liver fat at week 12 as measured by MRI-PDFF.
Additionally, new data demonstrated substantial, dose-dependent reductions in liver fat were observed across all key subgroups with 12 weeks of once daily ALG-055009 treatment. Statistically significant improvements in atherogenic lipids were achieved with 12 weeks of ALG-055009 treatment. Reductions in lipids/lipoproteins were observed even in the context of stable GLP-1 agonist or statin use. This data suggests a potential added benefit of ALG-055009 for patients at risk for cardiovascular disease in addition to the previously reported liver fat lowering properties in a MASLD/MASH population.
As shared previously, ALG-055009 demonstrated a favorable tolerability profile with no evidence of clinical hyper/hypothyroidism. Incidence of gastrointestinal-related treatment emergent adverse events were similar in ALG-055009 dose groups compared to placebo. Specifically, similar rates of diarrhea were observed in ALG-055009 dose groups compared to placebo, with no dose-response. Significant reductions in atherogenic lipids, including LDL-C, lipoprotein (a), and apolipoprotein B, were also observed (Loomba et al, AASLD 2024).
The company is continuing to evaluate a variety of options to fund continued development, including potential out-licensing.
ALG-097558: Potential best-in-class ritonavir-free small molecule pan-coronavirus protease inhibitor

The AGILE platform study (NCT04746183) assessing ALG-097558 monotherapy or in combination with remdesivir in high-risk subjects with COVID-19 began in 2024.
The NIAID is sponsoring a drug-drug interaction and relative bioavailability study of ALG-097558 in healthy volunteers that began dosing in the second quarter of 2025.
The company expects any future development of ALG-097558 to be funded by external sources.
Financial Results for the Second Quarter 2025

Cash, cash equivalents and investments totaled $122.9 million as of June 30, 2025, compared with $56.9 million as of December 31, 2024. Our cash, cash equivalents and investments are expected to provide sufficient funding of planned operations into the second half of 2026.

Net loss for the three months ended June 30, 2025 was $15.9 million or basic and diluted net loss per common share of $(1.53), compared to net income of $5.1 million or basic and diluted net income per common share of $0.81 for the three months ended June 30, 2024.

Research and development (R&D) expenses for the three months ended June 30, 2025 were $14.0 million, compared with $21.1 million for the same period of 2024. The decrease was primarily due to a decrease in third-party expenses due to reduced clinical study costs as a result of the completion of the MASH Phase 2a clinical trial, partially offset by increased spend in the chronic HBV infection program. Total R&D stock-based compensation expense incurred for the three months ended June 30, 2025 was $0.6 million, compared with $1.2 million for the same period of 2024.

General and administrative (G&A) expenses for the three months ended June 30, 2025 were $5.6 million, compared with $6.4 million for the same period of 2024. The decrease in G&A expenses for this comparative period is primarily due to a decrease in third-party expenses including legal expenses. Total G&A stock-based compensation expense incurred for the three months ended June 30, 2025 was $0.5 million, compared with $0.9 million for the same period of 2024.

Interest and other income, net, was income of $1.2 million each for the three months ended June 30, 2025 and June 30, 2024.

Change in fair value of 2023 common warrants for the three months ended June 30, 2025 was income of $1.7 million compared with income of $30.4 million for the same period of 2024.

On August 6, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that the strong clinical successes in oncology of its drug Ampligen will be presented in four separate aspects at the upcoming 5th Annual Marie Sklodowska-Curie Symposium on Cancer Research and Care in Warsaw, Poland (Press release, AIM ImmunoTech, AUG 6, 2025, View Source [SID1234654852]). This will include a presentation by AIM regarding its ongoing lead clinical program in late-stage pancreatic cancer; a presentation by Pawel Kalinski, MD, PhD, a world-renowned research oncologist and senior investigator for multiple oncology clinical studies involving Ampligen, outlining his clinical research with Ampligen in multiple other solid tumor types; a presentation of Kathleen Kokolus, PhD, a senior scientist in Dr. Kalinski’ laboratory, who will discuss cellular and molecular mechanisms of action of Ampligen; and finally a presentation and abstract on positive data strongly suggesting Ampligen’s potential as a therapy in the treatment of endometriosis.

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Dr. Kalinski observed, "This important global symposium is being held September 3-5, 2025. It will be attended by many of the top oncology researchers, government health officials and major pharma companies of Europe, in an effort to showcase and bring U.S.-developed, early-phase clinical trials to patients in Central and Eastern European Countries (CEEC) and to accelerate the development and clinical testing of such treatments to benefit patients in the United States and worldwide."

Oncology

An AIM representative will present data from AIM’s pancreatic cancer Early Access Program and advances in the Phase 2 pancreatic cancer clinical trial currently underway at Erasmus Medical Center in the Netherlands. Among the expected highlights will be recent data from the DURIPANC study, an ongoing Phase 2 clinical study evaluating the combination therapy of Ampligen and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor durvalumab in the treatment of late-stage metastatic pancreatic cancer patients. Following FOLFIRINOX, maintenance or second-line immunotherapies have historically shown limited survival benefit in comparison trials. Preliminary data from DURIPANC suggests that Ampligen may prove to change that equation for the better.

Last week, the Company released a DURIPANC Mid-Year Interim Clinical Progress Update showing that the therapy is, thus far, well-tolerated with positive preliminary survival data, especially given the historical difficulty of improving outcomes in this setting. Compared to historical data, the DURIPANC study mid-year report shows continuing promising early signs of both no significant toxicity and superior PFS and OS:

No significant toxicity, an encouraging safety profile for a post-chemo setting;
~21% of patients have PFS >6 months (3/14), with an additional 21% not yet progressed; and
OS >6 months in the majority (64%) of eligible patients-better than expected in this setting.
Patient-reported outcomes indicated a consistently high level of quality of life throughout the treatment period. This is particularly notable given that patients with advanced disease typically experience substantial symptom burden and functional decline. In the context of a Phase 1/2 study, where the primary objectives often include safety, tolerability and preliminary signals of efficacy, the preservation or improvement of quality of life serves as a critical complementary endpoint.

Dr. Kalinski’s presentation will highlight Ampligen’s overall oncological advances and successes in clinical trials for multiple other solid tumors, including late-stage recurrent ovarian, Stage-four triple-negative breast and late-stage metastatic colorectal cancer.

Dr. Kokolus will discuss cellular and molecular mechanisms of the Ampligen-based chemokine-modulatory regimen’s activity in enhancing the effectiveness of PD1 blockade in "cold" tumors

All of the late-stage cancers being challenged by Ampligen therapy whose results will be discussed are lethal malignancies and constitute serious and unmet global health care issues.

Endometriosis

The endometriosis abstract and presentation will be based on an analysis of data from AIM’s Phase 2 and Phase 3 clinical trials of Ampligen for the treatment of Chronic Fatigue Syndrome ("CFS"), which showed that a large percentage of female participants had significant comorbidity with endometriosis. Approximately 80% of subjects experienced improvement in symptoms in the analyzed data.

Endometriosis is a common chronic and debilitating inflammatory disease affecting approximately 10% (190 million) of women of reproductive age globally and is associated with a risk of ovarian cancer. The hallmark of endometriosis is the presence of endometrium-like tissue on the peritoneum and ovaries. Growth of ectopic tissue in endometriosis patients leads to chronic pelvic pain; painful menstrual cramps; long-term pain in the lower back and pelvis; pain during intercourse; and infertility. Available radical treatments – such as the removal of the fallopian tubes and ovaries – can be difficult to justify in this group of young, prime-of-life patients, which highlights the need for new treatments.

Read more on the link between CFS and endometriosis: "Endometriosis as a Comorbid Condition in Chronic Fatigue Syndrome (CFS): Secondary Analysis of Data From a CFS Case-Control Study"

Read more on the link between endometriosis and ovarian cancer: "Complement Pathway Is Frequently Altered in Endometriosis and Endometriosis-Associated Ovarian Cancer"

AIM believes that the data demonstrates a compelling rationale for further optimizing a treatment protocol of IV Ampligen in patients with endometriosis.

On August 6, 2025 Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the Company") reported financial results for the second quarter ended June 30, 2025, and provided a corporate update (Press release, Protagonist, AUG 6, 2025, View Source [SID1234654847]).

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"Thus far, 2025 has been a year of breakthrough accomplishments for Protagonist, as we saw rusfertide the topic of the prestigious ASCO (Free ASCO Whitepaper) Plenary Session in May, the announcement of an oral and injectable triple agonist anti-obesity peptide development candidate in June, and most recently the first ever NDA filing of icotrokinra for psoriasis last month," said Dinesh V. Patel, Ph.D., the Company’s President and CEO. "Over the coming months, we look forward to the NDA filing of rusfertide for polycythemia vera, and advancing our wholly owned early-stage assets PN-881 and PN-477 into clinical and IND-enabling studies respectively."

Second Quarter 2025 Recent Developments and Upcoming Milestones

Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood Disorders

· The full data set from the positive Phase 3 VERIFY trial of rusfertide in PV was presented during the prestigious plenary session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Sunday, June 1st.

· The Company hosted an investor conference call on Monday, June 2nd discussing data shared during the plenary presentation. A replay of the call and accompanying presentation is available on the Company’s Investor Relations Events and Presentations webpage here.

· Rusfertide U.S. NDA filing for treatment of patients with PV, by partner Takeda Pharmaceuticals, expected in Q4 of this year.

Icotrokinra (JNJ-2113): Oral IL-23 Receptor Antagonist

· On July 21st, the Company and its partner Johnson and Johnson announced the first icotrokinra NDA filing for the treatment of adults and adolescents 12 years of age and older with moderate to severe plaque psoriasis (PsO). The application included data from four pivotal Phase 3 studies conducted as part of the ICONIC clinical development program, including ICONIC-LEAD, ICONIC-TOTAL and ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2.

· On May 9th, data from the Phase 3 ICONIC-TOTAL study in difficult-to-treat scalp and genital psoriasis was presented at the Society for Investigative Dermatology Annual Meeting held in San Diego from May 7-10th.

On April 10th, data from the adolescent cohort of the Phase 3 ICONIC-LEAD study in moderate-to-severe plaque psoriasis was presented as a late-breaking abstract at the 2025 World Congress of Pediatric Dermatology (WCPD).

· On March 10th, positive top line results from the Phase 2b ANTHEM trial in moderately to severely active ulcerative colitis (UC) were announced. The full data set is scheduled for an oral presentation at the 33rd United European Gastroenterology Week (UEGW) on October 7th.

Development Pipeline: First-in-Class Oral IL-17 Peptide Antagonist (PN-881) & GLP-1, GIP, & GCG Triple Agonist (PN-477)

· On June 30th, the Company hosted an investor call announcing the selection of PN-477, a potential best-in-class GLP-1, GIP, GCG receptor triple agonist peptide with oral and subcutaneous routes of administration, as a development candidate for the treatment of obesity. A replay of the call and accompanying presentation is available on the Company’s Investor Relations Events and Presentations webpage here.

· On May 9th, preclinical data on PN-881 was presented at the Society for Investigative Dermatology (SID) Annual Meeting held in San Diego from May 7-10th. Key takeaways from the pre-clinical characterization of the IL-17 oral peptide antagonist PN-881:

o Potently and selectively binds IL-17A and -17F, blocking the three dimeric forms of the cytokine.

o Nanomolar to picomolar in vitro potency comparable to bimekizumab and superior (70-fold) to secukinumab.

o Metabolic stability in several matrices across several species, making it a suitable candidate for oral delivery.

o Pharmocodynamic-based target engagement in a mouse IL-17 challenge model after oral dosing.

o Dose-dependent efficacy with significant reduction in skin thickness in a 5-day rat IL-23 induced skin inflammation model after oral dosing.

Second Quarter 2025 Financial Results

· Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of June 30, 2025, were $673.0 million as compared to $559.2 million as of December 31, 2024.

Three Months Ended Six Months Ended
June 30, June 30,
(in thousands, except per share amounts) 2025 2024 2025 2024

(Unaudited)
License and collaboration revenue $ 5,546 $ 4,167 $ 33,867 $ 259,120
Research and development expense $ 37,036 $ 33,520 $ 72,929 $ 67,254
General and administrative expense $ 10,551 $ 9,440 $ 22,289 $ 24,350
Net (loss) income $ (34,771 ) $ (30,616 ) $ (46,426 ) $ 176,724
Basic (loss) earnings per share $ (0.55 ) $ (0.50 ) $ (0.73 ) $ 2.89
Diluted (loss) earnings per share $ (0.55 ) $ (0.50 ) $ (0.73 ) $ 2.77

· License and Collaboration Revenue:

License and collaboration revenue of $5.5 million and $4.2 million for the second quarter of 2025 and 2024, respectively, was comprised of development services we provided under the Takeda collaboration agreement.

License and collaboration revenue of $33.9 million for the six months ended June 30, 2025 was comprised of (i) proportional recognition of a $25 million milestone earned from Takeda in Q1 25, and (ii) development services we provided during the period. License and collaboration revenue of $259.1 million for the six months ended June 30, 2024 included (i) $254.1 million of the $300.0 million initial transaction price for the Takeda collaboration agreement allocated to the rusfertide license upon effectiveness of the agreement, and (ii) development services we provided during the period.

· Research and Development ("R&D") Expense: The increases in R&D expense from the prior year periods were primarily due to increases in pre-clinical and drug discovery research expenses, including costs related to our new product candidates, IL-17 oral peptide antagonist PN-881 and obesity triple agonist peptide PN-477, partially offset by decreases in rusfertide expenses related to the Phase 3 VERIFY clinical trial.

· General and Administrative ("G&A") Expense: The increase in G&A expense for the second quarter of 2025 from the prior year period was primarily due to increases in stock-based compensation and other personnel-related expenses. The decrease in G&A expense for the six months ended June 30, 2025 from the prior year period was primarily due to $4.6 million in advisory and legal fees recognized in 2024 related to the Takeda collaboration, partially offset by increases in stock-based compensation expense and other personnel-related expenses.

· Net (Loss) Income: Net loss was $34.8 million, or $0.55 per basic and diluted share, for the second quarter of 2025 as compared to net loss of $30.6 million, or $0.50 per basic and diluted share, for the second quarter of 2024. Net loss was $46.4 million, or $0.73 per basic and diluted share, for the six months ended June 30, 2025 as compared to net income of $176.7 million, or $2.89 per basic share and $2.77 per diluted share, for the six months ended June 30, 2024, which included recognition of $259.1 million revenue related to the Takeda collaboration agreement upfront payment of $300.0 million.

On August 6, 2025 Amplia Therapeutics (ASX: ATX) reported it has released new topline data from an ongoing trial of its best-in-class selective FAK inhibitor narmafotinib on advanced pancreatic cancer (Press release, Amplia Therapeutics, AUG 6, 2025, View Source [SID1234654810]).

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The ACCENT clinical trial is investigating the safety, tolerability, pharmacokinetics and preliminary efficacy of narmafotinib when used in combination with standard-of-care chemotherapies gemcitabine and Abraxane.

Latest data to 20 July has shown a progression free survival (PFS) of 7.6 months in trial participants, representing a two-month improvement over chemotherapy alone, and superior to the PFS obtained with the more aggressive (but less tolerated) FOLFIRINOX chemotherapy combination that attacks cancer cells in different ways.

Objective Response Rate
Narmafotinib’s objective response rate currently sits at 31%, significantly better compared to chemotherapy alone (23%), whilehe drug has also demonstrated a strong tolerability profile with adverse events being very similar in type and occurrence to those observed for chemotherapy.

Durability of response has been strong with seven patients having stayed on the trial for more than 12 months.

The mean days on trial for evaluable patients is 202 days and is substantially better than the 117 days the benchmark MPACT study reported for chemotherapy alone.

At the data cut-off date, 17 patients remained on trial.

Leading Cause of Death
Pancreatic cancer is the eighth most-diagnosed cancer in Australia and the nation’s third leading cause of cancer death.

While survival rates are increasing, it remains a serious diagnosis with an extremely poor prognosis.

Amplia is developing Narmafotinib as an inhibitor of FAK — a protein overexpressed in pancreatic cancer — and the treatment is gaining increasing attention for its role in solid tumours.

Quarterly Developments
The latest ACCENT results follow significant developments achieved in the trial during the three months to end June, with Amplia reporting a key activity threshold of 15 confirmed partial responses (PRs), demonstrating that the combination of narmafotinib with chemotherapy was superior to chemotherapy alone.

The company also announced that two trial participants had achieved pathological complete responses, with one patient experiencing a decrease in cancer lesion size over the course of treatment to the point where the lesions were no longer detectable.

Pathology showed a presumed residual tumour surgically removed from the second patient to be non-malignant tissue, meaning that the patient had achieved a pathological complete response.

This finding is extremely rare in metastatic pancreatic cancer sufferers, resulting in significant media attention for the patient and the hospital that had delivered the treatment.

Impressive Results
Amplia chief executive officer Dr Chris Burns said the trial continued to deliver impressive results.

"Data from our ACCENT trial of narmafotinib combined with chemotherapy continues to outperform chemotherapy alone across a variety of measures," he said.

"A PFS of 7.6 months at this interim stage is a significant improvement on existing chemotherapy regimens and we expect to provide further positive updates as the trial matures."

Dr Burns said the company was progressing a second trial of narmafotinib combined with FOLFIRINOX, with ethics approval for trial sites in the US and Australia received from the US Institutional Review Board during the June quarter.

Capital Raising
Post-quarter, Amplia launched a $27.5 million capital raising to support ongoing clinical activities and additional planned activities through to 2027.

The raising took the form of a $25m institutional placement and $2.5m share purchase plan and was supported by existing and new institutional and sophisticated investors in Australia and overseas.

Amplia finished the June quarter with a cash position of $7m, compared to $10.9m in the previous quarter, while net operating cash outflow totalled $3.9m, comprising $900,000 in administrative costs and $3m for research and development (R&D) activities primarily related to the ACCENT trial.

The company expects to receive a $3.8m R&D tax incentive refund in the next quarter, for the year ended March 2025.