On October 28, 2025 Alkermes plc (Nasdaq: ALKS) reported financial results for the third quarter of 2025.

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"Alkermes delivered another successful quarter, achieving strong revenue growth and robust profitability, fueled by focused execution and underlying demand across our commercial portfolio. We ended the quarter in a strong financial position and have raised our financial outlook for 2025, underscoring the momentum of the business. Our proposed acquisition of Avadel Pharmaceuticals announced last week represents another potential growth driver for our business and an important element of our strategic plan as we seek to become a leader in the treatment of central disorders of hypersomnolence," said Richard Pops, Chief Executive Officer of Alkermes. "During the quarter, we also advanced our development pipeline, with notable progress in our orexin 2 receptor agonist program. We recently presented positive data from Vibrance-1, our phase 2 study of alixorexton in patients with narcolepsy type 1, and expect to report topline results from Vibrance-2, in narcolepsy type 2, next month. As we prepare to initiate our phase 3 clinical program in early 2026, we believe alixorexton represents a compelling opportunity to create value and deliver meaningful innovation to patients."

Key Financial Highlights

Revenues

(In millions)

Three Months Ended
September 30,

Nine Months Ended
September 30,

2025

2024

2025

2024

Total Revenues

$

394.2

$

378.1

$

1,091.4

$

1,127.6

Total Proprietary Net Sales

$

317.4

$

273.0

$

869.2

$

775.8

VIVITROL

$

121.1

$

113.7

$

343.8

$

323.2

ARISTADAi

$

98.1

$

84.7

$

272.8

$

249.6

LYBALVI

$

98.2

$

74.7

$

252.6

$

203.1

Profitability

(In millions)

Three Months Ended
September 30,

Nine Months Ended
September 30,

2025

2024

2025

2024

GAAP Net Income From Continuing Operations

$

82.8

$

92.8

$

192.3

$

226.4

GAAP Net Income (Loss) From Discontinued Operations

$

—

$

(0.4)

$

—

$

(5.8)

GAAP Net Income

$

82.8

$

92.4

$

192.3

$

220.6

EBITDA From Continuing Operations

$

96.9

$

112.3

$

221.2

$

282.4

EBITDA From Discontinued Operations

$

—

$

(0.5)

$

—

$

(6.9)

EBITDA

$

96.9

$

111.8

$

221.2

$

275.5

Adjusted EBITDA

$

121.5

$

134.3

$

293.7

$

351.4

Revenue Highlights

LYBALVI

Revenues for the quarter were $98.2 million.
Revenues and total prescriptions for the quarter grew 32% and 25%, respectively, compared to the third quarter of 2024.
ARISTADAi

Revenues for the quarter were $98.1 million.
Revenues for the quarter grew 16% compared to the third quarter of 2024.
During the quarter, the company recorded ARISTADA revenue of approximately $5.0 million related to gross-to-net favorability, primarily driven by Medicaid utilization adjustments.
VIVITROL

Revenues for the quarter were $121.1 million.
Revenues for the quarter grew 7% compared to the third quarter of 2024.
During the quarter, the company recorded VIVITROL revenue of approximately $8.0 million related to gross-to-net favorability, primarily driven by Medicaid utilization adjustments.
Manufacturing & Royalty Revenues

VUMERITY manufacturing and royalty revenues for the quarter were $35.6 million.
Royalty revenues from XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI for the quarter were $30.2 million.
Key Operating Expenses
Please see Note 1 below for details regarding discontinued operations.

(In millions)

Three Months Ended
September 30,

Nine Months Ended
September 30,

2025

2024

2025

2024

R&D Expense – Continuing Operations

$

81.7

$

59.9

$

230.9

$

187.2

R&D Expense – Discontinued Operations

$

—

$

0.5

$

—

$

6.9

SG&A Expense – Continuing Operations

$

171.8

$

150.4

$

514.3

$

498.2

SG&A Expense – Discontinued Operations

$

—

$

—

$

—

$

—

Balance Sheet
At Sept. 30, 2025, the company recorded cash, cash equivalents and total investments of $1.14 billion, compared to $1.05 billion at June 30, 2025.

Financial Expectations for 2025
Today, Alkermes raised its financial expectations for 2025, as set forth below. All line items are according to GAAP, except as otherwise noted.

In millions

Previous 2025 Expectations

(provided Feb. 12, 2025)

Updated 2025 Expectations

(provided Oct. 28, 2025)

Total Revenues

$1,340 – $1,430

$1,430 – $1,490

VIVITROL Net Sales

$440 – $460

$460 – $470

ARISTADAi Net Sales

$335 – $355

$360 – $370

LYBALVI Net Sales

$320 – $340

$340 – $350

Cost of Goods Sold

$185 – $205

$195 – $205

R&D Expense

$305 – $335

$315 – $325

SG&A Expense

$655 – $685

$675 – $705

GAAP Net Income a

$175 – $205

$230 – $250

EBITDA b

$215 – $245

$270 – $290

Adjusted EBITDA b

$310 – $340

$365 – $385

Effective Tax Rate

~17%

~17%

a Expected 2025 weighted average basic share count of approximately 165.5 million shares outstanding and a weighted average diluted share count of approximately 169.5 million shares outstanding

b Non-GAAP measure

Notes and Explanations
1. The company determined that upon the separation of its former oncology business, completed on Nov. 15, 2023, the oncology business met the criteria for discontinued operations in accordance with Financial Accounting Standards Board Accounting Standards Codification 205, Discontinued Operations. Accordingly, the accompanying selected financial information has been updated to present the results of the oncology business as discontinued operations for the three and nine months ended Sept. 30, 2024.

Conference Call
Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (12:00 p.m. GMT) on Tuesday, Oct. 28, 2025, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes’ website.

(Press release, Alkermes, OCT 28, 2025, View Source [SID1234657059])

On October 28, 2025 Alexion and AstraZeneca reported that its rare disease Koselugo (selumetinib), an oral, selective MEK inhibitor, has been approved in the European Union (EU) for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adult patients with neurofibromatosis type 1 (NF1).

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The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and is based on results from KOMET, the largest and only placebo-controlled global Phase III trial in this patient population, which were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and published in The Lancet.2

NF1 is a rare, progressive, genetic condition usually diagnosed in early childhood, but often progressing into adulthood, that can impact every organ system.3,4 Up to 50% of people living with NF1 may develop a type of non-malignant tumour called PN that may affect the brain, spinal cord and nerves.4,5 PN may appear later in a person’s life and can grow and become large, leading to pain, disfigurement and muscle weakness, among other debilitating symptoms.4,5

Prof. Pierre Wolkenstein, MD, PhD, Head of the Department of Dermatology at Henri Mondor Hospital, APHP, Paris East University (UPEC), and National Coordinating Investigator of the KOMET trial in Europe, said: "The approval of Koselugo for adults with NF1 PN in Europe offers patients and physicians a meaningful approach to close treatment gaps beyond childhood. As demonstrated in the KOMET Phase III trial, the most robust late-stage clinical trial conducted in this patient group to-date, adults administered Koselugo saw significant tumour volume reduction with a safety profile consistent with its established use in paediatric patients, validating the clinical benefits of Koselugo for newly diagnosed adults and those transitioning to adult care."

Marc Dunoyer, Chief Executive Officer, Alexion, said: "The European Commission approval extends the life-changing potential of Koselugo to adults with NF1 PN in the region, including continuity of care into adulthood. This milestone, along with our pioneering leadership in NF1 PN treatment landscape, embodies Alexion’s unwavering commitment to addressing the unmet needs in the rare disease community. We look forward to bringing Koselugo to those adults in need across Europe as soon as possible."

In the primary analysis of the trial, Koselugo showed a statistically significant objective response rate (ORR) of 20% (n=14/71, 95% CI: 11.2, 30.9) compared to 5% with placebo (n=4/74, 95% CI: 1.5, 13.3; p=0.01) by cycle 16. After 12 cycles, patients on placebo were switched to Koselugo and patients on Koselugo remained on treatment for an additional 12 cycles.2

The safety profile of Koselugo in the KOMET Phase III trial was consistent with its known profile and established use in paediatric patients.2

Koselugo has been recently approved in Japan and other countries for the treatment of adult patients with NF1 who have symptomatic, inoperable PN based on data from the KOMET Phase III trial, and additional regulatory reviews are ongoing.

Notes

NF1
NF1 is a rare, progressive, genetic condition that is caused by a spontaneous or inherited mutation in the NF1 gene.3,4 NF1 is associated with a variety of symptoms, including soft lumps on and under the skin (cutaneous neurofibromas) and, in up to 50% of patients, tumours called plexiform neurofibromas (PN) may develop on the nerve sheaths.4,5 These PN can cause clinical issues such as disfigurement, motor dysfunction, pain, airway dysfunction, visual impairment and bladder or bowel dysfunction.4,5

KOMET
KOMET is a global Phase III randomised, double-blind, placebo-controlled, multicentre trial designed to evaluate the efficacy and safety of Koselugo in adults with NF1 who have symptomatic, inoperable PN. The trial enrolled 145 adults from 13 countries across North America, South America, Europe, Asia and Australia, with participants’ baseline characteristics, including gender and distribution of PN, reflective of the global adult NF1 patient population. Patients were enrolled and randomised to receive Koselugo or placebo (1:1) for 12 28-day cycles. Participants were required to have diagnosis of NF1, at least one symptomatic, inoperable PN measurable by volumetric MRI analysis, chronic PN pain score documented during screening, adequate organ and marrow function and stable chronic PN pain medication use at enrolment.2,6

The primary endpoint is confirmed objective response rate (ORR) by cycle 16 as assessed by ICR. ORR is defined as the percentage of patients with confirmed complete response (disappearance of PNs) or partial response (at least 20% reduction in tumour volume). Secondary endpoints include improved PN-related pain and health-related quality of life (HRQoL) at cycle 12.2,6

After 12 cycles, patients on placebo were switched to Koselugo and patients on Koselugo remained on treatment for an additional 12 cycles. Patients who had the opportunity to complete 24 cycles of treatment have the option to participate in a long-term extension period and continue to receive Koselugo.2,6

Koselugo

Koselugo (selumetinib) is a kinase inhibitor that blocks specific enzymes (MEK1 and MEK2), which are involved in stimulating cells to grow. In NF1, these enzymes are overactive, causing tumour cells to grow in an unregulated way creating so-called plexiform neurofibromas (PN). By blocking these enzymes, Koselugo slows down the growth of tumour cells and, therefore, the PN growth.

Koselugo is approved in the US, EU, Japan, China and other countries for the treatment of certain paediatric patients with NF1 who have symptomatic, inoperable PN.

Koselugo is approved in the EU, Japan and other countries for the treatment of adult patients with NF1 who have symptomatic, inoperable PN, and additional regulatory reviews are ongoing.

Koselugo has been granted Orphan Drug Designation in the US, EU, Japan and other countries for the treatment of NF1.

(Press release, AstraZeneca, OCT 28, 2025, View Source [SID1234657076])

On October 28, 2025 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, inflammatory and autoimmune diseases, reported financial results for the third quarter ended September 30, 2025, and provided a pipeline update on its clinical-stage investigational molecules and discovery programs.

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"Data from the ARC-20 study demonstrate that casdatifan has a best-in-class profile, based on a meaningfully higher response rate and longer PFS relative to data for the only marketed HIF-2a inhibitor," said Terry Rosen, Ph.D., chief executive officer of Arcus. "With our global Phase 3 PEAK-1 study now enrolling, and based on the encouraging, emerging data from cohorts evaluating casdatifan-based regimens in early-line settings, we are extremely excited about the potential for casdatifan to be a transformative therapy in clear cell renal cell carcinoma (ccRCC). We remain well capitalized and funded through readout of multiple Phase 3 trials, and we are looking forward to a steady cadence of key data events in 2026 and beyond."
Corporate Update

•In October, Taiho exercised its option for an exclusive license to casdatifan in Japan and certain territories in Asia; in exchange, Taiho will make an option payment to Arcus along with milestone payments upon achievement of clinical, regulatory and commercialization milestones, and additionally make royalty payments on net sales.
Casdatifan (HIF-2a inhibitor)

Casdatifan Development Program:

•PEAK-1, a global Phase 3 study evaluating casdatifan + cabozantinib versus cabozantinib in immunotherapy (IO)-experienced metastatic ccRCC is enrolling and, with a primary endpoint of PFS, represents an opportunity for a rapid path to approval.

•The company is pursuing a multi-pronged strategy for the development of casdatifan in early-line ccRCC, likely in combination with standard-of-care mechanisms, with the goal of initiating a Phase 3 study in early-line ccRCC in the second half of 2026. This study will be informed by emerging data from eVOLVE-RCC02 and ARC-20.
▪eVOLVE-RCC02, a Phase 1b/3 study sponsored and operationalized by AstraZeneca, evaluating casdatifan + volrustomig, an investigational anti-PD-1/CTLA-4 bispecific antibody, in first-line (1L), metastatic ccRCC, was initiated in mid-2025.
•The Phase 1b portion of the study has recruited rapidly, and in the context of this rapid enrollment, following observations of potential immune-mediated adverse events (AEs), none of which exceeded Grade 3, a decision was made to temporarily pause recruitment, while continuing to treat participants already enrolled in the study. No Grade 4 or 5 events were observed, and the majority of AEs were Grade 1 or 2.
•Arcus and AstraZeneca will continue to monitor these participants to further characterize the safety profile of the combination with longer follow-up. These data, along with any discussions with health authorities, will inform next steps for the study.
▪ARC-20 includes three cohorts evaluating casdatifan in earlier-line settings: casdatifan plus zimberelimab in 1L ccRCC, casdatifan monotherapy in favorable risk ccRCC and casdatifan monotherapy in immunotherapy-experienced, TKI-naive ccRCC.
◦Arcus expects to complete enrollment for these cohorts by the end of 2025 and to report data for one or more of these cohorts in the second half of 2026.

Recent Data Update:

•Data, including overall response rate (ORR) and PFS data, from the four monotherapy cohorts of the Phase 1/1b ARC-20 study in late-line ccRCC were presented at an investor event in October.
▪Casdatifan performed better on every efficacy measure evaluated, for each individual cohort and across all four monotherapy cohorts (n=121), relative to published data from studies with the only marketed HIF-2a inhibitor.
▪At the time of data cutoff (DCO, August 15, 2025), mPFS was 12.2 months, and 18-month landmark PFS was 43% in the pooled analysis of all four monotherapy cohorts.
▪In the 100mg once-daily cohort (the Phase 3 PEAK-1 dose and formulation), confirmed ORR was 35%, with two responses (including one that occurred after the DCO) pending confirmation, and mPFS had not been reached with greater than 12 months median follow-up.
▪Seventy-four percent (28 of the 38) of confirmed responders across all four cohorts remained on treatment.
▪No unexpected safety signals were observed at the time of DCO, and casdatifan had an acceptable and manageable safety profile across all doses.

Planned Data Readouts:

•1H 2026: Additional analyses from the ARC-20 cohorts evaluating casdatifan monotherapy in late-line ccRCC.
•Mid-2026: More mature data from the ARC-20 cohort evaluating casdatifan plus cabozantinib in the IO-experienced setting. This is the same setting and combination being evaluated in the ongoing Phase 3 PEAK-1 study.
•2H 2026: Initial data from one or more ARC-20 cohorts evaluating casdatifan in early-line settings.
•2H 2026: Data from the Phase 1b portion and a go-no-go decision on the Phase 3 portion of eVOLVE-RCC02.

Domvanalimab (Fc-silent anti-TIGIT antibody) plus Zimberelimab (anti-PD-1 antibody)

Recent Data Presentation:

•OS data from Arm A1 of the Phase 2 EDGE-Gastric study, evaluating domvanalimab plus zimberelimab and chemotherapy in upper gastrointestinal (GI) adenocarcinomas, were presented in an oral session at the 2025 ESMO (Free ESMO Whitepaper) Congress in October. This is the same regimen and patient population being evaluated in the ongoing Phase 3 study, STAR-221.
◦Domvanalimab plus zimberelimab and chemotherapy showed 26.7 months of median OS, well beyond what would be required to demonstrate clinically meaningful benefit over standard of care in this setting.
◦The regimen was generally well tolerated and had a safety profile that is consistent with that of anti-PD-1 and chemotherapy.

Planned Data Readout:

•Data from the ongoing Phase 3 study STAR-221, evaluating domvanalimab plus zimberelimab and chemotherapy in PD-L1 all-comer 1L unresectable or metastatic upper GI adenocarcinomas are expected in 2026.

Quemliclustat (small-molecule CD73 inhibitor)

•Enrollment has been completed for PRISM-1, a Phase 3 trial of quemliclustat combined with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in 1L metastatic pancreatic ductal adenocarcinoma, within 12 months of study initiation.

Emerging I&I Portfolio

•In October, Arcus disclosed five new research and preclinical programs addressing targets for inflammatory and autoimmune diseases. Potential new drug candidates include:
◦MRGPRX2 small-molecule inhibitor, a potential treatment for atopic dermatitis and chronic spontaneous urticaria
◦TNF-a (TNFR1) small-molecule inhibitor, a potential treatment for rheumatoid arthritis (RA), psoriasis and inflammatory bowel disease (such as ulcerative colitis)
◦CCR6 small-molecule inhibitor, a potential treatment for psoriasis
◦CD89 monoclonal antibody, a potential treatment for RA
◦CD40L small-molecule inhibitor, a potential treatment for multiple sclerosis and systemic lupus erythematosus
•Arcus expects to select development candidates for at least three of these programs within the next 12 months. The first of these, a small molecule directed against MRGPRX2, is expected to enter the clinic in 2026.

Financial Results for Third Quarter 2025:

•Cash, Cash Equivalents and Marketable Securities were $841 million as of September 30, 2025, compared to $992 million as of December 31, 2024. The decrease during the period is primarily due to the use of cash in our research and development activities partially offset by the net proceeds from our underwritten offering in February 2025 and the additional $50 million draw down under our term loan facility in June 2025. We believe our cash, cash equivalents and marketable securities, together with available facilities, will be sufficient to fund operations through the initial pivotal readouts for domvanalimab, quemliclustat and casdatifan, which include PEAK-1.

•Revenues were $26 million for the third quarter 2025, compared to $48 million for the same period in 2024. The decrease in revenue was primarily driven by the prior year license revenue of $15 million as a result of Taiho’s exercise of its option for quemliclustat and lower revenues from the Gilead collaboration. Arcus expects to recognize GAAP revenue of between $225 million and $235 million for the full year 2025.

•Research and Development (R&D) Expenses were $141 million for the third quarter 2025, compared to $123 million for the same period in 2024. The net increase of $18 million was primarily due to costs incurred for our late-stage programs, resulting from increased enrollment and start-up activities for PRISM-1 and PEAK-1 and partially offset by lower costs from STAR-221. Non-cash stock-based compensation expense was $7 million for the third quarter 2025, compared to $9 million for the same period in 2024. For the third quarters 2025 and 2024, Arcus recognized gross reimbursements of $28 million and $37 million, respectively, for shared expenses from its collaborations. R&D expenses by quarter may fluctuate due to the timing of clinical manufacturing and standard-of-care therapeutic purchases with a corresponding impact on reimbursements. Arcus expects R&D expenses to decline commencing in the fourth quarter 2025 as costs related to the domvanalimab Phase 3 development program decrease significantly.
•General and Administrative (G&A) Expenses were $27 million for the third quarter 2025, compared to $30 million for the same period in 2024. The decrease was primarily driven by a decrease in compensation and personnel costs driven by lower stock-based compensation, partially offset by an increase in expenses shared under the Gilead collaboration. Non-cash stock-based compensation expense was $7 million for the third quarter 2025, compared to $10 million for the same period in 2024.

•Net Loss was $135 million for the third quarter 2025, compared to $92 million for the same period in 2024.

(Press release, Arcus Biosciences, OCT 28, 2025, View Source [SID1234657060])

On October 28, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company"), reported it will host an edition of the Company’s Innovation Series R&D Day at 09:00 a.m. Eastern Standard Time (3:00 p.m. CET) on Tuesday, November 11, 2025 in New York City, U.S.

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On the day, members of BioNTech’s leadership team will provide an overview of the Company’s strategy and clinical progress across its pipeline.

Investors, analysts and the interested public are invited to join the event online via this link.

A replay of the webcast will be available shortly after the conclusion of the event and archived on the Company’s website for one year following the call. The public may also access the presentation slides via the "Events & Presentations" page of the Investor Relations section of the Company’s website at www.BioNTech.com.

(Press release, BioNTech, OCT 28, 2025, View Source [SID1234657061])

On October 28, 2025 Pinetree Therapeutics, a preclinical-stage biotechnology company pioneering targeted protein degraders for drug-resistant cancers, reported the successful closing of an oversubscribed $47 million Series B financing. The proceeds will advance its lead preclinical oncology programs to Phase I clinical studies and accelerate development of Pinetree’s AbReptor platform. Participating investors include existing investors DSC Investment, WIDWIN Investment, STIC Ventures, Samho Green Investment, Atinum Investment, S&S Investment, SJ Investment Partners, Smilegate Investment, and Gauss Capital Management, as well as new investors Korea Investment Partners and SV Investment.

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Founded in 2019, Pinetree is an industry leader in the targeted protein degradation (TPD) field, developing a novel class of modular bispecific and multispecific protein degraders designed to selectively eliminate disease-driving membrane-bound and extracellular proteins. The AbReptor platform has demonstrated compelling preclinical efficacy and safety in degrading receptor tyrosine kinases (RTKs) that drive tumor growth and resistance, including targets refractory to existing tyrosine kinase inhibitors (TKIs) and immune checkpoint therapies.

"The AbReptor platform has repeatedly demonstrated durable activity across a broad range of RTK targets, including models resistant to standard-of-care therapies, and has unlocked the potential to develop a novel class of degrading antibody drug conjugates (ADCs), which aim to overcome the limitations of traditional ADCs, including tolerability and limited durability. Our platform also offers new therapeutic approaches for targeting inflammatory cytokines in disease tissues, representing a potential alternative to current immunology and inflammation therapies," said Ho-Juhn Song, Ph.D., Founder and CEO of Pinetree Therapeutics. "We are thrilled by the strong support from our investors and look forward to using these proceeds to advance differentiated therapies that address significant unmet clinical needs."

The Series B financing will support IND-enabling studies and Phase I clinical trials for Pinetree’s lead programs, expand its multispecific degrader portfolio, and enable strategic collaborations to unlock new target classes. "We are excited to continue our partnership with Pinetree as they advance a highly differentiated platform with the potential to meaningfully impact patients with RTK-driven tumors," said Yohan Kim, Executive Director of DSC Investment. "We see significant promise in Pinetree’s approach to overcoming resistance and improving tolerability, particularly for patients with limited treatment options."

This financing follows a July 2024 collaboration with AstraZeneca, which included an exclusive global license option for Pinetree’s preclinical EGFR degrader candidate, valued at over $500 million in potential milestones and royalties, reflecting growing interest in AbReptor therapeutics. Pinetree continues to expand its pipeline and strategic partnerships to deliver novel TPD programs that aim to transform treatment for patients with hard-to-treat cancers and other diseases.

(Press release, PineTree Therapeutics, OCT 28, 2025, View Source [SID1234657078])