On November 4, 2025 Catalent, Inc., a leading global contract development and manufacturing organization, reported new innovations from its SMARTag antibody-drug conjugate (ADC) technology platform. The company announced preclinical efficacy and tolerability data demonstrating the potential of CAT-09-833, a SMARTag ADC targeting MUC1, for the treatment of platinum-resistant ovarian cancer. The company also introduced SMARTag Enhanced Conjugates, a new class of ADCs that combines different payload types to benefit more patients by amplifying efficacy without compromising safety.

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The updates were presented at the 16th World ADC San Diego conference in a session in the Translational Medicine track entitled "SMARTag Enhanced Conjugates: Novel Payload Combinations to Enhance ADC Efficacy & Payload Delivery." The presentation was made by Ayodele Ogunkoya, Ph.D., Bioconjugation Group Leader, Catalent. World ADC provides a leading opportunity for Catalent to spotlight its ADC technologies and services to more than 1,400 ADC biopharma attendees actively seeking new partnerships and solutions.

"There is a growing appreciation for the role that ADCs may play in ovarian cancer treatment. The MUC1 tumor-associated antigen, which is highly expressed in ovarian tumors, demonstrates expression complementary to that of other ovarian ADC targets, such as folate receptor alpha," said Penelope Drake, Ph.D., Head of R&D Bioconjugates, Catalent. "Our novel antibody offers a unique way to access this target with an ADC, and the data thus far suggest that CAT-09-833 has a promising preclinical profile. We look forward to seeing the molecule advance and learning more about its potential to help cancer patients."

Catalent’s new SMARTag Enhanced Conjugates incorporate both cytotoxic and non-cytotoxic payloads to create unique dual- and triple-payload ADCs that can be optimized to the specific biology of the target tumor to amplify the effect of the cytotoxic payload without compromising safety. They are enabled by the SMARTag platform, which allows for a tunable drug-to-antibody ratio (DAR). Catalent presented data from a xenograft model demonstrating that the use of certepetide as a non-cytotoxic payload can yield improved ADC efficacy and broaden the distribution of the ADC cytotoxic payload and antibody in the tumor microenvironment. Certepetide is an internalizing RGD (iRGD) cyclic peptide that Catalent licensed (along with its analogs) from Lisata Therapeutics, Inc. for use with its SMARTag technology platform, with a goal of selectively targeting and penetrating solid tumors with ADCs more effectively.

Mike Blank, General Manager, Catalent, said, "We have a history of innovation dating back to 2008 when we spun the SMARTag technology out of the Bertozzi lab at UC Berkeley. Since then, we have made continuous progress on expanding the capabilities of the platform and understanding the design elements that underpin a successful ADC. We believe the new SMARTag Enhanced Conjugates represent the latest innovation in ADCs, allowing for the creation of an entirely new class of molecules that we hope will expand the scope of treatable cancer indications, reaching—and ultimately helping—more patients in need."

(Press release, Catalent, NOV 4, 2025, https://www.catalent.com/catalent-news/catalents-smartagadc-pipeline-and-new-enhanced-conjugates-offering-featured-at-16th-world-adc-san-diego/ [SID1234659383])

On November 4, 2025 Ankyra Therapeutics, a clinical-stage biotechnology company pioneering anchored drug conjugate technology for cancer and other diseases, reported the publication online of Part 1 results from its Phase 1 first-in-human study of tolododekin alfa in Nature Communications in the September 29, 2025, issue. Ankyra recently completed dose escalation of a phase 1 first-in-human study of monotherapy tolododekin alfa, the first anchored IL-12 designed for local tumor retention. The study was conducted at several centers in the United States and Canada in patients with progressive solid tumors. Data from Part 1 of the study focused on patients with superficially accessible tumors. "Tolododekin alfa demonstrated a tolerable safety profile and treatment was associated with monotherapy clinical activity in several types of cancers", said Howard L. Kaufman, MD. "This data opens the door for realizing the therapeutic potential of interleukin-12 for patients with cancer."

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"The emerging data supports the proposed mechanism action for tolododekin alfa", stated Joe Elassal, MD, chief medical officer at Ankyra Therapeutics, "and provides initial proof of concept for the anchored drug conjugate platform". The company has an emerging pipeline and will be presenting initial data with their ANK-201 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting on November 7, 2025.

Ankyra Therapeutics Announces Multiple Scientific Presentations at SITC (Free SITC Whitepaper) Meeting

Highlights include:

NKT Cells as Predictive Biomarkers of Response to IL-12 Conjugate Immunotherapy Abstract# 189 (oral presentation)
Exploratory analysis of phase 1 solid tumor patients treated demonstrates baseline levels of circulating natural killer T (NKT) cells may serve as predictive biomarkers of response to anchored IL-12 treatment.
First-in-Class ANK-201 Data Abstract # 999
Preclinical results from Ankyra’s next-generation candidate, ANK-201, will be presented for the first time, highlighting the expansion of the company’s pipeline beyond cytokines.
Combination anchored IL-12 and HDAC inhibitor therapy improves therapeutic responses Abstract #631
Results from an ongoing collaboration with the National Cancer Institute Center for Immuno-Oncology will report on anchored murine IL-12 in combination with a histone deacetylase (HDAC) inhibitor in checkpoint-refractory tumor models.
Pharmacologic evaluation of a canine anchored IL-12 (JEN-101) in dogs with melanoma Abstract #1195
In collaboration with Timothy M. Fan, DVM, PhD from the Department of Veterinary Clinical Medicine and Cancer Center at Illinois, University of Illinois at Urbana-Champaign and Jenga Biosciences, new data will be presented from a clinical trial of weight-based versus volume-based dosing of JEN-101, a canine anchored IL-12 conjugate, in dogs with melanoma.
"We are pleased with the data to be presented at the SITC (Free SITC Whitepaper) meeting showing the therapeutic potential of anchored immunotherapy", stated Howard Kaufman, MD.

About Tolododekin alfa (ANK-101)
Tolododekin alfa (ANK-101) is an anchored drug conjugate composed of interleukin-12 (IL-12) linked to aluminum hydroxide. ANK-101 enables local delivery of functional IL-12 to the tumor microenvironment where it remains biologically active for several weeks with transient exposure to the systemic circulation, thereby avoiding systemic toxicity. Treatment with ANK-101 in animal models has been associated with immune activation and rapid tumor regression. ANK-101 is being evaluated for the treatment of advanced solid tumors alone and in combination with anti-PD-1 agents. The first-in-human clinical trial of ANK-101 (NCT06171750) consists of monotherapy dose escalation, dose expansion in combination with cemiplimab, and dose optimization cohorts. The ANK-101-004 clinical trial (NCT07027514) will focus on non-mutated metastatic non-small cell lung cancer.

(Press release, Ankyra Therapeutics, NOV 4, 2025, View Source [SID1234659400])

On November 4, 2025 Boehringer Ingelheim and CDR-Life, Inc. reported a new global licensing agreement to develop CDR-Life’s unique antibody-based molecule CDR111 for autoimmune diseases. CDR111 is a trispecific M-gager, an antibody-based T-cell engager designed to selectively target and deplete B cells, with the goal of achieving immune system reset.

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Dysregulated B cells play a central role in driving many autoimmune and inflammatory conditions such as lupus, multiple sclerosis and certain forms of arthritis. Therefore, an approach that can deeply deplete these cells could have broad and far-reaching potential across multiple indications.

The agreement builds on the companies’ successful collaboration on an investigational antibody fragment. Boehringer has developed this molecule with technology licensed from CDR-Life, with the goal of preserving vision in people living with geographic atrophy (GA). It is currently being investigated in the VERDANT Phase 2 trial (NCT06722157).

"Our expanded collaboration with Boehringer underscores the growing recognition of our platform’s ability to design high quality biologics that may translate into meaningful therapeutic advances," said Christian Leisner, PhD, Chief Executive Officer of CDR-Life. "Having already demonstrated encouraging clinical progress together in GA, this new agreement further validates the versatility of our T-cell engager technology, and we are excited to see Boehringer advance CDR111 toward the clinic."

"We are excited to expand upon our work with CDR-Life and apply their trispecific M-gager approach to autoimmune and inflammatory diseases with high unmet need, further broadening our differentiated pipeline," said Carine Boustany, US Innovation Unit Site Head and Global Head of Immunology and Respiratory Diseases at Boehringer Ingelheim. "We see strong potential for CDR111 to demonstrate a deep and durable immune reset that may deliver transformative options for patients living with serious autoimmune disease."

Under the terms of the agreement, CDR-Life is eligible for up to a total of CHF 456 million (approximately USD 570 million)in payments including CHF 38 million (approximately USD 48 million)in upfront and near-term payments, plus tiered royalties on future sales.

(Press release, CDR-Life, NOV 4, 2025, View Source [SID1234666503])

On November 4, 2025 Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported its third quarter 2025 financial results and highlighted recent corporate achievements.

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"Our third quarter results reflect acceleration across every key dimension of OJEMDA’s performance and growing confidence among prescribers as we continue to build the case for second-line standard-of-care through execution and additional data readouts," said Jeremy Bender, Ph.D., chief executive officer of Day One. "Combined with steady pipeline progress, we are well positioned to deliver sustainable growth for shareholders while we continue our mission to bring meaningful therapies to patients."

OJEMDA Commercial Performance

•
OJEMDA net product revenue was $38.5 million in the third quarter of 2025, an increase of 15% from the second quarter of 2025.

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Achieved $102.6 million in U.S. OJEMDA net product revenue for 2025 year-to-date through the third quarter of 2025, representing an 89% increase over fiscal year 2024.

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Quarterly prescriptions (TRx) grew to 1,256 in the third quarter of 2025, representing an 18% increase compared to the second quarter of 2025.

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Third quarter new patient starts grew 19% compared to the second quarter of 2025, driven by the FIREFLY-1 clinical trial 2-year follow-up data.

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The Company is raising the OJEMDA full-year 2025 net product revenue guidance to $145 to $150 million, reflecting continued strength in underlying demand.

Program Highlights

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Progressing enrollment in the pivotal Phase 3 FIREFLY-2 clinical trial in first-line pediatric low-grade glioma (pLGG), with enrollment completion anticipated in the first half of 2026.

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Advancing dose escalation in the Phase 1a clinical trial of DAY301, a PTK7-targeted antibody drug conjugate (ADC).

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Tovorafenib added as a category 2a recommended therapy in the National Comprehensive Cancer Network (NCCN) treatment guidelines for adult patients with recurrent or progressive BRAF-altered glioma.

Corporate Highlights

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Seasoned biopharmaceutical executive Heather Adkins Huet, PhD, joined Day One in September 2025 as Chief Scientific Officer. Dr. Huet brings over two decades of experience leading and managing the full life cycle of oncology therapeutics, from discovery through life-cycle management of approved products, in biotech startup, mid-cap and large-cap companies including ImmunoGen, Takeda Pharmaceuticals, and Unum Therapeutics.

Third Quarter 2025 Financial Highlights

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Product Revenue, Net: OJEMDA net product revenue was $38.5 million for the third quarter of 2025 compared to $20.1 million for the third quarter of 2024 driven by higher patient demand.

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License Revenue: License revenue from the sale of ex-U.S. commercial rights for tovorafenib was $1.3 million for the third quarter of 2025 compared to $73.7 million for the third quarter of 2024 during which period the upfront consideration received from Ipsen for the pLGG license rights of $73.5 million was recognized.

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R&D Expenses: Research and development expenses were $31.4 million for the third quarter of 2025 compared to $33.6 million for the third quarter of 2024.

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SG&A Expenses: Selling, general and administrative expenses were $28.1 million for the third quarter of 2025 compared to $29.0 million for the third quarter of 2024.

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Net Loss: Net loss totaled $19.7 million for the third quarter of 2025 with non-cash stock-based compensation expense of $9.6 million, compared to a net income of $37.0 million for the third quarter of 2024, with non-cash stock-based compensation expense of $11.6 million.

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Cash Position: The Company’s cash, cash equivalents and short-term investments totaled $451.6 million as of September 30, 2025.

Upcoming Events

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Three-year data from the pivotal FIREFLY-1 trial will be presented in an oral presentation titled ‘Clinical stability following tovorafenib treatment in relapsed/refractory pediatric low-grade glioma:

updated results from the phase 2 FIREFLY-1 trial’ on Sunday, Nov. 23 at 11:49 a.m. HST during the 2025 Society for Neuro Oncology Annual Meeting.

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Piper Sandler 37th Annual Healthcare Conference, December 2-4, 2025.

Conference Call

Day One will host a conference call and webcast today, Nov. 4 at 4:30 p.m. Eastern Time. To access the live conference call by phone, dial 877-704-4453 (domestic) or 201-389-0920 (international), and provide the access code 13745150. Live audio webcast will be accessible from the Events page. To ensure a timely connection to the webcast, it is recommended that participants register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events section of the Day One Media & Investors page for 30 days following the event.

About OJEMDA

OJEMDA (tovorafenib) is a Type II RAF kinase inhibitor of mutant BRAF V600, wild-type BRAF, and wild-type CRAF kinases.

OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Tovorafenib was granted Breakthrough Therapy and Rare Pediatric Disease designations by the FDA for the treatment of patients with pLGG harboring an activating RAF alteration, and it was evaluated by the FDA under priority review. Tovorafenib has also received Orphan Drug designation from the FDA for the treatment of malignant glioma and from the European Commission for the treatment of glioma.

For more information, please visit www.ojemda.com.

(Press release, Day One, NOV 4, 2025, View Source [SID1234659351])

On November 4, 2025 Pfizer Inc. (NYSE: PFE) reported financial results for the third quarter of 2025 and reaffirmed its 2025 Revenue guidance(1) while raising and narrowing guidance for Adjusted(2) diluted EPS.

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Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates(5).
Results for the third quarter and first nine months of 2025 and 2024(6) are summarized below.
($ in millions, except per share amounts)
Third-Quarter Nine Months
2025 2024
% Change
2025 2024
% Change
Revenues $ 16,654 $ 17,702 (6%) $ 45,022 $ 45,864 (2%)
Reported(3) Net Income
3,541 4,465 (21%) 9,419 7,621 24%
Reported(3) Diluted EPS
0.62 0.78 (21%) 1.65 1.34 23%
Adjusted(2) Income
4,949 6,050 (18%) 14,620 14,124 4%
Adjusted(2) Diluted EPS
0.87 1.06 (18%) 2.56 2.48 3%

REVENUES
($ in millions) Third-Quarter Nine Months
2025 2024 % Change 2025 2024 % Change
Total Oper. Total Oper.
Global Biopharmaceuticals Business (Biopharma) $ 16,310 $ 17,392 (6%) (7%) $ 44,056 $ 44,987 (2%) (2%)
Pfizer CentreOne (PC1) 344 285 21% 18% 929 820 13% 13%
Pfizer Ignite — 25 (99%) (99%) 37 56 (34%) (34%)
TOTAL REVENUES $ 16,654 $ 17,702 (6%) (7%) $ 45,022 $ 45,864 (2%) (2%)

2025 FINANCIAL GUIDANCE(1)
■Reaffirms full-year 2025 Revenue guidance of $61.0 to $64.0 billion.
■Raises and narrows Adjusted(2) diluted EPS guidance(1) to a range of $3.00 to $3.15 from $2.90 to $3.10 previously.
■The updated 2025 Adjusted(2) diluted EPS guidance takes into consideration our solid year-to-date performance, continued confidence in our business, progress with ongoing cost improvement initiatives, and improvement in our effective tax rate.
–Includes a one-time $1.35 billion Acquired In-Process R&D charge related to the in-licensing agreement with 3SBio, Inc. recorded in the third quarter of 2025 with an unfavorable impact of approximately $0.20.
■The company’s guidance absorbs the impact of the currently imposed tariffs from China, Canada, and Mexico.
Revenues
$61.0 to $64.0 billion
Adjusted(2) SI&A Expenses
$13.1 to $14.1 billion
Adjusted(2) R&D Expenses
$10.0 to $11.0 billion
(previously $10.4 to $11.4 billion)
Effective Tax Rate on Adjusted(2) Income
Approximately 11.0%
(previously approximately 13.0%)
Adjusted(2) Diluted EPS
$3.00 to $3.15
(previously $2.90 to $3.10)

CAPITAL ALLOCATION
During the first nine months of 2025, Pfizer deployed its capital in a variety of ways, which primarily included:
▪Reinvesting capital into initiatives intended to enhance the future growth prospects of the company, including:
•$7.2 billion invested in internal research and development projects, and
•Approximately $1.6 billion invested in business development transactions, primarily reflecting the 3SBio in-licensing deal.
▪Returning capital directly to shareholders through $7.3 billion of cash dividends, or $1.29 per share of common stock.
No share repurchases have been completed to date in 2025. As of November 4, 2025, Pfizer’s remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2025. The company expects to continue to de-lever in a prudent manner in order to maintain a balanced capital allocation strategy. This includes maintaining the flexibility to deploy capital towards potential value-creating business development transactions and the potential to return capital to shareholders through share repurchases.
Diluted weighted-average shares outstanding of 5,714 million and 5,705 million were used to calculate Reported(3) and Adjusted(2) diluted EPS for third-quarter 2025 and 2024, respectively.
QUARTERLY FINANCIAL HIGHLIGHTS (Third-Quarter 2025 vs. Third-Quarter 2024)
Third-quarter 2025 revenues totaled $16.7 billion, a decrease of $1.0 billion, or 6%, compared to the prior-year quarter, reflecting an operational decrease of $1.3 billion, or 7%, and a favorable impact of foreign exchange of $203 million. The operational decrease was primarily driven by a year-over-year decline in COVID-19 product revenues largely due to lower infection rates impacting Paxlovid demand as well as a narrower vaccine recommendation for COVID-19 in the U.S. that reduced the eligible population for Comirnaty.
Third-quarter 2025 operational revenue reflected higher revenues primarily for:
▪Eliquis globally, up 22% operationally, driven primarily by higher demand globally and favorable net price in the U.S. as a result of the expected favorable year-over-year impact of the elimination of the coverage gap as part of the IRA Medicare Part D Redesign, partially offset by generic entry and price erosion in certain international markets;
▪Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 7% operationally, driven largely by strong demand with continuing uptake in patient diagnosis primarily in the U.S. and certain international developed markets, as well as improved patient affordability in the U.S.; partially offset by lower net price in the U.S. mostly due to the impact of higher manufacturer discounts resulting from the IRA Medicare Part D Redesign, as well as new payer contracts; and
▪Nurtec ODT/Vydura globally, up 22% operationally, driven primarily by strong demand in the U.S. and recent launches in certain international markets, partially offset by lower net price in the U.S. mainly due to unfavorable changes in channel mix;
more than offset primarily by lower revenues for:
▪Paxlovid, down 55% operationally, driven primarily by lower COVID-19 infections across U.S. and international markets and lower international government purchases, as well as the non-recurrence of a $442 million favorable U.S. government stockpile purchase in the third quarter of 2024; partially offset by favorable adjustments of rebate accruals related to prior periods, as well as higher net price in the U.S. following transition from the U.S. government agreement; and
▪Comirnaty, down 20% operationally, mainly due to a narrower recommendation for vaccination in the U.S. as well as delayed approval of the new variant vaccine; partially offset by a lower returns provision and higher market share in the U.S., as well as higher contractual deliveries in certain international markets.
EXECUTIVE COMMENTARY
Dr. Albert Bourla, Chairman and CEO of Pfizer:
"I am proud of Pfizer’s leadership as the first in our industry to reach an agreement with the U.S. Government, which we believe provides greater clarity for our business. Additionally, our recent strategic actions have strengthened opportunities to advance innovation that could address significant medical needs in high growth markets, helping us deliver value for patients and shareholders."
David Denton, CFO and EVP of Pfizer:
"Our third-quarter performance demonstrates our continued focus on execution and financial discipline. We raised and narrowed our full-year 2025 Adjusted diluted EPS guidance, underscoring confidence in our ability to deliver strong results for our shareholders."
OVERALL RESULTS
■Third-Quarter 2025 Revenues of $16.7 Billion, Representing a 7% Year-over-Year Operational Decline
–Strengthened Commercial Execution Drives 4% Operational Revenue Growth of Non-COVID Portfolio
■Third-Quarter 2025 Reported(3) Diluted EPS of $0.62, and Adjusted(2) Diluted EPS of $0.87
■Reaffirms Full-Year 2025 Revenue Guidance(1) in a Range of $61.0 to $64.0 Billion
■Raises and narrows Full-Year 2025 Adjusted(2) Diluted EPS Guidance(1) to a Range of $3.00 to $3.15
■On Track to Deliver Approximately $7.2 Billion in Overall Anticipated Net Cost Savings from Previously Announced Cost Improvement Initiatives(4) by End of 2027, Driving Productivity Gains and Operating Margin Expansion

(Press release, Pfizer, NOV 4, 2025, View Source [SID1234659367])