Calidi Biotherapeutics Announces New Data to be Presented on its Therapeutic Lead, CLD-401, at the 2025 SITC Annual Meeting

On October 30, 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 the presentation of new data on its first therapeutic candidate from its RedTail platform, CLD-401, at the Society of Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.

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CLD-401 is a tumor-tropic oncolytic virus designed to home to metastatic sites after systemic administration, replicate only in tumors cells, induce an immune priming event at the tumor site, and express high levels of IL-15 superagonist, a potent cytokine that induces NK and T-cell responses to the tumor, in the tumor microenvironment (TME).

"The RedTail platform represents a major advance in virotherapy and genetic medicines," said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. "RedTail allows for systemically administered genetic medicines that avoid immune clearance, are tropic for tumor cells, induce tumor lysis and immunologically prime the TME, and can deliver a genetic payload."

"In our syngeneic models, CLD-401 can reach metastatic sites when administered systemically where it can destroy tumor cells through a novel mechanism that also induces an immune priming effect," added Eric Poma, PhD, Chief Executive Officer. "CLD-401 builds on these mechanisms by also delivering high levels of IL-15 superagonist to the TME to activate a potent T-cell and NK cell response to the tumor."

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.

CLD-401 Presentation

Meeting: SITC (Free SITC Whitepaper) 40th Anniversary Annual Meeting, November 7–9, 2025, National Harbor, MD
Title: In Situ Tumor Delivery of IL-15 Superagonist via RedTail Gene Therapy Achieves Durable Tumor Clearance
Abstract Number: 1175
Presentation Time: Friday, November 7, 2025, 12:15–1:45 PM and 5:35–7:00 PM

(Press release, Calidi Biotherapeutics, OCT 30, 2025, View Source [SID1234657145])

Bristol Myers Squibb Reports Third Quarter Financial Results for 2025

On October 30, 2025 Bristol Myers Squibb (NYSE: BMY) reported results for the third quarter of 2025.

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"We delivered strong results this quarter as a result of continued execution across the business and ongoing Growth Portfolio momentum," said Christopher Boerner, Ph.D., board chair and chief executive officer, Bristol Myers Squibb. "We’re focused on building for the future by accelerating innovation, advancing our pipeline, staying agile and delivering more transformational medicines to more patients."

Third Quarter Results
$ in millions, except per share amounts 2025 2024 Change
Change Excl. FX**
Total Revenues $12,222 $11,892 3 % 2 %
Earnings/(Loss) Per Share – GAAP* 1.08 0.60 81 % N/A
Earnings/(Loss) Per Share – Non-GAAP* 1.63 1.80 (9) % N/A
Acquired IPRD Charges and Licensing Income Net Impact on Earnings/(Loss) Per Share (0.20) (0.09) N/A N/A

*GAAP and Non-GAAP earnings/(loss) per share include the net impact of Acquired IPRD charges and licensing income.
**See "Use of Non-GAAP Financial Information".

1

THIRD QUARTER RESULTS
All comparisons are made versus the same period in 2024 unless otherwise stated.
•Growth Portfolio revenues of $6.9 billion increased 18%, or 17% Ex-FX. Revenue growth was primarily driven by our immuno-oncology (IO) portfolio, Reblozyl, Camzyos and Breyanzi.
•Legacy Portfolio revenues of $5.4 billion decreased 12%, or 13% Ex-FX. Demand increased for Eliquis, which was more than offset by expected continued generic impact across the remainder of the Legacy Portfolio.
•Total revenues of $12.2 billion increased 3%, or 2% Ex-FX.
◦U.S. revenues of $8.3 billion increased 1%.
◦International revenues of $3.9 billion increased 6%, or 3% Ex-FX.
THIRD QUARTER PRODUCT REVENUE HIGHLIGHTS(d)

($ amounts in millions) Quarter Ended September 30, 2025
% Change from Quarter Ended September 30, 2024
% Change from Quarter Ended September 30, 2024 Ex-FX**

U.S.
Int’l
WW(c)
U.S.
Int’l
WW(c)
Int’l
WW(c)
Growth Portfolio
Opdivo $ 1,454 $ 1,077 $ 2,532 6 % 8 % 7 % 6 % 6 %
Opdivo Qvantig 60 7 67 N/A N/A N/A N/A N/A
Orencia 721 243 964 2 % 6 % 3 % 3 % 2 %
Yervoy 455 284 739 14 % 17 % 15 % 13 % 14 %
Reblozyl 494 121 615 38 % 35 % 37 % 31 % 37 %
Opdualag 259 40 299 20 % 122 % 28 % 115 % 27 %
Breyanzi 251 109 359 45 % 115 % 60 % 104 % 58 %
Camzyos 238 57 296 76 % 177 % 89 % 168 % 88 %
Zeposia 113 48 161 8 % 13 % 9 % 6 % 7 %
Abecma 51 86 137 (34) % 80 % 9 % 71 % 6 %
Sotyktu 51 29 80 — % 91 % 21 % 87 % 20 %
Krazati 48 5 53 52 % 144 % 58 % 133 % 57 %
Cobenfy 43 — 43 N/A N/A N/A N/A N/A
Other Growth Products(a)
195 319 514 8 % 22 % 16 % 21 % 16 %
Total Growth Portfolio
4,432 2,425 6,857 17 % 20 % 18 % 17 % 17 %
Legacy Portfolio
Eliquis 2,631 1,115 3,746 29 % 16 % 25 % 11 % 23 %
Revlimid 485 89 575 (60) % (55) % (59) % (56) % (59) %
Pomalyst/Imnovid 596 79 675 (15) % (61) % (25) % (61) % (25) %
Sprycel 69 49 119 (69) % (24) % (59) % (25) % (59) %
Abraxane 24 50 74 (84) % (50) % (71) % (49) % (70) %
Other Legacy Products(b)
92 85 177 (11) % (29) % (21) % (30) % (21) %
Total Legacy Portfolio 3,897 1,468 5,365 (12) % (11) % (12) % (14) % (13) %
Total Revenues $ 8,329 $ 3,893 $ 12,222 1 % 6 % 3 % 3 % 2 %

** See "Use of Non-GAAP Financial Information".
(a) Includes Augtyro, Onureg, Inrebic, Nulojix, Empliciti and royalty revenues.
(b) Includes other mature brands.
(c) Worldwide (WW) includes U.S. and International (Int’l).
(d) For the above table and all subsequent tables, certain totals may not sum due to rounding. Percentages have been calculated using unrounded amounts.

2

THIRD QUARTER COST & EXPENSES
All comparisons are made versus the same period in 2024 unless otherwise stated.
The table below presents selected line-item information.

Three Months Ended September 30, 2025 Three Months Ended September 30, 2024
($ amounts in millions)
GAAP
Specified Items**
Non-GAAP
GAAP
Specified Items**
Non-GAAP
Cost of products sold
$ 3,435 (122) $ 3,312 $ 2,957 (101) $ 2,856
Gross margin(a)
71.9 % 72.9 % 75.1 % 76.0 %
Selling, general and administrative
1,789 (1) 1,788 1,983 (7) 1,976
Research and development
2,528 (95) 2,433 2,374 (21) 2,353
Acquired IPRD
633 — 633 262 — 262
Amortization of acquired intangible assets
831 (831) — 2,406 (2,406) —
Other (income)/expense, net
(108) (98) (206) 234 (275) (41)
Effective tax rate
29.5 % (7.2) % 22.3 % 27.5 % (9.0) % 18.5 %

**See "Use of Non-GAAP Financial Information" and refer to the Specified Items schedule below for further detail.
(a) Represents revenue minus cost of products sold divided by revenue.

•Gross margin on a GAAP and non-GAAP basis was 71.9% and 72.9% in 2025, and 75.1% and 76.0% in 2024, respectively, reflecting the change in product mix.
•Selling, general and administrative expenses of $1.8 billion decreased 10% on a GAAP and non-GAAP basis, primarily driven by our ongoing strategic productivity initiative.
•Research and development expenses of $2.5 billion increased 6% on a GAAP basis, primarily due to an IPRD impairment charge. Non-GAAP research and development expenses of $2.4 billion increased 3%, primarily due to the impact of recent acquisitions, partially offset by our ongoing strategic productivity initiative.
•Acquired IPRD charges of $633 million increased from $262 million on a GAAP and non-GAAP basis, primarily driven by the Philochem licensing arrangement and achievement of a milestone under the SystImmune collaboration. Licensing income increased from $25 million to $107 million on a GAAP and non-GAAP basis, primarily reflecting the execution of an out-licensing arrangement in 2025.
•Amortization of acquired intangible assets of $831 million decreased 65% on a GAAP basis, primarily due to lower amortization expense related to Revlimid.
•Effective tax rate increased from 27.5% to 29.5% on a GAAP basis, and from 18.5% to 22.3% on a non-GAAP basis. The increase in the non-GAAP effective tax rate was driven by jurisdictional earnings mix.
•Net income attributable to Bristol Myers Squibb of $2.2 billion, or $1.08 per share, increased from $1.2 billion, or $0.60 per share, on a GAAP basis. On a non-GAAP basis, net income attributable to Bristol Myers Squibb of $3.3 billion, or $1.63 per share, decreased from $3.7 billion, or $1.80 per share. GAAP and non-GAAP EPS include the impacts of Acquired IPRD charges and licensing income.

PRODUCT AND PIPELINE UPDATES
Entries organized by date and inclusive of third quarter and recent updates.
Asset(s)
Date Announced
Milestone
Sotyktu (deucravacitinib)
October 27
52-week data from the pivotal Phase 3 POETYK PsA-1 trial demonstrated that Sotyktu improved and maintained meaningful clinical responses, inhibition of radiographic progression and patient-reported outcomes in adults with active psoriatic arthritis.

In addition, data from an integrated analysis of the Phase 2 PAISLEY-SLE and PAISLEY long-term extension studies supported the safety and efficacy with up to four years of Sotyktu treatment for moderate-to-severe systemic lupus erythematosus (SLE).
CD19 NEX-T (BMS-986353)
October 25
Announced positive, updated data and early results from the Phase 1 Breakfree-1 study evaluating BMS-986353, an investigational, autologous CD19-targeted NEX-T CAR T cell therapy, across the systemic sclerosis, SLE and idiopathic inflammatory myopathies cohorts. The preliminary Phase 1 safety and efficacy results are consistent with the potential for immune reset, showing robust CAR T cell expansion, complete B cell depletion and re-emergence of a naive B cell phenotype across all three cohorts.
izalontamab brengitecan
(iza-bren)
October 17
First disclosure of safety and efficacy data presented with SystImmune from the global Phase I US-Lung-101 study of iza-bren, a potentially first-in-class EGFR x HER3 bispecific antibody-drug conjugate, demonstrated promising antitumor activity in heavily pre-treated patients across multiple tumor types, as well as a manageable safety profile.
BMS-986446 October 1
The U.S. Food and Drug Administration (FDA) granted Fast Track Designation to BMS-986446, a potential best-in-class, anti-microtubule binding region-tau antibody currently in Phase 2 development for the treatment of early Alzheimer’s disease.
Sotyktu September 25
Announced an expansion of the company’s direct-to-patient offerings, providing eligible U.S. patients with steeply discounted prices for Sotyktu via the new BMS Patient Connect platform, beginning January 2026.
iberdomide September 23
The Phase 3 EXCALIBER-RRMM study evaluating iberdomide, an investigational cereblon E3 ligase modulator (CELMoD), combined with standard therapies (daratumumab + dexamethasone) in patients with relapsed or refractory multiple myeloma demonstrated a statistically significant improvement in minimal residual disease (MRD) negativity rates, compared with the control arm, in a planned interim analysis of the MRD endpoint.
pumitamig (BNT327 / BMS-986545)
September 8
First disclosure of data presented with BioNTech SE from the global randomized Phase 2 trial (NCT06449209) evaluating pumitamig, an investigational bispecific antibody targeting PD-L1 x VEGF-A, plus chemotherapy in patients with extensive-stage small cell lung cancer demonstrated encouraging anti-tumor responses with a positive trend in the secondary endpoint of progression free survival.

Additionally, this week pivotal studies for pumitamig and chemotherapy combinations are now initiating in first-line (1L) microsatellite stable colorectal cancer and 1L gastric cancer.
Camzyos (mavacamten)
August 29
Results from the global, retrospective COLLIGO-HCM study showed that Camzyos was associated with reductions in left ventricular outflow tract obstruction and improvements in symptom burden in a racially diverse population of patients with symptomatic obstructive hypertrophic cardiomyopathy treated in an international, real-world setting.

iza-bren
August 18
The FDA granted Breakthrough Therapy Designation to iza-bren for the treatment of locally advanced or metastatic non-small cell lung cancer with epidermal growth factor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor and platinum-based chemotherapy.
Breyanzi (lisocabtagene maraleucel)
August 4
The FDA accepted the supplemental biologics license application for Breyanzi as a potential treatment for adult patients with relapsed or refractory marginal zone lymphoma who have received at least two prior lines of systemic therapy. The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act goal date of December 5, 2025.

Business Development
In October 2025, the company announced a definitive agreement to acquire Orbital Therapeutics. The acquisition includes OTX-201, Orbital’s lead RNA immunotherapy preclinical candidate currently in IND-enabling studies. This investigational, next-generation CAR T-cell therapy is designed to reprogram cells in vivo and has the potential to offer a best-in-class profile for treating autoimmune diseases, aligned with Bristol Myers Squibb’s overall immune reset strategy. This in vivo approach, in which the patient’s own body serves as the manufacturer of CAR T-cells, has the potential to offer a reduced treatment burden, added convenience and improved accessibility compared to ex vivo CAR T-cell therapies. Bristol Myers Squibb will also gain access to Orbital’s differentiated RNA technology platform that integrates advanced RNA engineering and delivery methods, offering the potential to expand therapeutic applications and address additional diseases. The transaction is subject to the satisfaction of customary closing conditions.

Financial Guidance
Bristol Myers Squibb is increasing its full-year 2025 non-GAAP revenue guidance from a range of approximately $46.5 billion to $47.5 billion, to a range of approximately $47.5 billion to $48.0 billion. This update primarily reflects the continued strong performance of our Growth Portfolio.
Full-year other income and expense in 2025 is now expected to be approximately $500 million of income due to higher-than-anticipated royalties and licensing income, as well as favorable interest income.
Non-GAAP EPS is now expected to be in the range of $6.40 – $6.60, inclusive of an $(0.80) per share net impact related to Acquired IPRD charges and licensing income.
Non-GAAP2,3

July
(Prior) October
(Updated)
Total Revenues
(Reported & Ex-FX)
~$46.5 – $47.5 billion ~$47.5 – $48.0 billion
Gross Margin % ~72% No change
Operating Expenses1
~$16.5 billion No change
Other income/(expense) ~$250 million ~$500 million
Effective tax rate ~18% No change
Diluted EPS $6.35 – $6.65 $6.40 – $6.60
Acquired IPRD Charges and Licensing Income Included in Diluted EPS $(0.60) $(0.80)

1 Operating Expenses = SG&A and R&D.
2 See "Use of Non-GAAP Financial Information."
3 July was calculated using foreign exchange rates as of July 25, 2025, and October was calculated using foreign
exchange rates as of October 28, 2025.

The 2025 financial guidance excludes the impact of any potential future strategic acquisitions, including Orbital Therapeutics, which is expected to close in the fourth quarter of 2025, divestitures, specified items that have not yet been identified and quantified, and the impact of future Acquired IPRD charges and licensing income. To the extent we have quantified the impact of significant R&D charges or other income resulting from upfront or contingent milestone payments in connection with asset acquisitions or licensing of third-party intellectual property rights, we may update this information from time to time on our website, www.bms.com, in the "Investors" section. Non-GAAP guidance assumes exchange rates as of the date noted. The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this press release.

(Press release, Bristol-Myers Squibb, OCT 30, 2025, View Source [SID1234657142])

Biogen reports strong third quarter 2025 results and updates full year 2025 guidance

On October 30, 2025 Biogen Inc. (Nasdaq: BIIB) reported third quarter 2025 financial results. Commenting on the quarter, President and Chief Executive Officer Christopher A. Viehbacher said:

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"We delivered another quarter of strong financial performance driven by continued commercial momentum in our launch products, resilience in our MS franchise and our ongoing focus on disciplined cost management. Looking ahead we are further advancing our new Biogen roadmap with a cadence of potentially registrational Phase 3 readouts beginning next year, including data now expected in 2026 from both SLE studies for litifilimab which are fully enrolled. We believe this execution on our strategic objectives, combined with our resilient business model and footprint, positions Biogen to deliver long-term sustainable growth."
Financial Highlights
Q3 ’25 Q3 ’24 △
r (CC*)
Total Revenue (in millions) $2,535 $2,466 3% 2%
GAAP diluted EPS $3.17 $2.66 19% N/A
Non-GAAP diluted EPS $4.81 $4.08 18% N/A

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period.
N/A = not applicable.
* Percentage changes in revenue growth at constant currency (CC) are presented excluding the impact of changes in foreign currency exchange rates and hedging gains or losses. Foreign currency revenue values are converted into U.S. Dollars using the exchange rates from the end of the previous calendar year.

A reconciliation of GAAP to Non-GAAP financial measures can be found in Table 4 at the end of this news release.
Revenue Summary
(in millions) Q3 ’25 Q3 ’24 △
r (CC*)
Multiple sclerosis (MS) product revenue(1)
$1,062 $1,054 1% —%
Rare disease revenue(2)
$533 $495 8% 6%
Biosimilars revenue $197 $197 —% —%
Other product revenue(3)
$55 $24 129% 130%
Total product revenue $1,847 $1,769 4% 3%
Revenue from anti-CD20 therapeutic programs $494 $446 11% 11%
Alzheimer’s collaboration revenue(4)
$43 $19 130% 129%
Contract manufacturing, royalty and other revenue $151 $232 (35)% (35)%
Total revenue $2,535 $2,466 3% 2%

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period. Numbers may not foot or recalculate due to rounding.
NMF = no meaningful figure.
(1) Multiple sclerosis includes TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA. Effective
January 1, 2025, our collaboration and license agreement for FAMPYRA global commercialization rights was terminated.
(2) Rare disease includes SPINRAZA, SKYCLARYS and QALSODY.
(3) Other includes ADUHELM, FUMADERM and ZURZUVAE.
(4) Includes Biogen’s 50% share of net revenue and cost of sales, including royalties, from the LEQEMBI Collaboration.
2

Expense Summary
(in millions, except effective tax rate) Q3 ’25 Q3 ’24 △
GAAP cost of sales*
$674 $639 (6)%
% of Total Revenue 27% 26%
Non-GAAP cost of sales*
$510 $593 14%
% of Total Revenue 20% 24%
GAAP R&D expense $436 $516 16%
Non-GAAP R&D expense $432 $465 7%
GAAP SG&A expense $595 $588 (1)%
Non-GAAP SG&A expense $592 $556 (6)%
GAAP acquired IPR&D, upfront and milestone expense $2 $27 NMF
Non-GAAP acquired IPR&D, upfront and milestone expense $2 $27 NMF

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period
IPR&D = in-process R&D; NMF = no meaningful figure.
* Excluding amortization and impairment of acquired intangible assets

•The increase in third quarter 2025 GAAP cost of sales as a percentage of total revenue was driven primarily by a pre-tax charge related to a judgment on Genentech’s claim for past royalties and interest on sales of TYSABRI, partially offset by favorable product mix, particularly the year-over-year decrease in contract manufacturing revenue. The decrease in third quarter 2025 Non-GAAP cost of sales as a percentage of total revenue was driven primarily by favorable product mix, particularly the year-over-year decrease in contract manufacturing revenue.

•The decrease in third quarter 2025 GAAP and Non-GAAP R&D expense was driven primarily by the favorable impact from the Company’s Fit for Growth initiative and R&D funding received, partially offset by increased investment in late-stage programs including felzartamab and litifilimab.

•The increase in third quarter 2025 GAAP and Non-GAAP SG&A was driven primarily by sales and marketing spend to support product launches, partially offset by savings from the Company’s Fit for Growth initiative.

•Third quarter 2025 GAAP and Non-GAAP acquired IPR&D, upfront and milestone expense was approximately $2 million.
Other Financial Highlights

•Third quarter 2025 GAAP and Non-GAAP collaboration profit sharing was a net expense of approximately $87 million, which includes approximately $67 million related to Biogen’s collaboration with Samsung Bioepis, and approximately $21 million related to Biogen’s collaboration with Supernus Pharmaceuticals, Inc. for the commercialization of ZURZUVAE in the U.S.

•Third quarter 2025 GAAP and Non-GAAP other expense was approximately $34 million and approximately $44 million, respectively, primarily driven by net interest expense.

•Third quarter 2025 GAAP and Non-GAAP effective tax rates were 16.3% and 17.2%, respectively. Third quarter 2024 GAAP and Non-GAAP effective tax rates were 13.9% and 13.8%, respectively.
Financial Position

•Third quarter 2025 net cash flow from operations was approximately $1.3 billion. Capital expenditures were approximately $46 million, and free cash flow, a Non-GAAP financial measure defined as net cash flow from operations less capital expenditures, was approximately $1.2 billion.

•As of September 30, 2025, Biogen had cash and cash equivalents totaling approximately $4.0 billion and approximately $6.3 billion in total debt, resulting in net debt of approximately $2.3 billion.

•For the third quarter of 2025 the Company’s weighted average diluted shares were approximately 147 million.
Full Year 2025 Financial Guidance

Biogen is updating its guidance for full year 2025 to reflect a stronger business outlook since July 2025 and the impact of business development transactions that are expected to close in the fourth quarter of 2025. Full year 2025 Non-GAAP diluted EPS range is expected as follows:
Full Year 2025 Non-GAAP Diluted EPS
Prior Guidance (July 2025) $15.50 to $16.00
Benefit from stronger business outlook +$0.25
Revised business outlook (October 2025) $15.75 to $16.25
Approx. impact from BD transactions expected to close in Q4’25 ~($1.25)
Updated Guidance $14.50 to $15.00

This updated Non-GAAP diluted EPS guidance range reflects a $0.25 EPS benefit from an expected stronger business outlook for the full year, partially offset by the expected ~($1.25) EPS impact from business development transactions expected to close in the fourth quarter of 2025.
For 2025 as compared to 2024, Biogen now expects total revenue to be approximately flat to increasing 1%, at constant currency. This reflects the strong revenue performance year-to-date, including the resilient performance of the U.S. MS business. Biogen expects increased competitive pressures on the ex-U.S. MS business in the fourth quarter of 2025, particularly for TECFIDERA in Europe. Due to planned campaign timing of contract manufacturing versus Biogen innovator product manufacturing, Biogen expects manufacturing revenue in the fourth quarter of 2025 of between $10 million and $20 million.

The Fit for Growth program is expected to generate approximately $1 billion of gross savings and $800 million net of reinvestment by the end of 2025. In 2025, Biogen plans to make additional investments in R&D to enable acceleration and expansion of the clinical development activities, primarily in support of rare disease, as well as additional investments in spend to support launch products. Biogen expects combined Non-GAAP R&D expense and Non-GAAP SG&A expense to total approximately $1.1 billion in the fourth quarter of 2025.
This financial guidance incorporates the Company’s view that Biogen’s 2025 financial outlook is not currently expected to be materially impacted by potential tariffs announced by the U.S. Administration during 2025, even if the exemption for pharmaceuticals were to be removed. This expectation is based on both a significant proportion of U.S. revenue being derived from products which have manufacturing operations in the U.S., and the Company’s current global inventory positions. The U.S. and international tariff landscape remains uncertain, and this guidance does not include contemplation of any new tariffs.
This financial guidance also assumes that foreign exchange rates as of October 24, 2025, will remain in effect for the remainder of the year, net of hedging activities.
Unless expressly stated above, this financial guidance does not include any impact from potential acquisitions or business development transactions or pending and future litigation or any impact of potential healthcare reform, as all are hard to predict. Some other financial considerations will be provided on the conference call and webcast.

Biogen may incur charges, realize gains or losses, or experience other events or circumstances in 2025 that could cause any of these assumptions and expectations to change and/or actual results to vary from this financial guidance.
Biogen does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking Non-GAAP financial measures to the most directly comparable GAAP reported financial measures because the Company is unable without unreasonable effort to predict with reasonable certainty the financial impact of items such as the transaction, integration, and certain other costs related to acquisitions or large business development transactions; unusual gains and losses; potential future asset impairments; gains and losses from equity security investments; and the ultimate outcome of pending or future litigation. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the Company is unable to address the significance of the unavailable information, which could be material to future results.

Other Key Recent Events

•In October 2025, Biogen announced a license agreement granting Biogen exclusive worldwide rights to Vanqua Bio’s preclinical, oral C5aR1 antagonist designed to modulate neutrophil-driven inflammation, a central mechanism underlying many inflammatory diseases. Under the terms of the agreement, Vanqua Bio will receive a $70 million upfront payment.

•In September 2025, Biogen announced it entered into a definitive agreement to acquire Alcyone Therapeutics. As part of an existing partnership with Alcyone Therapeutics, the companies are advancing ThecaFlex DRx, an implantable subcutaneous port and catheter device being investigated for the intrathecal delivery of antisense oligonucleotides. Under the terms of the agreement, Biogen has agreed to acquire Alcyone Therapeutics for an upfront cash payment of $85 million plus certain milestones payable related to the development and regulatory approval of ThecaFlex DRx with nusinersen and additional pipeline products, securing all rights to ThecaFlex DRx. The transaction is subject to customary closing conditions.

Conference Call and Webcast

The Company’s earnings conference call for the third quarter will be broadcast via the internet at 8:30 a.m. ET on October 30, 2025 and will be accessible through the Investors section of Biogen’s website, www.biogen.com. Supplemental information in the form of a slide presentation is also accessible at the same location on the internet and will be subsequently available on the website for at least 90 days.

(Press release, Biogen, OCT 30, 2025, View Source [SID1234657141])

Bicycle Therapeutics Reports Recent Business Progress and Third Quarter 2025 Financial Results

On October 30, 2025 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported financial results for the third quarter ended September 30, 2025, and provided recent corporate updates.

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"We are currently seeking broad regulatory feedback to make an informed decision on our path forward with zelenectide pevedotin in metastatic urothelial cancer. We look forward to providing updates in the first quarter of 2026," said Bicycle Therapeutics CEO Kevin Lee, Ph.D. "We have also been executing across the rest of our pipeline with the goal of helping patients live longer and live well. The development of zelenectide pevedotin for multiple Nectin-4 associated cancers is ongoing, with the Phase 1/2 Duravelo-3 trial for NECTIN4-amplified breast cancer and the Phase 1/2 Duravelo-4 trial for NECTIN4-amplified non-small cell lung cancer open and actively enrolling. Additionally, we were pleased to welcome additional esteemed global oncology leaders to the Bicycle Board of Directors and to our Research and Innovation Advisory Board to further strengthen our innovation and strategic growth."

Third Quarter 2025 and Recent Events

Phase 2/3 Duravelo-2 pivotal trial evaluating zelenectide pevedotin in combination with pembrolizumab in patients with metastatic urothelial cancer (mUC). Bicycle Therapeutics is currently seeking regulatory feedback on zelenectide pevedotin, a Bicycle Drug Conjugate (BDC). The company now expects to provide an update on dose selection for Duravelo-2 and zelenectide pevedotin’s potential approval pathway in mUC following meetings with multiple regulatory agencies in the first quarter of 2026.

Data for an early Bicycle Radioconjugate (BRC) molecule targeting MT1-MMP presented at European Association of Nuclear Medicine (EANM) 2025 Congress. An e-poster presentation outlined the first clinical experience with an early Bicycle Imaging Agent (BIA) targeting MT1-MMP. An additional e-poster presented by the German Cancer Consortium (DKTK), part of a cooperative network with the German Cancer Research Center (DKFZ), highlighted preclinical BRC data demonstrating the potential of this approach for radiotheranostic use. Altogether, the data build on preclinical and first human imaging data previously disclosed at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 and EANM 2024. The company believes this data further supports the potential of MT1-MMP as a novel target in the treatment of cancer, demonstrates the translatability of BRC preclinical data and highlights the potential of Bicycle molecules for targeted radionuclide therapies and radiopharmaceutical imaging.

The company continues to advance its emerging BRC pipeline, with initial EphA2 human imaging data expected in the first half of 2026 and the initiation of the first company-sponsored clinical trial expected in 2026.

Trial in Progress data for Phase 1/2 Duravelo-3 trial for zelenectide pevedotin in NECTIN4-amplified breast cancer and tissue sample data in patients with NECTIN4-amplified non-small cell lung cancer (NSCLC) presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025. The Phase 1/2 Duravelo-3 trial for zelenectide pevedotin in NECTIN4-amplified breast cancer and the Phase 1/2 Duravelo-4 trial for zelenectide pevedotin in NECTIN4-amplified NSCLC are open and actively enrolling. Data from post-hoc analyses of late-line breast cancer and lung cancer patients enrolled in Duravelo-1 showed enhanced anti-tumor activity of zelenectide pevedotin in patients with NECTIN4 amplification and/or polysomy. Based on these data, the U.S. Food and Drug Administration (FDA) previously granted Fast Track designation to zelenectide pevedotin for the treatment of adult patients with previously treated, NECTIN4-amplified, advanced or metastatic triple-negative breast cancer and NSCLC.

BT5528, a potential first-in-class EphA2 targeting BDC molecule. Phase 1 BT5528 combination data with nivolumab in mUC patients will now be presented at a scientific conference in the first half of 2026.

BT7480, a Bicycle tumor-targeted immune cell agonist (Bicycle TICA), is a Nectin-4 targeted CD137 agonist designed to overcome immune agonist toxicities and activate the immune system in Nectin-4 expressing tumors. Phase 1 BT7480 combination data with nivolumab will now be presented at scientific conference in the first half of 2026.

Strengthened Board of Directors with the addition of Charles Swanton, M.D., Ph.D., FRS, FMedSci, FRCP, Roger Dansey, M.D. and Hervé Hoppenot. Dr. Swanton leads the Cancer Evolution and Genome Instability Laboratory at the Francis Crick Institute. Dr. Dansey currently serves on the Boards of Directors of Inovio Inc. and Ottimo Pharma. Mr. Hoppenot is an advisor to the CEO and serves on the Board of Directors of Incyte, after serving 11 years as its chairman and CEO. He is also Chairman of the Board of Directors of Maze Therapeutics.

Expanded Research and Innovation Advisory Board (RAB) with the appointment of additional esteemed global leaders in oncology to further support scientific advancement and strategic growth across the company’s discovery research programs. The new RAB members are as follows:

Steve Davidsen, Ph.D., is a biotech executive with over 35 years of experience in drug discovery and development. Dr. Davidsen currently serves as the founder and president of Predawn Discovery Advisors LLC, providing technical and strategic input to organizations engaged in therapeutic drug discovery. He also serves on the Scientific Advisory Boards of Nitrase Therapeutics and BioLoomics. Previously, Dr. Davidsen served as vice president, oncology discovery research at AbbVie, where he was responsible for discovery efforts across all of AbbVie’s oncology programs and sites. He held various positions of increasing responsibility at Abbott prior to the separation of AbbVie. Dr. Davidsen has directed research teams and partnerships leading to more than 40 first-in-human clinical trials across a broad range of platforms and biology targeting both hematologic and solid tumor indications. He has more than 70 scientific publications across a diverse range of topics including metalloproteinase inhibitors, kinase inhibitors and the discovery of histone deacetylase inhibitors. Dr. Davidsen earned a Ph.D. in organic chemistry from the University of Texas at Austin and a B.S. in chemistry from the University of Maryland.

Gilles Gallant, B.Pharm, Ph.D., FOPQ, is an advisor and a consultant to biotechnology and pharmaceutical companies developing oncology drugs. He recently served as chief development officer at Mythic Therapeutics, responsible for the strategy, direction and execution of the company’s clinical development program. He also serves as a scientific advisor for Iteru Systems and is the founder and principal consultant of GG Biotech Consulting LLC. Previously, Dr. Gallant was senior vice president, global head of oncology clinical development at Daiichi Sankyo, leading the development of the company’s global oncology portfolio. At Daiichi, he led the clinical development and global approval of the antibody-drug conjugate (ADC) Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of advanced breast cancer, gastric cancer and non-small cell lung cancer. Dr. Gallant also held leadership roles of increasing responsibility at Bristol-Myers-Squibb, Human Genome Sciences and BioMarin. Dr. Gallant earned a Ph.D. in medicinal chemistry and a B.Pharm from the Université de Montréal and is a Fellow of the Order of Pharmacists of Québec.

Ken Herrmann, M.D., MBA, is a well-known leader in oncologic nuclear medicine with more than a decade of experience in clinical investigation. He currently serves on the Board of Directors of Aktis Oncology and as the chair of Aktis’ Scientific Advisory Board. Dr. Herrmann also serves as chair of the Department of Nuclear Medicine at the Universitätsklinikum Essen in Germany, member of Pentixapharm Holding AG’s Supervisory Board and associate editor of the Journal of Nuclear Medicine. Previously, he served as chair of the European Associates of Nuclear Medicine Oncology & Theranostics Committee, vice chair of the Department of Nuclear Medicine at the Universitätsklinikum Würzburg and associate professor in the Ahmanson Translational Imaging Division at the University of California, Los Angeles. To date, he has authored more than 700 peer-reviewed publications. Dr. Herrmann earned his M.D. from Humboldt Universität Berlin and his MBA from the Universität Zurich.

John Lambert, Ph.D., is a recognized global leader in ADC discovery and development, currently serving as a consultant/advisor to biopharma and pharma on ADC technologies. He serves on the Avipep Therapeutics Board of Directors and is a scientific advisor to Cureteq AG, Synaffix BV, CytomX Therapeutics and Mythic Therapeutics, among other companies. Previously, Dr. Lambert was chief scientific officer and executive vice president of research at ImmunoGen. During his tenure in leadership roles there, ImmunoGen invented the ADC technology that resulted in Kadcyla (ado-trastuzumab emtansine) and Elahere (mirvetuximab soravtansine-gynx) for the treatment of HER2+ breast cancer and platinum-resistant ovarian cancers, respectively. He is a fellow of the American Institute for Medical and Biological Engineering and an honorary professor at Queen’s University Belfast. Dr. Lambert earned a Ph.D. in biochemistry from the University of Cambridge.
Participation in Upcoming Investor Conference

Bicycle Therapeutics management will participate in the following investor conference in November:

Jefferies Global Healthcare Conference in London on Tuesday, Nov. 18; fireside chat at 10:30 a.m. GMT
A live webcast of the fireside chat will be accessible in the Investor section of the company’s website at www.bicycletherapeutics.com. An archived replay of the webcast will be available following the event.

Third Quarter 2025 Financial Results

Cash and cash equivalents were $648.3 million as of September 30, 2025, compared to $879.5 million as of December 31, 2024. The decrease in cash and cash equivalents is primarily due to cash used in operations, including increased cash payments for clinical program activities. In October 2025, we received $38.2 million related to our U.K. research and development (R&D) tax credit claim for the year ended December 31, 2024.
R&D expenses were $58.4 million for the three months ended September 30, 2025, compared to $48.3 million for the three months ended September 30, 2024. The increase in expense of $10.1 million was primarily due to increased clinical program expenses for zelenectide pevedotin development, discovery, platform and other expenses, and higher personnel-related costs, including severance-related expenses of our workforce reduction in August 2025, offset by decreased clinical program expenses for Bicycle TICA molecules.
General and administrative expenses were $18.9 million for the three months ended September 30, 2025, compared to $18.3 million for the three months ended September 30, 2024. The increase in expense of $0.6 million was primarily due to increased personnel-related costs, offset by decreased professional and consulting fees.
Net loss was $59.1 million, or $(0.85) basic and diluted net loss per share, for the three months ended September 30, 2025, compared to net loss of $50.8 million, or $(0.74) basic and diluted net loss per share, for three months ended September 30, 2024.

(Press release, Bicycle Therapeutics, OCT 30, 2025, View Source [SID1234657140])

Avenzo Therapeutics to Present Initial Results from the Phase 1 Study of AVZO-021, a Potential Best-in-Class CDK2 Inhibitor, at the 2025 San Antonio Breast Cancer Symposium

On October 30, 2025 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, reported the acceptance of two abstracts for poster presentations at the 2025 San Antonio Breast Cancer Symposium (SABCS) taking place in San Antonio, Texas from December 9-12, 2025.

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Avenzo will present preliminary safety and efficacy results from the Phase 1 portion of its ongoing Phase 1/2 clinical study of AVZO-021, its potential best-in-class cyclin-dependent kinase 2 (CDK2) selective inhibitor. The company will also highlight the Phase 1/2 study design evaluating AVZO-023, its potential best-in-class cyclin-dependent kinase 4 (CDK4) selective inhibitor, as a single agent and in combination with AVZO-021 and/or endocrine therapy.

Details of the presentations are as follows:

Abstract: 2206

Title: A phase 1/2, first-in-human study of AVZO-021, a selective cyclin-dependent kinase 2 inhibitor (CDK2i), as a monotherapy and in combination for patients with advanced solid tumors, including hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer and cyclin E1 (CCNE1)-amplified solid tumors: preliminary safety and efficacy results

Presentation Number: PS4-06-08

Date and Time: Thursday, Dec. 11, 2025, 5:00 to 6:30 p.m. CT

Abstract: 2267

Title: A phase 1/2 study of AVZO-023, a next-generation selective cyclin-dependent kinase 4 inhibitor (CDK4i), as a single agent and in combination with AVZO-021, a selective cyclin-dependent kinase 2 inhibitor (CDK2i), and/or endocrine therapy in patients with advanced solid tumors

Presentation Number: PS5-12-17

Date and Time: Friday, Dec. 12, 2025, 12:30 to 2:00 p.m. CT

(Press release, Avenzo Therapeutics, OCT 30, 2025, View Source [SID1234657139])