Pfizer Reports Second-Quarter Results And Raises Midpoint of 2026 Revenue Guidance

On August 4, 2026 Pfizer Inc. (NYSE: PFE) reported financial results for the second quarter of 2026 and raised its full-year 2026 Revenue guidance by $500 million at the midpoint while reaffirming guidance(2) for Adjusted(3) diluted EPS, which absorbs an impact of approximately $0.10 related to the Innovent Biologics, Inc. transaction.

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EXECUTIVE COMMENTARY

Dr. Albert Bourla, Chairman and CEO of Pfizer:

"Pfizer had another strong quarter, delivering on our financial commitments and advancing our strategy. Our launched and acquired products(1) performed well, our obesity program is advancing with meaningful momentum and our oncology portfolio remains a source of strength. I am confident we will create substantial future value for patients and shareholders."
Cecile Guegan, Incoming Interim CFO and EVP of Pfizer:
"Our second-quarter results are attributable to our solid commercial performance globally as well as our ongoing focus on operational efficiency. This quarter, I’m particularly pleased with the 18% year-over-year operational revenue growth from our launched and acquired products(1). Our updated full-year 2026 guidance reflects the continued strength of and confidence in our business."
OVERALL RESULTS
■Second-Quarter 2026 Revenues of $15.0 Billion, Representing 1% Year-over-Year Operational Growth
–Excluding Contributions from Comirnaty and Paxlovid, Revenues Grew 5% Operationally
–Revenues of Launched and Acquired Products(1) Grew 18% Operationally
■Second-Quarter 2026 Reported(4) Loss Per Share of $(0.04), and Adjusted(3) Diluted EPS of $0.77
–Reported(4) Loss Per Share Reflects $4.3 Billion in Non-Cash Intangible Asset Impairments
■Announces Additional Anticipated Productivity Enhancement Savings of $2.5 Billion(5) Associated with Ongoing Initiatives, Expected to be Realized From 2027 Through 2029
■Raises Full-Year 2026 Revenue Guidance(2) by $500 Million at the Midpoint to a Range of $60.5 to $62.5 Billion
■Reaffirms Full-Year 2026 Adjusted(3) Diluted EPS Guidance in a Range of $2.80 to $3.00, which Absorbs an Impact of Approximately $0.10 Related to the Innovent Biologics, Inc. Transaction

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(6).
Results for the second quarter and first six months of 2026 and 2025(7) are summarized below.
($ in millions, except per share amounts)
Second-Quarter Six Months
2026 2025
% Change
2026 2025
% Change
Revenues $ 15,034 $ 14,653 3% $ 29,484 $ 28,367 4%
Reported(4) Net Income/(Loss)
(248) 2,910 * 2,440 5,877 (58%)
Reported(4) Diluted EPS/(LPS)
(0.04) 0.51 * 0.43 1.03 (59%)
Adjusted(3) Income
4,440 4,434 —% 8,730 9,671 (10%)
Adjusted(3) Diluted EPS
0.77 0.78 —% 1.52 1.69 (10%)
* Indicates calculation not meaningful or results are greater than 100%.

REVENUES
($ in millions) Second-Quarter Six Months
2026 2025 % Change 2026 2025 % Change
Total Oper. Total Oper.
Global Biopharmaceuticals Business (Biopharma) $ 14,661 $ 14,305 2% 1% $ 28,822 $ 27,746 4% 2%
Pfizer CentreOne
373 348 7% 5% 662 622 7% 3%
TOTAL REVENUES $ 15,034 $ 14,653 3% 1% $ 29,484 $ 28,367 4% 2%

2026 FINANCIAL GUIDANCE(2)
■Raises full-year 2026 Revenue guidance(2) by $500 million at the midpoint to a range of $60.5 to $62.5 billion, from $59.5 to $62.5 billion previously.
–The 2026 full-year Revenue guidance reflects better than expected performance of the non-COVID products by approximately $1.5 billion and the revised revenue expectation for our COVID-19 products, down to approximately $4 billion from approximately $5 billion previously.
■Reaffirms full-year 2026 Adjusted(3) diluted EPS guidance(2) in a range of $2.80 to $3.00.
–The 2026 Adjusted(3) diluted EPS guidance takes into consideration our strong year-to-date performance, continued confidence in our business and progress with ongoing cost improvement initiatives.
–Absorbs a $650 million Acquired In-Process R&D charge related to the completed licensing agreement with Innovent Biologics, Inc. that will be recorded in the third quarter of 2026 with an expected unfavorable impact of approximately $0.10.
Previous 2026 Financial Guidance Anticipated Impact of Non COVID-19 Products Anticipated Impact of COVID-19 Products Anticipated Impact of Innovent Biologics, Inc. Transaction
Revised 2026 Financial Guidance(2)
Revenues ($ in billions)
Midpoint
$59.5 to $62.5
$61.0
+$1.5
-$1.0
-
$60.5 to $62.5
$61.5
Adjusted(3) SI&A Expenses ($ in billions)
$12.5 to $13.5
$12.5 to $13.5
Adjusted(3) R&D Expenses ($ in billions)
$10.5 to $11.5
$10.5 to $11.5
Effective Tax Rate on Adjusted(3) Income
~15.0%
~15.0%
Adjusted(3) Diluted EPS
$2.80 to $3.00
+$0.10
-$0.10
$2.80 to $3.00

CAPITAL ALLOCATION
During the first six months of 2026, 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:
–$5.3 billion invested in internal research and development projects, and
–Approximately $170 million invested in business development transactions. In addition, on July 10, 2026, we completed the Innovent Biologics, Inc. transaction, which will be recorded in the third quarter of 2026.
■Returning capital directly to shareholders through $4.9 billion of cash dividends, or $0.86 per share of common stock.
Our capital allocation framework is designed to enhance long-term shareholder value, and is based on three core pillars: (i) reinvesting in the business, including maintaining the flexibility to deploy capital towards potential value-creating business development transactions, (ii) maintaining and, over the long term, growing our dividend, and (iii) in the future, the potential to resume the return of capital to shareholders through value-enhancing share repurchases after de-levering our balance sheet. The company expects to continue to de-lever over the longer term in a prudent manner in order to maintain a balanced capital allocation strategy.
No share repurchases have been completed to date in 2026. As of August 4, 2026, Pfizer’s remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2026.
For the second-quarter of 2026, basic weighted-average shares outstanding of 5,699 million were used to calculate Reported(4) LPS and diluted weighted-average shares outstanding of 5,734 million were used to calculate Adjusted(3) diluted EPS. Diluted weighted-average shares outstanding of 5,706 million were used to calculate Reported(4) and Adjusted(3) diluted EPS for second-quarter 2025.
QUARTERLY FINANCIAL HIGHLIGHTS (Second-Quarter 2026 vs. Second-Quarter 2025)
Second-quarter 2026 revenues totaled $15.0 billion, an increase of $381 million, or 3%, compared to the prior-year quarter, reflecting an operational increase of $164 million, or 1%, and a favorable impact of foreign exchange of $217 million. The operational increase was driven by an increase in revenues for Eliquis, Padcev, the Vyndaqel family, Lorbrena and several other products across categories, partially offset by a decline in COVID-19 product revenues and several other products across categories. Excluding contributions from Comirnaty and Paxlovid, revenues for the second quarter grew 5% operationally. Additionally, second-quarter revenues of our Launched and Acquired Products(1) grew 18% operationally.
Second-quarter 2026 operational revenue growth was driven primarily by:
■Eliquis globally, up 19% operationally, driven primarily by higher net price in the U.S. primarily due to pricing dynamics, including lower rebates and channel mix favorability, as well as higher demand globally; partially offset by declines due to generic entry and price erosion in certain international markets;
■Padcev globally, up 23% operationally, driven primarily by increased market share in first-line locally advanced or metastatic urothelial cancer (la/mUC), as well as launch uptake in the cisplatin-ineligible indication for muscle-invasive bladder cancer; partially offset by a one-time favorable impact associated with transition to a wholesaler distribution model in the U.S. in the prior-year quarter;
■Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 8% operationally. International growth was primarily driven by strong demand with continuing uptake in patient diagnosis across international markets, as well as improved access in certain international markets. In the U.S., growth was primarily driven by continued market expansion, partially offset by net price erosion as a result of new payer contracts; and
■Lorbrena globally, up 37% operationally, driven primarily by increased patient share in the first-line ALK-positive metastatic non-small cell lung cancer (ALK+ mNSCLC) treatment setting in the U.S., China, and certain other international markets; partially offset primarily by lower revenues for:
■Paxlovid globally, down 95% operationally, driven primarily by lower COVID-19 infections across the U.S. and international markets and lower government purchases in certain international markets; and
■Comirnaty globally, down 34% operationally, driven primarily by a lower favorable adjustment to the returns provision, as well as lower utilization in the U.S. primarily resulting from a narrower recommendation for vaccination.
GAAP Reported(4) Statement of Operations Highlights
SELECTED REPORTED(4) COSTS AND EXPENSES
($ in millions) Second-Quarter Six Months
2026 2025 % Change 2026 2025 % Change
Total Oper. Total Oper.
Cost of Sales(4)
$ 4,092 $ 3,778 8% 7% $ 7,640 $ 6,624 15% 10%
Percent of Revenues
27.2 % 25.8 % N/A N/A 25.9 % 23.4 % N/A N/A
SI&A Expenses(4)
3,411 3,415 —% (1%) 6,372 6,446 (1%) (3%)
R&D Expenses(4)
2,809 2,482 13% 13% 5,299 4,685 13% 12%
Acquired IPR&D Expenses(4)
16 2 * * 153 11 * *
Other (Income)/Deductions—net(4)
3,716 739 * * 4,577 1,692 * *
Effective Tax Rate on Reported(4) Income/(Loss)
62.4 % 4.6 % 2.1 % (0.8%)
* Indicates calculation not meaningful or results are greater than 100%.

Second-quarter 2026 Cost of Sales(4) as a percentage of revenues increased by 1.4 percentage points compared to the prior-year quarter, primarily driven by an unfavorable change in sales mix and higher amortization of the fair value step-up of acquired inventory, primarily driven by the Oxbryta impairment.
Second-quarter 2026 SI&A Expenses(4) decreased 1% operationally compared to the prior-year quarter, primarily reflecting lower spending in corporate enabling functions, largely offset by an increase in implementation costs associated with our cost realignment program.

Second-quarter 2026 R&D Expenses(4) increased 13% operationally compared to the prior-year quarter, driven primarily by an increase in spending in certain oncology and obesity product candidates, which was anticipated.
Other (income)/deductions—net(4) was $3.7 billion for the second quarter of 2026. The increase compared to the prior-year quarter is primarily the result of intangible asset impairment charges, and to a lesser extent, charges for certain legal matters, partially offset by a net gain in 2026 from the sale of our previous investment in ViiV Healthcare Limited.
Pfizer’s higher effective tax rate on Reported(4) loss for the second quarter of 2026 reflects a tax benefit on the pre-tax loss resulting from changes in jurisdictional mix of earnings, primarily due to intangible asset impairments.

Adjusted(3) Statement of Operations Highlights
SELECTED ADJUSTED(3) COSTS AND EXPENSES
($ in millions) Second-Quarter Six Months
2026 2025 % Change 2026 2025 % Change
Total Oper. Total Oper.
Adjusted(3) Cost of Sales
$ 3,656 $ 3,503 4% 3% $ 7,061 $ 6,096 16% 10%
Percent of Revenues 24.3 % 23.9 % N/A N/A 23.9 % 21.5 % N/A N/A
Adjusted(3) SI&A Expenses
3,344 3,395 (1%) (3%) 6,259 6,404 (2%) (4%)
Adjusted(3) R&D Expenses
2,730 2,438 12% 12% 5,164 4,611 12% 11%
Acquired IPR&D Expenses(3)
16 2 * * 153 11 * *
Adjusted(3) Other (Income)/Deductions—net
108 186 (42%) (35%) 496 431 15% 11%
Effective Tax Rate on Adjusted(3) Income
14.1%
13.2 % 15.5 % 10.3 %
* Indicates calculation not meaningful or results are greater than 100%.

See the reconciliations of certain Reported(4) to non-GAAP Adjusted(3) financial measures and associated footnotes in the financial tables section of this press release.
RECENT NOTABLE DEVELOPMENTS (Since May 5, 2026)
Product Developments
Product/Project Milestone Recent Development Link
Braftovi
(encorafenib) Phase 3 Results
May 2026. Announced detailed progression-free survival (PFS) and overall survival (OS) results from Cohort 3, a randomized cohort of the Phase 3 BREAKWATER trial, evaluating Braftovi in combination with cetuximab and FOLFIRI (fluorouracil, leucovorin, and irinotecan) versus FOLFIRI with or without bevacizumab in patients with previously untreated mCRC with a BRAF V600E mutation. Results for the key secondary endpoint of PFS by blinded independent central review showed a clinically meaningful and statistically significant 56% reduction in the risk of disease progression or death was observed for patients treated with the Braftovi combination regimen versus the comparator (Hazard Ratio [HR] of 0.44; 95% Confidence Interval [CI], 0.27–0.70; p=0.0002). Updated OS, a descriptive secondary endpoint, showed a 44% reduction in the risk of death for patients treated with the Braftovi combination regimen versus the comparator (HR of 0.56; 95% CI, 0.34–0.94) with a median follow-up of approximately 20 months for both arms. The safety profile of Braftovi in combination with cetuximab and FOLFIRI in the Cohort 3 analysis continued to be consistent with the known safety profile of each respective agent in the regimen, and no new safety signals were identified.
Full Release

Comirnaty (COVID-19 Vaccine, mRNA) Regulatory
July 2026. Pfizer and BioNTech announced the European Commission (EC) granted marketing authorization for the companies’ 2026-2027 COVID-19 vaccine formula, targeting the XFG variant, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. Pfizer and BioNTech have already initiated manufacturing of the monovalent XFG-adapted COVID-19 vaccine at risk to ensure supply readiness in anticipation of the respiratory disease season, when the demand for COVID-19 vaccination is expected to increase.
Full Release
Regulatory
May 2026. Pfizer and BioNTech announced the European Commission approved an update to the marketing authorization for the companies’ COVID-19 vaccine for children aged 6 months through 4 years. With this authorization, the vaccine will be administered as a 10-μg dose for all children aged 6 months through 11 years and reduces the primary vaccination series in this age group to two doses.
Full Release
Hympavzi (marstacimab) Regulatory
June 2026. Announced the U.S. Food and Drug Administration (FDA) approved an expanded indication for Hympavzi to include the treatment of patients with hemophilia A or B 12 years and older with inhibitors and pediatric patients (ages 6 to 11 years) with or without inhibitors. Hympavzi is now indicated in the U.S. for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 6 years of age and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors, or hemophilia B (congenital factor IX deficiency) with or without factor IX inhibitors.
Full Release
Regulatory
May 2026. Announced the European Commission granted marketing authorization to expand the approved indication for Hympavzi to include patients 12 years of age and older weighing at least 35 kg with hemophilia A (congenital factor VIII [FVIII] deficiency) with FVIII inhibitors or hemophilia B (congenital factor IX [FIX] deficiency) with FIX inhibitors. Hympavzi is the only once-weekly subcutaneous treatment approved in the European Union for both people living with hemophilia A or B, with or without inhibitors.
Full Release
Ibrance (palbociclib) Regulatory
June 2026. Announced FDA approval of Ibrance in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-positive (HER2+) locally advanced or metastatic breast cancer (MBC) following induction treatment based on data from the collaborative Phase 3 PATINA trial. With this approval, Ibrance is the first and only CDK 4/6 inhibitor approved for HR+ metastatic disease regardless of HER2 status.
Full Release

Litfulo (ritlecitinib) Phase 3 Results
July 2026. Announced positive topline results from two Phase 3 trials evaluating the efficacy and safety of Litfulo once daily in patients with both active and stable nonsegmental vitiligo (NSV) and who had a broad range of disease severity. The TRANQUILLO study included patients aged 12 years and older, while TRANQUILLO 2 enrolled adults only. Across the studies, both the 50 and 100 milligram doses of Litfulo delivered significant, clinically meaningful improvements over placebo on co-primary endpoints for the facial and total body Vitiligo Area Scoring Index, or VASI. The safety profile of Litfulo in NSV was consistent with the established safety profile in alopecia areata. No new safety signals were observed. Based on these results, Pfizer intends to submit global regulatory filings for Litfulo as a potential new oral systemic therapy for NSV for adults.
Full Release
Lorbrena (lorlatinib) Phase 3 7-Year Analysis
May 2026. Announced unprecedented seven-year follow-up results from the Phase 3 CROWN trial evaluating Lorbrena versus Xalkori in people with previously untreated, anaplastic lymphoma kinase (ALK)-positive advanced or metastatic non-small cell lung cancer (NSCLC). At seven years, patients treated with Lorbrena had a 55% likelihood of remaining alive without disease progression (95% CI, 46-63) compared to 3% (95% CI, 1-8) in the Xalkori treatment arm. An updated analysis at seven years of median follow-up showed that investigator-assessed median PFS had not been reached with Lorbrena, with an estimated HR of 0.19 (95% CI, 0.13-0.26), representing an 81% reduction in the risk of disease progression or death compared to Xalkori. The safety profiles of Lorbrena and Xalkori were consistent with previous findings, with no new safety signals observed.
Full Release

Padcev (enfortumab vedotin) Regulatory
July 2026. Pfizer and Astellas Pharma Inc. announced FDA approval of Padcev plus pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph as neoadjuvant and adjuvant (before and after surgery) treatment for adult patients with muscle-invasive bladder cancer (MIBC) regardless of cisplatin eligibility. Approval was based on results from the pivotal Phase 3 EV-304 clinical trial (also known as KEYNOTE-B15) and marks the first platinum-free regimen approved for adult patients with MIBC, regardless of cisplatin eligibility.
Full Release
Talzenna (talazoparib) Regulatory
July 2026. Announced the FDA accepted for priority review a supplemental New Drug Application (sNDA) for Talzenna in combination with Xtandi which aims to expand use to men with homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC). The application is supported by data from the TALAPRO-3 study. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date in the last quarter of 2026.
Full Release
Phase 3 Results
May 2026. Announced detailed results from the pivotal, investigational Phase 3 TALAPRO-3 study of Talzenna in combination with Xtandi in men with HRR gene-mutated mCSPC, also known as mHSPC. Talzenna plus Xtandi demonstrated a 52% reduction in the risk of radiographic progression or death compared to placebo plus Xtandi (HR of 0.48; 95% CI, 0.36–0.65; p ˂ 0.0001). At three years, radiographic progression-free survival (rPFS) rates were estimated at 77% in patients treated with Talzenna plus Xtandi versus 56% in patients treated with placebo plus Xtandi. The safety profile of Talzenna plus Xtandi in TALAPRO-3 was consistent with the known profiles of each medicine, and no new safety signals were identified.
Full Release

Pipeline Developments
A comprehensive update of Pfizer’s development pipeline was published today and is now available at www.pfizer.com/science/drug-product-pipeline. It includes an overview of Pfizer’s research and a list of compounds in development with targeted indication and phase of development, as well as mechanism of action for some candidates in Phase 1 and all candidates from Phase 2 through registration.

Product/Project Milestone Recent Development Link
berobenatide
(PF’3944)
Phase 2 Results
June 2026. Presented detailed results from multiple Phase 2b studies of berobenatide (PF’3944), an investigational, potential first-in-class monthly GLP-1 receptor agonist (GLP-1 RA) peptide. Across both weekly and monthly dosing in participants with obesity or overweight, with and without type 2 diabetes, the data from the Phase 2b VESPER-1, 2 and 3 studies provided proof of concept for berobenatide as a potential first-in-class monthly GLP-1 RA peptide that can deliver competitive weight loss; showed favorable tolerability for berobenatide, including low gastrointestinal adverse events and discontinuations despite rapid dose escalation and no allowed step-down; and highlighted the potential for monthly delivery in a patient-friendly presentation with a very low 0.5 mL injection volume that provides convenience and scalability advantages.
These data support Pfizer’s plans to advance 10 Phase 3 studies for berobenatide in 2026 for chronic weight management and obesity-related comorbidities including knee osteoarthritis and obstructive sleep apnea, as part of a broader program of 20+ obesity trials.
Full Release
PF-07872412 (25-valent pneumococcal conjugate vaccine candidate) Phase 2 Results
May 2026. Announced data from the Phase 2 study (NCT06524414) evaluating the safety, tolerability and immunogenicity of a four-dose series of an investigational 25-valent pneumococcal conjugate vaccine candidate PF-07872412 (25vPnC) in infants compared to four doses of Prevnar 20 at months 2, 4, 6 and 12-15. The Phase 2 data demonstrated robust immunogenicity with 25vPnC, including enhanced response against serotype 3, alongside expanded protection across 25 serotypes and was well-tolerated with no safety concerns identified. Based on the results from the Phase 2 program and discussions with regulatory authorities, a pivotal Phase 3 pediatric program began in May 2026. Also announced a fifth generation 35-valent vaccine adult candidate is expected to enter clinical development by the end of 2026, pending alignment with regulatory authorities.
Full Release
sigvotatug vedotin Phase 3 Results
June 2026. Announced topline results from the Phase 3 SigVie-002 study (previously known as Be6A Lung-01) evaluating sigvotatug vedotin, an investigational, potential first-in-class integrin beta-6 (IB6) directed antibody-drug conjugate (ADC). The study enrolled adults with locally advanced, unresectable or metastatic non-squamous NSCLC who had received one or more lines of prior therapy. In the overall population, sigvotatug vedotin did not show a statistically significant improvement in the primary endpoint of OS compared to docetaxel. The safety profile of sigvotatug vedotin was manageable and consistent with prior studies. In patients who received only one prior line of systemic therapy, which represents two-thirds of the study population, a stronger trend was observed for OS and PFS for sigvotatug vedotin over docetaxel. In the exploratory analysis, no clear IB6 expression-response relationship was observed. Pfizer is evaluating sigvotatug vedotin in several ongoing studies across multiple stages and patient populations in NSCLC and other solid tumors.
Full Release

Topic Recent Development Link
Expansion of Ongoing Cost Savings Programs(5)
Announced at Q2-2026 Earnings. Pfizer announced $1.0 billion of additional anticipated net cost savings associated with its ongoing cost realignment program (the "Realigning Our Cost Base Program") driven by further productivity enhancements from technology and simplification efforts across our commercial, R&D and enabling functions. These additional net savings are expected to further reduce costs in SI&A and be realized from 2027 through 2029. Pfizer expects one-time costs to achieve the additional savings to be incurred through 2029 and to total approximately $2.0 billion, primarily representing cash expenditures for digital enablement, implementation and severance. Pfizer previously announced that it remains on track to deliver anticipated net cost savings of approximately $5.7 billion by the end of 2026 and, with the additional anticipated savings, Pfizer now expects total net cost savings of approximately $6.7 billion from the Realigning our Cost Base Program through 2029.
The estimate of costs that Pfizer expects to incur and savings that Pfizer expects to achieve, and the timing thereof, are subject to a number of assumptions and actual results may differ from current expectations. Pfizer may also incur other charges or cash expenditures not currently contemplated due to events that may occur as a result of, or associated with, the Realigning our Cost Base Program.
N/A
Announced at Q2-2026 Earnings. Pfizer announced the next phase of its multi-year program designed to reduce our cost of goods sold. This phase of the cost reduction program (the "program") is focused on network structure changes, product portfolio enhancements and additional operational efficiencies and is expected to deliver additional anticipated savings of approximately $1.5 billion through 2029, some of which is expected to begin being realized in 2027. The one-time costs to achieve the savings associated with this phase of the program are expected to be approximately $4.0 billion, with approximately 60% of non-cash expenditures for accelerated depreciation and asset write-downs and 40% of cash expenditures for severance, implementation and exit costs. The costs to achieve these savings are expected to be incurred through 2029. Pfizer previously announced that it remains on track to deliver anticipated net cost savings from the first phase of this program of approximately $1.5 billion by the end of 2027 and, with the additional targeted savings from this phase, Pfizer now expects total net cost savings of approximately $3.0 billion from this program through 2029.
The estimate of costs that Pfizer expects to incur and savings that Pfizer expects to achieve, and the timing thereof, are subject to a number of assumptions and actual results may differ from current expectations. Pfizer may also incur other charges or cash expenditures not currently contemplated due to events that may occur as a result of, or associated with, the program as well as for potential future phases.
N/A

– 11 –

Topic Recent Development Link
Business Development
May 2026. Pfizer and Innovent Biologics, Inc. announced the companies have entered into a strategic global licensing and collaboration agreement for the research and development of 12 promising new early-stage and de novo cancer medicines. The partnership includes licensing, co-development, and co-commercialization opportunities across a diverse portfolio of antibody-drug conjugates (ADCs) with novel differentiated payloads and multi-specific antibodies with differentiated immune-engaging features and unique designs. Under the terms of the agreement, Innovent Biologics, Inc. received a $650 million upfront payment and is eligible for up to $9.85 billion in development, regulatory and commercial milestone payments. Additionally, Innovent Biologics, Inc. will receive up to double-digit royalties on sales of each licensed product if approved. For the four programs to be co-developed and co-commercialized by Pfizer and Innovent Biologics, Inc., the two companies will share the profits in the U.S., the U.K. and the European Union. The transaction closed on July 10, 2026.
Full Release
Finance Leadership
June 2026. Announced Dave Denton will step down from his current role as Chief Financial Officer and leave the company on August 15 and named Cecile Guegan, currently Senior Vice President, Finance, Global Biopharmaceutical Business, as Interim Chief Financial Officer, effective August 16, while Pfizer conducts a comprehensive internal and external search for its next Chief Financial Officer.
Full Release

PFIZER TO HOST CONFERENCE CALL
Pfizer will host a live conference call and webcast today, August 4, 2026, at 10:00 AM EDT. To access the live conference call, the second-quarter 2026 earnings presentation, and the accompanying prepared remarks from management, visit our website at pfizer.com/investors.
You can also listen to the conference call by dialing either 800-456-4352 in the U.S. and Canada or 785-424-1086 outside of the U.S. and Canada. The passcode is "29301".
The transcript and webcast replay of the call will be made available on our website at pfizer.com/investors within 24 hours after the end of the live conference call and will be accessible for at least 90 days.

(Press release, Pfizer, AUG 4, 2026, View Source [SID1234669664])

Silexion Therapeutics Reports New Positive Preclinical Findings Demonstrating Multi-Mechanism Immune Sensitization by SIL204 in KRAS-Driven Cancers

On August 4, 2026 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, reported additional positive preclinical findings from its ongoing translational immuno-oncology program evaluating SIL204 in human KRAS-mutant cancer cells. The new findings further expand SIL204’s therapeutic profile by demonstrating a coordinated immune-sensitizing effect on tumor cells, reinforcing the scientific rationale for combining SIL204 with anti-PD-(L)1 checkpoint inhibitor therapies. In newly reported studies performed across three human cancer cell lines representing three different KRAS mutations, SIL204 treatment produced statistically significant increases in expression of FAS, a well-established immune "death receptor," and statistically significant reductions in expression of HLA-G, an immune checkpoint that tumors use to evade immune surveillance. The findings, generated in human pancreatic (KRAS G12D) and non-small cell lung cancer (NSCLC; KRAS G12V and G12C) cell lines, build on the Company’s previously reported MHC-I upregulation data announced in May 2026, and further support SIL204’s potential to act as a multi-mechanism immune sensitizer in KRAS-driven tumors.

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"These new findings meaningfully extend and reinforce the immuno-oncology profile of SIL204 that we first reported in May," said Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics. "In one integrated dataset, we are now seeing that SIL204 modulates three of the most important mechanisms by which KRAS-driven tumors evade the immune system – upregulating antigen presentation via MHC-I, upregulating FAS to restore sensitivity to immune-mediated cell death, and downregulating the HLA-G immune checkpoint to remove a key inhibitory signal to immune cells. SIL204 is producing this coordinated immune-sensitizing effect across multiple KRAS mutations and both of the largest KRAS-driven tumor types. We believe this profile supports the rationale for further evaluation of SIL204 in combination with anti-PD-(L)1 checkpoint inhibitor therapies, particularly in indications like pancreatic cancer where these agents have historically shown limited single-agent efficacy."

FAS (also known as CD95) is a cell surface death receptor whose engagement by Fas ligand (FasL) – which is expressed on activated CD8+ T cells and natural killer (NK) cells – triggers programmed cell death of the target cell. Cancer cells, and KRAS-driven tumors in particular, commonly downregulate FAS to evade immune-mediated killing. Recent research published in Developmental Cell (Cell Press) has demonstrated that elimination of oncogenic KRAS in genetic mouse models of pancreatic ductal adenocarcinoma restores FAS expression and enables FasL-expressing CD8+ T cells to eradicate KRAS-driven tumors.¹ In the newly reported Silexion study, SIL204 treatment produced statistically significant, dose-dependent increases in FAS expression at 72 hours in human KRAS G12D-mutant pancreatic cancer cells (PK59; up to approximately 2-fold, P<0.0001 vs. control) and in KRAS G12V-mutant NSCLC cells (CORL23; P<0.05 vs. control).

HLA-G is a non-classical HLA class I molecule that functions as a potent immune checkpoint. When expressed on tumor cells, HLA-G binds inhibitory receptors – including ILT-2 (LILRB1), ILT-4 (LILRB2), and KIR2DL4 – on CD8+ T cells, NK cells, and myeloid immune cells, suppressing their anti-tumor activity and enabling immune escape.² HLA-G is a recognized and increasingly prominent drug target in oncology, with multiple HLA-G-directed programs currently in clinical development in advanced solid tumors. In the newly reported study, SIL204 treatment produced statistically significant, dose-dependent reductions in HLA-G expression in human KRAS G12C-mutant NSCLC cells (NCI-H358; P<0.001 at 24 hours and P<0.01 at 72 hours vs. control at the 200 nM dose), with additional reductions observed in KRAS G12D-mutant pancreatic and KRAS G12V-mutant NSCLC cells.

Taken together with the Company’s previously reported May 2026 findings demonstrating statistically significant upregulation of MHC-I (HLA-ABC) in KRAS G12R-mutant pancreatic cancer cells, these new data support a coordinated immune-sensitization signature across three key immune pathways. The immune-modulatory effects have now been observed across four distinct KRAS mutations (G12D, G12V, G12C, and G12R) in both pancreatic and non-small cell lung cancer models, reinforcing the potential applicability of SIL204’s mechanism across the largest KRAS-driven cancer patient populations.

The findings arrive at a moment when the oncology field is actively exploring combinations of KRAS-directed therapies with immune checkpoint inhibitors, with recent academic and industry work demonstrating that combining KRAS inhibition with anti-PD-1 or anti-PD-L1 agents can produce sustained tumor regression and reprogramming of the tumor microenvironment in KRAS-driven cancers.³ Pancreatic ductal adenocarcinoma and KRAS-mutant NSCLC together represent the largest KRAS-driven patient populations, with KRAS mutations present in approximately 90% of pancreatic cancers and 30–35% of lung adenocarcinomas. Immune checkpoint inhibitors have shown limited single-agent efficacy in pancreatic cancer and variable response rates in KRAS-mutant NSCLC, driving substantial scientific and commercial interest in strategies capable of converting "immunologically cold" tumor phenotypes into more immunotherapy-responsive tumors. The Company believes these findings provide additional translational support for SIL204’s ongoing Phase 2/3 clinical development.

(Press release, Silexion Therapeutics, AUG 4, 2026, View Source [SID1234669681])

CUMBERLAND PHARMACEUTICALS REPORTS
COMPANY UPDATE & Q2 2026 FINANCIAL RESULTS

On August 4, 2026 Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), an innovation-focused biopharmaceutical company, reported its second quarter 2026 financial results and provided an update following the successful closing of its Strategic Transaction with Apotex Health.

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During the second quarter, Cumberland completed a transaction with Apotex Health, the largest Canadian pharmaceutical company, to integrate their branded business. Under the terms of the agreement, Apotex acquired Cumberland’s portfolio of FDA-approved brands and related commercial organization for $100 million in cash at closing, plus an additional $11 million in funding for inventory and transition services.

Following the transaction, Cumberland will transition into a development-stage biopharmaceutical organization focused on advancing differentiated medicines for rare diseases and other areas of significant unmet medical need.

Cumberland returned capital to shareholders through a special cash dividend while retaining sufficient resources to fund its long-term operations, advance its development pipeline and pursue additional strategic opportunities. Cumberland retains its development pipeline of late stage candidates, including four Phase 2 clinical programs, as well as its majority ownership in Cumberland Emerging Technologies.

"The second quarter marked a defining milestone for Cumberland," said A.J. Kazimi, CEO of Cumberland Pharmaceuticals. "With the successful completion of our Strategic Transaction, we have unlocked substantial value for our shareholders, while positioning Cumberland for its next phase as an innovation-focused biopharmaceutical company. We have strengthened our balance sheet, returned capital to shareholders through a special dividend and remain well-capitalized to advance our pipeline of differentiated product candidates designed to address significant unmet medical needs."

RECENT COMPANY DEVELOPMENTS INCLUDE:

Completion of Strategic Transaction with Apotex
On July 1, 2026, Cumberland announced the closing of its agreement with Apotex to integrate the U.S. branded businesses. Under the terms of the agreement, Apotex acquired Cumberland’s portfolio of FDA-approved brands for $100 million in cash consideration, plus an additional $11 million in funding for inventory and transition services.
The transaction was unanimously approved by Cumberland’s Board of Directors, which was followed by approval from Cumberland’s shareholders, with over 99% of the voting shares in favor of the transaction. Cumberland has retained its development programs, as well as its majority ownership in Cumberland Emerging Technologies. This transaction positions Cumberland to operate as an innovation-focused development-stage biopharmaceutical organization.

Board Declares a Special Dividend

Cumberland’s Board of Directors authorized and declared a special cash dividend of $1.50 per share of the company’s common stock. The dividend was paid on July 31, 2026, to the shareholders of record as of July 23, 2026.
Following the closing of the transaction with Apotex, an analysis by Cumberland’s tax advisors, along with refined financial projections, indicated greater net cash from the transaction than originally projected. Therefore, Cumberland’s Board assessed its future cash needs and evaluated possible alternatives for the excess capital. The Board of Directors determined that after the payout of the special dividend, Cumberland will still have significant liquidity and financial flexibility to fund its long-term product development efforts, with additional reserves available to address any new opportunities.

Updated DMD Results Shared at PPMD Conference

In June 2026, Cumberland presented updated results from its Phase 2 FIGHT DMD clinical trial evaluating ifetroban in patients with Duchenne muscular dystrophy-associated cardiomyopathy at the annual Parent Project Muscular Dystrophy (PPMD) Conference.

The updated data included new blood biomarker findings directionally consistent with heart muscle protection, with increases in markers of cardiac protection and repair and reductions in markers of heart muscle injury and cell damage with ifetroban treatment. These biomarker results reinforce the previously reported improvements in cardiac function, consistent with ifetroban’s ability to slow the progression of DMD-related heart disease. Together, the findings strengthen the case for developing ifetroban as a therapy targeting cardiomyopathy, the leading cause of death in patients with DMD.

Positive Results in Cancer Metastasis Prevention
In collaboration with Vanderbilt Health, Cumberland announced results from a randomized, placebo-controlled Phase 2 study evaluating ifetroban as a potential therapy to inhibit cancer metastasis in patients with Stage I to III malignant solid tumors at high risk of metastatic recurrence. The study met its primary objective of assessing safety and feasibility. Ifetroban was found to be safe and well-tolerated, and no safety signals were identified in markers of blood clotting function.

Although intentionally not powered for efficacy, the study also compared the percentage of patients with distant metastatic recurrence 12 months after completion of therapy in both groups (10 placebo-treated and 18 ifetroban-treated participants) as a prespecified secondary endpoint.
Metastatic recurrence occurred in 3 of 18 patients (17%) receiving ifetroban, compared with 5 of 10 patients (50%) receiving placebo, a difference that did not reach statistical significance (odds ratio 0.21; p=0.09). There were no deaths from distant metastatic disease among patients receiving ifetroban, compared with 3 of 10 patients (30%) receiving placebo (p=0.037). The findings support the continued clinical development of ifetroban as a potential approach to inhibiting the metastatic process, an area of significant unmet medical need.
FINANCIAL RESULTS:
Net Revenue: During the second quarter of 2026, Cumberland reorganized its income statement to classify the revenues and expenses associated with the Apotex transaction as discontinued operations. The ongoing investment in research and development, supported by the remaining general and administrative expenses, resulted in a loss from continuing operations of $3.1 million for the quarter. With the addition of discontinued operations, the net loss for the quarter was $4.1 million.
Balance Sheet: At June 30, 2026, Cumberland had approximately $63 million in total assets, including $4 million in cash and cash equivalents. Liabilities totaled $46 million and total shareholders’ equity was $17 million on June 30, 2026. Cumberland retired its bank line of credit through a payment of $5.2 million at the end of the second quarter.
EARNINGS REPORT CALL:
A conference call will be held today, August 4, 2026, at 4:30 p.m. Eastern Time to provide a company update and discuss the financial results.
The link to register is View Source
Registered participants can dial in from their phone using a dial-in and PIN number that will be provided to them. Alternatively, they can choose a "Call Me" option to have the system automatically call them at the start of the conference.
A replay of the call will be available for one year and can be accessed via Cumberland’s website or by visiting: View Source

(Press release, Cumberland Pharmaceuticals, AUG 4, 2026, View Source [SID1234669724])

Precigen Reports Second Quarter 2026 Financial Results Highlighted by Accelerating PAPZIMEOS Revenue Growth

On August 4, 2026 Precigen, Inc. (Nasdaq: PGEN), a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, reported second quarter 2026 financial results and business updates.

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"We delivered a historic second quarter, with the rapid adoption of PAPZIMEOS demonstrating the strength of our groundbreaking science and innovative commercial strategy," said Helen Sabzevari, PhD, President and CEO of Precigen. "This momentum provides a strong foundation for our next phase of growth as we work to expand PAPZIMEOS globally and into the pediatric population. PAPZIMEOS demonstrates the AdenoVerse platform’s ability to target HPV-associated diseases. We are building on that validated capability by advancing PRGN-2009 in HPV-driven cancers, with a pipeline update expected by year-end. With growing commercial momentum, a validated platform, and multiple opportunities ahead, we believe Precigen is well positioned to deliver sustained value for patients across various indications, the broader healthcare community, and our shareholders."

"We continue to see the key elements of the PAPZIMEOS commercial launch drive revenue growth: 100% field engagement with our initial target accounts, active patient and HCP campaigns, a permanent J-code supporting access and site activations, payer coverage across nearly all insured US lives, growing physician consensus reflected in a RRP position paper, and continued patient hub enrollments," said Phil Tennant, Chief Commercial Officer of Precigen. "This progress translated into strong quarterly revenue growth and increasing adoption across major medical centers and community practices as PAPZIMEOS becomes established as a new standard of care for adults with RRP. We remain focused on converting demand into treated patients and further expanding access to PAPZIMEOS across the RRP community."

KEY PROGRAM HIGHLIGHTS

PAPZIMEOS: First-line Standard of Care for the Treatment of Adults with RRP

PAPZIMEOS (zopapogene imadenovec-drba) is a non-replicating adenoviral vector-based immunotherapy designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with recurrent respiratory papillomatosis (RRP). PAPZIMEOS has been approved by the US Food and Drug Administration (FDA) for the treatment of adults with RRP.

· Broad US adoption: Well over 500 patients have registered through Precigen’s patient hub, with additional patients outside of the hub being identified and receiving treatment as institutions support patient access directly and independently.
· Market exclusivity: PAPZIMEOS was granted seven years of market exclusivity by the FDA, providing long-term protection against prospective competition. PAPZIMEOS remains the first and only approved therapy for adults with RRP and the only treatment designed to target the underlying cause of the disease.
· Broad payer coverage: PAPZIMEOS has payer coverage across approximately 315 million US lives through private health plans, Medicare, and Medicaid, representing nearly 100% of insured lives nationwide.
· Permanent J-code: The Centers for Medicare and Medicaid Services assigned permanent J-code, J3404, to PAPZIMEOS, effective April 1, 2026. The J-code provides a standard pathway for reimbursement, helps institutions process claims more efficiently, and reduces uncertainty for sites that are still building PAPZIMEOS into their workflows.
· First-line standard of care: An expert position paper sponsored and published by the Recurrent Respiratory Papillomatosis Foundation and authored by 16 leading RRP physicians recommended PAPZIMEOS as the first-line standard of care for adults with RRP in the United States.
· Redosing study enrolling patients: The Company’s open-label study to evaluate redosing efficacy of zopapogene imadenovec in adults with RRP is currently enrolling (clinical trial identifier: NCT06538480).
· MAA under review by the EMA: The European Medicines Agency (EMA) has validated and is reviewing the Marketing Authorization Application (MAA) submitted in November 2025 for zopapogene imadenovec for the treatment of adults with RRP. PAPZIMEOS has been granted orphan drug designation from the European Commission.

PRGN-2009 AdenoVerse Immunotherapy in HPV-associated Cancers

PRGN-2009 is an investigational AdenoVerse immunotherapy designed to activate the immune system to recognize and target HPV-associated cancers.

· PRGN-2009 Phase 2 clinical trials under a cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI) in newly diagnosed HPV-associated oropharyngeal cancer are ongoing.
· A multicenter Phase 2 clinical trial of PRGN-2009 in combination with pembrolizumab in recurrent/metastatic cervical cancer is ongoing.
· The Company plans to provide an update on progress across the AdenoVerse portfolio, including PRGN-2009, by the end of the year.

FINANCIAL RESULTS

"We are thrilled to report that Precigen achieved profitability in the second quarter, marking a significant milestone for the company. Net income was driven by strong PAPZIMEOS revenue of $53.1 million. As we progress through the third quarter of 2026, we are seeing continued growth in PAPZIMEOS demand," said Harry Thomasian Jr., Chief Financial Officer of Precigen. "Based upon our current revenue trajectory and present financial forecast, we continue to believe that our current cash position and anticipated cash to be received from PAPZIMEOS sales will fund operations through cash flow break-even by the end of 2026."

Second Quarter 2026 Financial Results Compared to Prior Year Period

Total revenues were $55.0 million for the three months ended June 30, 2026, an increase of $54.1 million compared to the three months ended June 30, 2025. The significant increase in total revenues was primarily due to the recording of commercial sales of PAPZIMEOS. Revenues related to the sale of PAPZIMEOS for the three months ended June 30, 2026 were $53.1 million.

Cost of products and services increased by $1.7 million, compared to the three months ended June 30, 2025, almost entirely due to costs related to the recording of commercial sales of PAPZIMEOS following its FDA approval in August 2025. Prior to regulatory approval, costs associated with the production of PAPZIMEOS were expensed as research and development in accordance with the Company’s accounting policy. Upon FDA approval and the commencement of commercial sales, these costs are now capitalized as inventory and recognized in cost of product and services as product is sold.

R&D expenses decreased by $4.2 million, compared to the three months ended June 30, 2025, primarily due to the change in the accounting treatment of PAPZIMEOS manufacturing costs. The Company expects that R&D expenses will increase as the year progresses.

SG&A expenses increased by $6.1 million, compared to the three months ended June 30, 2025. This increase was primarily driven by commercial activities related to PAPZIMEOS following its FDA approval in August 2025. The higher expenses reflect increased costs to support commercialization, expanded marketing and promotional activities to drive product awareness and adoption, and increased personnel costs, including stock compensation expense.

In the three months ended June 30, 2025, the Company recorded $3.9 million in impairment related to its Exemplar reporting unit with no comparable charge in the second quarter of 2026.

Total other expense, net was $2.6 million for the three months ended June 30, 2026 compared to other income, net of $5.1 million for the three months ended June 30, 2025, a change of $7.7 million. This change was primarily attributable to the absence of a $4.5 million gain related to the decrease in the fair value of warrant liabilities that was recorded in the prior-year period. The remaining change primarily relates to an increase of $3.0 million in interest expense related to long term debt that originated in the third quarter of 2025.

Net income was $20.1 million, or $0.06 per basic and $0.05 per diluted share for the three months ended June 30, 2026, compared to a net loss of $26.6 million, or $(0.09) per basic and diluted share, for the three months ended June 30, 2025.

First Six Months 2026 Financial Results Compared to Prior Year Period

Total revenues were $78.2 million for the six months ended June 30, 2026, an increase of $76.0 million compared to the six months ended June 30, 2025. The significant increase in total revenues was primarily due to the recording of commercial sales of PAPZIMEOS. Revenues related to the sale of PAPZIMEOS for the six months ended June 30, 2026 were $74.7 million.

Cost of products and services increased by $3.2 million, compared to the six months ended June 30, 2025, almost entirely due to costs related to the recording of commercial sales of PAPZIMEOS following its FDA approval in August 2025. Prior to regulatory approval, costs associated with the production of PAPZIMEOS were expensed as research and development in accordance with the Company’s accounting policy. Upon FDA approval and the commencement of commercial sales, these costs are now capitalized as inventory and recognized in cost of product and services as product is sold.

R&D expenses decreased by $9.0 million, compared to the six months ended June 30, 2025, primarily due to the change in the accounting treatment of PAPZIMEOS manufacturing costs. The Company expects that R&D expenses will increase as the year progresses.

SG&A expenses increased by $14.8 million, compared to the six months ended June 30, 2025. This increase was primarily driven by commercial activities related to PAPZIMEOS following its FDA approval in August 2025. The higher expenses reflect increased costs to support commercialization, expanded marketing and promotional activities to drive product awareness and adoption, and increased personnel costs, including stock compensation expense.

In the six months ended June 30, 2025, the Company recorded $3.9 million in impairment related to its Exemplar reporting unit with no comparable charge in the six months ended June 30, 2026.

Total other expense, net decreased by $21.9 million, compared to the six months ended June 30, 2025. This decrease was primarily attributable to the absence of a $28.0 million charge related to the increase in the fair value of warrant liabilities that was recorded in the prior-year period. The remaining change (an increase in other expense) primarily relates to an increase of $5.9 million in interest expense related to long-term debt that was entered into in the third quarter of 2025.

Net income was $12.1 million, or $0.03 per basic and diluted share for the six months ended June 30, 2026, compared to a net loss of $80.8 million, or $(0.27) per basic and diluted share, for the six months ended June 30, 2025.

(Press release, Precigen, AUG 4, 2026, View Source [SID1234669665])

Amplia Signs Collaboration Agreement With Lilly, Evaluating Narmafotinib Plus Lilly’s Kras G12C Inhibitor, Olomorasib, in Non-small Cell Lung Cancer

On August 4, 2026 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), reported that it has entered into a Clinical Trial Collaboration and Supply Agreement ("CTCSA") with Eli Lilly & Company ("Lilly"), to evaluate the combination of Amplia’s investigational FAK inhibitor, narmafotinib, with Lilly’s investigational KRAS G12C inhibitor, olomorasib. The Phase 1b/2b clinical trial will evaluate the safety and efficacy of this novel targeted therapy combination as a second line treatment in patients with advanced stage non-small cell lung cancer (NSCLC).

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Under the terms of the CTCSA, Amplia will conduct the study, which is planned to begin in late 2026, at sites in Australia and the USA. Prior to signing the CTCSA, Lilly and Amplia have worked together to finalize an advanced draft clinical study protocol and will now collaborate to finalize both the protocol and other associated clinical study documents.

Dr Chris Burns, Amplia CEO and Managing Director commented, "This collaboration is an exciting new stage in the clinical progression of narmafotinib. We and others have shown that the combination of FAK and KRAS inhibition can lead to improved outcomes, and we are excited to advance with this clinical study to explore the combination potential with olomorasib, Lilly’s leading KRAS G12C inhibitor currently undergoing two global Phase 3 studies in NSCLC."

Strategic significance

The collaboration with Lilly supports and enhances Amplia’s strategy to position narmafotinib as a versatile oncology combination agent with the potential to enhance existing and investigational therapies across several high-value indications.

Leverages narmafotinib’s growing clinical evidence base. This study builds on the promising clinical data from Amplia’s ACCENT study, which has shown that narmafotinib has no significant tolerability burden over chemotherapy alone, together with a range of compelling efficacy signals across responses and survival1.
Expansion into major new indication. The study extends narmafotinib’s clinical development from pancreatic cancer into NSCLC, materially broadening Amplia’s addressable opportunity. The NSCLC market is currently valued at approx. US$31 B and estimated to grow to over US$60 B by 20332. KRAS G12C mutations occur in 13% of patients with NSCLC and 1-3% of patients with other solid tumors.
Capital-efficient growth and enhanced clinical strategy. Lilly’s in-kind supply of olomorasib gives Amplia the ability to efficiently pursue this new program in a high-value indication.
Scientific rationale

Approved KRAS G12C inhibitors such as sotorasib and adagrasib have advanced the treatment of KRAS G12C-mutant NSCLC and are approved for use after prior therapy. However, the clinical benefit of these drugs as single agents is frequently short-lived: response rates are modest and the majority of patients develop resistance, with reported median progression-free survival of only several months. There is therefore a clear and urgent need for strategies that deepen and prolong the benefit of KRAS G12C blockade.

This study combines the potential of Lilly’s potent and highly selective next-generation KRAS G12C inhibitor, olomorasib, with narmafotinib’s role as a suppressor of resistance mechanisms via inhibition of FAK.

Next generation KRAS G12C inhibitor. In studies to date, olomorasib has demonstrated an efficacy and safety profile that has supported later stage clinical development, with Lilly now advancing olomorasib in two separate, global Phase 3 registrational trials.
FAK as a central mediator of resistance to KRAS G12C. A growing body of preclinical and translational research has identified Focal Adhesion Kinase (FAK) as a central mediator of adaptive resistance to KRAS G12C inhibition. This adaptive FAK activation supports tumor cell survival and proliferation, driving resistance through several interconnected mechanisms including FAK-YAP signaling, along with FAK-driven fibrogenesis and remodeling of the tumor microenvironment.
This ASX announcement was approved and authorized for release by the Board of Amplia Therapeutics and Lilly.

(Press release, Amplia Therapeutics, AUG 4, 2026, View Source [SID1234669682])