Genprex Announces Collaboration with Roche Diagnostics for Biomarker Assay Validation Studies

On August 3, 2026 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported its collaboration with Roche Diagnostics to validate biomarkers for patient selection in clinical trials for non-small cell lung cancer (NSCLC). Building on promising preclinical and clinical data, this collaboration intends to refine patient identification using TROP2 as a biomarker.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Genprex’s initial research demonstrated that high TROP2 H-scores and low PTEN H-scores predicted patient response in preclinical studies. These findings were further correlated with longer Progression Free Survival (PFS) in clinical studies, specifically for NSCLC patients with TROP2 H-scores above 100 and PTEN H-scores below 100. This data underscores the potential of these biomarkers to enable targeted patient selection and precision medicine. Additional data have shown that intensity of TROP2 expression may have a correlation with PFS.

"This strategic partnership with Roche Diagnostics, a recognized leader in NSCLC assay development and the recipient of an FDA Breakthrough Device Designation for their AI-driven TROP2 diagnostic, is a testament to our shared commitment to advancing precision treatments in oncology," said Ryan Confer, President and Chief Executive Officer at Genprex. "By utilizing the same validated TROP2 antibody that Roche has used in other studies, we are poised to shorten the time for patient identification and recruitment for NSCLC clinical trials, ultimately delivering more effective, personalized treatment options."

The collaboration leverages Roche Diagnostics’ expertise in assay development. Roche Diagnostics received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for the first AI-driven companion diagnostic for NSCLC that uses a TROP2 score to evaluate NSCLC specimens, and Genprex will use the same antibody against TROP2 for its validation studies. This strategic alignment ensures consistency and builds upon established diagnostic methods.

Genprex is expanding on its preclinical and clinical studies to potentially integrate TROP2 expression for patient selection in NSCLC clinical studies. Roche Diagnostics will perform the necessary assay validation using its TROP2 antibody. Genprex anticipates completing these validation studies by approximately the end of 2026, with subsequent integration into its NSCLC clinical program shortly thereafter, dependent on the results of the validation studies. This collaboration exemplifies Genprex’s commitment to delivering innovation that enables more precise diagnosis and treatment strategies in oncology, ultimately aiming to improve outcomes for NSCLC patients.

About Reqorsa Gene Therapy

REQORSA (quaratusugene ozeplasmid) consists of a plasmid containing the TUSC2 gene encapsulated in non-viral lipid-based nanoparticles in a lipoplex form (the Company’s Oncoprex Delivery System), which has a positive charge. REQORSA is injected intravenously and specifically targets cancer cells. REQORSA is designed to deliver the functioning TUSC2 gene to negatively charged cancer cells while minimizing uptake by normal tissue. Laboratory studies conducted at MD Anderson show that the uptake of TUSC2 in tumor cells in vitro after REQORSA treatment was 10 to 33 times the uptake in normal cells.

(Press release, Genprex, AUG 3, 2026, View Source [SID1234669606])

Curium Announces Definitive Agreement to Merge with Lantheus

On August 3, 2026 Curium, a leading, global radiopharmaceutical company with proven expertise in the development, manufacturing and supply of radiopharmaceuticals that improve the way cancer is diagnosed and treated, and Lantheus Holdings, Inc. ("Lantheus" or "Company") (NASDAQ: LNTH), reported that Curium US Holdings LLC ("Curium US") and Lantheus have entered into a definitive agreement under which Lantheus, a leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, will merge with a wholly-owned subsidiary of Curium US.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the definitive agreement, Curium US will acquire all of the outstanding shares of Lantheus for $102.50 per share in cash at closing, plus non-transferable Contingent Value Rights ("CVRs") providing for up to $12.00 per share in potential additional cash payments, subject to achievement of specified commercial milestones for Lantheus’ products through 2030. The transaction represents a total per share consideration of up to $114.50 and a total transaction value of up to approximately $8.0 billion. Together, Curium and Lantheus are positioned to create a radiopharmaceutical company spanning diagnostics and therapeutics, with the infrastructure and capabilities to serve patients in more than 70 countries. The Board of Directors of Lantheus has unanimously approved the transaction.

The cash consideration provides for near-term certain value to Lantheus shareholders at closing and the CVR structure provides meaningful potential additional upside participation in the commercial performance of Lantheus’ main product lines. The total transaction value represents a premium of 38% to Lantheus’ unaffected 60-day volume-weighted average price ("VWAP"), a premium of 29% to Lantheus’ unaffected 30-day VWAP, and a premium of 21% to Lantheus’ unaffected closing price, in each case as of May 21, 2026, the last trading day prior to the first media report of a potential sale transaction.

"Lantheus is the ideal partner to accelerate what we have been building at Curium," said Renaud Dehareng, Chief Executive Officer of Curium Group. "We have executed a strategy to build an innovative, theranostics platform by expanding our global manufacturing footprint, advancing our radioligand therapy pipeline across key regions, and positioning Curium to drive the next generation of theranostics innovation. Lantheus’ complementary business accelerates our strategy with a robust U.S. commercial infrastructure, a complementary F18-isotope based prostate diagnostics franchise and marks our entry in the U.S. market for diagnostic solutions targeting Neurology and Echocardiography. Together, we will provide meaningful theranostic options to patients from SPECT and PET diagnostics to targeted radioligand therapy across the globe. This combination unlocks an opportunity that neither company could achieve alone, as it positions us to reach significantly more patients and clinicians globally."

"We believe this transaction is the ultimate validation of what the Lantheus team has built over seven decades of innovation in radiopharmaceuticals," said Mary Anne Heino, Executive Chair and Chief Executive Officer of Lantheus. "Combining strategically with Curium brings together two pioneers with complementary strengths and a shared passion for nuclear medicine. Together, we can broaden and accelerate patient access to life-changing diagnostics and therapeutics and fully realize the differentiated outcomes and value radiopharmaceuticals can deliver. I am tremendously proud of everything our people have achieved, and I am confident this combination is the best path forward for our shareholders, our employees, and the millions of patients we serve."

Curium was established in 2017 by global investment firm CapVest Partners LLP ("CapVest") which remains its controlling shareholder and last year completed the successful recapitalization of Curium in a transaction which valued the Curium Group at approximately $7 billion. Kate Briant, Senior Partner at CapVest and Chair of Curium’s Board of Directors, said: "This transaction underlies our ongoing commitment to Curium’s growth and emphasizes our strong conviction in the potential of nuclear medicine and the future of the sector. This highly strategic combination will allow the combined company to capitalize on the significant emerging opportunities and, most importantly, will allow us to accelerate bringing life-changing solutions to healthcare professionals and benefit millions of patients (and their families) around the world."

Curium has a proven record of developing, manufacturing, and supplying diagnostic and therapeutic radiopharmaceuticals globally with a deep manufacturing expertise, and a robust theranostics pipeline. Lantheus has pioneered the radiodiagnostics landscape in the U.S. for 70 years and has demonstrated success building and growing a commercial diagnostic business, including PYLARIFY that helped establish PSMA PET as the standard of care in prostate cancer imaging, maintaining DEFINITY’s position as a category leader in cardiac ultrasound enhancing agents for 25 years, and driving Neuraceq to become the fastest-growing beta-amyloid PET agent on the market. The combined entity will span the full nuclear medicine value chain: from isotope production and manufacturing to diagnostic imaging and targeted radionuclide therapy, delivering nuclear medicine solutions to patients and healthcare systems across more than 70 countries.

The Lantheus Board of Directors, with the assistance of its financial advisors, conducted a comprehensive evaluation of its strategic options, including outreach to multiple third parties and remaining as a standalone company. After concluding this robust process, the Board unanimously determined that this transaction is in the best interests of Lantheus and its shareholders as the value maximizing path relative to the other strategic options.

Transaction Details

Under the terms of the agreement, Curium US will acquire all of the outstanding shares of Lantheus common stock for $102.50 per share in cash at closing. In addition, Lantheus shareholders will receive up to $12.00 per share in non-transferable CVRs, entitling holders to the following additional cash payments upon achievement of applicable milestones:

There can be no assurance that any payments will be made with respect to the CVRs. If all milestones are achieved, per share consideration under the CVRs would be $12.00 per share.

The transaction is expected to be financed through a combination of debt and equity and is not subject to any financial conditions or other related contingencies.

Until the transaction closes, Lantheus will continue to operate as an independent, publicly traded company. Upon completion, Lantheus will cease to be a publicly traded company.

The transaction is currently expected to close in the first half of 2027, subject to satisfaction of customary closing conditions, including receipt of Lantheus shareholder approval and required regulatory approvals.

Lantheus Second Quarter Financial Results

Lantheus is expected to announce its financial results and provide a business update for the second quarter of 2026 prior to market open on August 6, 2026. Due to the pending transaction with Curium, Lantheus will not be hosting a conference call and will be suspending its previously issued FY 2026 guidance.

Advisors

Morgan Stanley & Co. LLC acted as lead financial advisor to Lantheus, and BofA Securities, Inc. and Solomon Partners Securities LLC also acted as financial advisors to Lantheus. Covington & Burling LLP and Ropes & Gray LLP acted as legal counsel to Lantheus.

Jefferies LLC acted as lead financial advisor to Curium. J.P. Morgan Securities LLC and PJT Partners LP also acted as financial advisors to Curium. Kirkland & Ellis LLP and Arnold & Porter Kaye Scholer LLP acted as legal counsel to Curium.

(Press release, Curium Pharma, AUG 3, 2026, View Source [SID1234669605])

BioNTech Announces Appointment of Guido Oelkers to Management Board as Chief Executive Officer

On August 3, 2026 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported that its Supervisory Board has appointed Guido Oelkers, Ph.D., to the Management Board as Chief Executive Officer ("CEO"), who will take office by February 1, 2027, at the latest. Succeeding Prof. Ugur Sahin, M.D., Guido Oelkers will join BioNTech from the global Nasdaq Stockholm-listed biopharmaceutical company Swedish Orphan Biovitrum AB (STO: SOBI, "Sobi"), where he has served as CEO since 2017.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Guido Oelkers is a seasoned CEO and strategic leader with over 30 years of experience in the biotechnology and pharmaceutical industries. He has a strong track record in transforming and scaling global organizations, driving sustainable growth through disciplined execution, focused capital allocation, and operational excellence. Throughout his career, Guido Oelkers has successfully built, prioritized and strengthened complex and innovative product portfolios across multiple areas, including oncology and immunology, while driving strong global business operations in key markets, notably in the United States.
"Guido Oelkers is an experienced executive in the pharmaceutical industry. Throughout his impressive international career, he has consistently demonstrated sound strategic leadership in global organizations, seamlessly transforming scientific excellence into commercial success," said Helmut Jeggle, Chairman of the Supervisory Board of BioNTech. "His expertise in scaling innovation-driven organizations in a focused and capital-efficient manner, coupled with his deep knowledge in relevant markets, will position the Company well to deliver on its key objectives to become a multi-product company, and continue BioNTech’s remarkable success story."

"BioNTech stands out through its scientific foundation and particularly its strong late-stage oncology pipeline," said Guido Oelkers, Ph.D., designated Chief Executive Officer of BioNTech. "I am deeply honored to be leading BioNTech and prioritizing its evolution into a global biopharmaceutical company with multiple approved products by 2030, while continuing to advance its innovative pre-clinical and clinical portfolio in line with the Company’s strategy. I look forward to joining my colleagues on the Management Board and our teams worldwide on the journey ahead to deliver on BioNTech’s patient-centric strategy and create sustainable, long-term value."

"BioNTech is in a pivotal phase as the Company focuses on advancing its diversified pipeline into approved products and sustainable medical benefits for patients. I have come to know Guido Oelkers as a leader who combines a deep understanding of the pharmaceutical industry and strong strategic acumen with genuine respect for the culture and people of our organization," said Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. "With Guido Oelkers taking over, I feel confident that BioNTech is in a strong position to realize its vision. To ensure a smooth and successful handover, I will be actively supporting his onboarding."

The appointment of the new CEO is the result of a comprehensive selection process led by the Supervisory Board. As previously announced, BioNTech’s Chief Medical Officer, Prof. Özlem Türeci, M.D., will transition into the management of a new, independent company, which she will lead together with her husband and co-founder, Prof. Ugur Sahin, M.D. The search for her successor is ongoing and focuses on identifying a leader with exceptional medical and scientific expertise, extensive experience in late-stage clinical development, and a proven track record of advancing innovative platforms and complex product candidates.

About Guido Oelkers

Guido Oelkers, Ph.D., is an accomplished executive who has served multiple times as CEO throughout his career at both publicly traded companies and private equity portfolio companies in Europe and the Asia-Pacific region. Most recently, he has served as CEO of Swedish Orphan Biovitrum AB ("Sobi"), where he more than quadrupled the company’s revenues over a nine-year period (financial years 2017 to 2026). During his tenure, he significantly increased Sobi’s profitability and strengthened its late-stage pipeline, positioning the company for sustained long-term success. Prior to joining Sobi, he served as CEO of the medical technology manufacturer BSN Medical Holding GmbH, as President and CEO of the Swedish medtech company Gambro AB and as CEO of the specialty pharmaceutical company Invida Holdings Pte. Ltd. Guido Oelkers held a number of executive roles in companies such as Nycomed International Management GmbH, DKSH Group, Aventis Pharma S.A. China and Hoechst AG, where he started his career. He holds a PhD in Business Management from Adelaide University, Australia, and completed his undergraduate and postgraduate studies in business management and economics in Mainz and London, respectively. Guido Oelkers is a German citizen and will be based in BioNTech’s headquarters in Mainz, Germany.

(Press release, BioNTech, AUG 3, 2026, View Source [SID1234669604])

Autolus Therapeutics Reports Preliminary Second Quarter 2026 Net Product Revenue and Announces Credit Facility of up to $250 Million with Perceptive Advisors

On August 3, 2026 Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies and candidates, reported preliminary second quarter 2026 AUCATZYL net product revenue of approximately $45 million and gross margin of approximately 35% year-to-date. Autolus also announced that it has entered into a strategic financing with Perceptive Advisors ("Perceptive"), a leading global healthcare specialist investor, for the sale of notes of up to $250 million in aggregate principal amount in a five-year, interest-only senior credit facility (the "Credit Facility"), subject to certain conditions. An initial $75 million principal amount of notes has been issued by Autolus to Perceptive on July 30, 2026, and an additional $25 million in aggregate principal amount will be available at Autolus’ option for up to six months post-closing. An additional $150 million in aggregate principal amount of subsequent capital may become available in separate tranches upon achievement of certain pre-specified revenue milestones.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In the second quarter, AUCATZYL sales increased approximately 70% over Q1 2026 and more than 100% compared to Q2 2025. The strong sales growth is driven by expanding product use within existing authorized treatment centers, as well as the addition of new centers coming online. Physician adoption of AUCATZYL is underscored by the real-world experience reported by the ROCCA consortium earlier in the year," said Dr. Christian Itin, Chief Executive Officer of Autolus. "The increased product volumes, combined with the ongoing operational efficiency initiatives announced in April 2026, together drove a significant step up in gross margin from a negative gross margin of approximately 20% in the second half of 2025 to a positive gross margin of approximately 35% in the first half of 2026. We expect gross margin to continue to improve."

"The strategic financing with Perceptive Advisors provides us with additional capital to support key inflection points for the business, including clinical data milestones in our oncology and autoimmune development programs, and is underpinned by the positive sales and gross margin development from our core adult lymphoblastic leukemia (ALL) commercial business," said Rob Dolski, Chief Financial Officer of Autolus. "With obe-cel’s unique profile we have a meaningful opportunity to expand into new and larger markets which we view as significant growth drivers. The potential additional tranches in this financing, if drawn down, provide optionality and flexibility to invest in these larger autoimmune indications."

"Our goal is to support technologies that carry a meaningful opportunity to help patients, and we are pleased to partner with Autolus in their mission to deliver obe-cel to people with cancer and autoimmune diseases. With this facility, we are providing flexible growth capital to enable the Company to deliver on its strategic priorities and catalyze value creation," said Sam Chawla, Portfolio Manager at Perceptive Advisors. "This financing reflects our confidence in the leadership team at Autolus to continue to deliver on obe-cel’s commercial and development plans."

The Credit Facility will bear interest at a rate per annum equal to the one month secured overnight financing rate ("SOFR") (subject to a SOFR floor of 3.50%), plus 7.25%, and will be interest-only until maturity. Interest margin reductions may become available upon achievement of certain revenue milestones. At closing of the Credit Facility, Autolus issued Perceptive a warrant to purchase up to 3.5 million American Depositary Receipts (ADSs), each ADS representing one ordinary share, at an exercise price of $1.9314 per ADS, equal to 125% of the 30-day VWAP immediately preceding the closing date.

The combined first and second tranches from the Credit Facility, totaling $100 million in aggregate principal amount, together with Autolus’ most recently reported cash, cash equivalents and marketable securities, provide funding into Q2 2028, and are expected to allow the Company to deliver on key strategic priorities.

Autolus will report full second quarter 2026 financial results on August 11, 2026. Further information on the terms of the credit facility can be found in the Company’s filings with the U.S. Securities and Exchange Commission in connection with the Credit Facility.

Jefferies International Limited acted as debt advisor and Cooley served as legal advisor to Autolus Therapeutics in connection with the Credit Facility. Latham & Watkins served as legal advisor to Perceptive.

(Press release, Autolus, AUG 3, 2026, View Source [SID1234669603])

AIM ImmunoTech Ahead of Schedule on ‘Last Dose’ DURIPANC Critical Clinical Inflection Point

On August 3, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that the final subject has received their last dose of Ampligen (rintatolimod) under the study protocol, reaching this milestone ahead of schedule in the Phase 2 DURIPANC clinical trial evaluating Ampligen in combination with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) for the treatment of metastatic pancreatic cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Following planned data collection, DURIPANC Primary Endpoint analysis is anticipated to begin in December 2026 and topline results are anticipated in Q1 2027. DURIPANC’s primary endpoint is Clinical Benefit Rate ("CBR"), defined as the proportion of patients achieving stable disease, partial response or complete response at 24 weeks following initiation of combination therapy.

Analysis of the DURIPANC Overall Survival Endpoint is expected to begin in June 2027, or 49 weeks after this final subject received their first dose. DURIPANC’s Secondary Endpoints include Overall Survival – the gold standard in oncology trials – as well as progression-free survival and a completed immune profiling analysis that could potentially help identify subsets of future pancreatic cancer patients likely to experience the best clinical benefit and overall survival results, which could be critical to the design of a pivotal Phase 3 clinical trial.

AIM saw encouraging results in a Dutch Ministry of Health-approved Named Patient Program that provided more than 50 post-standard of care pancreatic cancer patients with access to Ampligen as a monotherapy. While the program was not designed to assess efficacy and the findings were exploratory observations, analysis of biomarker stratifications was extremely promising. For example, Ampligen achieved a median Overall Survival of 34.8 months compared to 12.5 months for historical controls – for an improvement of 22.3 months – in the patient subset with immune biomarker Neutrophil/Lymphocyte ratios less than 4.5. AIM hopes to see similar trends in the final DURIPANC overall survival results.

AIM Chief Executive Officer Thomas Equels stated: "While the tremendous improvement in overall survival seen in our Named Patient Program is an important signal, it is one which requires Phase 2 and Phase 3 clinical trials to verify efficacy and support statistical validity. The execution of DURIPANC Phase 2 milestones ahead of schedule affirms our commitment to analyze biomarker stratifications as we set about designing a pivotal Phase 3 clinical trial that will help move Ampligen toward eventual submission of a New Drug Application for the treatment of pancreatic cancer."

About DURIPANC

DURIPANC is an investigator-initiated, exploratory, open-label, single-center Phase 2 study. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center in the Netherlands. In addition to the Primary Endpoint of clinical benefit rate, the secondary/exploratory objectives include assessing overall survival and progression-free survival; exploring immune-monitoring using available tissue biopsies and peripheral immune profiling; and assessing quality of life.

Read more about the DURIPANC study at ClinicalTrials.gov NCT05927142.

(Press release, AIM ImmunoTech, AUG 3, 2026, View Source [SID1234669602])