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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.

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"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.

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])

Abeona Therapeutics® Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On August 3, 2026 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported it has granted equity awards to new non-executive employees who joined the Company. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).

On July 31, 2026, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment to two individuals hired by Abeona, which equity awards relate to, in the aggregate, up to 10,800 restricted shares of Abeona common stock. One-third of the shares subject to such restricted stock awards is scheduled to vest yearly on each anniversary of the Grant Date, such that the shares subject to such restricted stock awards granted to each employee are scheduled to be fully vested on the third anniversary of the Grant Date, in each case, subject to each employee’s continued employment with Abeona on the applicable vesting dates.

(Press release, Abeona Therapeutics, AUG 3, 2026, View Source [SID1234669601])

Leads Biolabs’ PD-L1/4-1BB Bispecific Antibody IND Application for Combination Therapy in Metastatic Colorectal Cancer Approved, Further Strengthening Gastrointestinal Oncology Franchise

On August 2, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has approved the investigational new drug (IND) application for an open-label, multicenter Phase Ib/II clinical trial of its proprietary PD-L1/4-1BB bispecific antibody, Opamtistomig (LBL-024), in combination therapy for metastatic colorectal cancer (mCRC). The study is designed to evaluate the safety and efficacy of Opamtistomig combination regimens in patients with mCRC and to explore potential predictive biomarkers. This marks an important step in expanding the indications for Opamtistomig in gastrointestinal cancers, extending the company’s immuno-oncology footprint from biliary tract cancer, gastric cancer and esophageal squamous cell carcinoma into colorectal cancer (CRC), an area of high unmet clinical need.

mCRC is difficult to treat and carries a very poor prognosis, with a 5-year survival rate of less than 13%. While immunotherapy has achieved breakthroughs in the microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) subtype, these patients account for only about 5% of mCRC cases. For the vast majority—up to 95%—of patients with microsatellite stable (MSS)/mismatch repair proficient (pMMR) tumors, conventional immune checkpoint inhibitors offer limited benefit. The current first- and second-line standard of care remains chemotherapy combined with targeted therapy, leaving an urgent need for more effective immunotherapy options.

Opamtistomig simultaneously blocks PD-1/PD-L1-mediated immunosuppression and conditionally activates 4-1BB co-stimulatory signaling. This dual mechanism restores T cell function while promoting T cell proliferation and long-term memory formation. The mechanistic advantages of Opamtistomig have been validated in multiple tumor types, including extrapulmonary neuroendocrine carcinoma (EP-NEC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and biliary tract cancer (BTC), and are expected to translate into meaningful clinical benefit in CRC as well, further reinforcing its position as an IO 2.0 pan-tumor cornerstone therapy.

Executive Commentary
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated: "MSS/pMMR mCRC is widely recognized as an immunologically ‘cold’ tumor, and patients continue to face significant unmet medical needs with limited effective treatment options. Through the synergistic dual targeting of PD-L1 and 4-1BB, Opamtistomig has the potential to restore anti-tumor immune activity in cold tumors, a differentiated mechanism that has already shown encouraging preliminary signals in earlier clinical studies. We are excited to further explore this novel combination strategy in the ongoing Phase Ib/II study and hope to bring a more effective immunotherapy option to patients with metastatic colorectal cancer."

About Colorectal Cancer (CRC)
CRC is one of the most common gastrointestinal malignancies worldwide. According to 2022 data from the International Agency for Research on Cancer (IARC), there were approximately 1.926 million new cases and 904,000 deaths from CRC globally, making it the third most common cancer and the second leading cause of cancer-related death. Data from the China National Cancer Center show that in 2022, there were 517,100 new cases and 240,000 deaths from CRC in China, ranking second in incidence and fourth in mortality among all malignancies. Approximately 15%–30% of CRC patients have distant metastases at initial diagnosis, and 20%–50% of patients with initially localized CRC eventually develop mCRC. mCRC is difficult to treat and has a very poor prognosis, with a 5-year survival rate of less than 13%. Currently, immunotherapy is primarily approved for MSI-H/dMMR CRC patients, but these account for only about 5% of mCRC cases. The remaining 95% of patients with MSS/pMMR tumors are resistant to conventional immunotherapy, representing a significant unmet clinical need.

About Opamtistomig
Opamtistomig (LBL-024) is emerging as a next-generation pan-cancer backbone therapy with potential overall survival (OS) benefit that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. Developed using Leads Biolabs’ proprietary X-Body bispecific platform, Opamtistomig is designed to simultaneously block PD-1/L1 immune suppression and conditionally activate 4-1BB, an agonist pathway, resulting in a potent and synergistic anti-tumor immune response. It has a safety profile comparable to PD-1/PD-L1 inhibitors and demonstrates broader-spectrum anti-cancer potential. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across four indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), and extrapulmonary neuroendocrine carcinoma (EP-NEC).

As the first 4-1BB–targeting bispecific antibody globally to advance to a single-arm pivotal trial as monotherapy, Opamtistomig has been evaluated in 13 solid tumor indications in China, including 1 pivotal registration trial and 8 proof-of-concept studies. These cover EP-NEC, NSCLC, SCLC, BTC, ovarian cancer (OC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), malignant melanoma, and other areas with high unmet medical needs.

Mechanistically, 4-1BB agonism can reactivate exhausted T cells and promote robust T-cell proliferation, offering significant promise for PD-1/PD-L1–resistant or immunologically "cold" tumors. Recognizing its clinical potential, Opamtistomig received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) in October 2024, and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of neuroendocrine carcinoma in November 2024. Additionally, in January 2026, Opamtistomig was granted Fast Track Designation (FTD) by the FDA and ODD by the European Commission for the treatment of EP-NEC, further underscoring its potential to address unmet medical needs in this patient population.

(Press release, Nanjing Leads Biolabs, AUG 2, 2026, View Source [SID1234669595])

New Chemotherapy-Free Immunotherapy Combination for Follicular Lymphoma Listed on the PBS

On August 2, 2026 Specialised Therapeutics (ST) reported the listing of Minjuvi (tafasitamab), in combination with rituximab and lenalidomide, on the Pharmaceutical Benefits Scheme (PBS) for the treatment of Australian adults with relapsed or refractory follicular lymphoma (R/R FL) (Grade 1-3a).[1] This milestone follows the Australian registration of Minjuvi for R/R FL by the Therapeutic Goods Administration (TGA) in April 2026, via the Project Orbis process.[6]

The PBS listing of Minjuvi marks the availability of the first and only chemotherapy-free CD19 and CD20 dual-targeted immunotherapy combination regimen funded in Australia for this group of patients.[1],[2] Effective 1 August 2026, eligible patients with FL who have experienced relapses or disease progression on existing therapies will now have equitable access to a new treatment option for this difficult-to-treat condition.[1]

"As the first new therapy to be reimbursed on the PBS for R/R FL in nine years, we are extremely proud to have partnered with Incyte to bring Minjuvi to Australia," said Carlo Montagner, ST Chief Executive Officer. "After securing TGA registration for Minjuvi in R/R FL earlier this year, we have been focused on expediting PBS listing to ensure eligible Australian patients could have subsidised access to a new treatment option that may help lower the risk of disease progression, relapse or death, without delay."

ST entered into an exclusive distribution agreement with Incyte (NASDAQ:INCY) in 2021 to commercialise Minjuvi in Australia, New Zealand and Singapore.

Minjuvi is a CD19 targeting immunotherapy that works within a patient’s immune system to help find and eliminate malignant B-cells.[7] In combination with rituximab and lenalidomide, Minjuvi delivers a complementary immune-mediated approach that helps control disease progression and supports improved long-term outcomes for patients with follicular lymphoma.[7]

The PBS reimbursement underscores the growing recognition of innovative immunotherapy-based treatment strategies in follicular lymphoma and reinforces ST’s commitment to improving access to life-changing therapies for patients across the Asia-Pacific region.

"While follicular lymphoma can be a slow-growing disease that usually responds well to the first treatment, most patients are not cured. Many patients experience frequent relapses and require multiple therapies over their lifetime, which become progressively less effective, especially for those whose disease comes back soon after initial chemotherapy treatment," said Associate Professor Philip Thompson, Clinical Haematologist at the Peter MacCallum Cancer Centre and Royal Melbourne Hospital in Melbourne. "Today’s PBS listing announcement is welcome news for the Australian clinical and patient community, providing us with a new, chemotherapy-free immunotherapy treatment for R/R FL."

Minjuvi is administered via intravenous (IV) infusion in a clinic or hospital setting.[7] Patients with R/R FL receive up to 12 treatment cycles of Minjuvi, along with oral lenalidomide capsules, while rituximab is delivered intravenously for the first five cycles.[7]

"Knowing that a chemotherapy-free immunotherapy is now funded by the PBS is an important development for the follicular lymphoma community," said Sharon Winton, Chief Executive Officer of Lymphoma Australia. "As patients manage the challenges of recurring disease, this new treatment milestone offers a valuable option that is deeply meaningful to them and their families."

The PBS listing of Minjuvi for R/R FL means these patients will now have equitable access to a new targeted immunotherapy combination treatment when they need it. It is important that patients with R/R FL speak with their doctor to understand the most suitable treatment option available for them.

For further details on Minjuvi, contact your healthcare professional and please refer to the approved Australian Consumer Medicine Information or Product Information available from the TGA website.

(Press release, Specialised Therapeutics Australia, AUG 2, 2026, View Source [SID1234669594])