Nkarta Reports Second Quarter 2026 Financial Results and Corporate Highlights

On August 10, 2026 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biotechnology company developing engineered natural killer (NK) cell therapies to treat autoimmune diseases, reported financial results for the second quarter ended June 30, 2026.

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!

"Expanding access to NKX019 in the communities where autoimmune patients already receive care is central to how we’re advancing this program," said Paul J. Hastings, Chief Executive Officer of Nkarta. "This quarter, we continued to enroll patients across all indications in Ntrust-1 and Ntrust-2 at the 4 billion cell dose level. Following our recent agreement with the FDA on outpatient dosing, we have begun administrating NKX019 through our expanding network of community-based sites, with re-dosing available, if needed, to patients in both trials. We look forward to presenting our initial clinical dataset from Ntrust-1 and Ntrust-2 at a medical conference in 2026."

NKX019 Clinical Program Progress and Upcoming Milestones


Enrollment continues across Ntrust-1 and Ntrust-2, our multi-center, open-label, dose-escalation clinical trials evaluating NKX019 in multiple autoimmune diseases.

Outpatient dosing is underway within our network of community-based sites, broadening patient access beyond those who can travel to academic medical centers.

Patients are being dosed at 4 billion cells per dose x 3 doses (12 billion cells total) across all indications in Ntrust-1 and Ntrust-2.

Initial clinical data from Ntrust-1 and Ntrust-2 are planned for presentation at a medical conference in 2026.

Second Quarter 2026 Financial Highlights


Nkarta had cash, cash equivalents, restricted cash, and investments in marketable securities of $243.2 million as of June 30, 2026.

Research and development (R&D) expenses were $29.0 million for the second quarter of 2026. Non-cash stock-based compensation expense included in R&D expense was $0.7 million for the second quarter of 2026.

General and administrative (G&A) expenses were $14.1 million for the second quarter of 2026. Non-cash stock-based compensation expense included in G&A expense was $1.1 million for the second quarter of 2026.

Net loss was $40.4 million, or $0.54 per basic and diluted share, for the second quarter of 2026. This net loss includes non-cash charges of $11.8 million that consisted primarily of share-based compensation of $1.9 million, depreciation of $2.7 million, and impairment of right-of-use assets, leasehold improvements and other equipment of $8.0 million.

Financial Guidance


Nkarta expects its current cash and cash equivalents to fund its current operating plan into 2029.

About the Ntrust℠ Clinical Trials in Autoimmune Disease

Ntrust-1 (NCT06557265) and Ntrust-2 (NCT06733935) are multi-center, open label, dose escalation clinical trials in patients with autoimmune disease receiving lymphodepletion followed by CD19-targeted CAR-NK cell therapy. Both trials will assess the safety of NKX019 in people living with autoimmune diseases as well as its potential to achieve durable remission via a "reset" of the immune system through the elimination of pathogenic B cells.

The Ntrust trials are enrolling up to 12 patients per dose level per disease indication across systemic sclerosis, idiopathic inflammatory myopathy, ANCA-associated vasculitis, rheumatoid arthritis, lupus nephritis, and primary membranous nephropathy. Additional participants may be enrolled if needed to refine patient populations for further study.

In both studies, patients now receive a three-dose cycle of NKX019 on Days 0, 3, and 7 following lymphodepletion with fludarabine and cyclophosphamide or cyclophosphamide alone, if they have significant cytopenia at baseline. Leveraging the engineering of NKX019, no patients in either trial will receive supplemental cytokines or antibody-based therapeutics. This approach is designed to evaluate the single-agent activity of NKX019 and facilitate a more rapid path to regulatory approval. Patients in both trials may also receive additional cycles, if needed, to restore response or enable a deeper response.

About NKX019

NKX019 is an allogeneic, cryopreserved, off-the-shelf immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed chimeric antigen receptor (CAR) for enhanced cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal B cells as well as those implicated in autoimmune disease. Nkarta is evaluating NKX019 in multiple autoimmune conditions.

(Press release, Nkarta, AUG 10, 2026, View Source [SID1234669903])

INNATE PHARMA ENTERS STRATEGIC PARTNERSHIP WITH SOBI TO LICENSE LACUTAMAB IN T-CELL LYMPHOMA

On August 10, 2026 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") and Swedish Orphan Biovitrum AB (publ) (Sobi) reported that they have entered a strategic partnership to enable initiation of the TELLOMAK-3 confirmatory Phase 3 study in cutaneous T-cell lymphoma (CTCL), a key step toward filing for accelerated approval of lacutamab in Sézary syndrome, a subtype of CTCL.

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 agreement, Innate will conduct the TELLOMAK-3 Phase 3 confirmatory trial in cutaneous T-cell lymphoma, supporting a planned accelerated approval filing in Sézary syndrome. The planned TELLOMAK-3 study will subsequently support applications for full approvals in key jurisdictions in Sézary syndrome and mycosis fungoides, the most common subtype. Sobi will receive exclusive global rights to commercialize lacutamab upon potential accelerated approval and will be eligible to assume full global development rights following positive Phase 3 results. Closing of the transaction is subject to closing conditions, including the receipt of transaction related anti-trust clearance.
"We are thrilled to partner with Sobi and enable TELLOMAK-3 initiation, the pivotal next step in advancing lacutamab toward a potential accelerated approval in Sézary syndrome," said Jonathan Dickinson, CEO of Innate Pharma. "Sobi is the ideal partner to help unlock the full potential of lacutamab. Their expertise in rare diseases, proven commercial capabilities and global reach perfectly complement Innate’s expertise in CTCL clinical development. Together, we share the ambition to bring lacutamab to patients globally as quickly as possible."

"This agreement is an important step in strengthening our portfolio and reflects our strategy of partnering with leading innovators to bring differentiated therapies to patients with rare diseases. We look forward to working with Innate Pharma to advance lacutamab and, subject to regulatory approvals, make it available to patients globally," said Guido Oelkers, President and CEO of Sobi.

Transaction details

Under the terms of the agreement, Sobi will pay Innate Pharma USD 75 million, payable on closing. Innate will be eligible to receive up to a further USD 40 million in respect of near-term development milestones connected to Sézary syndrome. Additionally, Innate will be eligible to receive up to USD 465 million related to the option for Sobi to get full development rights and to future regulatory and commercial milestones. Innate will be eligible to receive tiered double-digit royalties on net sales.

About Lacutamab

Lacutamab is a first-in-class anti-KIR3DL2 antibody, currently developed in cutaneous T-cell lymphoma (CTCL). CTCL is a group of rare non-Hodgkin lymphomas that includes Sézary syndrome, a rare and aggressive leukemic form, and mycosis fungoides, the most common subtype in CTCL.

The program has received Fast Track designation from the FDA, PRIME designation from the EMA for Sézary syndrome, Orphan Drug designation in both the U.S. and EU for CTCL, and Breakthrough Therapy Designation from the FDA for relapsed or refractory Sézary syndrome. The program is advancing toward a pivotal Phase 3 TELLOMAK-3 study, an open-label, multicenter, randomized trial in patients with Sézary syndrome and mycosis fungoides who have failed at least one prior systemic therapy. The study includes a confirmatory cohort in Sézary syndrome intended to support a potential accelerated approval and upon study completion a full approval for Sézary syndrome, and a registrational cohort in mycosis fungoides intended to support full approval, with progression-free survival (PFS) as the primary endpoint.

(Press release, Innate Pharma, AUG 10, 2026, View Source [SID1234669902])

Heron Therapeutics Announces Second Quarter 2026 Financial Results

On August 10, 2026 Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, reported financial results for the three and six months ended June 30, 2026, and highlighted recent corporate updates.

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!

"Second quarter revenue grew compared to the first quarter but came in below our expectations," said Craig Collard, Chief Executive Officer of Heron. "What we did over the past ninety days matters more: we reset our balance sheet, tightened our spending, and we are considering strategic alternatives as we continue to execute our current plan. Our job now is execution."

Business Highlights


Heron generated total net revenue of $37.7 million in Q2 2026 and ended the quarter with $42.7 million in cash, cash equivalents and short-term investments.


Acute Care franchise updates: Net revenue increased 43.9% year-over-year for the three months ended June 30, 2026 and increased 38.2% year-over-year for the six months ended June 30, 2026. ZYNRELEF contributed $11.1 million and $21.3 million net revenue in the three and six months ended June 30, 2026, respectively. APONVIE contributed $4.2 million and $7.7 million net revenue in the three and six months ended June 30, 2026, respectively.


Oncology Supportive Care franchise updates: Net revenue was $22.3 million in the three months ended June 30, 2026 and $43.4 million in the six months ended June 30, 2026.

Financial Guidance for 2026

The Company is withdrawing its previously issued full-year 2026 guidance of net product sales and Adjusted EBITDA, and investors should no longer rely on that guidance. Three factors led to this decision. First, following the June 2026 decision of the U.S. District Court for the District of Delaware (the "Court") regarding certain patents covering CINVANTI, the Company does not believe it can reliably forecast the timing or terms of potential generic entry with respect to its largest product. Second, in response to the Court’s decision, the Company paused the sales force expansion that its operating plan had assumed for the second half of 2026 and tightened spending, and under which its previously issued guidance was built on. Third, the Company is considering strategic alternatives as it continues to execute its current plan. The Company has not set a timetable for this process, there can be no assurance that it will result in any transaction, and the Company does not intend to comment further on such matters unless and until it determines that additional disclosure is appropriate or required by law.

Net Revenue Performance – Three Months Ended June 30

(in thousands)

(unaudited)

2026

2025

Dollar Change

Percentage Change

Acute Care

$ 15,333

$ 10,653

$ 4,680

43.9%

APONVIE

$ 4,277

$ 2,464

$ 1,813

73.6%

ZYNRELEF

$ 11,056

$ 8,189

$ 2,867

35.0%

Oncology

$ 22,333

$ 26,547

($ 4,214)

(15.9%)

CINVANTI

$ 21,793

$ 24,143

($ 2,350)

(9.7%)

SUSTOL

$ 540

$ 2,404

($ 1,864)

(77.5%)

Total Net Revenue

$ 37,666

$ 37,200

$ 466

1.3%

Net Revenue Performance – Six Months Ended June 30

(in thousands)

(unaudited)

2026

2025

Dollar Change

Percentage Change

Acute Care

$ 28,961

$ 20,954

$ 8,007

38.2%

APONVIE

$ 7,670

$ 4,724

$ 2,946

62.4%

ZYNRELEF

$ 21,291

$ 16,230

$ 5,061

31.2%

Oncology

$ 43,416

$ 55,149

($ 11,733)

(21.3%)

CINVANTI

$ 42,328

$ 49,886

($ 7,558)

(15.2%)

SUSTOL

$ 1,088

$ 5,263

($ 4,175)

(79.3%)

Total Net Revenue

$ 72,377

$ 76,103

($ 3,726)

(4.9%)

Conference Call and Webcast

Heron will host a conference call and live webcast on Monday, August 10, 2026, at 8:30 a.m. ET. The conference call can be accessed by phone by utilizing the following registration link which will provide participants with dial-in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. The conference call will also be available via webcast under the Investor Relations section of Heron’s website at www.herontx.com. The investor presentation to be used for the conference call and webcast can be accessed from Heron’s website prior to the conference call and webcast. An archive of the teleconference, webcast, and investor presentation will also be made available on Heron’s website for sixty days following the call.

About ZYNRELEF for Postoperative Pain

ZYNRELEF is the first and only extended-release dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the FDA in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF’s indication to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. On January 23, 2024, the FDA approved ZYNRELEF for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.

Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com.

About APONVIE for Prevention of Postoperative Nausea and Vomiting (PONV) Prevention

APONVIE is a substance P/neurokinin 1 (NK1) Receptor Antagonist (RA), indicated for the prevention of post operative nausea and vomiting (PONV) in adults. Delivered via a 30-second IV push, APONVIE 32 mg was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron’s approved drug product CINVANTI. APONVIE is supplied in a single-dose vial that delivers the full 32 mg dose for PONV. APONVIE was approved by the FDA in September 2022 and became commercially available in the U.S. on March 6, 2023.

Please see full prescribing information at www.APONVIE.com.

About CINVANTI for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is a single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the U.S. prescribing information for CINVANTI include 100 mg or 130 mg administered as a 30-minute IV infusion or a 2-minute IV injection.

About SUSTOL for CINV Prevention

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-hydroxytryptamine type 3 RA that utilizes Heron’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy).

Please see full prescribing information at www.SUSTOL.com.

(Press release, Heron Therapeutics, AUG 10, 2026, View Source [SID1234669901])

Cogent Biosciences Reports Recent Business Highlights and Second Quarter 2026 Financial Results

On August 10, 2026 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported financial results for the second quarter ended June 30, 2026.

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!

"The first half of 2026 has been marked by transformative milestones toward our vision of creating best-in-class therapies for patients fighting rare, mutationally driven diseases as we submitted three New Drug Applications following positive results from each of the bezuclastinib pivotal trials," said Andrew Robbins, the Company’s President and Chief Executive Officer. "We are excited to welcome the new Cogent customer facing team to the company, and supported by our strong balance sheet, we are well prepared to launch bezuclastinib and advance the standard of care for patients with GIST and Systemic Mastocytosis while continuing to invest in our broader pipeline of precision therapies for genetically defined diseases."

Recent Business Highlights

Cogent Biosciences Integrated Business Team


Successfully hired and onboarded all Integrated Business Team members, spanning clinical account managers, patient access navigators and patient educators. Selected for their expertise in commercializing Oncology and Rare Disease products, Cogent now has an exceptional commercial field team in place across the country. Together with our existing medical affairs team, Cogent is well prepared for potential launch with a broad, expert, cross-functional customer-facing organization.

Bezuclastinib in GIST


Presented detailed clinical data from the Phase 3 PEAK trial evaluating bezuclastinib in combination with sunitinib vs. sunitinib monotherapy in patients with imatinib-resistant or intolerant Gastrointestinal Stromal Tumors (GIST) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

o
As of the cutoff date, September 30, 2025, the bezuclastinib combination demonstrated a substantial and highly statistically significant clinical benefit on the primary endpoint of PFS, reducing risk of disease progression or death compared to the current standard of care by 50% (hazard ratio of 0.50, 95% CI: 0.39 – 0.65). mPFS, as assessed by blinded independent central review, was 16.5 months for the bezuclastinib combination vs. 9.2 months for sunitinib monotherapy. Additionally, the bezuclastinib combination demonstrated an unprecedented ORR in imatinib-resistant/intolerant patients, with 46% of patients treated with the bezuclastinib combination achieving an objective response compared to 26% of patients treated with sunitinib. Data for overall survival remains immature.

o
Based on the ongoing patients receiving treatment on the bezuclastinib arm as of March 31, 2026, the mean duration of treatment for the bezuclastinib combination is estimated to be 21.4 months.


Announced the initiation of a single-arm, 40 patient extension cohort of the PEAK trial investigating the safety and efficacy of the bezuclastinib combination in first-line GIST patients with KIT exon 9 primary mutations who have received limited or no imatinib treatment. This cohort is designed to prospectively measure ORR and PFS in this patient population, building upon the 25.1 month mPFS reported in a subgroup of 32 patients with detectable exon 9 mutations treated with the bezuclastinib combination in the Phase 3 PEAK trial.


Announced FDA acceptance of the New Drug Application (NDA) with priority review for bezuclastinib in combination with sunitinib in patients with GIST who have received prior treatment with imatinib.

Bezuclastinib in Systemic Mastocytosis


Announced submission of the NDA for bezuclastinib in Advanced Systemic Mastocytosis (AdvSM).


Presented detailed data from the pivotal APEX trial at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Congress.
o
As of the March 31, 2026 data cutoff, 81 AdvSM patients were treated with 150 mg of bezuclastinib, including 57 patients with SM-AHN, 11 patients with ASM and 13 patients with MCL. The primary endpoint of response per mIWG-MRT-ECNM was assessed on 68 evaluable patients and showed 65% ORR (CR+CRh+PR+CI), including 57% of patients who achieved CR, CRh or PR as best response.


Announced completion of enrollment in the "avapritinib switch" SUMMIT extension trial with preliminary results expected by end of 2026.


Presented preclinical data from the novel JAK2 V617F program at EHA (Free EHA Whitepaper).
o
The poster highlighted CGT1145, a potent inhibitor of the JAK2 V617F mutation with >100x selectivity over JAK2 WT and the JAK1/3 isoforms, along with high oral bioavailability and low clearance across species. CGT1145 has the potential to eradicate JAK2 V617F myeloproliferative neoplasm propagating cells and induce molecular remission with improved hematologic tolerability.

Anticipated Upcoming Milestones


Potential FDA approval of bezuclastinib in GIST – PDUFA date of November 30, 2026

Potential FDA approval of bezuclastinib in NonAdvSM – PDUFA date of December 30, 2026

Submit Investigational New Drug (IND) applications for CGT1815, Cogent’s novel, selective pan-KRAS(ON) inhibitor, and CGT1145, Cogent’s novel, selective JAK2 V617F inhibitor

Complete dose escalation for CGT4255, Cogent’s CNS-penetrant, selective mutant ErbB2 inhibitor

Second Quarter 2026 Financial Results

Cash Position: As of June 30, 2026, Cogent had cash, cash equivalents and marketable securities of $792.3 million. The company expects its existing cash, cash equivalents and marketable securities, with the $73.6 million gross proceeds from shares sold through the Company’s at-the-market (ATM) facility after the end of the quarter, will be sufficient to fund its operating expenses and capital expenditure requirements into late 2028, including through potential FDA approvals of bezuclastinib for GIST, NonAdvSM and AdvSM and early commercial launch activities.

R&D Expenses: Research and development expenses were $70.8 million for the second quarter of 2026 as compared to $62.2 million for the second quarter of 2025. The increase was primarily driven by costs to support the SUMMIT, PEAK and APEX clinical programs, regulatory activities associated with potential approvals of bezuclastinib, continued investment in the company’s early-stage research pipeline, and pre-approval manufacturing costs that will be capitalized following anticipated FDA approval.

R&D expenses include non-cash stock compensation expense of $8.6 million for the second quarter of 2026 as compared to $5.0 million for the second quarter of 2025.

G&A Expenses: General and administrative expenses were $31.8 million for the second quarter of 2026 as compared to $13.4 million for the second quarter of 2025. The increase was primarily driven by continued investments in commercial readiness, including personnel and infrastructure to support the anticipated launch of bezuclastinib, as well as overall organizational growth.

G&A expenses include non-cash stock compensation expense of $8.5 million for the second quarter of 2026 as compared to $4.8 million for the second quarter of 2025.

Net Loss: Net loss was $96.4 million for the second quarter of 2026 as compared to a net loss of $73.5 million for the same period of 2025.

(Press release, Cogent Biosciences, AUG 10, 2026, View Source [SID1234669900])

AIM ImmunoTech Reports Second Quarter 2026 Financial Results and Highlights Significant Operational Execution Advancing Ampligen® Toward Planned Phase 3 Development in Pancreatic Cancer

On August 10, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported financial results for the second quarter ended June 30, 2026, and provided a business update highlighting continued operational execution across its lead pancreatic cancer program.

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!

"AIM continues to execute a clear and disciplined strategy centered on advancing Ampligen in pancreatic cancer," said AIM Chief Executive Officer Thomas K. Equels. "Over the past year, we have strengthened our financial position while completing enrollment and Ampligen dosing in the metastatic pancreatic cancer Phase 2 clinical trial – critical steps as we move toward an anticipated Phase 3 study in metastatic pancreatic cancer. We anticipate DURIPANC data on clinical benefit in Q1 2027 and on Overall Survival – the gold standard data point in oncology – in Q3 2027. AIM expects that this data will amplify median Overall Survival findings from Ampligen’s Dutch-government approved Named Patient Program in late-stage pancreatic cancer, where Ampligen achieved a median Overall Survival of 34.8 months compared to 12.5 months for historical controls – with favorable safety profile and high quality of life – in a large, easily identifiable and key patient immune biomarker subset. This median improvement of 22.3 months will be a critical component of the foundation for our pivotal Phase 3 clinical trial design in metastatic pancreatic cancer."

Second Quarter and Recent Operational Highlights

Completed patient enrollment and Ampligen dosing in the ongoing Phase 2 DURIPANC study evaluating Ampligen in combination with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in metastatic pancreatic cancer.
Engaged Thermo Fisher Scientific’s PPD clinical research business to support study design of a planned pivotal Phase 3 clinical trial in metastatic pancreatic cancer.
Maintained encouraging observations from Erasmus MC Cancer Institute, including favorable safety findings, progression-free and overall survival trends, and consistently reported high quality of life among treated patients.
Strengthened the Company’s balance sheet through multiple financing transactions, providing additional resources to support continued clinical execution.
Successfully regained full compliance with NYSE American’s continued listing standards.
Planning government-focused initiatives to evaluate Ampligen’s antiviral potential against Ebola virus disease, consistent with the Company’s strategy of pursuing non-dilutive funding opportunities for select infectious disease programs while maintaining pancreatic cancer as its primary strategic focus.
For more information, please visit the Company’s website at aimimmuno.com.

Summary of Financial Highlights for Second Quarter 2026

As of June 30, 2026, AIM reported $9.9 million in cash and cash equivalents, as compared to approximately $3.0 million as of December 31, 2025.
Research and development expenses for the three months ended June 30, 2026 were approximately $589,000, compared to $1.2 million during the same period in 2025.
General and administrative expenses were approximately $2.9 million for the second quarter of 2026, compared to $1.5 million during the same period in 2025.
Net loss for the three months ended June 30, 2026 was approximately $(3.8 million), or $(0.43) per share, compared to $(2.8 million), or $(3.68) per share, for the second quarter of 2025.
The Company believes its strengthened financial position supports continued execution of its clinical development strategy and key upcoming milestones. Please refer to the Company’s Form 10-Q for the quarter ended June 30, 2026, for complete financial results and additional disclosures.

(Press release, AIM ImmunoTech, AUG 10, 2026, View Source [SID1234669899])