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.

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"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])

On August 10, 2026 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported financial and operating results for the second quarter ended June 30, 2026.

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"Our commitment to transforming the metastatic breast cancer treatment paradigm remains resolute as we continue to advance palazestrant as a potentially differentiated endocrine therapy across multiple regimens. Importantly, enrollment in our pivotal OPERA-01 Phase 3 trial is complete and we now expect to report top-line data in the first quarter of 2027," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Beyond palazestrant, we made significant progress with OP-3136, our novel KAT6 inhibitor. The initial monotherapy Phase 1 data, presented at ASCO (Free ASCO Whitepaper), demonstrated that OP-3136 was well-tolerated and showed evidence of anti-tumor activity across multiple dose levels and various tumor types. These data, taken together with our first clinical collaboration for OP-3136, established with Bayer to evaluate OP-3136 in combination with darolutamide in metastatic castration-resistant prostate cancer, reinforce our confidence in its potential as a best-in-class, differentiated option for patients with advanced solid tumors."

Bohen continued, "Supported by a strong balance sheet, we are intently focused on execution in the second half of the year as we ramp preparations for our first potential commercial launch of palazestrant as a monotherapy, work to establish palazestrant as a potential combination agent of choice in breast cancer, and continue our transformation into a fully integrated oncology company."

Recent Progress

Completed enrollment in the pivotal Phase 3 OPERA-01 trial of palazestrant as a monotherapy in patients with second or third-line estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC).
Presented initial Phase 1 clinical data for OP-3136 as a monotherapy in multiple solid tumor types and a trial-in-progress poster for the pivotal Phase 3 OPERA-02 trial evaluating palazestrant in combination with ribociclib in frontline ER+/HER2- MBC at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Announced a clinical trial collaboration and supply agreement with Bayer to evaluate OP-3136 in combination with darolutamide, Bayer’s androgen receptor inhibitor, in patients with metastatic castration-resistant prostate cancer (mCRPC).
Completed enrollment in the Phase 1b/2 study of palazestrant in combination with atirmociclib in ER+/HER2- MBC.
Advanced enrollment in the pivotal Phase 3 OPERA-02 trial and the Phase 1 study of OP-3136 as a monotherapy and in combination with fulvestrant and palazestrant in ER+/HER2- MBC.
Anticipated Upcoming Events

Initiate enrollment in the Phase 1b/2 study evaluating OP-3136 in combination with darolutamide in mCRPC in collaboration with Bayer in the fourth quarter of 2026.
Report top-line data from the pivotal Phase 3 OPERA-01 trial in the first quarter of 2027.
Second Quarter 2026 Financial Results
Cash, cash equivalents, and marketable securities as of June 30, 2026, were $461.1 million.

Net loss for the quarter ended June 30, 2026 was $63.2 million, as compared to $43.8 million for the quarter ended June 30, 2025. The increase in net loss for the second quarter was related to higher spending on clinical development and research and corporate-related activities related to late-stage clinical trials for palazestrant and the advancement of OP-3136.

GAAP research and development (R&D) expenses were $57.8 million for the quarter ended June 30, 2026, as compared to $43.9 million for the quarter ended June 30, 2025. The increase in R&D expenses was primarily related to increased spending on clinical development-related activities as we continue to advance palazestrant through late-stage clinical trials and OP-3136 in early-stage clinical studies, and increased personnel-related costs to support expanding development activities, including an increase in non-cash stock-based compensation expense of $5.2 million, mainly due to higher grant prices in 2026 and higher headcount. These increases were partially offset by the $10.0 million milestone expense related to the Aurigene agreement that was recognized in the same period in 2025.

Non-GAAP R&D expenses were $48.9 million for the quarter ended June 30, 2026, excluding $8.9 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $40.2 million for the quarter ended June 30, 2025, excluding $3.7 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

GAAP G&A expenses were $9.4 million for the quarter ended June 30, 2026, as compared to $4.0 million for the quarter ended June 30, 2025. The increase in G&A expenses was primarily due to higher corporate-related costs that reflect continued investment in personnel and corporate infrastructure to support our expanding late-stage clinical development activities and anticipated future commercial operations, including an increase in non-cash stock-based compensation expense of $3.0 million, mainly due to higher grant prices in 2026, and an increase in professional fees of $1.8 million.

Non-GAAP G&A expenses were $5.4 million for the quarter ended June 30, 2026, excluding $4.0 million non-cash stock-based compensation expense. Non-GAAP G&A expenses were $3.0 million for the quarter ended June 30, 2025, excluding $1.0 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

(Press release, Olema Oncology, AUG 10, 2026, View Source [SID1234669919])

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.

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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])

On August 10, 2026 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on August 7, 2026, regarding its New Drug Application (NDA) for 177Lu-edotreotide (ITM-11), an investigational agent for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

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The CRL stated that the FDA is unable to approve the NDA in its present form and cited CMC- and third-party commercial facility-related items that must be addressed before the application can be approved.

The FDA did not identify any concerns regarding the clinical or nonclinical data package or safety profile of ITM-11. ITM is reviewing the agency’s feedback and assessing the appropriate next steps with the relevant external parties.

The Company remains confident in the potential of ITM-11 and is reviewing the FDA’s feedback to determine the most appropriate path forward. The Company intends to resubmit to complete the review of the NDA.

"Our confidence in ITM-11’s therapeutic potential has not wavered, and we are committed to working closely with the FDA and our partners to address the items outlined in the CRL," said Dr. Andrew Cavey, chief executive officer of ITM. "Our pivotal COMPETE trial data package stands, and our goal remains unchanged as we work toward bringing ITM-11 to patients living with advanced GEP-NETs."

About the COMPETE Trial
The COMPETE trial (NCT03049189) evaluated 177Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with 177Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. 177Lu-edotreotide is an investigational product and is not approved by any regulatory authority for the safety and/or efficacy of any intended use. It is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, somatostatin receptor (SSTR)-positive GEP-NETs.

(Press release, ITM Isotopen Technologien Munchen, AUG 10, 2026, View Source [SID1234669920])

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.

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"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])