On August 8, 2025 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, reported financial results for the second quarter ended June 30, 2025 (Press release, Y-mAbs Therapeutics, AUG 8, 2025, View Source [SID1234655041]).

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Recent Transaction Announcement with SERB

● On August 5, 2025, Y-mAbs announced it has entered into a definitive agreement with affiliated entities of SERB Pharmaceuticals ("SERB"), under which SERB, a global specialty pharmaceutical company, agreed to acquire Y-mAbs in a transaction at an equity value of $412.0 million. The transaction was unanimously approved by the Y-mAbs Board of Directors. Under the terms of the merger agreement, SERB is obligated to commence a tender offer by August 19, 2025 to purchase all outstanding shares of Y-mAbs for $8.60 per share in cash, representing a 105% premium to Y-mAbs’ closing share price on August 4, 2025, the last full trading day prior to the transaction announcement;
● The transaction is expected to close by the fourth quarter of 2025, assuming a majority of outstanding Y-mAbs shares are tendered into, and not withdrawn from, the tender offer, and subject to the satisfaction of customary conditions, including the receipt of a majority of Y-mAbs shares in the tender offer and expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

Financial Results

Revenues

Total revenues for the quarter ended June 30, 2025 were $19.5 million, which was a 14% decrease from the $22.8 million of total revenues for the quarter ended June 30, 2024, driven by a $2.9 million decrease in Ex-U.S. DANYELZA net product revenues and a $0.9 million decrease in U.S. DANYELZA net product revenues, partially offset by a $0.5 million increase related to license revenue recognized in the three months ended June 30, 2025. Total DANYELZA net product revenues for the quarter ended June 30, 2025 were $19.0 million, which was a 17% decrease over $22.8 million total DANYELZA net product revenues for the quarter ended June 30, 2024.

Total revenues for the six months ended June 30, 2025 were $40.4 million, which was a 5% decrease from the $42.7 million of total revenues for the six months ended June 30, 2024, driven by a $6.1 million decrease in U.S DANYELZA net product revenues, partially offset by a $3.8 million increase in Ex-U.S. DANYELZA net product revenues. The total revenues in the six months ended June 30, 2025 and 2024 include $0.5 million license revenue, respectively.

The Company’s U.S. DANYELZA net product revenues for the quarter ended June 30, 2025 were $14.3 million, representing a decrease of 6% from the same period in 2024. The decline in the U.S. DANYELZA net product revenues was driven by declining patient volume due to enrollments in clinical studies and competition in the three months ended June 30, 2025.

The Company’s Ex-U.S. DANYELZA net product revenues for the quarter ended June 30, 2025 were $4.7 million, representing a decrease of $2.9 million from the same period in 2024. Ex-U.S. DANYELZA net product revenues include $2.1 million from Western Europe and $3.4 million from Eastern Asia for the three months ended June 30, 2024, which was a result of stocking orders from Western Europe and Eastern Asia in 2024. The Company did not have any stocking orders from Western Europe or Eastern Asia in the three months ended June 30, 2025. The decrease in Ex-U.S. DANYELZA net product revenues was partially offset by a $2.0 million increase in DANYELZA net product revenues in Western Asia, where a named patient program launched in Turkey in late 2024.

During the three and six months ended June 30, 2025, the Company recognized $0.5 million license revenue, which was earned in prior periods, in connection with sales-based milestone achievements by our partner in Israel. There was no license revenue in the three months ended June 30, 2024. During the six months ended June 30, 2024, the Company had license revenues of $0.5 million, which included license revenue from the Latin America distribution partner, Adium, related to price approval for DANYELZA in Brazil from the Brazilian Medicines Market Regulation Chamber.

Cost of Goods Sold

Cost of goods sold was $2.7 million and $3.0 million for the three months ended June 30, 2025 and 2024, respectively. The decrease in cost of goods sold in the three months ended June 30, 2025 compared to the same period in 2024 was primarily driven by decreased sales.

Cost of goods sold was $5.7 million and $5.1 million for the six months ended June 30, 2025 and 2024, respectively. The increase in cost of goods sold in the six months ended June 30, 2025 compared to the same period in 2024 was primarily driven by increased cost of production.

Gross Profit

Gross profit stayed consistent at $16.8 million and $19.8 million for the three months ended June 30, 2025 and 2024, respectively. Gross margins were relatively flat at 86% and 87% for the three months ended June 30, 2025 and 2024, respectively.

Gross profit was $34.8 million and $37.6 million for the six months ended June 30, 2025 and 2024, respectively. Gross margins were 86% and 88% for the six months ended June 30, 2025 and 2024, respectively. The gross margin decreased primarily due to increased cost of production and lower product sales to Western Europe, where product sales generally have higher gross margin.

Operating Costs and Expenses

Research and Development

Research and development expenses were $11.1 million and $12.3 million for the three months ended June 30, 2025 and 2024, respectively. The $1.2 million decrease in research and development expenses was primarily driven by a decrease of $0.9 million in personnel and stock-based compensation costs which was primarily related to our business realignment announced in January 2025.

Research and development expenses were $22.5 million and $25.6 million for the six months ended June 30, 2025 and 2024, respectively. The $3.1 million decrease in research and development expenses was primarily driven by a $1.8 million decrease in personnel and stock-based compensation costs, which was primarily related to our business realignment announced in January 2025, and a total $0.4 million decrease in clinical trials and outsourced research and supplies due to the timing of completion in our GD2-SADA program and investment in our ongoing SADA PRIT programs.

Selling, General, and Administrative

Selling, general, and administrative expenses were $11.3 million and $17.2 million for the three months ended June 30, 2025 and 2024, respectively. The $5.9 million decrease in selling, general and administrative expenses was primarily attributable to a net impact of $3.8 million related to litigation settlements during the three months ended June 30, 2024 and a $1.7 million decrease in legal expenses.

Selling, general, and administrative expenses were $24.4 million and $28.7 million for the six months ended June 30, 2025 and 2024, respectively. The $4.3 million decrease in selling, general, and administrative expenses was primarily attributable to a net impact of $3.8 million related to litigation settlements in the six months ended June 30, 2024, as noted above.

Interest and Other Income

Interest and other income were $2.3 million and $0.6 million for the three months ended June 30, 2025 and 2024, respectively. Interest and other income increased by $1.7 million primarily due to $2.0 million of foreign currency transaction gains in the three months ended June 30, 2025, partially offset by a $0.3 million decrease in interest earned on cash and cash equivalents.

Interest and other income were $3.7 million and $1.1 million for the six months ended June 30, 2025 and 2024, respectively. Interest and other income increased by $2.6 million primarily due to $3.3 million of foreign currency transaction gains, partially offset by a $0.7 million decrease in interest earned on cash and cash equivalents.

Net Loss

Y-mAbs reported a net loss for the quarter ended June 30, 2025, of $3.2 million, or ($0.07) per basic and diluted share, compared to a net loss of $9.2 million, or ($0.21) per basic and diluted share, for the quarter ended June 30, 2024. The decrease in net loss for the quarter ended June 30, 2025 was primarily driven by the above noted $3.8 million in litigation settlements in the quarter end June 30, 2024 and the favorable impact of $2.0 million of foreign currency transaction gains in the quarter ended June 30, 2025.

Cash and Cash Equivalents

As of June 30, 2025, Y-mAbs had approximately $62.3 million in cash and cash equivalents. The Company continues its efforts to be capital efficient in its operations.

In light of the pending transaction, Y-mAbs will not be holding a webcast and conference call to discuss its second quarter 2025 results.

On August 8, 2025 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a clinical-stage precision oncology company, reported financial results for the second quarter ended June 30, 2025 (Press release, Repare Therapeutics, AUG 8, 2025, View Source [SID1234655040]).

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"We remain focused on exploring strategic alternatives and partnerships across our portfolio to enhance long-term shareholder value, as exemplified by our recent worldwide licensing agreement with Debiopharm for lunresertib and out-licensing of early-stage discovery platforms to DCx," said Steve Forte, President, Chief Executive Officer and Chief Financial Officer of Repare. "In parallel to evaluating these strategic opportunities for our remaining programs, we expect to deliver initial data from the LIONS and POLAR trials in the fourth quarter."

Second Quarter 2025 and Recent Portfolio Highlights:

•
Entered into a worldwide licensing agreement with Debiopharm for lunresertib
o
In July 2025, Repare entered into an exclusive worldwide licensing agreement with Debiopharm International S.A. ("Debiopharm") for lunresertib, a first-in-class precision oncology PKMYT1 inhibitor. Under the terms of the agreement, Repare will receive a $10 million upfront payment, and is eligible to receive up to $257 million in potential clinical, regulatory, commercial and sales milestones, including up to $5 million in potential near-term payments, and single-digit royalties on global net sales. This agreement builds on the success of Repare and Debiopharm’s clinical study and collaboration agreement to explore the synergy between lunresertib and Debio 0123, a potential best-in-class, brain penetrant and highly selective WEE1 inhibitor. Debiopharm will assume sponsorship of the MYTHIC study and take over existing and future development activities related to lunresertib.

•
Announced out-licensing of its discovery platforms to DCx Biotherapeutics
o
In May 2025, Repare out-licensed its early-stage discovery platforms, including certain platform and program intellectual property, to DCx Biotherapeutics Corporation ("DCx"), a newly-launched Canadian biotechnology company developing next generation precision drug conjugates supported by Amplitude Ventures. In connection with this agreement, Repare received a $1 million upfront payment and is expected to receive $3 million in near-term payments. In addition, Repare received a 9.99% equity position in DCx, including certain dilution protection rights, and is eligible to receive potential future out-licensing, clinical and commercial milestone payments, as well as low single-digit sales royalties for the development of certain products by DCx. In connection with this transaction, Repare recognized a $5.7 million gain during the quarter.
•
RP-3467: Potential best-in-class, oral Polθ ATPase/helicase inhibitor
o
Repare is conducting a Phase 1 clinical trial of RP-3467 (POLAR), dosing patients alone and in combination with the poly-ADP ribose polymerase (PARP) inhibitor, olaparib. POLAR is a multicenter, open-label, dose-escalation Phase 1 clinical trial designed to investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RP-3647 alone or in combination with olaparib in adults with locally advanced or metastatic epithelial ovarian cancer, metastatic breast cancer, metastatic castration-resistant prostate cancer, or pancreatic adenocarcinoma.
o
Upcoming expected milestone:
•
Q4 2025: Topline safety, tolerability and early efficacy data from the POLAR trial in monotherapy and in combination with olaparib.
•
RP-1664: First-in-class, oral selective PLK4 Inhibitor
o
Repare completed enrolment of 29 patients in its Phase 1 LIONS clinical trial, evaluating RP-1664 as a monotherapy in adult and adolescent patients with TRIM37-high solid tumors. LIONS is a first-in-human, multicenter, open-label Phase 1 clinical trial designed to investigate safety, pharmacokinetics, pharmacodynamics and the preliminary efficacy of RP-1664.
o
Upcoming expected milestone:
•
Q4 2025: Initial topline safety, tolerability and early efficacy data from the LIONS trial.
•
Amended our collaboration and license agreement with Bristol-Myers Squibb Company to include an additional druggable target in the collaboration
o
Repare recognized $0.3 million during the quarter as revenue related to druggable targets, reflecting this option fee payment.
•
Exploring strategic alternatives to maximize shareholder value
o
Repare continues to actively explore strategic alternatives, partnerships and sale opportunities across its portfolio to maximize shareholder value.

Second Quarter 2025 Financial Results

•
Cash, cash equivalents and marketable securities: Cash, cash equivalents and marketable securities as of June 30, 2025 were $109.5 million.
•
Revenue from collaboration agreements: Revenue from collaboration agreements were $0.3 million for the three and six months ended June 30, 2025, respectively, as compared to $1.1 million and $53.5 million for three and six months ended June 30, 2024.
•
Research and development expense, net of tax credits (Net R&D): Net R&D expenses were $14.3 million and $34.6 million for the three and six months ended June 30, 2025, respectively, as compared to $30.1 million and $63.1 for the three and six months ended June 30, 2024.
•
General and administrative (G&D) expenses: G&A expenses were $6.0 million and $13.7 million for the three and six months ended June 30, 2025, respectively, compared to $8.3 million and $16.9 million for the three and six months ended June 30, 2024.
•
Net loss: Net loss was $16.7 million, or $0.39 per share, and $46.8 million, or $1.09 per share, in the three and six months ended June 30, 2025, respectively, compared to $34.8 million, or $0.82 per share, and $21.6 million, or $0.51 per share, in the three and six months ended June 30, 2024, respectively.

On August 8, 2025 Oncolytics Biotech Inc. (Nasdaq: ONCY) (TSX: ONC) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported financial results and recent highlights for the second quarter of 2025. All dollar amounts are expressed in Canadian currency unless otherwise noted (Press release, Oncolytics Biotech, AUG 8, 2025, View Source [SID1234655039]).

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"We have turned the corner from proof-of-concept studies and will be sprinting toward regulatory clarity for the remainder of the year," said Jared Kelly, Chief Executive Officer of Oncolytics. "As we shore up our intellectual property, get a clear registration path for pelareorep, and allow our GOBLET data to mature, we will establish our position as the only platform immunotherapy in gastrointestinal tumors."

Second Quarter and Subsequent Highlights

Poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting features translational data further demonstrating pelareorep’s mechanism of action. Additional analyses of the combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab in first-line ("1L") metastatic pancreatic ductal adenocarcinoma ("mPDAC") patients enhance the understanding of pelareorep’s ability to stimulate the immune system and enable treatment regimens to be effective in a traditionally hostile tumor microenvironment (click here for the PR, click here for the poster). Pelareorep expands reovirus-specific T cells, increases cytokines and chemokines, and increases tumor-infiltrating lymphocytes ("TILs") in the blood.

New Chief Executive Officer Jared Kelly and Chief Business Officer Andrew Aromando hired to optimize pelareorep’s development path. Both are experienced biotech executives with decades of experience advising companies, advancing clinical programs, and navigating successful transactions. They were both instrumental in guiding the sale of Ambrx Biopharma to Johnson & Johnson.

Analyses of clinical data show pelareorep’s ability to improve survival, and translational data confirming how the intended benefits are achieved. Recently highlighted survival data in mPDAC and breast cancer point to meaningful survival benefits for patients treated with pelareorep-based regimens compared to either control arms or historical data (click here for the PR). In 1L mPDAC, a review of landmark studies shows a historical benchmark of 9.2% two-year survival for chemotherapy regimens, in contrast to the 21.9% two-year survival rate recorded for 100 patients receiving pelareorep and chemotherapy. Translational data from multiple studies and tumor types provide evidence as to how these impressive results have been achieved (click here for the PR). In the GOBLET and AWARE-1 studies, pelareorep converted immunologically "cold" tumors to "hot" ones as a result of the upregulation of interferons, CXCL9/10/11, and PD-L1 in addition to the expansion and mobilization of TILs in the blood, which is correlated with a reduction in tumor size.

Key Opinion Leader ("KOL") webinar discussion solidifies pelareorep’s opportunity in mPDAC and other gastrointestinal cancers. Presentations from KOLs and a roundtable discussion of pelareorep’s clinical data in mPDAC and gastrointestinal cancers point to a potentially significant opportunity for an immunotherapeutic drug candidate that already has shown the ability to extend survival for patients (click here for the PR). Specifically, 1L mPDAC would be ideal for pelareorep as there are no immunotherapies approved for that line of treatment, multiple 1L studies have already demonstrated pelareorep’s ability to improve survival in that patient population, and it is backed up by translational data showing the ability to activate the immune system and alter the tumor microenvironment so it is more amenable to therapeutic intervention.

Strategic decision to pursue registration-enabling pivotal study for pelareorep in 1L mPDAC. Discussions with regulators are underway to finalize the approval pathway for pelareorep in 1L mPDAC (click here for the PR). This includes decisions on which treatment regimens will be involved, whether to collaborate with a third party on the study, and formalizing overall survival as the primary endpoint. The prioritization of the pancreatic cancer program is based on the compelling survival and translational data from previous studies involving over 100 patients, and the particularly high unmet medical need in this indication. Pelareorep has already received Fast Track and Orphan Drug designation from the U.S. Food and Drug Administration (the "FDA") for mPDAC. If discussions with regulators proceed as expected and the feedback is positive, start-up activities for the study are expected to commence as early as Q4 2025.

Commitment to limiting dilutive financing and maximizing shareholder value. Oncolytics intends to terminate its At-the-Market financing facility with Cantor Fitzgerald and Equity Line of Credit with Alumni Capital. The Company believes it has sufficient capital to reach critical regulatory and clinical milestones this fall and pursue strategic opportunities that demonstrate pelareorep’s potential without the need for near-term dilutive financings at this time. Additionally, as separately announced, the Company has given formal notice to delist from the Toronto Stock Exchange (the "TSX"). Once delisted from the TSX, the Company’s common shares will continue to trade under the symbol "ONCY" on the Nasdaq.

Financial Highlights

•As of June 30, 2025, the Company reported $14.6 million in cash and cash equivalents, projecting a cash runway through key milestones and into the first quarter of 2026.

•The net loss for the second quarter of 2025 was $6.2 million, compared to a net loss of $7.3 million for the second quarter of 2024. The basic and diluted loss per share was $0.07 in the second quarter of 2025, compared to a basic and diluted loss per share of $0.10 in the second quarter of 2024.

•Research and development ("R&D") expenses for the second quarter of 2025 were $2.8 million, compared to $4.6 million for the second quarter of 2024. The decrease was primarily attributable to lower clinical trial expenses as the Company focused its R&D efforts on Cohort 5 of the GOBLET study, which is supported by the Pancreatic Cancer Action Network ("PanCAN") Therapeutic Accelerator Award.

•General and administrative expenses for the second quarter of 2025 were $2.9 million, compared to $3.4 million for the second quarter of 2024. The decrease was primarily due to lower public company-related expenses, and partially offset by higher personnel-related expenses associated with changes to the management team.

•Net cash used in operating activities for the six months ended June 30, 2025, was $12.0 million, compared to $14.3 million for the six months ended June 30, 2024. The decrease reflected lower operating activities in 2025, partially offset by higher non-cash working capital changes.

Anticipated Milestones

•Q3 2025: Provide an updated clinical timeline for the registration-enabling pivotal study for pelareorep in 1L mPDAC.
•As early as Q4 2025: Initiate start-up activities for the registration-enabling study for pelareorep in 1L mPDAC.
•End of 2025: Updated clinical data regarding safety and efficacy in Cohort 4 of the GOBLET study investigating pelareorep combined with atezolizumab in anal carcinoma.
•Q4 2025: Initial responses from the U.S. Patent and Trademark Office ("PTO") regarding the company’s application to extend patent protection for pelareorep.

Annual General Meeting and Conference Call Change

Management is hosting the Annual General Meeting later today at 10:00 a.m. ET, August 8, 2025. Oncolytics’ Chief Executive Officer, Jared Kelly, will provide a brief update after the formal portion of the meeting. To access the meeting as a guest (i.e., a non-voting shareholder):
•Visit the webcast site: https://virtual-meetings.tsxtrust.com/en/1824/
•Click the button "I am a Guest" and complete the form
•If necessary, provide the case-sensitive password: onc2025

Information on how to vote your shares by proxy and attend the meeting as a shareholder is available in the Company’s most recent Management Information Circular (the "Circular") dated June 18, 2025. The Circular is available on the Reports page of the investor relations section of the Company’s website at View Source and in Canadian and American securities filings.

Going forward, Oncolytics will continue to announce quarterly financial results via press releases and in securities filings, but will no longer host quarterly conference calls with the management team.

On August 8, 2025 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, 2025 and recent corporate updates (Press release, Heron Therapeutics, AUG 8, 2025, View Source [SID1234655038]).

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"As today’s release demonstrates, we enter the third quarter with strong momentum and a clear focus on accelerating the expansion of our core products," said Craig Collard, Chief Executive Officer of Heron. "Our performance reflects the dedication of our team and the growing demand for innovative solutions that address critical patient needs. We remain committed to executing our strategic priorities, driving sustainable growth, and delivering long-term value to our stakeholders."

Financial Guidance for 2025

Item

2025 Full-Year Guidance for Net Revenue and Adjusted EBITDA (in millions)

Original

Q1 Updated Guidance

Q2 Updated Guidance

Net Revenue

$153.0 to $163.0

Adjusted EBITDA

$0 – $8.0

$4.0 – $12.0

$9.0 – $13.0

Business Highlights

Heron’s Acute Care franchise delivered revenue growth of 55.5% year-over-year in Q2 2025 and 70.5% year-over-year for the first half of 2025, reflecting continued commercial execution and expanding adoption across the portfolio.
ZYNRELEF Updates:
ZYNRELEF unit demand grew 6.3% in Q2 as compared to Q1 2025, as momentum builds ahead of expanded commercial pull-through initiatives planned for the second half of the year.
Commercial initiatives include launch of a reorganized, dedicated ZYNRELEF sales team in Q3 2025, and enhanced distributor incentives in select accounts – including both formulary and high potential non formulary accounts – to drive growth and accelerate adoption.
Transition to the Vial Access Needle ("VAN") will be completed in Q3 2025, optimizing product preparation, handling and operating field sterility with ZYNRELEF in hospitals and ambulatory surgical centers across U.S.
The Centers for Medicare and Medicaid Services ("CMS") has granted a permanent, product specific J-code for ZYNRELEF, effective October 1, 2025, streamlining reimbursement and improving billing clarity for both CMS and commercial payers in both hospital and ambulatory surgical center settings.
APONVIE Updates:
APONVIE unit demand increased 19% in Q2 as compared to Q1 2025, reflecting strong growth and setting the stage for further expansion.
As of July 1, a dedicated sales team is now focused exclusively on promoting APONVIE, leveraging recent access wins that collectively represent approximately 4 million of the approximately 35 million annual surgical patients at moderate to high risk for postoperative nausea and vomiting in the U.S.
Cash, cash equivalents, and short-term investments were $40.6 million as of June 30, 2025.
Net Revenue Performance – Three Months Ended June 30 (in thousands)

2025

2024

Dollar Change

Percentage Change

Acute Care

$ 10,653

$ 6,851

$ 3,802

55.5 %

APONVIE

$ 2,464

$ 1,020

$ 1,444

141.6 %

ZYNRELEF

$ 8,189

$ 5,831

$ 2,358

40.4 %

Oncology

$ 26,547

$ 29,173

$ (2,626)

(9.0 %)

CINVANTI

$ 24,143

$ 24,927

$ (784)

(3.1 %)

SUSTOL

$ 2,404

$ 4,246

$ (1,842)

(43.4 %)

Total Net Revenue

$ 37,200

$ 36,024

$ 1,176

3.3 %

Net Revenue Performance – Six Months Ended June 30 (in thousands)

2025

2024

Dollar Change

Percentage Change

Acute Care

$ 20,954

$ 12,290

$ 8,664

70.5 %

APONVIE

$ 4,724

$ 1,446

$ 3,278

226.7 %

ZYNRELEF

$ 16,230

$ 10,844

$ 5,386

49.7 %

Oncology

$ 55,149

$ 58,404

$ (3,255)

(5.6 %)

CINVANTI

$ 49,886

$ 50,544

$ (658)

(1.3 %)

SUSTOL

$ 5,263

$ 7,860

$ (2,597)

(33.0 %)

Total Net Revenue

$ 76,103

$ 70,694

$ 5,409

7.7 %

Conference Call and Webcast

Heron will host a conference call and live webcast on Friday, August 8, 2025, 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. An archive of the teleconference and webcast 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.

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

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.

On August 8, 2025 Exicure, Inc. (Nasdaq: XCUR, the "Company") reported the following financial results for the fiscal quarter ended June 30, 2025 (Press release, Exicure, AUG 8, 2025, View Source [SID1234655037]).

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Second Quarter 2025 Financial Results

Cash Position: Cash and cash equivalents were $7.9 million as of June 30, 2025, as compared to $12.5 million as of December 31, 2024.

Research and Development (R&D) Expense: Research and development expenses were $0.9 million for the quarter ended June 30, 2025, as compared to $0 for the quarter ended June 30, 2024. The increase in R&D expense of $0.9 million for the three months ended June 30, 2025 was due to incurring research and development expenses in 2025 after the acquisition of GPCR Therapeutics USA Inc. ("GPCR USA"), which is conducting research. Immediately prior to closing the acquisition of GPCR USA, the Company recorded no research or development expenses.

General and Administrative (G&A) Expense: General and administrative expenses were $1.5 million for the quarter ended June 30, 2025, as compared to $1.2 million for the quarter ended June 30, 2024. The increase in G&A expense of $0.3 million for the three months ended June 30, 2025 was mostly due to the additional expenses incurred from the acquisition of GPCR USA and increased professional services compared to the same prior year quarter.

Loss from sale or disposal of property and equipment: The Company recognized a $60,000 loss from GPCR USA’s sale of fixed assets.

Other Income and Expense: The Company recognized a loss of $159,000 related to the change in the fair value of its contingent liability.

Net Income (Loss): The Company had a net loss of $2.6 million for the quarter ended June 30, 2025, as compared to a net loss of $0.6 million for the quarter ended June 30, 2024. The increase in net loss of $2 million was primarily due to the increased operating expenses from the acquisition of GPCR USA.

Going Concern: Management believes that the Company’s existing cash and cash equivalents is not sufficient to continue to fund operations. The Company has already engaged in significant cost reductions, and our ability to further cut costs and extend the Company’s operating runway is limited. As a result, substantial additional financing is needed in the short term to pay expenses, fund the ongoing exploration of strategic alternatives and pursue any alternatives that may be identified. The Company also needs to raise capital to fund its operations. There can be no assurance that such additional financing will be available and, if available, can be obtained on acceptable terms.