On August 14, 2023 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease ("PD"), Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, reported financial results for the second quarter ended June 30, 2023 and highlighted recent developments (Press release, Inhibikase Therapeutics, AUG 14, 2023, View Source [SID1234634370]).

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!

"We have made significant clinical progress in the first half of 2023," said Dr. Milton H. Werner, President and Chief Executive Officer of Inhibikase. "Our Phase 2 ‘201’ trial of IkT-148009 for the treatment for Parkinson’s disease is progressing, with screening ongoing at 22 sites and up to 32 sites expected to be open and screening by close of the third quarter. Patients are enrolling and the first patient has completed 12 weeks dosing as of the date of this release. Our newly launched patient portal provides a central hub for patient engagement with our clinical sites, allows patients to test their suitability for participation in the study and acts as a launching point for engagement with community neurologists, caregivers and support groups. The ‘501’ trial evaluating IkT-001Pro, our imatinib prodrug, has also reached important milestones, including the completion of the pivotal trial phase to confirm the bioequivalent dose. Following discussions with the FDA, we are considering the addition of a high dose bioequivalence cohort between IkT-001Pro and 600 mg imatinib to further substantiate the safety benefit of imatinib delivered as prodrug. As we look ahead, our focus remains on execution in our clinical programs, and we expect to provide additional updates as enrollment progresses in our ‘201’ trial later this year and a full data description from the ‘501’ trial."

Recent Developments and Upcoming Milestones:

The Phase 2 ‘201’ clinical trial of IkT-148009 is screening and enrolling patients: 22 of 35 planned clinical sites are screening and enrolling patients, with the first patient having completed the 12 week dosing regimen. Up to 32 clinical sites are anticipated to be open for enrollment and screening patients by close of the third quarter. Additionally, the Company has launched a medical and patient awareness campaign to advance the pace of enrollment in the trial as well as provide patients with a central hub to learn about the trial through www.the201trial.com.
Completed bioequivalence phase of the ‘501’ trial of IkT-001Pro: In June 2023, Inhibikase completed the pivotal phase of the ‘501’ trial and selected a bioequivalent dose of IkT-001Pro. The Company expects to report data in the near term. With agreement on trial design finalized with the FDA, Inhibikase is considering to expand the 501 trial to evaluate the potential safety benefit of high dose imatinib delivered by IkT-001Pro in the third quarter.
Advancing preclinical development of IkT-148009 in MSA: Two models have been evaluated, one that measures the ability of IkT-148009 to block progression early in the course of disease, and a second that evaluates the ability to correct functional loss and neurodegeneration late in the course of disease. The Company has nearly completed the evaluation of the first model, which showed that IkT-148009 dosed once daily for 20 weeks blocked functional loss and preserved neural anatomy when IkT-148009 administration occurred early in the course of disease. Prevention of functional loss in this model was accompanied by significant reduction of the underlying alpha-synuclein pathology. Outcomes from the study of IkT-148009 when treatment begins late in the course of disease is expected to be completed by the end of 2023.
Regained Compliance with Nasdaq Listing Requirements: In June 2023, the Company effected a 1-for-6 reverse stock split of its common stock. The reverse split was approved by Inhibikase shareholders and came into effect on June 30, 2023. The reverse stock split and subsequent trading performance resulted in restoration of full compliance with the minimum bid price requirement of $1.00 per share under Nasdaq Listing Rule 5550(a)(2); the Company is in compliance with all other applicable listing standards.
Second Quarter Financial Results

Net Loss: Net loss for the quarter ended June 30, 2023 was $5.8 million, or $1.11 per share, compared to a net loss of $4.6 million, or $1.10 per share in the quarter ended June 30, 2022.

R&D Expenses: Research and development expenses were $4.5 million for the quarter ended June 30, 2023 compared to $3.0 million in the quarter ended June 30 2022. The increase was primarily due to the Company’s ongoing Phase 2 ‘201’ PD clinical trial costs.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended June 30, 2023 were $1.8 million compared to $1.7 million for the quarter ended June 30, 2022. The increase was driven by a net increase in normal selling, general and administrative expenses.

Cash Position: Cash and cash equivalents and marketable securities were $20.9 million as of June 30, 2023. The Company expects that existing cash and cash equivalents will be sufficient to fund operations into the fourth quarter of 2024.

Conference Call Information

The conference call can be accessed by dialing 1-833-816-1414 (United States) or 1-412-317-0506 (International) with the conference code 7774190. A live webcast may be accessed using the link here, or by visiting the investors section of the Company’s website at www.inhibikase.com. After the live webcast, the event will be archived on Inhibikase’s website for approximately 90 days after the call.

On August 14, 2023 Alaunos Therapeutics, Inc. ("Alaunos" or the "Company") (Nasdaq: TCRT), reported financial results for the second quarter ended June 30, 2023 (Press release, Alaunos Therapeutics, AUG 14, 2023, View Source [SID1234634369]). The Company also announced a strategic reprioritization to focus on its hunTR TCR discovery platform, wind down its TCR-T Phase 1/2 Library trial and explore broad strategic alternatives for the Company. Alaunos is implementing a cost-savings plan that includes a reduction in workforce by approximately 60%.

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!

"Over the past two years, we have advanced the medical field’s understanding of TCR-T cell therapies using our innovative Sleeping Beauty technology targeting high-frequency driver mutations," said Kevin S. Boyle, Sr., Chief Executive Officer of Alaunos. "We continue to believe that this approach has potential in targeting the heart of cancer growth. However, after a review of the funding needs of our TCR-T Library Phase 1/2 trial and the current financial markets, the Board of Directors has made the difficult decision to limit further drug development under our clinical trial and to focus on our promising hunTR TCR discovery platform as we explore all strategic alternatives."

Operational & Corporate Update

Interim Clinical Data from TCR-T Library Phase 1/2 Trial: Eight patients have been treated in the Company’s TCR-T Library Phase 1/2 trial to date, six of which are evaluable as of today. The trial showed that the Company’s T-cells were generally well-tolerated in all evaluable participants and achieved an 83% disease control rate in evaluable patients with metastatic, refractory solid tumors. Disease control is measured by objective responses and stable disease. Persistence of TCR-T cells in peripheral blood was detected in all evaluable patients at last follow-up.

hunTR TCR Discovery Platform Identifies Proprietary TCRs: Alaunos has discovered multiple proprietary TCRs targeting driver mutations through its hunTR TCR discovery platform. The hunTR platform can rapidly interrogate T-cell responses and has the potential to expand to multiple targets or cancer indications. Using hunTR, the Company has demonstrated the ability to isolate neoantigen specific TCRs from tumor resident T-cells. The presence of these driver mutation specific T-cells in the tumor potentially validates the relevance of the mutated target and safety of the TCR for use in other cancer patients expressing the same neoantigen.

Restructuring Organization and Winding Down TCR-T Library Phase 1/2 Trial: Alaunos has decided to wind down its TCR-T Library Phase 1/2 trial and prioritize the hunTR platform to explore potential partnering opportunities. Concurrently, the Company is exploring strategic alternatives and has engaged Cantor Fitzgerald & Co. to act as a strategic advisor for this process. Strategic options may include but are not limited to, an acquisition, merger, reverse merger, sale of assets, strategic partnerships, capital raises or other transactions. The Company will reduce its workforce by approximately 60% to streamline the organization, while retaining key R&D capabilities for the hunTR platform and to assist in the strategic alternatives review process. Alaunos does not intend to comment further on this process unless or until its Board of Directors has approved a definitive course of action or it is determined that other disclosure is appropriate.

Second Quarter Ended June 30, 2023, Financial Results

Research and Development Expenses: Research and development expenses were $5.2 million for the second quarter of 2023, compared to $5.9 million for the second quarter of 2022, a decrease of approximately 13%. The decrease was primarily due to an accrual adjustment related to one of our de-prioritized clinical programs of $0.7 million.

General and Administrative Expenses: General and administrative expenses were $3.0 million for the second quarter of 2023, compared to $3.4 million for the second quarter of 2022, a decrease of approximately 11%. The decrease was primarily due to lower employee-related expenses of $0.1 million due to our reduced headcount, a $0.1 million decrease in consulting and professional services related to lower legal fees and the reduced use of consultants, and a $0.2 million decrease in insurance fees.

Net Loss: Net loss was $8.8 million, or $(0.04) per share, for the second quarter of 2023, compared to a net loss of $9.9 million, or $(0.05) per share, for the second quarter in 2022.

Cash, Cash Equivalents and Restricted Cash: As of June 30, 2023, Alaunos had approximately $18.3 million in cash balances. The Company expects to have sufficient cash resources to fund operations into the fourth quarter of 2023, after implementing the strategic reprioritization laid out above.

On August 14, 2023 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), an AI-driven innovator of precision antibody immunotherapies, reported positive pre-clinical in vivo data for three immuno-oncology candidates, anti-EGFRvIII, CCR8 and a bispecific TROP-2 x CD3, advancing these programs to clinical candidate selection stage (Press release, iBioPharma, AUG 14, 2023, View Source [SID1234634368]).

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 anti-EGFRvIII antibody was specially engineered to enhance its ability to attack cancer cells and has proven effective in a mouse model for head and neck cancer. In preclinical studies, iBio’s anti-EGFRvIII antibody demonstrated a 43 percent reduction in tumor growth compared to untreated animals. iBio developed the antibody using its patented AI epitope steering technology. This innovative approach allows iBio to target a specific variant of the Epidermal Growth Factor Receptor (EGFR) found in tumors without affecting the normal version of the receptor present in healthy tissue. By focusing solely on the tumor-specific variant, iBio aims to reduce potential side effects.

In addition to the anti-EGFR program, iBio’s CCR8 antibody has proven effective in a mouse model for colon cancer. Preclinical studies show the anti-CCR8 molecule inhibited tumor growth and achieved a 22 percent reduction in tumor size compared to its pre-treatment dimensions. Using its patented AI epitope steering platform, iBio specifically engineered the anti-CCR8 molecule to enhance its ability to attack cancer cells without affecting its close relative, CCR4, even though their binding regions are highly similar. This selective targeting demonstrates the power of iBio’s epitope steering platform and is believed to minimize potential side effects.

In a recent study involving a humanized mouse model of squamous cell carcinoma, iBio’s TROP-2 x CD3 bi-specific antibody demonstrated a significant 36 percent reduction in tumor size within just 14 days after tumor implantation, and after only a single dose. iBio’s TROP-2 x CD3 was engineered using its proprietary EngageTx T-cell engager antibody platform, which represents a cutting-edge approach to developing next-generation bispecific antibodies for immuno-oncology applications. TROP-2 x CD3 is a bispecific antibody targeting an overexpressed cell surface protein in multiple solid tumors, including breast, lung, colorectal, and pancreatic cancers. iBio is currently exploring whether the molecule also shows efficacy in other solid tumors.

Dillon Phan, PhD, iBio’s VP and Head of Early R&D, commented, "The swift and concurrent achievement of in vivo proof-of-concept for three of our pre-clinical programs showcases the power of our AI-enabled technology and the relentless dedication and focus of our drug discovery team. The development of bispecific antibodies, such as TROP-2 x CD3, is particularly challenging, so we are especially pleased with the recent addition of the T-cell engager platform, EngageTx, to our tech stack, which has enabled the discovery and advancement of this candidate so quickly. We are excited about the potential to further develop and initiate IND-enabling studies for all three molecules to support the continued advancement of iBio’s therapeutic pre-clinical pipeline."

On August 14, 2023 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, reported financial results for the second quarter ended June 30, 2023, and provided an overview of recent business highlights (Press release, Cytori Therapeutics, AUG 14, 2023, View Source [SID1234634367]).

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 past 12 months have been transformative for the company," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "We now have two lead indications, recurrent glioblastoma and leptomeningeal metastases, for our rhenium (186Re) obisbemeda investigational drug and we plan to fully leverage available external third-party funding to move both clinical development programs through Phase 2 and evaluate accelerated approval opportunities."

Q2 HIGHLIGHTS AND MILESTONE ACHIEVEMENTS

Leptomeningeal Metastases

▪
Completed Phase 1/Part A of the ReSPECT-LM clinical trial.
▪
Presented preliminary safety and efficacy results from Phase 1/Part A of the ReSPECT-LM clinical trial at the Society for Neuro Oncology (SNO)/American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Central Nervous System (CNS) Cancer Conference.
▪
Received U.S. Food and Drug Administration (FDA) approval to move to Phase 1/Part B of the ReSPECT-LM clinical trial.
▪
In the second quarter of 2023, achieved all Year 1 goals and objectives set forth in the Company’s 3-Year, $17.6M Cancer Prevention & Research Institute of Texas (CPRIT) grant.
Recurrent Glioblastoma

▪
Presented clinical updates on the ReSPECT-GBM Phase 1 dose escalation and Phase 2b trials for recurrent glioblastoma (GBM) at the SNO/ ASCO (Free ASCO Whitepaper) CNS Cancer Conference.
▪
Announced topline results from our propensity matched, recurrent GBM external control analysis for comparative evaluation of outcomes in our prospective recurrent glioblastoma trials at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023.

Supply Chain

Expanded collaboration with Piramal Pharma Solutions to produce additional cGMP liposome intermediate drug product to meet the increase in demand for rhenium (186Re) obisbemeda in ongoing and planned clinical trials.
Organization

▪
Strengthened clinical development leadership with the appointment of Pius Maliakal, M. Pharm., Ph.D., as Vice President of Clinical Operations.

SECOND QUARTER 2023 FINANCIAL RESULTS

▪
The Company’s cash balance was $10.9 million at June 30, 2023, compared to $18.1 million at December 31, 2022. A second grant payment from CPRIT, in the amount of $1.9 million, has been approved and is expected to be received prior to the end of August 2023.
▪
The Company recognized $1.9 million of grant revenue in the second quarter of 2023, which represents the CPRIT’s share of costs incurred in the development of rhenium (186Re) obisbemeda for the treatment of patients with LM.
▪
Total operating expenses for the second quarter of 2023 were $3.3 million, compared to total operating expenses of $5.1 million for the same period the prior year. The decrease is due primarily to a decrease in research and development expenses from completion of the initial cGMP development work on rhenium (186Re) obisbemeda.
▪
In addition to current cash on hand, the Company benefits from grant awards of $3 million from the National Institutes of Health and $17.6 million from CPRIT. The Company also has discretionary, or stockholder approved access to capital, subject to market conditions and securities laws compliance from its ATM and equity line of credit of at least $49 million. In aggregate, these capital sources could provide sufficient capital to fund currently planned and anticipated activities through 2025, if fully utilized.
▪
Net loss for the second quarter of 2023 was $(1.5) million, or $(0.59) per share, compared to a net loss of $(5.3) million, or $(3.56) per share, for the same period the prior year.

UPCOMING 2023 EVENTS AND MILESTONES

During the remainder of 2023, the Company plans to accomplish the following key business objectives:

▪
Initiate Phase 1/Part B of the ReSPECT-LM trial.
▪
Obtain FDA approval and initiate the Phase 1 ReSPECT-PBC trial for pediatric patients with ependymoma and high-grade glioma at Lurie Children’s Hospital in Chicago.
▪
Determine FDA regulatory designation for the 188RNL-BAM development.
▪
Add key second source supply chain vendors to support late-stage clinical trials.
▪
Publish ReSPECT-GBM Phase 1 data in peer-reviewed publication.
▪
Present safety and efficacy data from ReSPECT-GBM trials at the annual SNO conference in Vancouver on November 16-19, 2023.

▪
Various data presentations planned for the following 2023 medical meetings: EANM on September 9-13 and CPRIT’s Innovations in Cancer Prevention and Research Conference VI on October 2-3.

SECOND QUARTER 2023 RESULTS CONFERENCE CALL

The Company will hold a conference call and live audio webcast at 5:00 p.m. Eastern Time today to discuss its financial results and provide a general business update.

A live webcast will be available at ir.plustherapeutics.com/events.

Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.

Following the live call, a replay will be available on the Company’s website under the ‘For Investor’ section. The webcast will be available on the Company’s website for 90 days following the live call

On August 14, 2023 Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care, reported financial results for the three and six months ended June 30, 2023 and highlighted recent corporate updates (Press release, Heron Therapeutics, AUG 14, 2023, View Source [SID1234634366]).

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!

"During the second quarter of 2023, the new executive management team has been focused on resizing the business and recently announced a cost reduction program that is anticipated to save the Company approximately $75 million in cash spend through 2025," said Craig Collard, Chief Executive Officer of Heron. "We are in the early stages of revamping Heron into a commercially focused company with efficient operations. As we move through the remainder of 2023, our team is focused on commercial execution and we look forward to updating you on those efforts in the near-term. In addition to the cost-cutting, we were able to bolster the balance sheet by completing a $30 million equity financing with some of our largest shareholders, as well as closing on a $50 million working capital facility. Based on our current operational plan, we expect that this will provide the Company with enough capital to achieve profitability."

Recent Corporate Updates

•
Financings:

o
In July 2023, Heron completed a private placement equity financing with estimated net proceeds from the sale of Company common stock and pre-funded warrants of $29.7 million.

o
In August 2023, Heron entered into a working capital facility, providing for an aggregate gross principal amount of up to $50.0 million in working capital for the Company, subject to certain terms and conditions, with approximately $24.5 million in net proceeds drawn at closing.

Acute Care Franchise

•
Acute Care Franchise Net Product Sales: For the three and six months ended June 30, 2023, acute care franchise net product sales were $4.5 million and $8.3 million, respectively, which increased from $2.5 million and $3.5 million, respectively, for the same periods in 2022.

•
ZYNRELEF Net Product Sales and PDUFA Update:

o
Net product sales of ZYNRELEF (bupivacaine and meloxicam) extended-release solution for the three and six months ended June 30, 2023 were $4.2 million and $7.7 million, respectively, which increased from $2.5 million and $3.5 million, respectively, for the same periods in 2022.

o
On July 31, 2023, Heron was notified by the U.S. Food and Drug Administration (FDA) that the Prescription Drug User Fee Act (PDUFA) approval goal date for the supplemental New Drug Application (sNDA) for ZYNRELEF was extended by three months to provide for a full review of the submission. The FDA has set a new extended PDUFA approval goal date of January 23, 2024.

•
APONVIE Net Product Sales:

o
Net product sales of APONVIE for the three and six months ended June 30, 2023 were $0.3 million and $0.6 million, respectively, with no sales in the comparable prior year periods. APONVIE became commercially available in the U.S. on March 6, 2023.

Oncology Care Franchise

•
Oncology Care Franchise Net Product Sales: For the three and six months ended June 30, 2023, oncology care franchise net product sales were $27.3 million and $53.1 million, respectively, which increased from $25.1 million and $47.5 million, respectively, for the same periods in 2022.

•
CINVANTI Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three and six months ended June 30, 2023 were $24.5 million and $47.3 million, respectively, which increased from $22.7 million and $43.0 million, respectively, for the same periods in 2022.

•
CINVANTI ANDA Litigation: Heron recently had a favorable outcome at the Markman hearing in the pending Hatch-Waxman Abbreviated New Drug Application litigation against Fresenius Kabi to enforce our CINVANTI patents. We are pleased with the outcome and will continue to vigorously enforce and defend our patent portfolio.

•
SUSTOL Net Product Sales: Net product sales of SUSTOL (granisetron) extended-release injection for the three and six months ended June 30, 2023 were $2.8 million and $5.8 million, respectively, which increased from $2.4 million and $4.5 million, respectively, for the same periods in 2022.

•
2023 Oncology Care Franchise Net Product Sales Guidance: Heron is reiterating full-year 2023 net product sales guidance for the oncology care franchise of $99 million to $103 million.

The Company also recently granted equity awards to four new employees, with grant dates ranging from July 31 through August 14, 2023, as equity inducement awards outside of the Company’s Amended and Restated 2007 Equity Incentive Plan. The employees received, in the aggregate, options to purchase up to 710,000 shares of the Company’s common stock. The options subject to each respective award have an exercise price equal to the closing price per share of the Company’s common stock as reported on the Nasdaq Capital Market on each employee’s respective employment start date. The options subject to these awards each have a 10-year term with a four-year vesting schedule, with 25% of the shares subject to the option vesting on the first anniversary of the grant date and the remaining 75% vesting on a monthly basis over the next three years, subject to each respective employee’s continuous service through each vesting date. In accordance with Nasdaq Listing Rule 5635(c)(4), the inducement award grants were approved by Heron’s Compensation Committee of the Board of Directors and made as a material inducement to each employee entering into employment with the Company.

Conference Call and Webcast

Heron will host a conference call and webcast on August 14, 2023 at 4:30 p.m. ET. The conference call can be accessed by dialing (646) 307-1963 for domestic callers and (800) 715-9871 for international callers. Please provide the operator with the passcode 5410567 to join the conference call. 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 60 days following the call.

About ZYNRELEF for Postoperative Pain

ZYNRELEF is the first and only 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. In December 2022, we submitted an sNDA to support the proposed indication for greatly expanded use of ZYNRELEF in soft tissue and orthopedic surgical procedures. On July 31, 2023, the FDA notified Heron of an extension of the PDUFA approval goal date by three months to provide for a full review of the submission. The FDA has set a new extended PDUFA approval goal date of January 23, 2024. ZYNRELEF is now indicated in the U.S. in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. ZYNRELEF was granted a marketing authorization by the European Commission in September 2020 and by the United Kingdom Regulatory Authority in January 2021. In August 2023, we cancelled the U.K. marketing authorization for ZYNRELEF, as we do not plan to commercially launch ZYNRELEF in the U.K. As of August 2, 2023, ZYNRELEF is approved in 30 European countries including the countries of the European Union and the European Economic Area. ZYNRELEF is indicated in Europe for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults.

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

About APONVIE for Postoperative Nausea and Vomiting (PONV)

APONVIE is a substance NK1 Receptor Antagonist (RA), indicated for the prevention of 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 the only 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.