Case Western Reserve University, Lawrence Livermore National Laboratory agree to collaboration

On August 9, 2022 The leaders of Case Western Reserve University and Lawrence Livermore National Laboratory (LLNL) reported that signed an agreement today to accelerate their efforts in shared areas of excellence (Press release, Case Western Reserve University, AUG 9, 2022, View Source [SID1234617907]).

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After three years of steadily growing institutional collaboration in such areas as energy, materials science and polymer processing, Case Western Reserve President Eric W. Kaler welcomed Livermore Director Kim Budil to the university’s campus.

"Both of our teams have embraced opportunities to partner with enormous enthusiasm and ingenuity," President Kaler said. "We are grateful to Congresswoman Marcy Kaptur for helping to catalyze this connection, and very much look forward to building on our strong progress to date."

Located less than an hour’s drive from San Francisco, the Livermore Lab is one of 17 laboratories around the country operating under the auspices of the U.S. Department of Energy. Their mission is "to push the boundaries of science, engineering and technology" to advance aspects of the energy department’s mission.

"We’re pleased to continue our successful collaboration with Case Western Reserve," said LLNL Director Kim Budil. "This agreement provides an important framework as we partner to advance some of today’s most transformative science and technology."

In the document signed Tuesday, the two institutions agreed to:

Exchange and share science and technology ideas;
Enable student opportunities and internships; and
Pursue research activities in areas of joint interest and benefit.
Conversations to collaboration
The two organizations began discussions 2019 at the suggestion of U.S. Rep. Kaptur (D-Ohio) and then National Nuclear Security Administration leader Lisa Gordon-Hagerty, said Grant Goodrich, executive director of the university’s Great Lakes Energy Institute.

Case Western Reserve and LLNL officials said the university and lab have benefitted over the last several years as their relationship has grown. LLNL has provided funding and expertise to advance research at the university, and CWRU provided a talent pipeline to LLNL, beginning with five internships over the last few years and the hiring of an employee in 2020.

CWRU and LLNL representatives also visited their counterpart’s campus or held virtual meetings nearly a dozen times over the last several years, including for technical presentations and seminars.

Among the other highlights:

LLNL awarded four research grants totaling more than $2 million to CWRU faculty since 2020 from its research and development arm. It funded or collaborated on research being conducted by Dustin Tyler, the Kent H. Smith II Professor of Biomedical Engineering; Rohan Akolkar, the Milton and Tamar Maltz Professor of Energy Innovation and the Ohio Eminent Scholar in Advance Energy Research at the Case School of Engineering; Matthew Willard, professor of materials science and engineering; and Laura Bruckman, associate professor of materials science and engineering.

The lab awarded a $1.1 million grant to a broad-based team led by Roger French, the Kyocera Professor in the Department of Materials Science and Engineering at the Case School of Engineering and a team of researchers to investigate material degradation and lifetime extension of advanced materials. The lab is also a member of the National Science Foundation-funded Materials Data Science for Reliability Center at CWRU, a joint project with the University of Pittsburgh—also led by French.

Shared research projects among Akolkar and LLNL researcher Scott McCall; and João Maia, a professor of macromolecular science and engineering and director of the Center for Advanced Polymer Processing and LLNL researcher Fei Zhou.

Avidity Biosciences Reports Second Quarter 2022 Financial Results and Recent Highlights

On August 9, 2022 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs), reported financial results for the second quarter ended June 30, 2022 and highlighted recent corporate progress (Press release, Avidity Biosciences, AUG 9, 2022, View Source [SID1234617906]).

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"We are very pleased with the team’s execution on our ambitious goal of having three AOC programs addressing three distinct rare diseases in the clinic by the end of this year," said Sarah Boyce, president and chief executive officer. "Our AOC 1001 program for DM1 is progressing with patients from the MARINA trial now enrolling in the recently initiated MARINA-OLE trial. We remain on track to report a preliminary assessment from MARINA in the fourth quarter. We also continue to collaborate with the FSHD and DMD communities as we work to advance AOC 1020 and AOC 1044 into the clinic by the end of this year."

"Our strong cash balance of over $400 million, inclusive of additional funds raised subsequent to June 30th, positions us to be well funded through 2024. This allows us to meaningfully advance our DM1, FSHD and DMD programs, as well as other programs in skeletal muscle and expand the platform into other tissues and cell types," said Mike MacLean, chief financial and chief business officer.

Recent Highlights
Commenced enrolling patients from the MARINA study into a Phase 2 open-label extension study (MARINA-OLE) of AOC 1001 in adults with DM1. Click here for more information on the MARINA-OLE or visit www.clinicaltrials.gov and search for NCT05479981.
Presented data supporting Avidity’s approach of directly targeting DUX4 with AOC 1020 at the 29th Annual FSHD Society International Research Congress. Key highlight from the conference:
Data from a FSHD mouse model showed that a single intravenous dose with the murine version of AOC 1020 prevented development of muscle weakness demonstrated by three functional assays – treadmill running, in vivo force and compound muscle action potential.
Second Quarter 2022 Financial Results
Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities totaled $398.2 million as of June 30, 2022, compared to $405.5 million as of December 31, 2021. In addition, subsequent to June 30th, we have raised $18.7 million through our "at the market" program.

Collaboration Revenue: Collaboration revenue, including reimbursable expenses, primarily relates to Avidity’s partnership with Eli Lilly and Company (Lilly) and totaled $2.2 million for the second quarter of 2022 compared with $2.6 million for the second quarter of 2021, and $4.0 million for the first six months of 2022 compared with $5.3 million for the first six months of 2021. The decrease was primarily due to timing of reimbursable collaboration-related research and development expenses resulting in the recognition of lower corresponding revenue under the collaboration with Lilly.

Research and Development (R&D) Expenses: R&D expenses include external and internal costs associated with research and development activities. These expenses were $39.8 million for the second quarter of 2022 compared with $22.7 million for the second quarter of 2021, and $67.5 million for the first six months of 2022 compared with $43.4 million for the first six months of 2021. The increase was primarily driven by the advancement of AOC 1001, AOC 1020 and AOC 1044, as well as internal and external costs related to the expansion of the company’s overall research capabilities.

General and Administrative (G&A) Expenses: G&A expenses primarily consist of employee-related expenses, professional fees, insurance costs, and patent filing and maintenance fees. These expenses were $8.7 million for the second quarter of 2022 compared with $6.3 million for the second quarter of 2021, and $17.3 million for the first six months of 2022 compared with $12.2 million for the first six months of 2021. The increase was primarily due to higher personnel costs and professional fees as well as facilities costs to support the company’s expanded operations.

APDN Awarded Extension of Health Services Contract with CUNY

On August 9, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in polymerase chain reaction ("PCR")-based technologies, reported that The City University of New York (CUNY), the largest urban university in the United States, has extended its health services contract for COVID-19 testing and vaccine policy management with the Company’s wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC (ADCL), for 12 months through July 2023 and at the prior contract terms (Press release, Applied DNA Sciences, AUG 9, 2022, View Source [SID1234617905]). ADCL’s COVID-19 testing volumes, including the CUNY contract, fueled the Company’s record fiscal 2021 revenues and consecutive quarterly record revenues in the first half of fiscal 2022 ended March 31, 2022 .

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The contract has been successfully operational since August 2021. Through a partnership with Cleared4 software platform, ADCL provides a wide range of COVID-19 related health services to help CUNY mitigate COVID-19 associated risks. These services, which are provided to CUNY’s 25 campuses and covering 300,000+ students, employees, auxiliary workers, contractors and visitors, include: (i) high-throughput RT-PCR COVID-19 testing (weekly testing and a robust randomized testing program); (ii) vaccination policy and documentation management; and, (iii) facility access control.

"We commend the CUNY Board of Trustees for taking a forward-thinking approach to ensure the continued health and safety of all CUNY stakeholders while remaining committed to the promise and value of in-person learning. As New York City grapples with a resurgence of infections fueled by the Omicron BA.5 subvariant that can potentially elude rapid test detection and more easily reinfect people, including those who have been vaccinated, boosted and/or previously infected, our ability to deliver rapid PCR-based results with actionable reporting and access management for safeCircle clients remains a standout," stated Dr. James A. Hayward, president and CEO of Applied DNA. "Given our infrastructure and client concentration in New York City, we are pleased to continue servicing CUNY while we expand our test offering and services."

About safeCircle
safeCircle is a fully integrated health testing platform that offers a customized suite of services to institutions and their personnel/members that encompasses: program design, RT-PCR and rapid antigen testing, sample kit distribution and collection, test site management, results reporting to individuals and program administrators, facilities access management, variant tracking, and vaccination documentation management.

Ionis reports second quarter financial results and recent business achievements

On August 9, 2022 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) reported financial results for the second quarter of 2022 and recent business achievements (Press release, Ionis Pharmaceuticals, AUG 9, 2022, View Source [SID1234617904]).

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"Over the first half of this year, we moved significantly closer to delivering an abundance of new medicines to the market. We reported positive Phase 3 data from the NEURO-TTRansform study of eplontersen in patients with hereditary ATTR polyneuropathy and we are on track to file an NDA in the second half of this year. We were also pleased that the FDA accepted the NDA for tofersen and granted priority review, enabling tofersen to potentially be the first disease modifying treatment approved for a genetic form of ALS. These achievements mean eplontersen and tofersen could be our next marketed products as early as next year," said Brett P. Monia, Ph.D., chief executive officer of Ionis. "We also significantly advanced our late- and mid-stage pipeline. The pelacarsen Lp(a) HORIZON and olezarsen BALANCE Phase 3 studies recently completed enrollment. Additionally, we reported positive data from six mid-stage programs, positioning us to grow our rich Phase 3 pipeline to at least eight medicines across 10 indications. We are looking forward to continuing our positive momentum in the second half of this year by presenting Phase 3 eplontersen data at the International Symposium on Amyloidosis in September, filing our eplontersen NDA, and reporting data from several important programs. These upcoming catalysts, together with our recent achievements, position us well to drive increasing value for all stakeholders."

Second Quarter 2022 Summary Financial Results

On track to achieve 2022 financial guidance, based on the following second quarter results:

$134 million in total revenues
$195 million of operating expenses on a non-GAAP basis(1) and $220 million on a GAAP basis
$80 million net loss on a non-GAAP basis(1) and $105 million on a GAAP basis
$2.0 billion of cash and short-term investments
"We had a strong first half with year-over-year revenue growth of more than 15 percent. We continued to generate revenue from multiple diverse sources, with just over half from our marketed products and the balance from our numerous advancing partnered medicines. Additionally, our financial results reflect our accelerating investments in our rich late-stage pipeline and in our commercial readiness activities for eplontersen, olezarsen and donidalorsen," said Elizabeth L. Hougen, chief financial officer of Ionis. "With $2 billion of cash and investments, we have the financial resources to achieve our goal of bringing transformational medicines to the market. These results for the first half of the year keep us on track to meet our 2022 financial guidance."

Recent Marketed Products Highlights

SPINRAZA: the global market leader for the treatment of spinal muscular atrophy (SMA) patients of all ages

$431 million in worldwide SPINRAZA sales in the second quarter
Biogen reported new results from the RESPOND study of SPINRAZA, stating the results indicate there are residual unmet clinical needs in infants and toddlers with SMA who were previously treated with gene therapy
Biogen reported final data from Part A of the ongoing, three-part DEVOTE study demonstrating that a higher dosing regimen of SPINRAZA leads to higher levels of the drug in the cerebrospinal fluid and is generally well-tolerated
TEGSEDI and WAYLIVRA: important medicines approved for the treatment of patients with polyneuropathy caused by hereditary TTR amyloidosis (ATTRv-PN) and familial chylomicronemia syndrome (FCS), respectively

Continued to expand into new markets in Europe and Latin America through Swedish Orphan Biovitrum AB (Sobi) and PTC Therapeutics, respectively
Second Quarter 2022 and Recent Events

Advancing Ionis’ next two potential marketed products

Reported eplontersen met the co-primary and key secondary endpoints in the interim analysis of the Phase 3 NEURO-TTRansform study in patients with ATTRv-PN; on track to file the New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in the second half of this year
Biogen reported longer-term data from the Phase 3 VALOR study and ongoing open-label extension study of tofersen showing clinical benefit in patients with SOD1-ALS at the European Network to Cure ALS (ENCALS) meeting
Biogen reported that an NDA for tofersen was accepted and granted priority review by the FDA with a Prescription Drug User Fee Act (PDUFA) action date of January 25, 2023
Advancing Ionis’ late-stage pipeline

Novartis achieved full enrollment in the Phase 3 Lp(a) HORIZON cardiovascular outcomes study of pelacarsen in patients with established cardiovascular disease and elevated Lp(a) with data expected in 2025
Achieved full enrollment in the Phase 3 BALANCE study of olezarsen in patients with FCS with data expected in 2023
Advancing Ionis’ mid-stage pipeline

GSK presented positive data from the Phase 2b B-Clear study of bepirovirsen in patients with chronic hepatitis B at the European Association for the Study of the Liver’s (EASL) International Liver Congress. Based on these results, GSK plans to advance bepirovirsen into a Phase 3 monotherapy study in the first half of 2023
Roche reported positive data from the Phase 2 study of IONIS-FB-LRx in patients with immunoglobulin A nephropathy (IgAN). Based on these results, Roche licensed and plans to advance IONIS-FB-LRx into a Phase 3 study
Bayer reported fesomersen met the primary endpoint in the Phase 2b RE-THINc ESRD study in patients with end-stage renal disease. Fesomersen also demonstrated substantial and statistically significant reductions in Factor XI activity levels
Achieved full enrollment in the Phase 2b study of IONIS-AGT-LRx in patients with treatment-resistant hypertension, with data expected in the second half of 2022
Initiated a Phase 2 study of ION904, a follow-on medicine to IONIS-AGT-LRx in patients with treatment-resistant hypertension
Granted orphan drug designation and rare pediatric disease designation by the FDA for ION582 for the treatment of patients with Angelman syndrome
2022 Pipeline Milestones(2)

Anticipated 2022 Regulatory Updates

All non-GAAP amounts referred to in this press release exclude non-cash compensation expense related to equity awards and the related tax effects. In 2021 all non-GAAP amounts also excluded expenses related to the Akcea Merger and restructured commercial operations and the related tax effects. Please refer to the detailed reconciliation of non-GAAP and GAAP measures, which is provided later in this press release.

The Company’s revenue in the first half of 2022 increased more than 15 percent compared to the same period last year. The increase was driven by significant partner payments Ionis earned across multiple partnered programs, including $37 million from AstraZeneca for its share of the global Phase 3 development costs for eplontersen. Refer to the detailed table of costs and reimbursements for the eplontersen collaboration provided later in this release. The Company also earned $57 million from Biogen for advancing several neurology disease programs and $22 million from Roche for advancing IONIS-FB-LRx. Already in the third quarter of 2022, the Company has earned nearly $45 million from Roche and Biogen.

The Company’s commercial revenue in the first half of 2022 decreased 12 percent compared to the same period last year. SPINRAZA royalties decreased primarily due to competition outside of the U.S. In the U.S., SPINRAZA sales stabilized in the first half of 2022 compared to the same period last year, increasing two percent. TEGSEDI and WAYLIVRA revenue decreased due to the shift from product sales to distribution fees based on net sales generated by Sobi. The Company successfully completed the transition of its TEGSEDI and WAYLIVRA operations in the EU and North America to Sobi in the first and second quarters of 2021, respectively. As part of the transition, Ionis restructured its commercial operations in 2021 resulting in substantial cost savings. These decreases were partially offset by increasing licensing and royalty revenue.

Operating Expenses

Ionis is advancing a large late-stage pipeline and as a result, its non-GAAP operating expenses increased in the first half of 2022 compared to the same period in 2021. Higher R&D expenses were driven by the expanded number of Phase 3 studies the Company is conducting, which doubled from three to six studies in 2021. Lower SG&A expenses were largely due to the substantial savings Ionis achieved from integrating Akcea and restructuring its commercial operations in 2021. Ionis is redeploying these savings to advance its pipeline and go-to-market activities for eplontersen, donidalorsen and olezarsen.

Net Loss

Ionis’ non-GAAP net loss in the first half of 2022 increased compared to the same period in 2021, primarily related to higher R&D expenses, partially offset by higher revenue and lower SG&A expenses, as discussed above.

Balance Sheet

As of June 30, 2022, Ionis had cash, cash equivalents and short-term investments of $2.0 billion, compared with $2.1 billion at December 31, 2021. Ionis’ debt obligations and working capital did not change significantly from December 31, 2021 to June 30, 2022.

Webcast

Ionis will conduct a webcast today at 11:30 a.m. Eastern time to discuss this announcement and related activities. Interested parties may access the webcast here. A webcast replay will be available for a limited time at the same address.

Heron Therapeutics Announces Financial Results for the Three and Six Months Ended June 30, 2022 and Highlights Recent Corporate Updates

On August 9, 2022 Heron Therapeutics, Inc. (Nasdaq: HRTX), 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, 2022 and highlighted recent corporate updates (Press release, Heron Therapeutics, AUG 9, 2022, View Source [SID1234617903]).

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Recent Corporate Updates

Acute Care Franchise

ZYNRELEF:
Net product sales of ZYNRELEF (bupivacaine and meloxicam) extended-release solution for the three and six months ended June 30, 2022 were $2.5 million and $3.6 million, respectively. During the second quarter, ZYNRELEF net product sales grew by 140% over the prior quarter. Heron currently expects third quarter 2022 ZYNRELEF net product sales to increase in the range of 40% to 50% over the prior quarter.
ZYNRELEF end-user (ambulatory surgical centers (ASC) and hospitals) demand unit sales were 12,773 in the second quarter of 2022, representing an increase of 47% over the prior quarter.
During the first year of commercial launch and as of June 30, 2022, 602 unique accounts purchased ZYNRELEF with 84% of those accounts reordering the product.
As of July 31, 2022, ZYNRELEF has received 384 formulary approvals, reflecting a greater than 90% approval rate of formulary evaluations, with an estimated 68% of approvals supporting unrestricted use. Approximately 80 additional formulary review meetings are scheduled for the remainder of 2022.
Effective April 1, 2022, ZYNRELEF became the only local anesthetic separately reimbursed for Medicare patients in the Hospital Outpatient Department (HOPD) setting of care under a 3-year transitional pass-through status. Multiple commercial and Medicaid payers covering over 123 million lives have agreed to reimburse ZYNRELEF outside of the surgical bundle payment for surgeries performed in ASCs, with many of these covered lives also having their hospital outpatient procedures reimbursed outside the surgical bundle payment. Commercial and Medicaid payers represent greater than 80% of our targeted patients in the outpatient setting. Additionally, a specific C-code (C9088) for separate reimbursement in the ASC setting of care has been received.
All clinical studies planned for inclusion in the supplemental NDA to further expand the ZYNRELEF indication to soft tissue and orthopedic procedures are fully enrolled, with submission planned for late 2022.
HTX-019 for Prevention of PONV
Postoperative nausea and vomiting (PONV) represents a significant market opportunity in the acute care setting that leverages our existing sales organization. There are approximately 39 million surgical procedures annually where patients are at risk for PONV.
NDA Submission for HTX-019 for Prevention of PONV in Adults Under Review: A 505(b)(2) New Drug Application (NDA) for HTX-019 for the prevention of postoperative nausea and vomiting (PONV) in adults was submitted to the U.S. Food and Drug Administration (FDA) in November 2021. The FDA accepted the NDA for filing and set a Prescription Drug User Fee Act (PDUFA) goal date of September 17, 2022.
Oncology Care Franchise

2022 Oncology Care Franchise Net Product Sales: For the three and six months ended June 30, 2022, oncology care franchise net product sales were $25.1 million and $47.5 million, respectively, compared to $22.4 million and $42.5 million, respectively, for the same periods in 2021. During the second quarter, Heron’s oncology care franchise net product sales grew by 12% over the prior quarter with continued moderate growth compared to the prior year expected for the remainder of 2022.
CINVANTI Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three and six months ended June 30, 2022 were $22.7 million and $43.0 million, respectively, compared to $19.7 million and $38.2 million, respectively, for the same periods in 2021.
SUSTOL Net Product Sales: Net product sales of SUSTOL (granisetron) extended-release injection for the three and six months ended June 30, 2022 were $2.4 million and $4.5 million, respectively, compared to $2.7 million and $4.3 million, respectively, for the same periods in 2021.
2022 Oncology Care Franchise Net Product Sales Guidance Increased: Heron currently expects full-year 2022 net product sales for the oncology care franchise of $93 million to $95 million, up from prior guidance of $89 million to $93 million.
Corporate Restructuring and Cost Reduction Plan

In June 2022, we announced a corporate restructuring and cost reduction plan to address the current market dynamics and prepare the company for long-term sustainability. Annualized cost savings the Company expects from this restructuring, improved operating margins and other cost cutting efforts are expected to achieve over $50 million in reductions in annual operating expense in 2023.

The Company’s restructuring and cost reduction plan included the following:

Workforce reduction: The majority of the cost savings will result from a significant workforce reduction across the Company’s research and development organization, with approximately 70% of the total employee reductions coming from research and development. The remaining research and development team will support the label expansion for ZYNRELEF and the HTX-019 NDA for PONV. In total, these actions will result in a reduction of the total Company employee base by 34%.
Streamlined operational expenditures: Includes reductions and reallocations in overall sales, general and administrative expenses, as well as savings related to reduced external spend.
Improved operating margins: Heron has invested heavily in large-scale manufacturing capacity for both CINVANTI and ZYNRELEF, which are both expected to come on-line in 4Q2022. Larger scale production from these efforts should significantly improve cost of goods for both products.
"Our recent private placement financing is another important strategic step for Heron. Along with our restructuring and cost reduction plans, we now believe we have sufficient cash to take us through 2024 and to become cash flow positive," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "We are also excited to report today strong growth across both our business units, with a 140% increase in net product sales of ZYNRELEF compared to first quarter. We expect continued momentum in the second half of the year as more hospitals switch to ZYNRELEF due to its favorable clinical profile and strong reimbursement. For the oncology care franchise, we are pleased that our portfolio beat our guidance with net product sales of $25.1 million for the second quarter of 2022 and we are on track to achieve full-year 2022 net product sales of $93 million to $95 million, an increase from prior guidance. We look forward to large-scale manufacturing of CINVANTI coming on-line later this year, which is expected to substantially improve margins and drive greater profitability of the oncology care franchise. With recent changes in CMS reimbursement, CINVANTI has the opportunity for continued growth through 2023. Finally, as we near our September PDUFA date, interactions with the FDA regarding our pending NDA for HTX-019 for PONV remain on track."

Financial Results

Net product sales for the three and six months ended June 30, 2022 were $27.6 million and $51.1 million, respectively, compared to $22.4 million and $42.5 million, respectively, for the same periods in 2021.

Heron’s net loss for the three and six months ended June 30, 2022 was $56.4 million, or $0.55 per share, and $120.2 million, or $1.18 per share, respectively, compared to $61.0 million, or $0.62 per share, and $113.6 million, or $1.20 per share, respectively, for the same periods in 2021. Net loss for the three and six months ended June 30, 2022 included non-cash, stock-based compensation expense of $10.4 million and $21.3 million, respectively, compared to $11.2 million and $22.7 million, respectively, for the same periods in 2021.

As of June 30, 2022, Heron had cash, cash equivalents and short-term investments of $83.5 million. Adjusting for net proceeds of $75.2 million from our August 2022 private placement, Heron had pro-forma cash, cash equivalents and short-term investments of $158.7 million. This compares to $157.6 million as of December 31, 2021. Net cash used for operating activities for the three and six months ended June 30, 2022 was $28.4 million and $72.3 million, respectively, compared to $63.0 million and $104.9 million, respectively, for the same periods in 2021. The decrease in our net cash used for operating activities was primarily due to changes in working capital related to the launch of ZYNRELEF, including manufacturing of commercial inventory, partially offset by an increase in net loss.

With the proceeds from the recent private placement, pro-forma cash at the end of second quarter was $158.7 million, which we believe is projected to provide a cash runway through 2024.

Conference Call and Webcast

Heron will host a conference call and webcast on August 9, 2022 at 8:30 a.m. ET. The conference call can be accessed by dialing 1-646-307-1963 for domestic callers and 1-800-715-9871 for international callers. Please provide the operator with the passcode 4215874 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. 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. In September 2020, the European Commission granted a marketing authorization for ZYNRELEF for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. As of January 1, 2021, ZYNRELEF is approved in 31 European countries including the countries of the European Union and European Economic Area and the United Kingdom. In March 2022, Health Canada issued a Notice of Compliance for ZYNRELEF for instillation into the surgical wound for postoperative analgesia after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty surgical procedures.

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

About HTX-019 for PONV

HTX-019 is an IV injectable emulsion formulation designed to directly deliver aprepitant, the active ingredient in EMEND (aprepitant) capsules, which is the only substance P/neurokinin-1 (NK1) receptor antagonist (RA) to be approved in the U.S. for the prevention of PONV in adults. The FDA-approved dose of oral EMEND is 40 mg for PONV prevention, which is given within 3 hours prior to induction of anesthesia for surgery. In a Phase 1 clinical trial, 32 mg of HTX-019 as a 30-second IV injection was demonstrated to be bioequivalent to oral aprepitant 40 mg. The NDA for HTX-019 for PONV was submitted in November 2021 and the FDA set a PDUFA goal date of September 17, 2022.

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).