HRTX Heron Therapeutics Inc.

16.28
+0.05  (+0%)
Previous Close 16.23
Open 16.4
52 Week Low 9.6
52 Week High 26.81
Market Cap $1,479,123,535
Shares 90,855,254
Float 74,647,907
Enterprise Value $1,203,392,535
Volume 1,872,238
Av. Daily Volume 855,025
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Upcoming Catalysts

Drug Stage Catalyst Date
HTX-011
Post operative pain
NDA Filing
NDA Filing
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Drug Pipeline

Drug Stage Notes
CINVANTI (aprepitant) - (GUARDS-1)
COVID-19
Phase 2
Phase 2
Phase 2 initiation announced July 16, 2020.
HTX-034
Postoperative Pain
Phase 1/2
Phase 1/2
Phase 1b/2 trial initiation announced May 18, 2020.
HTX-011
Total knee arthroplasty
Phase 3
Phase 3
Phase 3b data released October 3, 2019.
CINVANTI (HTX-019)
Prevention of chemotherapy-induced nausea and vomiting (CINV)
Approved
Approved
FDA additional approval allowing IV injection in addition to current IV infusion.
APF530 - Sustol
Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)
Approved
Approved
CRL Mar 28 2013. Approved August 10 2016.

Latest News

  1. SAN DIEGO, Sept. 16, 2020 /PRNewswire/ -- Heron Therapeutics, Inc. (NASDAQ:HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the results from EPOCH 2 follow-on study (NCT03695367) of the investigational agent HTX-011 in open inguinal hernia repair surgery with mesh, have been published online by the journal, Surgery in an article entitled "Opioid-free recovery following herniorrhaphy with HTX-011 as the foundation of a multimodal analgesic regimen." In this study, more than 90% of patients receiving HTX-011, along with postoperative over-the-counter (OTC) acetaminophen and ibuprofen…

    SAN DIEGO, Sept. 16, 2020 /PRNewswire/ -- Heron Therapeutics, Inc. (NASDAQ:HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the results from EPOCH 2 follow-on study (NCT03695367) of the investigational agent HTX-011 in open inguinal hernia repair surgery with mesh, have been published online by the journal, Surgery in an article entitled "Opioid-free recovery following herniorrhaphy with HTX-011 as the foundation of a multimodal analgesic regimen." In this study, more than 90% of patients receiving HTX-011, along with postoperative over-the-counter (OTC) acetaminophen and ibuprofen, remained opioid-free throughout the 72-hour period following hernia repair surgery. The mean pain intensity never rose above the mild range through 72 hours following surgery.

    HTX-011 is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended–release local anesthetic to demonstrate in Phase 3 studies (EPOCH 1 in bunionectomy and EPOCH 2 in hernia repair) significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard–of–care local anesthetic for postoperative pain control. HTX-011 was well tolerated, with a safety profile comparable to placebo and bupivacaine solution.

    "Typically, the first 72 hours after surgery are the most difficult from a pain management perspective and is where patients experience the most severe pain requiring opioids," said Jay Redan, M.D., Chief of Surgery at AdventHealth Celebration. "The EPOCH 2 follow-on study provides important evidence that HTX-011, along with OTC analgesics, can keep patients in the mild pain range, allowing more than 90% to remain opioid-free. The study was able to identify patients who should receive an opioid discharge prescription and has the potential to personalize postoperative pain management so that opioids are only prescribed to those who will need them after discharge. This can help to substantially limit the amount of opioids going home with patients following hernia repair surgery."

    The Surgery article can be found here.

    About the EPOCH 2 Follow-On Study

    The EPOCH 2 follow-on study was a multicenter, postoperative pain management study evaluating the efficacy and safety of locally administered HTX-011 300 mg bupivacaine / 9 mg meloxicam via needle-free application into the surgical site in combination with a postoperative non-opioid multimodal analgesia (MMA) regimen of over-the-counter oral acetaminophen and ibuprofen in 63 patients. The study included two sequential cohorts, with identical procedures and MMA regimens, except that patients in Cohort 2 also received an intraoperative dose of ketorolac (15 mg or 30 mg, based on age, renal function and weight) prior to wound closure. The goal was to increase the proportion of opioid-free patients by combining HTX-011 with a postoperative regimen of readily available, oral analgesics. Key results of the study include the following:

    • In total, more than 90% of patients in this study did not require opioids to manage their postoperative pain during the first 72 hours.
    • Across all study patients, 87% were opioid-free through Day 10 and 83% were opioid-free throughout the entire 28-day follow-up period of the study.
    • Patients in the study who required an opioid during the 72-hour postoperative period could be identified retrospectively with the following algorithm: pain score ≥6 at 2 hours postoperatively or received opioid rescue medication within the first 2 hours postoperatively.
    • Mean pain intensity scores were similar between cohorts and never rose above the mild pain range (NRS <4) throughout the 72-hour postoperative period.
    • Addition of an intraoperative dose of ketorolac did not provide additional benefit for pain intensity or opioid use.

    HTX-011 was well tolerated, and co-administration with non-steroidal anti-inflammatory drugs did not affect the safety of HTX-011.

    About HTX-011 for Postoperative Pain

    HTX-011, an investigational non-opioid analgesic, is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. HTX-011 was granted Breakthrough Therapy designation and received Priority Review designation. A complete response letter (CRL) was received from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for HTX-011 in June 2020 relating to non–clinical information. No clinical safety or efficacy issues and no chemistry, manufacturing and controls (CMC) issues were identified. The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for HTX-011 under the proprietary name ZYNRELEFTM in July 2020. Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was granted Priority Review status and accepted by Health Canada. Heron is working to respond to a list of questions received from Health Canada in July 2020.

    About Heron Therapeutics, Inc.

    Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs. Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from pain or cancer. For more information, visit www.herontx.com.

    Forward-looking Statements

    This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to, those associated with: the timing of the NDA resubmission to the FDA; whether the FDA approves the NDA for HTX-011; the timing of the commercial launch of HTX-011 in the U.S.; the timing of the European Commission's (EC) review process for ZYNRELEF; whether the EC authorizes the Marketing Authorisation Application for ZYNRELEF; the timing of the commercial launch of ZYNRELEF in Europe; the timing of Health Canada's NDS review process for HTX-011; whether Health Canada issues a Notice of Compliance for the NDS for HTX-011; the extent of the impact of the ongoing Coronavirus Disease 2019 (COVID-19) pandemic on our business; and other risks and uncertainties identified in the Company's filings with the U.S. Securities and Exchange Commission. Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.

    Investor Relations and Media Contact:

    David Szekeres

    Chief Legal, Business and Administrative Officer

     

    858-251-4447

    Cision View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-announces-publication-of-results-from-epoch-2-follow-on-study-a-phase-2b-study-of-htx-011-in-patients-undergoing-hernia-repair-surgery-301131740.html

    SOURCE Heron Therapeutics, Inc.

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  2. SAN DIEGO, Sept. 11, 2020 /PRNewswire/ -- Heron Therapeutics, Inc. (NASDAQ:HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that Barry Quart, Pharm.D., President and Chief Executive Officer of Heron Therapeutics, will participate in a fireside chat at the Cantor Virtual Global Healthcare Conference on Thursday, September 17, 2020 at 1:20 p.m. EDT.  The conference is being held in a virtual format. 

    A live webcast of the fireside chat will be available on the Company's website at www.herontx.com in the Investor Resources section. A replay of the presentation will be archived on the site for…

    SAN DIEGO, Sept. 11, 2020 /PRNewswire/ -- Heron Therapeutics, Inc. (NASDAQ:HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that Barry Quart, Pharm.D., President and Chief Executive Officer of Heron Therapeutics, will participate in a fireside chat at the Cantor Virtual Global Healthcare Conference on Thursday, September 17, 2020 at 1:20 p.m. EDT.  The conference is being held in a virtual format. 

    A live webcast of the fireside chat will be available on the Company's website at www.herontx.com in the Investor Resources section. A replay of the presentation will be archived on the site for 60 days.

    About Heron Therapeutics, Inc.

    Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs. Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from pain or cancer. For more information, visit www.herontx.com.

    Forward-Looking Statements 

    This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, but are not limited to, risks and uncertainties identified in the Company's filings with the Securities and Exchange Commission. Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.

    Investor Relations and Media Contact:

    David Szekeres

    Chief Legal, Business and Administrative Officer

    Heron Therapeutics, Inc.



    858-251-4447

    Cision View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-to-present-at-cantor-virtual-global-healthcare-conference-301128506.html

    SOURCE Heron Therapeutics, Inc.

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  3. SAN DIEGO, Sept. 8, 2020 /PRNewswire/ -- Heron Therapeutics, Inc. (NASDAQ:HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced a successful Type A meeting with the U.S. Food and Drug Administration (FDA) in which alignment was reached on the plans for the Company to resubmit the New Drug Application (NDA) for HTX-011 for the management of postoperative pain in the fourth quarter of this year. 

    HTX-011 is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended–release local…

    SAN DIEGO, Sept. 8, 2020 /PRNewswire/ -- Heron Therapeutics, Inc. (NASDAQ:HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced a successful Type A meeting with the U.S. Food and Drug Administration (FDA) in which alignment was reached on the plans for the Company to resubmit the New Drug Application (NDA) for HTX-011 for the management of postoperative pain in the fourth quarter of this year. 

    HTX-011 is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended–release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard–of–care local anesthetic for postoperative pain control.

    "Our Type A meeting with the FDA was extremely constructive, with alignment on next steps for the HTX-011 NDA resubmission and with both parties committed to bringing this important non-opioid analgesic to patients in the U.S. as soon as possible. The FDA responded very positively to the information that Heron has generated to resolve the issues contained in the Complete Response Letter and agreed that the proposed specification change was acceptable," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron. "We expect to resubmit the HTX-011 NDA in the next few months and appreciate the FDA's commitment to an expeditious review for this Breakthrough Therapy product."

    About HTX-011 (ZYNRELEFTM in the European Union) for Postoperative Pain

    HTX-011, an investigational non-opioid analgesic, is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. HTX-011 was granted Fast Track designation from the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. Heron submitted a new drug application (NDA) to the FDA for HTX-011 in October 2018 and received Priority Review designation in December 2018. A complete response letter (CRL) was received from the FDA regarding the NDA for HTX-011 on June 26, 2020 relating to non–clinical information. No clinical safety or efficacy issues and no chemistry, manufacturing and controls (CMC) issues were identified. The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for ZYNRELEF in July 2020. Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was granted Priority Review status by Health Canada in October 2019 and accepted by Health Canada in November 2019. Heron is working to respond to a list of questions received from Health Canada in July 2020.

    About Heron Therapeutics, Inc.

    Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs. Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from pain or cancer. For more information, visit www.herontx.com.

    Forward-looking Statements

    This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to, those associated with: the timing of the submission of the new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011; whether the FDA approves the NDA for HTX-011; the timing of the commercial launch of HTX-011 in the U.S.; the timing of the European Commission's (EC) review process for ZYNRELEF; whether the EC authorizes the Marketing Authorisation Application for ZYNRELEF; the timing of the commercial launch of ZYNRELEF in Europe; the timing of Health Canada's New Drug Submission (NDS) review process for HTX-011; whether Health Canada issues a Notice of Compliance for the NDS for HTX-011; the extent of the impact of the ongoing Coronavirus Disease 2019 (COVID-19) pandemic on our business; and other risks and uncertainties identified in the Company's filings with the U.S. Securities and Exchange Commission. Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.                                      

    Investor Relations and Media Contact:

    David Szekeres

    Chief Legal, Business and Administrative Officer

    Heron Therapeutics, Inc.

     

    858-251-4447

    Cision View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-announces-successful-outcome-of-fda-type-a-meeting-to-discuss-htx-011-for-the-management-of-postoperative-pain-301125278.html

    SOURCE Heron Therapeutics, Inc.

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  4. SAN DIEGO, Aug. 5, 2020 /PRNewswire/ -- Heron Therapeutics, Inc. (NASDAQ:HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best–in-class treatments to address some of the most important unmet patient needs, today announced financial results for the three and six months ended June 30, 2020 and highlighted recent corporate updates.

    Recent Corporate Updates

    Pain Management Franchise

    • Positive CHMP Opinion Received for ZYNRELEF™ for the Management of Postoperative Pain: In July 2020, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for ZYNRELEF (formerly known as HTX-011…

    SAN DIEGO, Aug. 5, 2020 /PRNewswire/ -- Heron Therapeutics, Inc. (NASDAQ:HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best–in-class treatments to address some of the most important unmet patient needs, today announced financial results for the three and six months ended June 30, 2020 and highlighted recent corporate updates.

    Recent Corporate Updates

    Pain Management Franchise

    • Positive CHMP Opinion Received for ZYNRELEF™ for the Management of Postoperative Pain: In July 2020, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for ZYNRELEF (formerly known as HTX-011), intended for the treatment of postoperative pain. The CHMP's positive opinion will now be reviewed by the European Commission (EC), with a final decision on the Marketing Authorisation Application expected in the coming months. An EC marketing authorisation through the centralized procedure is valid in all 27 European Union (EU) member countries as well as the European Economic Area countries. The CHMP recommended that ZYNRELEF be indicated for treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. 

       
    • Complete Response Letter Received from the FDA Regarding the NDA for HTX-011 for the Management of Postoperative Pain: In June 2020, Heron received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for HTX-011. The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional non-clinical information. Based on the complete review of the NDA, the FDA did not identify any clinical safety or efficacy issues or chemistry, manufacturing and controls (CMC) issues. There are four non-clinical issues in the CRL, none of which relate to any observed toxicity. Three relate to confirming exposure of excipients in preclinical reproductive toxicology studies, and the fourth relates to changing the manufacturing release specification of the allowable level of an impurity based on animal toxicology coverage. We do not believe that any of the issues are significant barriers to ultimate approval, as all of the excipients have extensive histories of use in pharmaceuticals and the specification can be revised.

       
    • Initiation of Phase 1b/2 Clinical Study of HTX-034 for the Treatment of Postoperative Pain: In May 2020, Heron initiated a Phase 1b/2 clinical study in patients undergoing bunionectomy of HTX-034, Heron's next-generation product for the treatment of postoperative pain. The study initiation followed clearance from the FDA of Heron's Investigational New Drug (IND) application for HTX-034 for the treatment of postoperative pain.

    CINV Franchise

    • Initiation of Phase 2 Clinical Study of CINVANTI® for the Treatment of COVID-19: In July 2020, Heron initiated the GUARDS-1 Study, a Phase 2 clinical study evaluating CINVANTI (aprepitant) injectable emulsion in early hospitalized patients with Coronavirus Disease 2019 (COVID-19). The study initiation followed clearance from the FDA of Heron's IND application for CINVANTI for the treatment of COVID-19.

       
    • CINV Net Product Sales: For the three and six months ended June 30, 2020, chemotherapy–induced nausea and vomiting (CINV) franchise net product sales were $22.7 million and $48.1 million, respectively, compared to $36.7 million and $68.3 million, respectively, for the same periods in 2019.

       
      • CINVANTI Net Product Sales: Net product sales of CINVANTI for the three and six months ended June 30, 2020 were $22.6 million and $47.8 million, respectively, compared to $33.2 million and $61.2 million, respectively, for the same periods in 2019. Heron expects the impact of the generic arbitrage to be resolved in 2020, with a return to growth in 2021 and beyond.

         
      • SUSTOL® Net Product Sales: Net product sales of SUSTOL (granisetron) extended–release injection for the three and six months ended June 30, 2020 were $0.1 million and $0.3 million, respectively, compared to $3.5 million and $7.1 million, respectively, for the same periods in 2019. On October 1, 2019, the Company discontinued all discounting of SUSTOL, which resulted in significantly lower SUSTOL net product sales. Heron expects SUSTOL to return to growth in 2021 and beyond.

         
    • 2020 Net Product Sales Guidance: Although Heron anticipates a decrease in new diagnoses and chemotherapy patient starts because of the onging COVID-19 pandemic, the Company is maintaining its 2020 guidance for net product sales for the CINV franchise of $70 million to $80 million.

    "We are pleased with the CHMP's recent positive opinion for ZYNRELEF in the EU, and we remain committed to bringing this important non-opioid analgesic to patients in the U.S. as soon as possible. We have submitted a request for a Type A meeting with the FDA and look forward to working with the FDA to achieve this goal," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron. "In our CINV franchise, we are encouraged by the continued performance of CINVANTI during both a generic arbitrage period and the COVID-19 pandemic and are maintaining our 2020 net product sales guidance of $70 million to $80 million."

    Financial Results

    Net product sales for the three and six months ended June 30, 2020 were $22.7 million and $48.1 million, respectively, compared to $36.7 million and $68.3 million, respectively, for the same periods in 2019.

    Heron's net loss for the three and six months ended June 30, 2020 was $55.2 million and $106.8 million, or $0.61 per share and $1.18 per share, respectively, compared to $50.2 million and $113.2 million, or $0.63 per share and $1.43 per share, respectively, for the same periods in 2019. Net loss for the three and six months ended June 30, 2020 included non-cash, stock-based compensation expense of $11.1 million and $23.1 million, respectively, compared to $12.7 million and $30.6 million, respectively, for the same periods in 2019.

    As of June 30, 2020, Heron had cash, cash equivalents and short-term investments of $300.8 million, compared to $391.0 million as of December 31, 2019. Net cash used for operating activities for the six months ended June 30, 2020 was $90.2 million, compared to $72.1 million for the same period in 2019. Heron expects that its current cash, cash equivalents and short-term investments will be sufficient to fund its operations into 2022.

    About HTX-011 (ZYNRELEF in the European Union) for Postoperative Pain

    HTX-011 (ZYNRELEF in the European Union), an investigational non-opioid analgesic, is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. HTX-011 was granted Fast Track designation from the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. Heron submitted a new drug application (NDA) to the FDA for HTX-011 in October 2018 and received Priority Review designation in December 2018. A complete response letter (CRL) was received from the FDA regarding the NDA for HTX-011 on June 26, 2020 relating to non–clinical information. No clinical safety or efficacy issues and no chemistry, manufacturing and controls (CMC) issues were identified. The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for ZYNRELEF in July 2020. Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was granted Priority Review status by Health Canada in October 2019 and accepted by Health Canada in November 2019. Heron is working to respond to a list of questions received from Health Canada in July 2020.

    About CINVANTI (Aprepitant) Injectable Emulsion

    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, a substance P/neurokinin-1 (NK1) receptor antagonist (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 United States prescribing information for CINVANTI is a 30-minute IV infusion or a 2-minute IV injection.

    CINVANTI is under investigation for the treatment of COVID-19 as a daily 2-minute IV injection when added to the current standard of care.

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

    About SUSTOL (Granisetron) Extended-Release Injection

    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-HT3 receptor antagonist 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.

    About HTX-034 for Postoperative Pain

    HTX-034, an investigational non-opioid, is a fixed-dose combination, extended–release solution of the local anesthetic bupivacaine, the nonsteroidal anti-inflammatory drug meloxicam and an additional agent that further potentiates the activity of bupivacaine. HTX-034 is formulated in the same proprietary polymer as HTX-011. By combining two different mechanisms that each enhance the activity of the local anesthetic bupivacaine, HTX-034 is designed to provide superior and prolonged analgesia. Local administration of HTX-034 in a validated preclinical postoperative pain model resulted in sustained analgesia for 7 days.

    About Heron Therapeutics, Inc.

    Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs. Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from pain or cancer. For more information, visit www.herontx.com.

    Forward-looking Statements

    This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to, those associated with: whether the U.S. Food and Drug Administration (FDA) approves the new drug application (NDA) for HTX-011; the timing of the commercial launch of HTX-011 in the U.S.; the timing of the European Commission's (EC) review process for ZYNRELEF; whether the EC authorizes the Marketing Authorisation Application for ZYNRELEF; the timing of the commercial launch of ZYNRELEF in Europe; the timing of Health Canada's NDS review process for HTX-011; whether Health Canada issues a Notice of Compliance for the NDS for HTX-011; the full-year 2020 net product sales guidance for the CINV franchise; the expected future balances of Heron's cash, cash equivalents and short-term investments; the expected duration over which Heron's cash, cash equivalents and short-term investments balances will fund its operations; the extent of the impact of the ongoing Coronavirus Disease 2019 (COVID-19) pandemic on our business; and other risks and uncertainties identified in the Company's filings with the U.S. Securities and Exchange Commission. Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.

     

    HERON THERAPEUTICS, INC.

    Consolidated Balance Sheets

    (In thousands)











    June 30,

    2020



    December 31,

    2019







    (Unaudited)









    ASSETS















    Current assets:















    Cash and cash equivalents



    $

    80,728



    $

    71,898



    Short-term investments





    220,114





    319,074



    Accounts receivable, net





    37,502





    39,879



    Inventory





    41,442





    24,968



    Prepaid expenses and other current assets





    13,109





    23,245



    Total current assets





    392,895





    479,064



    Property and equipment, net





    21,886





    19,618



    Right-of-use lease assets





    17,594





    13,754



    Other assets





    346





    346



    Total assets



    $

    432,721



    $

    512,782



    LIABILITIES AND STOCKHOLDERS' EQUITY















    Current liabilities:















    Accounts payable



    $

    18,458



    $

    2,758



    Accrued clinical and manufacturing liabilities





    30,173





    34,614



    Accrued payroll and employee liabilities





    11,193





    15,248



    Other accrued liabilities





    23,728





    36,535



    Current lease liabilities





    2,830





    1,926



    Convertible notes payable to related parties, net of discount





    6,269





    5,624



    Total current liabilities





    92,651





    96,705



    Non-current lease liabilities





    16,012





    12,242



    Total liabilities





    108,663





    108,947



    Stockholders' equity:















    Common stock





    908





    903



    Additional paid-in capital





    1,594,436





    1,568,317



    Accumulated other comprehensive income





    953





    85



    Accumulated deficit





    (1,272,239)





    (1,165,470)



    Total stockholders' equity





    324,058





    403,835



    Total liabilities and stockholders' equity



    $

    432,721



    $

    512,782



















     

     

    HERON THERAPEUTICS, INC.

    Condensed Consolidated Statements of Operations

    (In thousands, except per share amounts)





    Three Months Ended

    June 30,



              Six Months Ended

    June 30,



    2020



    2019



    2020



    2019



    (unaudited)

    Revenues:















        Net product sales

    $ 22,668



    $      36,659



    $  48,068



    $   68,261

    Operating expenses:















        Cost of product sales

    9,005



    13,588



    19,627



    28,550

        Research and development

    44,004



    41,425



    80,898



    84,397

        General and administrative

    9,819



    9,778



    20,241



    19,426

        Sales and marketing

    15,589



    23,647



    35,785



    52,367

              Total operating expenses

    78,417



    88,438



    156,551



    184,740

















    Loss from operations

    (55,749)



    (51,779)



    (108,483)



    (116,479)

















    Other income, net

    559



    1,557



    1,714



    3,245

















    Net loss

    $   (55,190)



    $      (50,222)



    $  (106,769)



    $  (113,234)

















    Basic and diluted net loss per share

    $     (0.61)



    $        (0.63)



    $       (1.18)



    $       (1.43)

















    Shares used in computing basic and diluted net loss per share

    90,753



    79,548



    90,581



    78,987

     

     

    HERON THERAPEUTICS, INC.

    Consolidated Statements of Cash Flows

    (In thousands)

















    Six Months Ended

    June 30,











    2020





    2019













    (Unaudited)



    Operating activities:





















    Net loss







    $

    (106,769)





    $

    (113,234)



    Adjustments to reconcile net loss to net cash used for operating

       activities:





















    Stock-based compensation expense









    23,088







    30,608



    Depreciation and amortization









    1,366







    959



    Amortization of debt discount









    645







    507



    Realized gain on available-for-sale securities















    (8)



    Accretion of discount on short-term investments









    (82)







    (2,437)



    Impairment of property and equipment









    53







    54



    Loss on disposal of property and equipment















    53



    Change in operating assets and liabilities:





















    Accounts receivable









    2,377







    (2,169)



    Inventory









    (16,474)







    9,762



    Prepaid expenses and other assets









    10,136







    2,454



    Accounts payable









    15,700







    (8,866)



    Accrued clinical and manufacturing liabilities









    (4,441)







    913



    Accrued payroll and employee liabilities









    (4,055)







    (4,415)



    Other accrued liabilities









    (11,756)







    13,687



    Net cash used for operating activities









    (90,212)







    (72,132)



    Investing activities:





















    Purchases of short-term investments









    (66,915)







    (204,358)



    Maturities and sales of short-term investments









    166,825







    284,606



    Purchases of property and equipment









    (3,687)







    (4,299)



    Net cash provided by investing activities









    96,223







    75,949



    Financing activities:





















    Proceeds from stock option exercises









    1,309







    16,215



    Proceeds from purchases under Employee Stock Purchase Plan









    1,507







    1,170



    Proceeds from warrant exercises









    3









    Net cash provided by financing activities









    2,819







    17,385



    Net increase in cash and cash equivalents









    8,830







    21,202



    Cash and cash equivalents at beginning of year









    71,898







    31,836



    Cash and cash equivalents at end of period







    $

    80,728





    $

    53,038



     

    Investor Relations and Media Contact:

    David Szekeres

    Chief Legal, Business and Administrative Officer

    Heron Therapeutics, Inc.

     

    858-251-4447

    Cision View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-announces-financial-results-for-the-three-and-six-months-ended--june-30-2020-and-highlights-recent-corporate-updates-301106977.html

    SOURCE Heron Therapeutics, Inc.

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  5. SAN DIEGO, July 24, 2020 /PRNewswire/ -- Heron Therapeutics, Inc. (NASDAQ:HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for ZYNRELEF (formerly known as HTX-011), intended for the treatment of postoperative pain.

    ZYNRELEF is a non-opioid, dual-acting analgesic, utilizing a fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam, where meloxicam…

    SAN DIEGO, July 24, 2020 /PRNewswire/ -- Heron Therapeutics, Inc. (NASDAQ:HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for ZYNRELEF (formerly known as HTX-011), intended for the treatment of postoperative pain.

    ZYNRELEF is a non-opioid, dual-acting analgesic, utilizing a fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam, where meloxicam enhanced the efficacy of bupivacaine. ZYNRELEF uses Heron's proprietary Biochronomer® polymer delivery system to slowly release these drugs over approximately 72 hours.

    The CHMP's positive opinion is based on the results of Heron's two Phase 3 studies of ZYNRELEF. The primary endpoint and all 4 key secondary endpoints were met in both Phase 3 studies. ZYNRELEF demonstrated significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care anesthetic for postoperative pain control. ZYNRELEF significantly reduced pain intensity through 72 hours post–surgery, significantly reduced the use of opioid medications following surgery and significantly increased the proportion of patients who required no postoperative opioid medications. In both studies, ZYNRELEF was generally well tolerated, with a safety profile comparable to placebo and bupivacaine solution.

    The CHMP's positive opinion will now be reviewed by the European Commission (EC), with a final decision on the Marketing Authorisation Application expected in the coming months. An EC marketing authorisation through the centralized procedure is valid in all 27 European Union (EU) member countries as well as the European Economic Area countries. The CHMP recommended that ZYNRELEF be indicated for treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults.

    "Managing postoperative pain remains a major challenge for many physicians, given that up to 80% of patients across Europe report moderate to severe pain for several days after surgery. Postoperative pain causes avoidable suffering, resulting in longer hospital stays and higher healthcare costs," said Richard Langford M.D., FRCA, FFPMRCA, Honorary Consultant, Pain and Anaesthesia Research Centre, St. Bartholomew's Hospital, Barts Health NHS Trust, London, United Kingdom. "The indication recommended by the CHMP will allow surgeons to use the product for a wide range of surgeries, enabling a broad range of patients to benefit from the prolonged action of this important product."

    "Obtaining a positive opinion from the CHMP for ZYNRELEF is a major regulatory milestone and confirms the superiority of ZYNRELEF over bupivacaine solution, the current standard of care," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron. "We believe that the CHMP's positive opinion of ZYNRELEF is an important step forward to help improve the lives of patients across the EU by significantly reducing the proportion of patients who experience severe pain after surgery."

    About ZYNRELEF (HTX-011) for Postoperative Pain

    ZYNRELEF, an investigational non-opioid analgesic, is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. HTX-011 was granted Fast Track designation from the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. Heron submitted a New Drug Application (NDA) to the FDA for HTX-011 in October 2018 and received Priority Review designation in December 2018. A Complete Response Letter (CRL) was received from the FDA regarding the NDA for HTX-011 on June 26, 2020 relating to non–clinical information. No clinical safety or efficacy issues and no chemistry, manufacturing and controls (CMC) issues were identified. The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for ZYNRELEF in July 2020. Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was granted Priority Review status by Health Canada in October 2019 and accepted by Health Canada in November 2019. Heron is working to respond to a list of questions received from Health Canada in July 2020.

    About Heron Therapeutics, Inc.

    Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs. Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from pain or cancer. For more information, visit www.herontx.com.

    Forward-looking Statements

    This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to, those associated with: whether the U.S. Food and Drug Administration (FDA) approves the New Drug Application (NDA) for HTX-011; the timing of the commercial launch of HTX-011 in the U.S.; whether the European Commission (EC) authorizes the Marketing Authorisation Application for ZYNRELEF; the timing of the commercial launch of ZYNRELEF in Europe; the timing of Health Canada's New Drug Submission (NDS) review process for HTX-011; whether Health Canada issues a Notice of Compliance for the NDS for HTX-011; and other risks and uncertainties identified in the Company's filings with the U.S. Securities and Exchange Commission. Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.

    Investor Relations Contact:

    David Szekeres

    Chief Legal, Business and Administrative Officer

    Heron Therapeutics, Inc.

     

    858-251-4447

    Cision View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-receives-positive-chmp-opinion-for-zynrelef-htx-011-for-the-management-of-postoperative-pain-301099292.html

    SOURCE Heron Therapeutics, Inc.

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