1. SAN DIEGO, Feb. 24, 2021 /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 twelve months ended December 31, 2020 and highlighted recent corporate updates.

    Recent Corporate Updates

    Pain Management Franchise

    • New Drug Application Resubmission for HTX-011 Under Review: The New Drug Application (NDA) resubmission for HTX-011, an investigational agent for the management of postoperative pain, submitted November 12, 2020 to the U.S. Food and Drug Administration (FDA), continues under review. The FDA set a Prescription…

    SAN DIEGO, Feb. 24, 2021 /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 twelve months ended December 31, 2020 and highlighted recent corporate updates.

    Recent Corporate Updates

    Pain Management Franchise

    • New Drug Application Resubmission for HTX-011 Under Review: The New Drug Application (NDA) resubmission for HTX-011, an investigational agent for the management of postoperative pain, submitted November 12, 2020 to the U.S. Food and Drug Administration (FDA), continues under review. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of May 12, 2021.
    • European Commission Authorization for ZYNRELEF™ for the Treatment of Postoperative Pain: In September 2020, the European Commission (EC) granted a marketing authorization for ZYNRELEF (formerly known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. As Heron builds large-scale manufacturing capacity to meet the anticipated commercial demand in the U.S. and the rest of the world, we are developing a coordinated global marketing strategy. At this time, Heron anticipates making ZYNRELEF available to patients in Europe during 2022.
    • Low-Dose HTX-034 Produced Greater Pain Reduction Compared to Bupivacaine, the Current Standard-of-Care, Through 96 Hours in Bunionectomy Study: In the Phase 1b portion of this Phase 1b/2 double-blind, randomized, active-controlled, dose-escalation study in 33 patients undergoing bunionectomy, the reduction in pain intensity observed was greater with the lowest dose of HTX-034 evaluated (containing 21.7 mg of bupivacaine plus meloxicam and aprepitant) than with the bupivacaine 50 mg solution through 96 hours.
      • In addition, 45.5% of HTX-034 patients remained opioid-free through Day 15 with median opioid consumption of 2.5 mg morphine equivalents (same as one 5 mg oxycodone pill) through 72 hours, a 71% reduction compared to bupivacaine solution.
      • Heron expects to initiate the expanded Phase 2 portion of the study for HTX-034 in the first quarter of 2021.

    CINV Franchise

    • CINV 2020 Net Product Sales: For the three and twelve months ended December 31, 2020, chemotherapy-induced nausea and vomiting (CINV) franchise net product sales were $20.6 million and $88.6 million, respectively, compared to $35.1 million and $146.0 million for the same periods in 2019.
      • CINVANTI® Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three and twelve months ended December 31, 2020 were $20.3 million and $87.8 million, respectively, compared to $34.6 million and $132.2 million, respectively, for the same periods in 2019. Heron believes the most significant impact of the generic arbitrage is over and expects to grow CINVANTI market share in 2021 and beyond.
      • SUSTOL® Net Product Sales: Net product sales of SUSTOL (granisetron) extended-release injection for the three and twelve months ended December 31, 2020 were $0.3 million and $0.8 million, respectively, compared to $0.5 million and $13.8 million for the same periods in 2019. On October 1, 2019, we discontinued all discounting of SUSTOL to improve the reimbursement and net selling price of the product, which resulted in significantly lower SUSTOL net product sales in 2020. Heron expects SUSTOL to return to growth in 2021 and beyond.
    • Full-Year 2021 Net Product Sales Guidance: Heron expects full-year 2021 net product sales for the CINV franchise of $130 million to $145 million.

    HTX-019 for PONV

    • HTX-019 Achieved Bioequivalence to Approved Oral Aprepitant 40 mg Dose for Prevention of PONV: A new Investigational New Drug application for HTX-019 (aprepitant injectable emulsion) for postoperative nausea and vomiting (PONV) was approved by the FDA in late September of 2020. In the Phase 1 bioequivalence study, 32 mg of HTX-019 as a 30-second intravenous (IV) injection was bioequivalent to oral aprepitant 40 mg, which is approved for the prevention of PONV. An NDA for HTX-019 is planned in late 2021 for prevention of PONV in adults.

    Corporate Update

    • Year-End 2020 Cash Balance: Heron ended 2020 with $208.5 million in cash, cash equivalents and short-term investments.

    "We are very pleased that we exceeded our CINV sales guidance for the year, despite 2020 being a challenging year for Heron, with our CINV franchise impacted by both the COVID-19 global pandemic and the EMEND® IV generic arbitrage. We also achieved several important milestones in 2020, including the authorization of ZYNRELEF in Europe and the advancement of HTX-034 for postoperative pain and HTX-019 for PONV into clinical development," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "We believe that 2021 will be a transformational year for Heron, with significant growth expected in our CINV products with net product sales guidance of $130 million to $145 million, the anticipated FDA approval and commercial launch of HTX-011 in the U.S., and the submission of an NDA for HTX-019 for PONV in the fourth quarter."                                                         

    Financial Results

    Net product sales for the three and twelve months ended December 31, 2020 were $20.6 million and $88.6 million, respectively, compared to $35.1 million and $146.0 million, respectively, for the same periods in 2019.

    Heron's net loss for the three and twelve months ended December 31, 2020 was $62.3 million and $227.3 million, or $0.68 per share and $2.50 per share, respectively, compared to $57.9 million and $204.7 million, or $0.65 per share and $2.50 per share, respectively, for the same periods in 2019. Net loss for the three and twelve months ended December 31, 2020 included non-cash, stock-based compensation expense of $16.0 million and $50.2 million, respectively, compared to $11.1 million and $51.4 million, respectively, for the same periods in 2019.

    As of December 31, 2020, Heron had cash, cash equivalents and short-term investments of $208.5 million compared to $391.0 million as of December 31, 2019. Net cash used for operating activities for the twelve months ended December 31, 2020 was $184.8 million, compared to $124.6 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 for Postoperative Pain (ZYNRELEF in Europe)

    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. The FDA granted Breakthrough Therapy designation to HTX-011 and the NDA received Priority Review designation. A complete response letter was received from the FDA regarding the NDA for HTX-011 in June 2020 relating to non-clinical information. No clinical safety or efficacy issues and no chemistry, manufacturing and controls issues were identified. Heron resubmitted an NDA to the FDA for HTX-011 in November 2020 and the FDA set a PDUFA goal date of May 12, 2021. Heron is working to respond to a list of questions received from Health Canada in July 2020. In September 2020, the EC granted a marketing authorization for ZYNRELEF (also known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. The EC's centralized marketing authorization is valid for the 27 countries that are members of the European Union, the other countries in the European Economic Area, and the United Kingdom.

    About HTX-034 for Postoperative Pain

    HTX-034, an investigational non-opioid analgesic, is a triple-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam and aprepitant, 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 HTX-019 for Postoperative Nausea and Vomiting

    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, 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.

    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, 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 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 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.

    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 FDA approves the NDA for HTX-011; the timing of the commercial launch of HTX-011 in the U.S., if approved; 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 timing and results of studies for the HTX-034 and HTX-019 development programs; the full-year 2021 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 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 Statements of Operations

    (In thousands, except per share amounts)







    Three Months Ended



    Twelve Months Ended





    December 31,



    December 31,





    2020



    2019



    2020



    2019





    (Unaudited)









    Revenues:

















    Net product sales



    $        20,605



    $        35,083



    $        88,638



    $      145,968

    Operating expenses:

















    Cost of product sales



    9,392



    15,874



    36,189



    61,619

    Research and development



    44,453



    48,277



    174,533



    167,382

    General and administrative



    12,503



    9,874



    42,226



    37,897

    Sales and marketing



    15,553



    20,420



    63,853



    89,764

    Total operating expenses



    81,901



    94,445



    316,801



    356,662

    Loss from operations



    (61,296)



    (59,362)



    (228,163)



    (210,694)

    Other income (expense), net



    (985)



    1,442



    885



    5,945

    Net loss



    $      (62,281)



    $      (57,920)



    $    (227,278)



    $    (204,749)

    Basic and diluted net loss per share



    $          (0.68)



    $          (0.65)



    $          (2.50)



    $          (2.50)

    Shares used in computing basic and diluted net loss per share



    91,081



    89,112



    90,774



    81,779

     

    Heron Therapeutics, Inc.

    Consolidated Balance Sheets

    (in thousands)







    December 31,

    2020



    December 31,

    2019







    ASSETS









    Current assets:









    Cash and cash equivalents



    $               105,138



    $               71,898

    Short-term investments



    103,353



    319,074

    Accounts receivable, net



    41,850



    39,879

    Inventory



    41,905



    24,968

    Prepaid expenses and other current assets



    21,950



    23,245

    Total current assets



    314,196



    479,064

    Property and equipment, net



    22,737



    19,618

    Right-of-use lease assets



    16,277



    13,754

    Other assets



    346



    346

    Total assets



    $             353,556



    $            512,782

    LIABILITIES AND STOCKHOLDERS' EQUITY









    Current liabilities:









    Accounts payable



    $                    525



    $                2,758

    Accrued clinical and manufacturing liabilities



    49,962



    34,614

    Accrued payroll and employee liabilities



    13,597



    15,248

    Other accrued liabilities



    28,369



    36,535

    Current lease liabilities



    2,997



    1,926

    Convertible notes payable to related parties



    7,053



    5,624

    Total current liabilities



    102,503



    96,705

    Non-current lease liabilities



    14,561



    12,242

    Total liabilities



    117,064



    108,947











    Stockholders' equity:









            Preferred stock





            Common stock



    913



    903

    Additional paid-in capital



    1,628,070



    1,568,317

    Accumulated other comprehensive income



    257



    85

    Accumulated deficit



    (1,392,748)



    (1,165,470)

    Total stockholders' equity



    236,492



    403,835

    Total liabilities and stockholders' equity



    $             353,556



    $            512,782

     

    Investor Relations and Media Contact:

    David Szekeres

    Executive Vice President, Chief Operating 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-twelve-months-ended-december-31-2020-and-highlights-recent-corporate-updates-301234154.html

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  2. SAN DIEGO, Feb. 17, 2021 /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., Chairman and Chief Executive Officer of Heron Therapeutics, will present at the following virtual investor conferences:

    • SVB Leerink 10th Annual Global Healthcare Conference: Wednesday, February 24, 2021 at 5:00 pm ET
    • Cowen 41st Annual Healthcare Conference: Monday, March 1, 2021 at 11:40 am ET

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

    SAN DIEGO, Feb. 17, 2021 /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., Chairman and Chief Executive Officer of Heron Therapeutics, will present at the following virtual investor conferences:

    • SVB Leerink 10th Annual Global Healthcare Conference: Wednesday, February 24, 2021 at 5:00 pm ET
    • Cowen 41st Annual Healthcare Conference: Monday, March 1, 2021 at 11:40 am ET

    A live webcast of each presentation will be available on the Company's website at www.herontx.com in the Investor Resources section. A replay of each 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

    Executive Vice President, Chief Operating Officer

    Heron Therapeutics, Inc.



    858-251-4447

    Cision View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-to-present-at-several-upcoming-virtual-investor-conferences-301230369.html

    SOURCE Heron Therapeutics, Inc.

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  3. SAN DIEGO, Jan. 21, 2021 /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 an EPOCH 1 follow-on study (NCT03718039) of the investigational agent HTX-011 in bunionectomy, have been published online, by the Journal of the American Podiatric Medical Association in an article entitled "Opioid-Free Recovery from Bunionectomy with HTX-011, a Dual-Acting Local Anesthetic Combining Bupivacaine and Meloxicam, as the Foundation of Non-Opioid Multimodal Analgesia." In this study, 77% of patients receiving HTX-011, along with postoperative…

    SAN DIEGO, Jan. 21, 2021 /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 an EPOCH 1 follow-on study (NCT03718039) of the investigational agent HTX-011 in bunionectomy, have been published online, by the Journal of the American Podiatric Medical Association in an article entitled "Opioid-Free Recovery from Bunionectomy with HTX-011, a Dual-Acting Local Anesthetic Combining Bupivacaine and Meloxicam, as the Foundation of Non-Opioid Multimodal Analgesia." In this study, 77% of patients receiving HTX-011, along with postoperative over-the-counter (OTC) oral acetaminophen and ibuprofen, remained opioid-free through the 72-hour period following surgery and continued to be opioid-free through 28 days of recovery. The mean pain intensity never rose above the mild range through 72 hours postoperatively.

    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.

    "A bunionectomy is a very painful surgical procedure that often requires opioids, which can come with adverse side effects, including nausea, vomiting, constipation and slowed breathing in addition to being potentially addictive," said Richard Pollak, M.D., DPM, a podiatric surgery specialist at San Antonio Podiatry Associates and an author of the publication. "Our findings from this study suggest that HTX-011 can serve as the foundation of a non-opioid multimodal analgesic (MMA) regimen, providing profound pain reduction and enabling opioid-free recovery for most bunionectomy patients through the 28-day recovery period."

    The Journal of the American Podiatric Medical Association article can be found here.

    About the EPOCH 1 Follow-On Study

    The EPOCH 1 follow-on study was an open-label, multi-cohort study evaluating the efficacy and safety of locally administered HTX-011 60 mg bupivacaine / 1.8 mg meloxicam via needle-free application into the surgical site in combination with a postoperative non-opioid MMA regimen of OTC oral acetaminophen and ibuprofen in 31 patients undergoing unilateral bunionectomy with osteotomy. Key results of the study include the following:

    • 77% of bunionectomy patients receiving HTX-011 with a scheduled non-opioid MMA regimen of OTC acetaminophen and ibuprofen required no opioids during recovery through 28 days (opioid-free).
    • 71% of bunionectomy patients receiving HTX-011 with a scheduled regimen of over-the-counter acetaminophen and ibuprofen did not experience severe pain.
    • The mean total opioid consumption over the 72-hour postoperative period was 1.61 morphine milligram equivalents.

    HTX-011 was well tolerated and demonstrated no safety concerns when used with postoperative non-opioid MMAs (OTC acetaminophen and ibuprofen).

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

    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. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to HTX-011 and the New Drug Application (NDA) received Priority Review designation. A complete response letter (CRL) was received from the FDA regarding the 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. Heron resubmitted an NDA to the FDA for HTX-011 in November 2020 and the FDA set a Prescription Drug User Fee Act goal date of May 12, 2021. Heron is working to respond to a list of questions received from Health Canada in July 2020. In September 2020, the European Commission (EC) granted a marketing authorization for ZYNRELEF (also known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. The EC's centralized marketing authorization is valid for the 27 countries that are members of the European Union, and the other countries in the European Economic Area, including the United Kingdom.

    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 FDA approves the NDA for HTX-011; the timing of the commercial launch of HTX-011 in the U.S., if approved; 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

    Executive Vice President, Chief Operating Officer



    858-251-4447

    Cision View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-announces-publication-of-results-from-epoch-1-follow-on-study-of-htx-011-in-patients-undergoing-bunionectomy-surgery-301212178.html

    SOURCE Heron Therapeutics, Inc.

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  4. SAN DIEGO, Jan. 11, 2021 /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 highlights progress in its pain management and chemotherapy-induced nausea and vomiting (CINV) franchises and announces a new development program for postoperative nausea and vomiting (PONV).

    Recent Corporate Progress

    Pain Management Franchise

    • New Drug Application Resubmission for HTX-011 Under Review: The New Drug Application (NDA) resubmission for HTX-011, an investigational agent for the management of postoperative pain, submitted November 12, 2020 to the U.S. Food and Drug…

    SAN DIEGO, Jan. 11, 2021 /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 highlights progress in its pain management and chemotherapy-induced nausea and vomiting (CINV) franchises and announces a new development program for postoperative nausea and vomiting (PONV).

    Recent Corporate Progress

    Pain Management Franchise

    • New Drug Application Resubmission for HTX-011 Under Review: The New Drug Application (NDA) resubmission for HTX-011, an investigational agent for the management of postoperative pain, submitted November 12, 2020 to the U.S. Food and Drug Administration (FDA), continues under review. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of May 12, 2021.



    • Low Dose HTX-034 Produced Greater Pain Reduction to Bupivacaine, the Current Standard-of-Care, Through 96 hours in Bunionectomy Study: In the Phase 1b portion of this Phase 1b/2 double-blind, randomized, active-controlled dose-escalation study in 33 patients undergoing bunionectomy, the reduction in pain intensity observed with the lowest dose of HTX-034 evaluated (containing 21.7 mg of bupivacaine plus meloxicam and aprepitant) was greater than the bupivacaine 50 mg solution group through 96 hours.

      • In addition, 45.5% of HTX-034 patients remained opioid-free through Day 15 with median opioid consumption of 2.5 milligram morphine equivalents (same as one 5 mg oxycodone pill) through 72-hours, a 71% reduction compared to bupivacaine solution.
      • The expanded Phase 2 portion of the study for HTX-034 will begin this quarter.

    CINV Franchise

    • Fourth-Quarter 2020 Net Product Sales: Preliminary fourth-quarter 2020 net product sales for the CINV franchise were approximately $20.3 million. This included net product sales of approximately $20.0 million for CINVANTI® (aprepitant) injectable emulsion and approximately $0.3 million for SUSTOL® (granisetron) extended-release injection, compared to $34.6 million and $0.5 million, respectively, for the same periods in 2019. Heron believes the most significant impact of the generic arbitrage is over and expects to grow CINVANTI market share in 2021 and beyond.



    • Full-Year 2020 Net Product Sales: Preliminary full-year 2020 net product sales for the CINV franchise were approximately $88.3 million versus guidance of $85 million. This included net product sales of approximately $87.6 million for CINVANTI and approximately $0.7 million for SUSTOL, compared to $132.2 million and $13.8 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.



    • Full-Year 2021 Net Product Sales Guidance: Heron expects full-year 2021 net product sales for the CINV franchise of $130 million to $145 million.

    PONV Franchise

    • HTX-019 Achieved Bioequivalence to Approved Oral Aprepitant 40 mg Dose for Prevention of PONV: A new IND for HTX-019 (aprepitant injectable emulsion) for PONV was approved by the FDA in late September of 2020. In the Phase 1 bioequivalence study, HTX-019 32 mg as a 30-second intravenous (IV) injection was bioequivalent to oral aprepitant 40 mg, which is approved for the prevention of PONV. An NDA for HTX-019 is planned in late 2021 for prevention of PONV in adults.

    Corporate Update

    • Year-End 2020 Cash Balance: Heron ended 2020 with approximately $208.5 million in cash, cash equivalents and short-term investments.

    "We have made important advances in 2020 in both our pain management and CINV franchises, highlighted by receiving an EU marketing authorization for ZYNRELEFTM (also known as HTX-011), the rapid resubmission to the FDA of the NDA for HTX-011, very promising clinical data with HTX-034, and maintaining stronger than expected net product sales for CINVANTI. We are also excited to announce the development of HTX-019 for PONV, a market that is approximately 20-times larger than CINV, with an expected NDA submission late this year," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "2021 should be a transformational year for Heron with significant growth in our CINV products with net product sales guidance of $130 million - $145 million and the anticipated launch of HTX-011, if approved by the FDA."

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

    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. The U.S. FDA granted Breakthrough Therapy designation to HTX-011 and the NDA received Priority Review designation. A complete response letter (CRL) was received from the FDA regarding the 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. Heron resubmitted an NDA to the FDA for HTX-011 in November 2020 and the FDA set a PDUFA goal date of May 12, 2021. Heron is working to respond to a list of questions received from Health Canada in July 2020. In September 2020, the European Commission (EC) granted a marketing authorization for ZYNRELEF (also known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. The EC's centralized marketing authorization is valid for the 27 countries that are members of the European Union, and the other countries in the European Economic Area, including the United Kingdom.

    About HTX-034 for Postoperative Pain

    HTX-034, an investigational non-opioid analgesic, is a triple-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam and aprepitant, 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 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 HTX-019 for Postoperative Nausea and Vomiting

    HTX-019 is an IV injectable emulsion formulation designed to directly deliver aprepitant, the active ingredient in EMEND® capsules, which is the only NK1 RA to be approved in the United States for the prevention of PONV in adults. The FDA-approved dosing for oral EMEND is 40 mg capsules within 3 hours prior to induction of anesthesia for surgery. In a Phase 1 clinical trial, HTX-019 32 mg as a 30-second IV injection was demonstrated to be bioequivalent to oral aprepitant 40 mg.

    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 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.

    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: adjustments to the preliminary fourth-quarter 2020 and full-year 2020 net product sales for the CINV franchise in connection with completion of financial closing procedures and an audit for the 2020 fiscal year; risks associated with the full-year 2021 net product sales guidance for the CINV franchise; whether the FDA approves the NDA for HTX-011; the timing of the commercial launch of HTX-011 in the U.S., if approved; 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 timing and results of studies for the HTX-034 and PONV development programs; 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.

    Investor Relations and Media Contact:

    David Szekeres

    EVP, Chief Operating Officer

    Heron Therapeutics, Inc.

     

    858-251-4447

    Cision View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-highlights-progress-in-pain-management-and-cinv-franchises-and-announces-new-development-program-301204895.html

    SOURCE Heron Therapeutics, Inc.

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  5. SAN DIEGO, Nov. 13, 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 New Drug Application (NDA) was resubmitted to the U.S. Food and Drug Administration (FDA) for HTX-011, an investigational agent for the management of postoperative pain.

    The NDA for HTX-011 was resubmitted based on the outcome and final minutes of a Type A End-of-Review meeting with the FDA in September, which was conducted to obtain clarity on the information needed to address the Complete Response Letter (CRL) issued by the FDA in June 2020. The CRL stated…

    SAN DIEGO, Nov. 13, 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 New Drug Application (NDA) was resubmitted to the U.S. Food and Drug Administration (FDA) for HTX-011, an investigational agent for the management of postoperative pain.

    The NDA for HTX-011 was resubmitted based on the outcome and final minutes of a Type A End-of-Review meeting with the FDA in September, which was conducted to obtain clarity on the information needed to address the Complete Response Letter (CRL) issued by the FDA in June 2020. 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. There are four non-clinical issues in the CRL, 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. Since receiving the CRL, Heron generated data showing that peak plasma levels (Cmax) of excipients in reproductive toxicology studies are >50- to >200-fold higher than the levels observed in patients receiving the highest dose of HTX-011. These results provide validation of the previously submitted animal studies. At the Type A End-of-Review meeting in September, the FDA agreed with the change to the manufacturing specification proposed by Heron to address their concern. The FDA indicated at the Type A End-of-Review meeting that the submission will be classified as a Class 2 resubmission, which means that the FDA can take up to 6 months to review the new information included in the NDA resubmission.

    "We are pleased to have resubmitted the NDA for HTX-011, which we believe fully addresses the CRL based on advice from the FDA," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "In our resubmission, we provided compelling evidence responding to the issues identified in the CRL that should provide the basis for the approval of the HTX-011 NDA. Heron remains committed to bringing HTX-011 to patients and we look forward to working with the FDA to achieve this goal."

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

    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. The FDA granted Breakthrough Therapy designation to HTX-011 and the NDA received Priority Review designation. A CRL was received from the FDA regarding the NDA for HTX-011 in June 2020 relating to non-clinical information. No clinical safety or efficacy issues and no chemistry, manufacturing and controls issues were identified. Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was accepted by Health Canada. Heron is working to respond to a list of questions received from Health Canada in July 2020. In September 2020, the European Commission (EC) granted a marketing authorization for ZYNRELEF (also known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. The EC's centralized marketing authorization is valid for the 27 countries that are members of the European Union, and the other countries in the European Economic Area.

    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 FDA approves the NDA for HTX-011; the timing of the commercial launch of HTX-011 in the U.S.; 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 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 Contact:

    David Szekeres

    EVP, Chief Operating Officer

    Heron Therapeutics, Inc.

     

    858-251-4447

    Cision View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-resubmits-new-drug-application-to-fda-for-htx-011-for-the-treatment-of-postoperative-pain-301172545.html

    SOURCE Heron Therapeutics, Inc.

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  6. SAN DIEGO, Nov. 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., Chairman and Chief Executive Officer of Heron Therapeutics, will present at the following virtual investor conferences:

    • Stifel 2020 Virtual Healthcare Conference: Tuesday, November 17, 2020 at 3:20 pm ET
    • Jefferies Virtual London Healthcare Conference: Thursday, November 19, 2020 at 1:30 pm GMT
    • 3rd Annual Evercore ISI HealthCONx Conference: Tuesday, December 1, 2020 at 4:20 pm ET

    A live webcast of each presentation will be available on the Company's…

    SAN DIEGO, Nov. 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., Chairman and Chief Executive Officer of Heron Therapeutics, will present at the following virtual investor conferences:

    • Stifel 2020 Virtual Healthcare Conference: Tuesday, November 17, 2020 at 3:20 pm ET
    • Jefferies Virtual London Healthcare Conference: Thursday, November 19, 2020 at 1:30 pm GMT
    • 3rd Annual Evercore ISI HealthCONx Conference: Tuesday, December 1, 2020 at 4:20 pm ET

    A live webcast of each presentation will be available on the Company's website at www.herontx.com in the Investor Resources section. A replay of each 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

    Executive Vice President, Chief Operating Officer

    Heron Therapeutics, Inc.

     

    858-251-4447

    Cision View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-to-present-at-several-upcoming-virtual-investor-conferences-301171239.html

    SOURCE Heron Therapeutics, Inc.

    View Full Article Hide Full Article
  7. SAN DIEGO, Nov. 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 nine months ended September 30, 2020 and highlighted recent corporate updates.

    Recent Corporate Updates

    Pain Management Franchise

    • European Commission Authorization for ZYNRELEF™ for the Treatment of Postoperative Pain: In September 2020, the European Commission (EC) granted a marketing authorization for ZYNRELEF (formerly known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in…

    SAN DIEGO, Nov. 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 nine months ended September 30, 2020 and highlighted recent corporate updates.

    Recent Corporate Updates

    Pain Management Franchise

    • European Commission Authorization for ZYNRELEF™ for the Treatment of Postoperative Pain: In September 2020, the European Commission (EC) granted a marketing authorization for ZYNRELEF (formerly known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. The marketing authorization follows the European Medicines Agency's positive opinion from the Committee for Medicinal Products for Human Use in July 2020. The EC's centralized marketing authorization is valid for the 27 countries that are members of the European Union (EU), and the other countries in the European Economic Area (EEA). We are currently assessing the evolving global environment for pharmaceuticals and developing a coordinated global marketing strategy, and at this time we anticipate making ZYNRELEF available to patients in Europe during the second half of 2021.



    • Successful Outcome of FDA Type A Meeting to Discuss HTX-011 for the Management of Postoperative Pain: In September 2020, we announced a successful Type A meeting with the U.S. Food and Drug Administration (FDA) in which alignment was reached on the plans for Heron to resubmit the New Drug Application (NDA) for HTX-011 for the management of postoperative pain in the fourth quarter of 2020.

    CINV Franchise

    • CINV Net Product Sales: For the three and nine months ended September 30, 2020, chemotherapy–induced nausea and vomiting (CINV) franchise net product sales were $20.0 million and $68.0 million, respectively, compared to $42.6 million and $110.9 million, respectively, for the same periods in 2019.





      • CINVANTI® Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three and nine months ended September 30, 2020 were $19.8 million and $67.6 million, respectively, compared to $36.4 million and $97.6 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 nine months ended September 30, 2020 were $0.2 million and $0.4 million, respectively, compared to $6.2 million and $13.3 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 ongoing COVID-19 pandemic (COVID-19), the Company has increased its 2020 guidance for net product sales for the CINV franchise from a range of $70 million to $80 million to net product sales of $85 million.

    "The third quarter was highlighted by the authorization of ZYNRELEF in the EU and we remain focused on resubmitting the New Drug Application for HTX-011 in the U.S. as quickly as possible in order to bring this innovative non-opioid medicine to patients suffering from postoperative pain," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "In addition, our CINV franchise is advancing well, with continued strong performance of CINVANTI against a backdrop of arbitrage and the ongoing global pandemic. Based on the strong commercial execution, we are very pleased to increase our guidance for 2020 to $85 million in net product sales."

    Financial Results

    Net product sales for the three and nine months ended September 30, 2020 were $20.0 million and $68.0 million, respectively, compared to $42.6 million and $110.9 million, respectively, for the same periods in 2019.

    Heron's net loss for the three and nine months ended September 30, 2020 was $58.2 million and $165.0 million, or $0.64 per share and $1.82 per share, respectively, compared to $33.6 million and $146.8 million, or $0.42 per share and $1.85 per share, respectively, for the same periods in 2019. Net loss for the three and nine months ended September 30, 2020 included non-cash, stock-based compensation expense of $11.1 million and $34.2 million, respectively, compared to $9.7 million and $40.3 million, respectively, for the same periods in 2019.

    As of September 30, 2020, Heron had cash, cash equivalents and short-term investments of $258.1 million, compared to $391.0 million as of December 31, 2019. Net cash used for operating activities for the nine months ended September 30, 2020 was $132.3 million, compared to $97.6 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 for Postoperative Pain (ZYNRELEF in the EU and EEA)

    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. The FDA granted Breakthrough Therapy designation to HTX-011 and the NDA received Priority Review designation. A complete response letter (CRL) was received from the FDA regarding the NDA for HTX-011 in June 2020 relating to non clinical information. No clinical safety or efficacy issues and no chemistry, manufacturing and controls issues were identified. Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was accepted by Health Canada. Heron is working to respond to a list of questions received from Health Canada in July 2020. In September 2020, the EC granted a marketing authorization for ZYNRELEF (also known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. The EC's centralized marketing authorization is valid for the 27 countries that are members of the EU, and the other countries in the EEA.

    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 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 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 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.

    Condensed Consolidated Balance Sheets

    (In thousands)







    September 30,

    2020



    December 31,

    2019





    (Unaudited)





    ASSETS













    Current assets:













    Cash and cash equivalents



    $

    95,141



    $

    71,898

    Short-term investments





    163,005





    319,074

    Accounts receivable, net





    33,654





    39,879

    Inventory





    42,749





    24,968

    Prepaid expenses and other current assets





    16,446





    23,245

    Total current assets





    350,995





    479,064

    Property and equipment, net





    21,741





    19,618

    Right-of-use lease assets





    16,941





    13,754

    Other assets





    346





    346

    Total assets



    $

    390,023



    $

    512,782

    LIABILITIES AND STOCKHOLDERS' EQUITY













    Current liabilities:













    Accounts payable



    $

    12,067



    $

    2,758

    Accrued clinical and manufacturing liabilities





    40,718





    34,614

    Accrued payroll and employee liabilities





    13,235





    15,248

    Other accrued liabilities





    22,009





    36,535

    Current lease liabilities





    2,912





    1,926

    Convertible notes payable to related parties, net of discount





    6,637





    5,624

    Total current liabilities





    97,578





    96,705

    Non-current lease liabilities





    15,298





    12,242

    Total liabilities





    112,876





    108,947

    Stockholders' equity:













    Common stock





    909





    903

    Additional paid-in capital





    1,606,165





    1,568,317

    Accumulated other comprehensive income





    540





    85

    Accumulated deficit





    (1,330,467)





    (1,165,470)

    Total stockholders' equity





    277,147





    403,835

    Total liabilities and stockholders' equity



    $

    390,023



    $

    512,782

     

    HERON THERAPEUTICS, INC.

    Condensed Consolidated Statements of Operations

    (In thousands, except per share amounts)







    Three Months Ended

    September 30,



    Nine Months Ended

    September 30,





    2020



    2019



    2020



    2019





    (unaudited)

    Revenues:

























    Net product sales



    $

    19,965



    $

    42,624



    $

    68,033



    $

    110,885

    Operating expenses:

























    Cost of product sales





    7,170





    17,195





    26,797





    45,745

    Research and development





    49,182





    34,708





    130,080





    119,105

    General and administrative





    9,482





    8,597





    29,723





    28,023

    Sales and marketing





    12,515





    16,977





    48,300





    69,344

    Total operating expenses





    78,349





    77,477





    234,900





    262,217

    Loss from operations





    (58,384)





    (34,853)





    (166,867)





    (151,332)

    Other income, net





    156





    1,258





    1,870





    4,503

    Net loss



    $

    (58,228)



    $

    (33,595)



    $

    (164,997)



    $

    (146,829)



























    Basic and diluted net loss per share



    $

    (0.64)



    $

    (0.42)



    $

    (1.82)



    $

    (1.85)



























    Shares used in computing basic and diluted net loss per share





    90,849





    79,940





    90,671





    79,308

     

    HERON THERAPEUTICS, INC.

    Condensed Consolidated Statements of Cash Flows

    (In thousands)







    Nine Months Ended

    September 30,





    2020



    2019





    (unaudited)

    Operating activities:













    Net loss



    $

    (164,997)



    $

    (146,829)

    Adjustments to reconcile net loss to net cash used for operating activities:













    Stock-based compensation expense





    34,183





    40,312

    Depreciation and amortization





    2,135





    1,480

    Amortization of debt discount





    1,013





    780

    Realized gain on available-for-sale securities









    (8)

    Amortization of premium (accretion of discount) on short-term investments





    39





    (3,264)

    Impairment of property and equipment





    61





    80

    Loss on disposal of property and equipment









    53

    Change in operating assets and liabilities:













    Accounts receivable





    6,225





    (2,303)

    Inventory





    (17,781)





    14,860

    Prepaid expenses and other assets





    6,799





    (5,549)

    Accounts payable





    9,309





    (15,236)

    Accrued clinical and manufacturing liabilities





    6,104





    1,603

    Accrued payroll and employee liabilities





    (2,013)





    (3,263)

    Other accrued liabilities





    (13,343)





    19,681

    Net cash used for operating activities





    (132,266)





    (97,603)

    Investing activities:













    Purchases of short-term investments





    (92,040)





    (287,579)

    Maturities and sales of short-term investments





    248,525





    395,406

    Purchases of property and equipment





    (4,319)





    (3,251)

    Net cash provided by investing activities





    152,166





    104,576

    Financing activities:













    Net proceeds from sale of common stock









    (110)

    Proceeds from stock option exercises





    1,833





    20,239

    Proceeds from purchases under the Employee Stock Purchase Plan





    1,507





    1,170

    Proceeds from warrant exercises





    3





    Net cash provided by financing activities





    3,343





    21,299

    Net increase in cash and cash equivalents





    23,243





    28,272

    Cash and cash equivalents at beginning of year





    71,898





    31,836

    Cash and cash equivalents at end of period



    $

    95,141



    $

    60,108

    Investor Relations and Media Contact:

    David Szekeres

    EVP, Chief Operating 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-nine-months-ended--september-30-2020-and-highlights-recent-corporate-updates-301166525.html

    SOURCE Heron Therapeutics, Inc.

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  8. SAN DIEGO, Sept. 28, 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 Commission has granted a marketing authorization for ZYNRELEF (formerly known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. The marketing authorization follows the European Medicines Agency's (EMA) positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in July 2020. Heron currently expects to make ZYNRELEF available to patients in the European Union (EU) during…

    SAN DIEGO, Sept. 28, 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 Commission has granted a marketing authorization for ZYNRELEF (formerly known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. The marketing authorization follows the European Medicines Agency's (EMA) positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in July 2020. Heron currently expects to make ZYNRELEF available to patients in the European Union (EU) during 2021.

    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. For approximately 72 hours after ZYNRELEF is applied into the surgical site, ZYNRELEF releases bupivacaine and meloxicam, which are then absorbed into the surrounding tissues. Meloxicam potentiates the effect of bupivacaine, resulting in an increase in analgesia.

    The European Commission's authorization of ZYNRELEF is based on the results of Heron's two multi-center, double-blind, active and placebo-controlled 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 saline placebo and to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF also significantly increased the proportion of patients who required no postoperative opioids. The most common side effect with ZYNRELEF is dizziness.

    The European Commission's centralized marketing authorization is valid for the 27 countries that are members of the EU and the United Kingdom. Norway, Iceland and Liechtenstein will make corresponding decisions based on the decision of the European Commission.

    "The authorization of ZYNRELEF in the EU is an important milestone for Heron, as well as for the millions of surgical patients in the EU for whom safety, pain relief and recovery are of primary importance," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron. "With a novel dual mechanism of action, and single, needle-free application, ZYNRELEF has been clinically shown to better manage severe pain than standard-of-care bupivacaine over 72 hours and we believe that ZYNRELEF adds an effective therapeutic option for the management of postoperative pain for eligible patients."



    About ZYNRELEF (Approved in the European Union)

    ZYNRELEF, a 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 saline placebo and to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF is indicated for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. Efficacy and safety have not been established in major surgeries, including abdominal, vascular and thoracic surgeries. ZYNRELEF should be administered in a setting where trained personal and equipment are available to ensure prompt treatment of any toxic neurological or cardiac effects. ZYNRELEF received authorization from the European Commission in September 2020.

    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. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to HTX-011 and the New Drug Application (NDA) received Priority Review designation. A complete response letter (CRL) was received from the FDA regarding the 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. 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 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 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-european-commission-authorization-for-zynrelef-htx-011-for-the-treatment-of-postoperative-pain-301138692.html

    SOURCE Heron Therapeutics, Inc.

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  9. 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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  10. 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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  11. 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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  12. 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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  13. 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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  14. SAN DIEGO, July 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 the initiation of 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 follows clearance from the U.S. Food and Drug Administration (FDA) of Heron's Investigational New Drug application for CINVANTI for the treatment of COVID-19.

    CINVANTI is an intravenous formulation of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist…

    SAN DIEGO, July 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 the initiation of 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 follows clearance from the U.S. Food and Drug Administration (FDA) of Heron's Investigational New Drug application for CINVANTI for the treatment of COVID-19.

    CINVANTI is an intravenous formulation of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist (RA) approved for use for the prevention of chemotherapy-induced nausea and vomiting in patients with cancer. Substance P, and its receptor NK1, is distributed throughout the body in the cells of many tissues and organs, including the lungs. COVID-19, which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is associated with lower respiratory tract inflammation that often progresses to Acute Respiratory Distress Syndrome (ARDS). ARDS is associated with high mortality.

    Heron's rationale for the investigation of CINVANTI for the treatment of COVID-19 is based on multiple potential mechanisms for activity. Suppressing the cytokine storm could be a crucial step to prevent the clinical deterioration of patients with COVID-19. Administration of aprepitant injectable emulsion to these patients is expected to decrease the production and release of inflammatory cytokines mediated by the binding of substance P to NK1 receptors, which could prevent the progression of lung injury to ARDS. A hallmark of COVID-19 is a non-productive neurogenic cough, likely due to the increased susceptibility of lung tissue to neurogenic inflammation caused by the disease. Recent studies have demonstrated that administration of oral aprepitant resulted in significantly decreased severity of cough in patients with neurogenic cough associated with advanced lung cancer. Additionally, aprepitant may have direct antiviral activity. Using a computational screening approach, aprepitant was found to have the ability to form hydrogen bonds to key residues within the binding pocket of the main protease of SARS-CoV-2, which is a key enzyme required for replication. CINVANTI is approved for administration as a 2-minute intravenous injection. For these potential benefits, the plasma concentrations of aprepitant produced with the 2-minute intravenous injection of CINVANTI could provide a unique advantage over other methods of administration.

    GUARDS-1, also referred to as Study HTX-019-202, is a randomized, placebo-controlled, double-blinded, Phase 2 study designed to investigate the efficacy and safety of adding daily dosing of CINVANTI for 14 days as a 2-minute intravenous injection to standard of care to reduce mortality and the need for assisted ventilation in early hospitalized adult patients with a confirmed SARS–CoV-2 infection. The use of remdesivir through the Emergency Use Authorization and dexamethasone as standard of care are both permitted in the study. The study will include up to approximately 100 adult patients who are hospitalized with a confirmed SARS-CoV-2 infection less than 24 hours prior to randomization. Importantly, the participating clinical study sites have a high concentration of racial and ethnic minority patients affected by COVID-19.

    "The COVID-19 pandemic has impacted millions of Americans. With the rate of hospitalization increasing in many states, many intensive care units (ICUs) are reaching capacity. Identifying marketed drugs that may keep more patients out of the ICUs is the most efficient way to impact the current crisis," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron. "With an existing commercial supply chain for CINVANTI and a positive safety profile in over 1 million single-dose administrations to patients with cancer who also receive dexamethasone, we are hopeful that we can deliver an effective therapeutic option for patients with COVID-19."

    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.

    IMPORTANT SAFETY INFORMATION

    Contraindications

    CINVANTI is contraindicated in patients with hypersensitivity to any of the components of CINVANTI.

    Concurrent use of pimozide with CINVANTI is contraindicated.

    Warnings and Precautions

    Clinically Significant CYP3A4 Drug Interactions

    Aprepitant is a substrate, weak-to-moderate (dose-dependent) inhibitor, and an inducer of CYP3A4.

    • Use of CINVANTI with other drugs that are CYP3A4 substrates may result in increased plasma concentration of the concomitant drug.
      • Use of pimozide with CINVANTI is contraindicated due to the risk of significantly increased plasma concentrations of pimozide, potentially resulting in prolongation of the QT interval, a known adverse reaction of pimozide.
    • Use of CINVANTI with strong or moderate CYP3A4 inhibitors (e.g., ketoconazole, diltiazem) may increase plasma concentrations of aprepitant and result in an increased risk of adverse reactions related to CINVANTI.
    • Use of CINVANTI with strong CYP3A4 inducers (e.g., rifampin) may result in a reduction in aprepitant plasma concentrations and decreased efficacy of CINVANTI.

    Hypersensitivity Reactions

    Serious hypersensitivity reactions, including anaphylaxis, during or soon after administration of CINVANTI have occurred. Symptoms including dyspnea, eye swelling, flushing, pruritus, and wheezing have been reported. If hypersensitivity reactions occur, discontinue CINVANTI. Do not reinitiate CINVANTI in patients who experience these symptoms with previous use.

    Decrease in INR with Concomitant Warfarin

    Co-administration of CINVANTI with warfarin, a CYP2C9 substrate, may result in a clinically significant decrease in the International Normalized Ratio (INR) of prothrombin time. Monitor the INR in patients on chronic warfarin therapy in the 2-week period, particularly at 7 to 10 days, following initiation of CINVANTI with each chemotherapy cycle.

    Risk of Reduced Efficacy of Hormonal Contraceptives

    The efficacy of hormonal contraceptives may be reduced during administration of and for 28 days following the last dose of CINVANTI. Advise patients to use effective alternative or back-up methods of non-hormonal contraception during treatment with CINVANTI and for 1 month following administration of CINVANTI or oral aprepitant, whichever is administered last.

    Use in Specific Populations

    Avoid use of CINVANTI in pregnant women as alcohol is an inactive ingredient for CINVANTI. There is no safe level of alcohol exposure in pregnancy.

    Adverse Reactions

    The most common adverse reactions are:

    • Single-dose fosaprepitant with MEC (≥2%): fatigue, diarrhea, neutropenia, asthenia, anemia, peripheral neuropathy, leukopenia, dyspepsia, urinary tract infection, pain in extremity.
    • 3-day oral aprepitant with MEC (≥1% and greater than standard therapy): fatigue and eructation.
    • Single-dose fosaprepitant with HEC: generally similar to 3-day oral aprepitant. In addition, infusion site reactions (3%) occurred.
    • Single-dose CINVANTI (≥2%): headache and fatigue. The safety profile of CINVANTI in healthy subjects who received a single 2-minute injection was similar to that seen with a 30-minute infusion.

    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 and results of the studies for the HTX-019-202 development program; the potential market opportunity for HTX-019-202; 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-initiation-of-phase-2-clinical-study-of-cinvanti-for-the-treatment-of-covid-19-301094550.html

    SOURCE Heron Therapeutics, Inc.

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  15. SAN DIEGO, June 29, 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 it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on June 26, 2020 regarding its New Drug Application (NDA) for HTX-011 for the management of postoperative pain.

    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 CMC issues. There…

    SAN DIEGO, June 29, 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 it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on June 26, 2020 regarding its New Drug Application (NDA) for HTX-011 for the management of postoperative pain.

    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 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. The Company will request a Type A meeting to obtain agreement with the Agency on our responses and resubmit the application as quickly as possible.

    "We are committed to resolving the non-clinical issues outlined in the CRL with the FDA and resubmitting an NDA as soon as possible to bring this important non-opioid analgesic to patients," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron.

    Conference Call and Webcast

    Heron will host a conference call and webcast today, June 29, 2020, at 9:00 a.m. ET (6:00 a.m. PT). The conference call can be accessed by dialing 877-311-5906 for domestic callers and 281-241-6150 for international callers. Please provide the operator with the passcode 3252267 to join the conference call. The conference call will be available via webcast under the Investor Relations section of Heron's website at www.herontx.com. An archive of today's teleconference and webcast will be available on Heron's website for 60 days following the call.

    About HTX-011 for Postoperative Pain

    HTX-011, an investigational non-opioid, 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 of 2018 and received Priority Review designation in December of 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. A Marketing Authorisation Application (MAA) for HTX-011 was validated by the European Medicines Agency (EMA) in March 2019 for review under the Centralised Procedure. 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.

    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; the timing of the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) review process for HTX-011; whether the European Commission (EC) authorizes the Marketing Authorisation Application (MAA) for HTX-011; 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-complete-response-letter-for-htx-011-for-the-management-of-postoperative-pain-301084822.html

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  16. SAN DIEGO, June 4, 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 Study 209, a Phase 2b study of the investigational agent HTX-011 in primary unilateral total knee arthroplasty (TKA), have been published online by The Journal of Arthroplasty in an article entitled "HTX-011 Reduced Pain and Opioid Use After Primary Total Knee Arthroplasty: Results of a Randomized Phase 2b Trial." All primary and key secondary endpoints in Study 209 were achieved, with HTX-011 demonstrating statistically significant reductions in…

    SAN DIEGO, June 4, 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 Study 209, a Phase 2b study of the investigational agent HTX-011 in primary unilateral total knee arthroplasty (TKA), have been published online by The Journal of Arthroplasty in an article entitled "HTX-011 Reduced Pain and Opioid Use After Primary Total Knee Arthroplasty: Results of a Randomized Phase 2b Trial." All primary and key secondary endpoints in Study 209 were achieved, with HTX-011 demonstrating statistically significant reductions in pain intensity 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 significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard–of–care local anesthetic for postoperative pain control.

    In Study 209, patients undergoing primary unilateral TKA who received a single, needle-free application of HTX-011 demonstrated superior pain reduction when compared to patients receiving placebo or bupivacaine solution through 48 and 72 hours. In addition, patients receiving HTX–011 consumed fewer opioids when compared to patients receiving placebo or bupivacaine solution. Fewer patients receiving HTX-011 had severe pain through 72 hours, and more patients receiving HTX-011 were deemed ready for discharge at 8, 12 and 24 hours, both as compared to patients receiving placebo or bupivacaine solution. HTX-011 was well tolerated in Study 209, with a safety profile comparable to placebo and bupivacaine solution. 

    "Effective pain management is crucial after TKA to permit earlier mobilization, maximize patient satisfaction and facilitate outpatient surgery," said Alan J. Rechter, M.D., an orthopedic surgeon at Orthopaedic Associates, LLP. "Based on my experience in Study 209, the fast and easy needle-free administration of HTX-011 provided patients with effective and improved pain control despite taking fewer opioids."

    The Journal of Arthroplasty article can be found here.

    About Study 209

    Study 209 was a randomized, placebo- and active-controlled, double-blind, Phase 2b clinical study in patients undergoing primary unilateral total knee arthroplasty to evaluate the analgesic efficacy, safety and pharmacokinetics of HTX-011 locally administered into the surgical site. Following a dose-escalation phase, 232 patients were randomized, and 222 patients received treatment with: (1) HTX-011 400 mg bupivacaine/12 mg meloxicam administered via instillation into the surgical site; (2) HTX-011 400 mg bupivacaine/12 mg meloxicam administered via instillation into the surgical site plus a low dose of ropivacaine solution injected into the posterior capsule; (3) bupivacaine solution 125 mg administered via multiple injections into the surgical site; or (4) placebo. Ropivacaine solution and bupivacaine solution are generically available standard-of-care local anesthetics used in the management of postoperative pain. This study included a pre-specified hierarchical testing strategy for the primary and key secondary endpoints for the HTX-011 400 mg bupivacaine/12 mg meloxicam treatment groups. The primary endpoint was pain intensity as measured by the Area Under the Curve (AUC) from 0 to 48 hours post-surgery (AUC 0-48) for HTX-011 compared to placebo. The primary and key secondary endpoints were achieved:

    • HTX-011 alone and in combination with ropivacaine solution resulted in reductions of 19% and 22%, respectively, in pain intensity through 48 hours when compared to placebo (p=0.0002 and p<0.0001, respectively).  
    • HTX-011 alone and in combination with ropivacaine solution resulted in reductions of 18% and 22%, respectively, in pain intensity through 72 hours when compared to placebo (p=0.0004 and p<0.0001, respectively).
    • Sensitivity analyses using patient-reported pain scores without adjustment for opioid use confirmed that HTX-011 alone and in combination with ropivacaine solution resulted in reductions of 29% and 27%, respectively, in pain intensity through 48 hours, and 28% and 26%, respectively, in pain intensity through 72 hours when compared to placebo (p≤0.0002 for both comparisons).
    • Sensitivity analyses using patient-reported pain scores without adjustment for opioid use confirmed that HTX-011 alone and in combination with ropivacaine solution resulted in reductions of 19% and 17%, respectively, in pain intensity through 48 hours, and 17% and 16%, respectively, in pain intensity through 72 hours when compared to bupivacaine solution (P<0.05 for both comparisons).
    • Total opioid consumption for HTX-011 alone or in combination with ropivacaine solution was lower over 24, 48 and 72 hours when compared to placebo or bupivacaine solution.

    HTX-011 was well tolerated in Study 209, with a safety profile comparable to placebo and bupivacaine solution.

    About HTX-011 for Postoperative Pain

    HTX-011, an investigational non-opioid, 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 of 2018 and received Priority Review designation in December of 2018. A Complete Response Letter (CRL) was received from the FDA regarding the NDA for HTX-011 on April 30, 2019 relating to chemistry, manufacturing and controls and non-clinical information. No issues related to clinical efficacy or safety were noted. Heron resubmitted an NDA to the FDA for HTX-011 in September 2019. The Prescription Drug User Fee Act (PDUFA) goal date is June 26, 2020. A Marketing Authorisation Application (MAA) for HTX-011 was validated by the European Medicines Agency (EMA) in March 2019 for review under the Centralised Procedure. 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.

    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; the timing of the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) review process for HTX-011; whether the European Commission (EC) authorizes the Marketing Authorisation Application (MAA) for HTX-011; 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 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-study-209-a-phase-2b-study-of-htx-011-in-patients-undergoing-total-knee-arthroplasty-301070514.html

    SOURCE Heron Therapeutics, Inc.

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  17. SAN DIEGO, May 18, 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 it has 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 follows clearance from the U.S. Food and Drug Administration (FDA) of Heron's Investigational New Drug application for HTX-034 for the treatment of postoperative pain.

    HTX-034, an investigational non-opioid, is a fixed-dose combination, extended-release solution of the local anesthetic bupivacaine, the…

    SAN DIEGO, May 18, 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 it has 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 follows clearance from the U.S. Food and Drug Administration (FDA) of Heron's Investigational New Drug application for HTX-034 for the treatment of 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. HTX-034 is designed to provide superior and prolonged analgesia and enhance the activity of the local anesthetic bupivacaine via two different mechanisms. Local administration of HTX-034 in a validated preclinical postoperative pain model resulted in sustained analgesia for 7 days.

    The HTX-034 study is a randomized, active-controlled, double-blinded, Phase 1b/2 study in patients undergoing bunionectomy with an osteotomy and internal fixation. The study will evaluate the safety and efficacy of HTX-034 compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. The Phase 1b portion of the study is intended to select the optimal dose for the Phase 2 expansion portion.

    "We are excited to progress HTX-034 into a proof-of-concept study in patients undergoing bunionectomy, a highly painful surgery, where we have the opportunity to evaluate the magnitude and duration of analgesia," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron. "In the same highly predictive animal model where we optimized HTX-011, HTX-034 has shown enhanced analgesic benefit for 7 days after surgery."

    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 HTX-011 for Postoperative Pain

    HTX-011, an investigational non-opioid, 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 of 2018 and received Priority Review designation in December of 2018. A Complete Response Letter (CRL) was received from the FDA regarding the NDA for HTX-011 on April 30, 2019 relating to chemistry, manufacturing and controls and non-clinical information. No issues related to clinical efficacy or safety were noted. Heron resubmitted an NDA to the FDA for HTX-011 in September 2019. The Prescription Drug User Fee Act (PDUFA) goal date is June 26, 2020. A Marketing Authorisation Application (MAA) for HTX-011 was validated by the European Medicines Agency (EMA) in March 2019 for review under the Centralised Procedure. 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.

    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; the timing of the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) review process for HTX-011; whether the European Commission (EC) authorizes the Marketing Authorisation Application (MAA) for HTX-011; 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 timing and results of studies for the HTX-034 development program; 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-initiation-of-phase-1b2-clinical-study-of-htx-034-for-the-treatment-of-postoperative-pain-301060550.html

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  18. SAN DIEGO, May 6, 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 months ended March 31, 2020 and highlighted recent corporate updates.

    Recent Corporate Updates

    Pain Management Franchise

    • New Drug Application for HTX-011: In September 2019, Heron resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011, an investigational agent for the management of postoperative pain. The Prescription Drug User Fee Act (PDUFA) goal date is June 26, 2020.

    • Contract Manufacturing

    SAN DIEGO, May 6, 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 months ended March 31, 2020 and highlighted recent corporate updates.

    Recent Corporate Updates

    Pain Management Franchise

    • New Drug Application for HTX-011: In September 2019, Heron resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011, an investigational agent for the management of postoperative pain. The Prescription Drug User Fee Act (PDUFA) goal date is June 26, 2020.

    • Contract Manufacturing Site for HTX-011: In February 2020, Heron announced that the contract manufacturing site used to manufacture HTX-011 has been reinspected by the FDA with no Form 483 observations issued and with a recommendation by the FDA inspector for approval of the site. Heron has not been informed of any other manufacturing concerns.

    • Marketing Authorisation Application for HTX-011 in the European Union: In March 2019, Heron's Marketing Authorisation Application (MAA) for HTX-011 for the management of postoperative pain was validated by the European Medicines Agency (EMA) for review under the Centralised Procedure. The medical device certification required for approval in the European Union (EU) for the custom Luer lock applicator developed for application of HTX-011 without a needle was delayed. An opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) is now anticipated in the second half of 2020.

    • New Drug Submission for HTX-011 in Canada: In December 2019, 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. Health Canada's Priority Review status provides an accelerated 6-month review target for the NDS. Heron received the Certificate of Registration for the custom Luer lock applicator issued under the Medical Devices Single Audit Program for the medical device license in Canada. A decision by Health Canada on the NDS is anticipated in the third quarter of 2020.

    CINV Franchise

    • CINV Net Product Sales: For the three months ended March 31, 2020, chemotherapy-induced nausea and vomiting (CINV) franchise net product sales were $25.4 million, compared to $31.6 million for the same period in 2019.

      • CINVANTI® Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three months ended March 31, 2020 were $25.2 million, compared to $28.0 million for the same period 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 months ended March 31, 2020 were $0.2 million, compared to $3.6 million for the same period 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: Heron expects 2020 net product sales for the CINV franchise of $70 million to $80 million and the CINV franchise to return to growth in 2021 and beyond.

    "We are encouraged by a recent communication with the FDA where they indicated that they continue on schedule with their review of the NDA for HTX-011, with a PDUFA date of June 26, 2020," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron. "For the CINV franchise, our customers are benefiting from the administration of CINVANTI by 2-minute IV push, an important product advantage compared to competitive products, which has led to strong first-quarter net product sales of $25.4 million."

    Financial Results

    Net product sales for the three months ended March 31, 2020 were $25.4 million, compared to $31.6 million for the same period in 2019.

    Heron's net loss for the three months ended March 31, 2020 was $51.6 million, or $0.57 per share, compared to $63.0 million, or $0.80 per share, for the same period in 2019. Net loss for the three months ended March 31, 2020 included non-cash, stock-based compensation expense of $12.0 million, compared to $17.9 million for the same period in 2019.

    As of March 31, 2020, Heron had cash, cash equivalents and short-term investments of $356.3 million, compared to $391.0 million as of December 31, 2019. Net cash used for operating activities for the three months ended March 31, 2020 was $32.9 million, compared to $49.0 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 for Postoperative Pain

    HTX-011, an investigational non-opioid, 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 of 2018 and received Priority Review designation in December of 2018. A Complete Response Letter (CRL) was received from the FDA regarding the NDA for HTX-011 on April 30, 2019 relating to chemistry, manufacturing and controls and non-clinical information. No issues related to clinical efficacy or safety were noted. Heron resubmitted an NDA to the FDA for HTX-011 in September 2019. The Prescription Drug User Fee Act (PDUFA) goal date is June 26, 2020. A Marketing Authorisation Application (MAA) for HTX-011 was validated by the European Medicines Agency (EMA) in March 2019 for review under the Centralised Procedure. 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.

    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.

    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 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; the timing of the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) review process for HTX-011; whether the European Commission (EC) authorizes the Marketing Authorisation Application (MAA) for HTX-011; 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 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; 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)




    March 31,

    2020



    December 31,

    2019




    (Unaudited)





    ASSETS









    Current assets:









    Cash and cash equivalents


    $

    103,285



    $

    71,898


    Short-term investments



    253,061




    319,074


    Accounts receivable, net



    34,811




    39,879


    Inventory



    34,849




    24,968


    Prepaid expenses and other current assets



    12,442




    23,245


    Total current assets



    438,448




    479,064


    Property and equipment, net



    21,908




    19,618


    Right-of-use lease assets



    18,239




    13,754


    Other assets



    346




    346


    Total assets


    $

    478,941



    $

    512,782


    LIABILITIES AND STOCKHOLDERS' EQUITY









    Current liabilities:









    Accounts payable


    $

    11,562



    $

    2,758


    Accrued clinical and manufacturing liabilities



    35,321




    34,614


    Accrued payroll and employee liabilities



    8,770




    15,248


    Other accrued liabilities



    32,423




    36,535


    Current lease liabilities



    2,755




    1,926


    Convertible notes payable to related parties, net of discount



    5,934




    5,624


    Total current liabilities



    96,765




    96,705


    Non-current lease liabilities



    16,708




    12,242


    Total liabilities



    113,473




    108,947


    Stockholders' equity:









    Common stock



    906




    903


    Additional paid-in capital



    1,580,903




    1,568,317


    Accumulated other comprehensive income



    708




    85


    Accumulated deficit



    (1,217,049)




    (1,165,470)


    Total stockholders' equity



    365,468




    403,835


    Total liabilities and stockholders' equity


    $

    478,941



    $

    512,782












     

    HERON THERAPEUTICS, INC.

    Condensed Consolidated Statements of Operations

    (In thousands, except per share amounts)



    Three Months Ended

    March 31,



    2020


    2019



    (Unaudited)


    Revenues:





        Net product sales

    $      25,400


    $         31,602


    Operating expenses:





        Cost of product sales

    10,622


    14,962


        Research and development

    36,894


    42,972


        General and administrative

    10,422


    9,648


        Sales and marketing

    20,196


    28,720


              Total operating expenses

    78,134


    96,302







    Loss from operations

    (52,734)


    (64,700)







    Other income, net

    1,155


    1,688







    Net loss

    $   (51,579)


    $      (63,012)







    Basic and diluted net loss per share

    $       (0.57)


    $         (0.80)







    Shares used in computing basic and diluted net loss per share

    90,409


    78,419


     

    HERON THERAPEUTICS, INC.

    Consolidated Statements of Cash Flows

    (In thousands)






    Three Months Ended

    March 31,






    2020



    2019






    (Unaudited)


    Operating activities:











    Net loss




    $

    (51,579)



    $

    (63,012)


    Adjustments to reconcile net loss to net cash used for operating activities:











    Stock-based compensation expense





    11,974




    17,902


    Depreciation and amortization





    621




    467


    Amortization of debt discount





    310




    247


    Realized gain on available-for-sale securities








    (8)


    Accretion of discount on short-term investments





    (117)




    (1,357)


    Impairment of property and equipment





    27




    27


    Loss on disposal of property and equipment








    52


    Change in operating assets and liabilities:











    Accounts receivable





    5,068




    (9,355)


    Prepaid expenses and other assets





    10,803




    (346)


    Inventory





    (9,881)




    7,611


    Accounts payable





    8,804




    (6,052)


    Accrued clinical and manufacturing liabilities





    707




    (868)


    Accrued payroll and employee liabilities





    (6,478)




    (6,757)


    Other accrued liabilities





    (3,194)




    12,425


    Net cash used for operating activities





    (32,935)




    (49,024)


    Investing activities:











    Purchases of short-term investments





    (28,922)




    (127,763)


    Maturities and sales of short-term investments





    95,675




    164,009


    Purchases of property and equipment





    (2,938)




    (2,136)


    Net cash provided by investing activities





    63,815




    34,110


    Financing activities:











    Proceeds from stock option exercises





    504




    6,539


    Proceeds from warrant exercises





    3





    Net cash provided by financing activities





    507




    6,539


    Net increase (decrease) in cash and cash equivalents





    31,387




    (8,375)


    Cash and cash equivalents at beginning of year





    71,898




    31,836


    Cash and cash equivalents at end of period




    $

    103,285



    $

    23,461


    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-months-ended-march-31-2020-and-highlights-recent-corporate-updates-301053524.html

    SOURCE Heron Therapeutics, Inc.

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  19. SAN DIEGO, March 2, 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 twelve months ended December 31, 2019 and highlighted recent corporate updates.

    Recent Corporate Updates

    Pain Management Franchise

    • New Drug Application for HTX-011: In September 2019, Heron resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011, an investigational agent for the management of postoperative pain. In February 2020, Heron announced that the FDA has extended the review period…

    SAN DIEGO, March 2, 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 twelve months ended December 31, 2019 and highlighted recent corporate updates.

    Recent Corporate Updates

    Pain Management Franchise

    • New Drug Application for HTX-011: In September 2019, Heron resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011, an investigational agent for the management of postoperative pain. In February 2020, Heron announced that the FDA has extended the review period for the NDA for HTX-011 by up to three months. The new Prescription Drug User Fee Act (PDUFA) goal date is June 26, 2020.
    • Contract Manufacturing Site for HTX-011: In February 2020, Heron announced that the contract manufacturing site used to manufacture HTX-011 has been reinspected by the FDA with no Form 483 observations issued and with a recommendation by the FDA inspector for approval of the site. Heron has not been informed of any other manufacturing concerns.
    • Marketing Authorisation Application for HTX-011 in the European Union: In March 2019, Heron's Marketing Authorisation Application (MAA) for HTX-011 for the management of postoperative pain was validated by the European Medicines Agency (EMA) for review under the Centralised Procedure. An opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) is anticipated in the second quarter of 2020.
    • New Drug Submission for HTX-011 in Canada: In December 2019, 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. Health Canada's Priority Review status provides an accelerated 6-month review target for the NDS. A decision by Health Canada is anticipated in the third quarter of 2020.

    CINV Franchise

    • CINV 2019 Net Product Sales: For the three months ended December 31, 2019, chemotherapy-induced nausea and vomiting (CINV) franchise net product sales were $35.1 million, up 22% from the same period in 2018. For the twelve months ended December 31, 2019, CINV franchise net product sales were $146.0 million, up 88% from the same period in 2018.
      • CINVANTI® Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three and twelve months ended December 31, 2019 were $34.6 million and $132.2 million, respectively, compared to $23.4 million and $56.2 million, respectively, for the same periods in 2018.
      • SUSTOL® Net Product Sales: Net product sales of SUSTOL (granisetron) extended-release injection for the three and twelve months ended December 31, 2019 were $0.5 million and $13.8 million, respectively, compared to $5.4 million and $21.3 million for the same periods in 2018. On October 1, 2019, the Company made a business decision to discontinue all discounting of SUSTOL, which resulted in significantly lower SUSTOL net product sales.
    • 2020 Net Product Sales Guidance: Heron expects 2020 net product sales for the CINV franchise of $70 million to $80 million and the CINV franchise to return to growth in 2021 and beyond.

    "We have made important advances in 2019 in both our pain management and CINV franchises, highlighted by the advancement of HTX-011 toward marketing approvals and strong sales for our CINV franchise," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron Therapeutics. "We look forward to launching HTX-011 for postoperative pain management in the second half of 2020, pending FDA approval."

    Financial Results

    Net product sales for the three and twelve months ended December 31, 2019 were $35.1 million and $146.0 million, respectively, compared to $28.8 million and $77.5 million, respectively, for the same periods in 2018.

    Heron's net loss for the three and twelve months ended December 31, 2019 was $57.9 million and $204.7 million, or $0.65 per share and $2.50 per share, respectively, compared to $49.6 million and $178.8 million, or $0.63 per share and $2.44 per share, respectively, for the same periods in 2018. Net loss for the three and twelve months ended December 31, 2019 included non-cash, stock-based compensation expense of $11.1 million and $51.4 million, respectively, compared to $9.8 million and $33.4 million, respectively, for the same periods in 2018.

    As of December 31, 2019, Heron had cash, cash equivalents and short-term investments of $391.0 million compared to $332.4 million as of December 31, 2018. Net cash used for operating activities for the twelve months ended December 31, 2019 was $124.6 million, compared to $191.8 million for the same period in 2018. Heron expects that its current cash, cash equivalents and short-term investments will be sufficient to fund its operations into 2022.

    About HTX-011 for Postoperative Pain

    HTX-011, an investigational agent, 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 of 2018 and received Priority Review designation in December of 2018. A Complete Response Letter (CRL) was received from the FDA regarding the NDA for HTX-011 on April 30, 2019 relating to chemistry, manufacturing and controls and non-clinical information. No issues related to clinical efficacy or safety were noted. Heron resubmitted an NDA to the FDA for HTX-011 in September 2019. The Prescription Drug User Fee Act (PDUFA) goal date is June 26, 2020. A Marketing Authorisation Application (MMA) for HTX-011 was validated by the European Medicines Agency (EMA) in March 2019 for review under the Centralised Procedure. 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.

    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.

    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 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; the timing of the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) review process for HTX-011; whether the European Commission (EC) authorizes the Marketing Authorisation Application (MAA) for HTX-011; 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 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; 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, except par value amounts)




    December 31,

    2019



    December 31,

    2018






    ASSETS









    Current assets:









    Cash and cash equivalents


    $

    71,898



    $

    31,836


    Short-term investments



    319,074




    300,535


    Accounts receivable, net



    39,879




    64,652


    Inventory



    24,968




    39,032


    Prepaid expenses and other current assets



    23,245




    11,193


    Total current assets



    479,064




    447,248


    Property and equipment, net



    19,618




    14,677


    Right-of-use lease assets



    13,754





    Other assets



    346




    254


    Total assets


    $

    512,782



    $

    462,179


    LIABILITIES AND STOCKHOLDERS' EQUITY









    Current liabilities:









    Accounts payable


    $

    2,758



    $

    16,863


    Accrued clinical and manufacturing liabilities



    34,614




    24,470


    Accrued payroll and employee liabilities



    15,248




    13,397


    Other accrued liabilities



    36,535




    32,715


    Current lease liabilities



    1,926





    Convertible notes payable to related parties, net of discount



    5,624




    4,574


    Total current liabilities



    96,705




    92,019


    Non-current lease liabilities



    12,242





    Total liabilities



    108,947




    92,019


    Commitments and contingencies









    Stockholders' equity:









    Preferred stock, $0.01 par value: 2,500 shares authorized; no shares issued or outstanding at December 31, 2019 and 2018







    Common stock, $0.01 par value: 150,000 shares authorized; 90,304 and 78,174 shares issued and outstanding at December 31, 2019 and 2018, respectively



    903




    782


    Additional paid-in capital



    1,568,317




    1,330,186


    Accumulated other comprehensive income (loss)



    85




    (87)


    Accumulated deficit



    (1,165,470)




    (960,721)


    Total stockholders' equity



    403,835




    370,160


    Total liabilities and stockholders' equity


    $

    512,782



    $

    462,179


     

    HERON THERAPEUTICS, INC.

    Condensed Consolidated Statements of Operations

    (In thousands, except per share amounts)



    Three Months Ended

    December 31,


              Twelve Months Ended

    December 31,


    2019


    2018


    2019


    2018


    (unaudited)





    Revenues:








        Net product sales

    $    35,083


    $      28,844


    $  145,968


    $   77,474

    Operating expenses:








        Cost of product sales

    15,874


    11,572


    61,619


    27,512

        Research and development

    48,277


    39,891


    167,382


    140,032

        General and administrative

    9,874


    8,738


    37,897


    29,263

        Sales and marketing

    20,420


    19,957


    89,764


    64,604

              Total operating expenses

    94,445


    80,158


    356,662


    261,411









    Loss from operations

    (59,362)


    (51,314)


    (210,694)


    (183,937)









    Other income, net

    1,442


    1,755


    5,945


    5,097









    Net loss

    $   (57,920)


    $      (49,559)


    $  (204,749)


    $  (178,840)









    Basic and diluted net loss per share

    $       (0.65)


    $          (0.63)


    $        (2.50)


    $        (2.44)









    Shares used in computing basic and diluted net loss per share

    89,112


    78,086


    81,779


    73,193

     

    HERON THERAPEUTICS, INC.

    Consolidated Statements of Cash Flows

    (In thousands)




    Years Ended December 31,




    2019



    2018



    2017






    Operating activities:













    Net loss


    $

    (204,749)



    $

    (178,840)



    $

    (197,484)


    Adjustments to reconcile net loss to net cash used for operating activities:













    Stock-based compensation expense



    51,411




    33,367




    30,538


    Depreciation and amortization



    2,044




    1,513




    1,531


    Amortization of debt discount



    1,050




    890




    773


    Accretion of discount on short-term investments



    (3,730)




    (3,412)




    (278)


    Realized gain on available-for-sale investments



    (8)








    Impairment of property and equipment



    107




    72





    Loss on disposal of property and equipment



    62




    29




    39


    Change in operating assets and liabilities:













    Accounts receivable



    24,773




    (22,778)




    (39,914)


    Prepaid expenses and other assets



    (12,052)




    (7,482)




    3


    Inventory



    14,064




    (29,122)




    (4,768)


    Accounts payable



    (14,105)




    (1,906)




    11,955


    Accrued clinical and manufacturing liabilities



    10,144




    (3,614)




    13,713


    Accrued payroll and employee liabilities



    1,851




    4,537




    446


    Deferred revenue









    1,664


    Other accrued liabilities



    4,558




    14,941




    11,482


    Net cash used for operating activities



    (124,580)




    (191,805)




    (170,300)


    Investing activities:













    Purchases of short-term investments



    (477,035)




    (497,104)




    (121,570)


    Maturities and sales of short-term investments



    462,406




    227,700




    131,783


    Purchases of property and equipment



    (7,154)




    (9,171)




    (2,553)


    Proceeds from the sale of property and equipment






    25




    78


    Net cash (used for) provided by investing activities



    (21,783)




    (278,550)




    7,738


    Financing activities:













    Net proceeds from sale of common stock and/or pre-funded warrants



    162,151




    363,128




    306,279


    Proceeds from purchases under the Employee Stock Purchase Plan



    2,109




    1,179




    989


    Proceeds from stock option exercises



    22,164




    18,301




    11,463


    Proceeds from warrant exercises



    1








    Repayment of promissory note payable to related party






    (25,000)




    (25,000)


    Net cash provided by financing activities



    186,425




    357,608




    293,731


    Net increase (decrease) in cash and cash equivalents



    40,062




    (112,747)




    131,169


    Cash and cash equivalents at beginning of year



    31,836




    144,583




    13,414


    Cash and cash equivalents at end of year


    $

    71,898



    $

    31,836



    $

    144,583


    Supplemental disclosure of cash flow information: