On February 24, 2021 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, reported financial results for the three and twelve months ended December 31, 2020 and highlighted recent corporate updates (Press release, Heron Therapeutics, FEB 24, 2021, View Source [SID1234575527]).

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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).

On February 24, 2021 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, reported financial results for the three and twelve months ended December 31, 2020 and highlighted recent corporate updates (Press release, Heron Therapeutics, FEB 24, 2021, View Source [SID1234575526]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

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).

On February 24, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported that receipt of notification from Nasdaq that the Company has regained compliance with the minimum bid price requirement of Nasdaq Listing Rule 5550(a)(2) because the Company’s common stock had a closing price of at least $1.00 per share for a minimum 10 consecutive business days (Press release, Onconova, FEB 24, 2021, View Source [SID1234575525]). As previously reported, the Company was granted until April 5, 2021 to meet this requirement.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Steven Fruchtman, M.D., President and Chief Executive Officer of Onconova Therapeutics, said, "We are pleased that we have regained compliance with Nasdaq’s minimum bid requirement for continued listing of our stock. We appreciate the investor support and confidence we have seen recently. 2021 will continue to be a decisive year for Onconova as ON 123300 enters the clinic in the U.S. in a Phase 1 trial, and we are on target to initiate this trial in patients with advanced cancer in the next few months."

On February 24, 2021 Seagen Inc. (Nasdaq: SGEN) reported that management will participate in a fireside chat at the Cowen 41st Annual Healthcare Conference on Monday, March 1, 2021 at 2:40 p.m. Eastern Time (Press release, Seagen, FEB 24, 2021, View Source [SID1234575524]). The presentation will be webcast live and available for replay from Seagen’s website at www.seagen.com in the Investors section.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On February 24, 2021 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported that it will be hosting a key opinion leader (KOL) meeting on VIP152 for the treatment of hematologic and solid tumors on Friday, March 5, 2021 at 12:00pm Eastern Time (Press release, Vincerx Pharma, FEB 24, 2021, View Source [SID1234575523]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The event will feature presentations by KOLs Ian Flinn, M.D., Ph.D., Director of Sarah Cannon Center for Blood Cancer, John Byrd, M.D., D. Warren Brown Chair of Leukemia Research, The Ohio State University Comprehensive Cancer Center, and Howard "Skip" Burris III, M.D., President and Chief Medical Officer of Sarah Cannon, who will discuss the CDK9 inhibitor landscape in hematologic and solid tumors. Drs. Flinn, Byrd, and Burris will be available to answer questions following the formal presentations.

Vincerx’s management team will also discuss the development plan for their lead product VIP152, a potent and highly selective CDK9 inhibitor optimized for intermittent intravenous treatment. VIP152’s differentiated profile for selectivity, potency, and durability has translated to early signals of clinical activity in Phase 1, notably in patient populations with high unmet medical needs including double-hit DLBCL. In addition, VIP152 has demonstrated on-target disruption of PTEFb function with reductions in kinase activity and mRNA levels of key oncogenes including MYC and MCL-1.

KOLs
Ian Flinn, M.D., Ph.D. is an internationally recognized clinical investigator whose research focuses on the development of new therapies for patients with lymphoma and chronic lymphocytic leukemia. This research includes first in human to phase 3 trials with novel approaches such as immune effector cell therapies, inhibitors of the B cell receptor pathway, and BCL-2 inhibitors amongst others. He is an author of approximately 200 articles in journals such as the New England Journal of Medicine, Lancet, Journal of Clinical Oncology and Blood. Dr Flinn joined Tennessee Oncology and Sarah Cannon in 2006 and serves as Director of Lymphoma Research. In his role, he oversees lymphoma research throughout Sarah Cannon and its affiliates. Dr. Flinn also serves as the director for the Sarah Cannon Center for Blood Cancer at Tennessee Oncology.

John C. Byrd, M.D., is an internationally known researcher and clinical specialist in leukemia and other hematologic malignancies at Ohio State University’s Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute, where he serves as Senior Advisor for Cancer Experimental Therapeutics. He is a Distinguished University Professor of Medicine and Medicinal Chemistry and holds the D. Warren Brown Chair in Leukemia Research. Dr. Byrd is also the Chief Medical Officer for BEAT AML. Dr. Byrd received his medical degree from the University of Arkansas for Medical Sciences. His education continued in hematology and oncology at Walter Reed Army Medical Center and Johns Hopkins University before moving to Columbus to join the faculty at Ohio State University. Dr. Byrd has over 575 publications in leukemia and experimental therapeutics research. He runs a highly translational laboratory focused on drug development in chronic lymphocytic leukemia and related lymphoproliferative disorders. He has been part of the successful development of multiple therapeutics in acute myeloid leukemia and chronic lymphocytic leukemia.

Howard A. "Skip" Burris III, M.D., FASCO, FACP serves as President and Chief Medical Officer of Sarah Cannon, as well as the Executive Director, Drug Development for Sarah Cannon Research Institute. He is an associate of Tennessee Oncology, PLLC, where he practices medical oncology. Dr. Burris’ clinical research career has focused on the development of new cancer agents with an emphasis on first-in-human therapies, having led the trials of many novel antibodies, small molecules, and chemotherapies now FDA approved. In 1997, he established in Nashville the first community-based early phase drug development program, which grew into the Sarah Cannon Research Institute. He has authored over 400 publications and 700 abstracts. Dr. Burris served as President of ASCO (Free ASCO Whitepaper) in 2019-2020 and is serving as Chair of the Board for the 2020-2021 term. He also currently serves on the Board of ASCO (Free ASCO Whitepaper)’s Conquer Cancer Foundation. Additionally, in 2014, Dr. Burris was selected by his peers as a Giant of Cancer Care for his achievements in drug development. Dr. Burris completed his undergraduate education at the United States Military Academy at West Point, his medical degree at the University of South Alabama, and his internal medicine residency and oncology fellowship at Brooke Army Medical Center in San Antonio. While in Texas, he also served as the Director of Clinical Research at The Institute for Drug Development of the Cancer Therapy and Research Center and The University of Texas Health Science Center. He attained the rank of lieutenant colonel in the US Army, and among his decorations, he was awarded a Meritorious Service Medal with oak leaf cluster for his service in Operation Joint Endeavor.