On March 12, 2024 Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, reported financial results for the three and twelve months ended December 31, 2023 and highlighted recent corporate updates (Press release, Heron Therapeutics, MAR 12, 2024, View Source [SID1234641066]).

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"In the fourth quarter of 2023, Heron saw continued positive momentum and an increased sales trajectory in both our acute care and oncology care franchises, illustrating how the strategic decisions made over the past year have positioned the Company for long-term success and profitability," said Craig Collard, Chief Executive Officer of Heron. "I am pleased to share this quarterly update and look forward to building upon what we achieved in the fourth quarter of 2023, providing substantial value and meaningful solutions in the acute care and oncology care settings."

Business Highlights

The ZYNRELEF Vial Access Needle ("VAN") program, to allow for the rapid preparation and administration of ZYNRELEF in the operating room, remains on track for a Prior Approval Supplement ("PAS") submission in Q2 2024 and an anticipated launch in the second half of 2024.
The ZYNRELEF Prefilled Syringe ("PFS"), to allow for immediate use of ZYNRELEF, continues to progress with an expected submission for approval in 2026.
Gross Margin improved to 71% for the quarter, up from 58% in the same period last year.
ZYNRELEF generated record quarterly revenues of approximately $5.6 million.
The CrossLink Life Sciences, LLC partnership finalized on January 7, 2024, will ultimately provide up to 650 additional sales representatives promoting ZYNRELEF to orthopedic surgeons.
Received FDA approval of our supplemental New Drug Application ("sNDA") for ZYNRELEF which expands the ZYNRELEF label to approximately 13 million procedures annually.
Financial Guidance for 2024

The Company reaffirms its full-year 2024 guidance for Product Revenues, Net, Adjusted Operating Expenses and Adjusted EBITDA:

Product Revenues, Net

$138.0 to $158.0 million

Adjusted Operating Expenses
(Excluding Stock-Based Compensation and Depreciation and Amortization)

$108.0 to $116.0 million

Adjusted EBITDA
(Excluding Stock-Based Compensation and Depreciation and Amortization)

$(22.0) to $3.0 million

Acute Care Franchise

Acute Care Franchise Net Product Sales: For the three and twelve months ended December 31, 2023, acute care franchise Net Product Sales were $6.1 million and $19.1 million, respectively, which increased from $3.9 million and $10.2 million, respectively, for the same periods in 2022.
ZYNRELEF Net Product Sales: Net Product Sales of ZYNRELEF (bupivacaine and meloxicam) extended-release solution for the three and twelve months ended December 31, 2023 were $5.6 million and $17.7 million, respectively, which increased from $3.9 million and $10.2 million, respectively, for the same periods in 2022.
APONVIE Net Product Sales: Net Product Sales of APONVIE for the three and twelve months ended December 31, 2023 were $0.5 million and $1.4 million, respectively, with no sales in the comparable prior year periods. APONVIE became commercially available in the U.S. on March 6, 2023.
Oncology Care Franchise

Oncology Care Franchise Net Product Sales: For the three and twelve months ended December 31, 2023, oncology care franchise Net Product Sales were $28.1 million and $107.9 million, respectively, which increased from $26.1 million and $97.5 million, respectively, for the same periods in 2022.
CINVANTI Net Product Sales: Net Product Sales of CINVANTI (aprepitant) injectable emulsion for the three and twelve months ended December 31, 2023 were $24.3 million and $94.9 million, respectively, which increased from $23.1 million and $87.3 million, respectively, for the same periods in 2022.
SUSTOL Net Product Sales: Net Product Sales of SUSTOL (granisetron) extended-release injection for the three and twelve months ended December 31, 2023 were $3.8 million and $13.0 million, respectively, which increased from $3.0 million and $10.2 million, respectively, for the same periods in 2022.
Conference Call and Webcast

Heron will host a conference call and webcast on March 12th, 2024 at 4:30 pm ET. The conference call can be accessed by dialing (646) 307-1963 for domestic callers and (800) 715-9871 for international callers. Please provide the operator with the passcode 6135354 to join the conference call. The conference call will also be available via webcast under the Investor Relations section of Heron’s website at www.herontx.com. An archive of the teleconference and webcast will also be made available on Heron’s website for 60 days following the call.

About ZYNRELEF for Postoperative Pain

ZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the U.S. Food and Drug Administration (the "FDA") in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF’s indication to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. On January 23, 2024, the FDA approved ZYNRELEF for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. ZYNRELEF was granted a marketing authorization by the European Commission in September 2020 and by the United Kingdom Regulatory Authority in January 2021. In August 2023, we cancelled the ZYNRELEF U.K. marketing authorization and, in October 2023, we cancelled the ZYNRELEF European Union (EU) marketing authorization, as we do not plan to commercially launch ZYNRELEF in the U.K. or the EU.

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

About APONVIE for Postoperative Nausea and Vomiting (PONV)

APONVIE is a substance NK1 Receptor Antagonist (RA), indicated for the prevention of PONV in adults. Delivered via a 30-second IV push, APONVIE 32 mg was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron’s approved drug product CINVANTI. APONVIE is supplied in a single-dose vial that delivers the full 32 mg dose for PONV. APONVIE was approved by the FDA in September 2022 and became commercially available in the U.S. on March 6, 2023.

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

About CINVANTI for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the U.S. prescribing information for CINVANTI include 100 mg or 130 mg administered as a 30-minute IV infusion or a 2-minute IV injection.

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

About SUSTOL for CINV Prevention

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-hydroxytryptamine type 3 RA that utilizes Heron’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy).

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

On March 12, 2024 Halia Therapeutics, a clinical-stage biopharmaceutical company pioneering a novel class of small molecule medications designed to combat inflammation, reported that David J. Bearss, Ph.D., President and CEO of Halia Therapeutics, will present at the BIO-Europe Spring 2024 Conference on Tuesday, March 19 (Press release, Halia Therapeutics, MAR 12, 2024, View Source [SID1234641065]).

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Dr. Bearss’ presentation will highlight the recent developments in Halia’s pipeline of novel therapeutics designed to improve patients’ lives with chronic inflammatory disorders and neurodegenerative diseases, including the 2 ongoing Phase II clinical trials evaluating its lead asset, HT-6184, a selective and orally bioavailable first-in-class inhibitor of the NLRP3/NEK7 inflammasome. The presentation will include recent business updates and anticipated milestones.

Details about the presentation are as follows:

Presenter: David J. Bearss, Ph.D., President and CEO of Halia Therapeutics
Date: Tuesday, March 19, 2024, from 11:30 a.m. to 11:45 a.m. CET
Location: Barcelona International Convention Centre – CCIB, Barcelona, Spain
Room: 133/134
Registration: Here

This premier event will mark the 19th edition, bringing together over 1,000 companies, 2,000 visitors, and key decision-makers from around the globe to explore the latest advancements and forge strategic partnerships. Dr. Bearss and Jeff Burton, CFO, will be available for meetings with registered conference attendees.

On March 12, 2024 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that the Korean Patent Office has issued a Notice of Patent Grant for a broad patent that covers the use of Genprex’s lead drug candidate, Reqorsa Immunogene Therapy, in combination with anti-PD-1 and PD-L1 antibodies through 2037 (Press release, Genprex, MAR 12, 2024, View Source [SID1234641064]).

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This patent will expand on the previously granted patents in the U.S., Japan, Mexico, Russia, Australia, Chile and China to cover the use of REQORSA in combination with immune checkpoint inhibitors, e.g., PD-1 and PD-L1 inhibitors. These patents are applicable to Genprex’s Acclaim-2 and Acclaim-3 clinical trials.

"We continue to secure exclusivity for our drug combinations of REQORSA with PD-1 antibodies, such as Keytruda and PD-L1 antibodies, such as Tecentriq, for the treatment of cancer in some of the largest markets," said Thomas Gallagher, Esq., Senior Vice President of Intellectual Property and Licensing at Genprex. "It is important that we continue to add to our global intellectual property estate and to build protection around our drug combinations as we advance REQORSA through the clinic."

The Acclaim-2 study is a Phase 1/2 clinical trial that has three portions – a Phase 1 dose escalation portion, a Phase 2a expansion portion, and a Phase 2b randomized portion. The Acclaim-2 trial uses a combination of REQORSA and Merck & Co.’s Keytruda in patients with late-stage non-small cell lung cancer (NSCLC) whose disease has progressed after treatment with Keytruda. Patients are treated at the 0.06 mg/kg dose level in the first cohort of patients and, subject to the Acclaim-2 SRC approval, will be treated at successive dose levels of 0.09 mg/kg and 0.12 mg/kg. Genprex expects to complete enrollment in the Phase 1 dose escalation portion of the Acclaim-2 study in the second half of 2024. Genprex was granted FDA Fast Track Designation for the Acclaim-2 patient population.

The Acclaim-3 study has two portions – a Phase 1 dose escalation portion and a Phase 2 expansion portion. In November 2022 Genprex filed with the FDA the protocol for the Phase 1/2 Acclaim-3 clinical trial using a combination of REQORSA and Genentech’s Tecentriq as maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC) who develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. The Phase 1 portion of the Acclaim-3 study is open for enrollment, and Genprex expects to complete the Phase 1 portion of the study by the second half of 2024. Genprex was granted FDA Fast Track Designation and Orphan Drug Designation for the Acclaim-3 patient population.

On March 12, 2024 Domain Therapeutics ("Domain"), a clinical-stage global biopharmaceutical company developing innovative drug candidates in immuno-oncology targeting G Protein-Coupled Receptors (GPCRs), and Chime Biologics, a leading Contract Development and Manufacturing Organization (CDMO) that enables its partners’ success in biologics, reported the signing of a manufacturing service agreement for the production of Domain’s best-in-class Treg depleting anti-CCR8 antibody candidate, DT-7012 (Press release, Domain Therapeutics, MAR 12, 2024, View Source [SID1234641063]). This phase of manufacturing aims to deliver an effective therapeutic for cancer patients worldwide.

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Under the terms of the agreement, Chime Biologics will ensure stable cell line development (CLD) and DT-7012 candidate manufacturing to support clinical trials in strategic countries. Chime Biologics’ first global modular facility with single-use bioprocessing technology meets international cGMP standards with proven audit track records.

DT-7012 is a novel anti-CCR8 mAb depleting tumor-infiltrating Tregs, major immunosuppressive cells. Treg depletion with anti-CCR8 mAb has demonstrated a unique anti-tumor potency as a monotherapy.
DT-7012 has a proven best-in-class potential compared to other clinical-stage CCR8 antibodies, paving the way for effective GPCR-targeting immunotherapies, aiming to activate antitumor immunity for cancer patients unresponsive to other treatments. Phase I clinical studies of DT-7012 are expected to start in early 2025 for solid tumors and mid-2025 for cutaneous T-cell lymphoma (CTCL).

Dr. Jimmy Wei, President of Chime Biologics, commented: "We look forward to progressing this strategic partnership, which combines Domain’s leading anti-CCR8 antibody candidate with Chime Biologics’ CLD to commercial manufacturing expertise, contributing to the development of DT-7012 for various cancers".

Stephan Schann, Chief Scientific Officer of Domain Therapeutics, said: "We’re thrilled to collaborate with Chime Biologics, a great scientific and manufacturing expert, to advance DT-7012, our leading anti-CCR8 candidate, to the next development stage. This new GPCR-targeting immunotherapy has immense potential to unlock the immune system’s cancer fighting abilities and help patients globally. At Domain, we prioritize precision research and innovation and embrace new partnerships with organizations that share our vision and passion to advance immuno-oncology".

On March 12, 2024 Champions Oncology, Inc. (Nasdaq: CSBR), a global preclinical and clinical research services provider that offers end-to-end oncology solutions, reported its financial results for its third quarter of fiscal 2024, ended January 31, 2024 (Press release, Champions Oncology, MAR 12, 2024, View Source [SID1234641061]).

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Third Quarter and Recent Highlights:

•Third quarter revenue of $12.0 million, a decline of 6%
•Gross margin declined to 35%
•College of American Pathologists (CAP) has awarded accreditation to US-based laboratory

Ronnie Morris, CEO of Champions, commented, "As discussed over the course of the year, we’re navigating through a challenging economic environment, specifically in the biotech sector, that began approximately one year ago. However, we still remain confident that the tide is turning and we will emerge stronger over the coming quarters." Morris added, "We remain actively engaged with investors in an effort to raise capital for our wholly owned subsidiary, Corellia, AI. Conjunctively, our two lead targets continue to progress with the potential of a licensing deal in the coming quarters."

David Miller, CFO of Champions, added, "In response to our lower revenue growth, we’re strategically right-sizing the business to reduce costs and improve short term results as we rebound to previous revenue levels. These reductions will not have a long-term impact on the business and we believe our quarterly results will gradually improve going forward."

Third Fiscal Quarter Financial Results

Total revenue for the third quarter of fiscal 2024 was $12.0 million compared to $12.8 million for the same period last year, a decrease of 5.9%. The decline in revenue was primarily from customer

Exhibit 99.1
cancellations in prior periods which led to lower study revenue in the third quarter. Total costs and operating expenses for the third quarter of fiscal 2024 were $14.6 million compared to $15.2 million for the third quarter of fiscal 2023, a decrease of $635,000 or 4.2%.

For the third quarter of fiscal 2024, Champions reported a loss from operations of $2.6 million, including $379,000 in stock-based compensation and $481,000 in depreciation and amortization expenses, compared to a loss from operations of $2.5 million, inclusive of $331,000 in stock-based compensation and $575,000 in depreciation and amortization expenses, in the third quarter of fiscal 2023. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported an adjusted EBITDA loss of $1.7 million for the third quarter of fiscal 2024 compared to an adjusted EBITDA loss of $1.6 million in the third quarter of fiscal 2023.

Cost of oncology solutions was $7.8 million for the three-months ended January 31, 2024, an increase of $150,000, or 1.9% compared to $7.7 million for the three-months ended January 31, 2023. The increase in cost of sales was primarily from an increase in compensation expense and mouse costs resulting from some operational inefficiencies. For the three-months ended January 31, 2024, total gross margin was 34.7% compared to 39.7% for the three-months ended January 31, 2023. The lower margin resulted primarily from a combination of a decline in revenue against relatively unchanged fixed costs and higher variable costs due to some operational inefficiencies.

Research and development expense for the three-months ended January 31, 2024 was $2.2 million, a decrease of $1.0 million or 31.7%, compared to $3.2 million for the three-months ended January 31, 2023. The decrease was primarily due to reduced investment in our target discovery program. Sales and marketing expense for the three-months ended January 31, 2024 was $1.8 million, a slight increase of $36,000, or 2.0%, compared to $1.8 million for the three-months ended January 31, 2023. General and administrative expense for the three-months ended January 31, 2024 was $2.8 million, an increase of $195,000, or 7.6%, compared to $2.6 million for the three-months ended January 31, 2023. The increase was primarily from compensation and recruiting expenses and an increase in bad debt reserves.

Net cash used in operating activities was approximately $920,000 for the three-months ended January 31, 2024 and was primarily due to our operational loss, offset by net changes in our working capital accounts and deferred revenue in in the ordinary course of business. Net cash used in investing activities was approximately $125,000 for investment in additional lab and computer equipment. There were no financing activities for the third quarter of fiscal year 2024.

Year-To-Date Financial Results

For the first nine months of fiscal 2024, revenue decreased 11.4% to $36.2 million compared to $40.8 million for the first nine months of fiscal 2023. The decline in revenue was primarily from customer cancellations in fiscal year 2023 resulting in lower study revenue during fiscal year 2024. Total costs and operating expenses for the first nine months of fiscal 2024 were $43.2 million compared to $43.5 million for the first nine months of fiscal 2023, a decrease of $296,000 or 0.7%.

For the first nine months of fiscal 2024, Champions reported a loss from operations of $7.1 million, including $855,000 in stock-based compensation and $1.4 million in depreciation and amortization expenses, compared to a loss from operations of $2.7 million, inclusive of $656,000 in stock-based compensation and $1.7 million in depreciation and amortization expenses, in the first nine months of fiscal 2023. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported an adjusted EBITDA loss of $4.8 million for the first nine months of fiscal 2024 compared to an adjusted EBITDA loss of $400,000 in the first nine months of fiscal 2023.

Exhibit 99.1

Cost of oncology solutions was $22.2 million for the nine-months ended January 31, 2024, a slight decrease of $43,000, or 0.2% compared to $22.2 million for the nine-months ended January 31, 2023. For the nine-months ended January 31, 2024, total gross margin was 38.7% compared to 45.6% for the nine-months ended January 31, 2023. The lower margin resulted from lower revenue against a generally unchanged cost base. The variable cost component of cost of sales did not decline meaningfully despite the lower study volume due to some operational inefficiencies.

Research and development expense for the nine-months ended January 31, 2024 was $7.5 million, a decrease of $1.2 million or 13.8%, compared to $8.7 million for the nine-months ended January 31, 2023. The decrease was primarily from reduced investment in our target discovery program. Sales and marketing expense for the nine-months ended January 31, 2024 was $5.3 million, a slight increase of $135,000, or 2.6%, compared to $5.2 million for the nine-months ended January 31, 2023. The increase was the result of an increase in compensation expense. General and administrative expense for the nine-months ended January 31, 2024 was $8.3 million, an increase of $811,000, or 10.8%, compared to $7.5 million for the nine-months ended January 31, 2023. The increase was primarily due to an increase in compensation and recruiting expenses and allowances for bad debt, offset by a reduction in IT costs.

Net cash used in operating activities was $4.3 million for the nine-months ended January 31, 2024. The cash used in operating activities was primarily due to the net loss from operations excluding non-cash expenses. Net cash used in investing activities was $950,000 and was primarily from investment in additional lab and computer equipment. Net cash used in financing activities was approximately $382,000 resulting from repurchases of common stock and was offset by proceeds received from options exercises.

The Company ended the quarter with cash and cash equivalents on hand of approximately $4.5 million. The Company has no debt.

Conference Call Information:
The Company will host a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT) to discuss its third quarter financial results. To participate in the call, please call 877-545-0523 (Domestic) or 973-528-0016 (International) and enter the access code 860900, or provide the verbal reference "Champions Oncology".
Full details of the Company’s financial results will be available by or before March 18, 2024 in the Company’s Form 10-Q at www.championsoncology.com.
* Non-GAAP Financial Information