On May 7, 2024 Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, reported financial results for the three months ended March 31, 2024 and highlighted recent corporate updates (Press release, Heron Therapeutics, MAY 7, 2024, View Source [SID1234642773]).

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"We are extremely pleased with our ability to improve the financial efficiency of the business by growing revenues, improving margins, and reducing expenses. We made tremendous progress this quarter by promptly training CrossLink sales representatives and integrating them into our commercial execution, while also training our own commercial team on the newly expanded label for ZYNRELEF," said Craig Collard, Chief Executive Officer of Heron.

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 late 2024.

The ZYNRELEF Prefilled Syringe ("PFS"), to allow for immediate use of ZYNRELEF, continues to progress with an expected submission for approval in 2026.

The training and integration of CrossLink Life Sciences, LLC ("CrossLink") sales representatives to promote ZYNRELEF to orthopedic surgeons has progressed quickly, with a total of 191 CrossLink sales representatives, to date, having completed training and actively engaging with their respective physicians. As we continue to expand our reach across the nation, we anticipate an additional fifty CrossLink sales representatives will complete training and be ready to engage with their respective physicians on ZYNRELEF within the next thirty days.

Following the FDA’s approval for the expanded indication of ZYNRELEF on January 23, 2024, ZYNRELEF is now approved for postsurgical analgesia for up to 72 hours after soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. ZYNRELEF was previously approved for foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures in adults.

Heron will host its Investor Day event on Wednesday, May 15, 2024, from 9:30 a.m. – 12:30 p.m. ET in New York, New York. Members of Heron’s leadership team will give presentations during the event highlighting Heron’s recent organizational transformation and the commercial opportunity across the acute care and oncology franchises. To register for the event to attend in-person or virtually, please click here.
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 months ended March 31, 2024, acute care franchise Net Product Sales were $5.5 million, which increased from $3.8 million for the same period in 2023.

ZYNRELEF Net Product Sales: Net Product Sales of ZYNRELEF (bupivacaine and meloxicam) extended-release solution for the three months ended March 31, 2024 was $5.0 million, which increased from $3.5 million for the same period in 2023.

APONVIE Net Product Sales: Net Product Sales of APONVIE for the three months ended March 31, 2024 was $0.5 million, which increased from $0.3M, for the same period in 2023.
Oncology Care Franchise

Oncology Care Franchise Net Product Sales: For the three months ended March 31, 2024, oncology care franchise Net Product Sales was $29.2 million, which increased from $25.8 million for the same period in 2023.

CINVANTI Net Product Sales: Net Product Sales of CINVANTI (aprepitant) injectable emulsion for the three months ended March 31, 2024 was $25.6 million, which increased from $22.8 million for the same period in 2023.

SUSTOL Net Product Sales: Net Product Sales of SUSTOL (granisetron) extended-release injection for the three months ended March 31, 2024 was $3.6 million, which increased from $3.0 million, for the same period in 2023.
Conference Call and Webcast

Heron will host a conference call and webcast on May 7, 2024 at 8:30 a.m. 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 1497932 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 sixty days following the call.

On May 7, 2024 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines, reported financial results for the first quarter ended March 31, 2024, and provided an update on clinical and corporate developments (Press release, Fusion Pharmaceuticals, MAY 7, 2024, View Source [SID1234642772]).

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Chief Executive Officer John Valliant, Ph.D., commented, "In the first quarter, we demonstrated the potential of FPI-2265 to serve as an important new treatment option for patients with mCRPC, presenting interim data from the TATCIST trial at the 2024 AACR (Free AACR Whitepaper) Annual Meeting that we believe represent compelling early clinical activity and tolerability data. We look forward to continuing to develop FPI-2265 as the most advanced actinium-based prostate specific membrane antigen (PSMA) targeting therapy and expect to begin a Phase 2 dose optimization trial in the second quarter of this year, followed by a Phase 3 global registrational trial in 2025. In parallel, we are progressing our other clinical-stage programs as part of our diverse portfolio of alpha-emitting RCs."

Corporate Update

On March 19, 2024, Fusion announced that it entered into a definitive agreement to be acquired by AstraZeneca. Under the terms of the definitive agreement, AstraZeneca, through a subsidiary, will acquire all of Fusion’s outstanding shares pursuant to a plan of arrangement for a price of $21.00 per share in cash at closing plus a non-transferable contingent value right (CVR) of $3.00 per share in cash payable upon the achievement of a specified regulatory milestone.

On April 22, 2024 at 11:59pm, the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, expired with respect to the transaction, satisfying one of the closing conditions. On May 1, 2024, the Canadian Competition Bureau issued a no-action letter stating that it would not challenge the transaction, satisfying another closing condition. The transaction is expected to close in the second quarter of 2024, subject to other customary closing conditions, including the approval of Fusion shareholders.

Portfolio Update

FPI-2265: A 225Ac-based RC targeting PSMA for the treatment of patients with mCRPC.

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In April 2024, Fusion presented interim data from the Phase 2 TATCIST trial evaluating FPI-2265 at the 2024 AACR (Free AACR Whitepaper) Annual Meeting. Results demonstrated that FPI-2265 is active in heavily pretreated patients with progressive mCRPC, including patients who received prior lutetium-based radioligand therapy (RLT), and support Fusion’s ongoing FPI-2265 Phase 2/3 development program.
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In January 2024, the Company announced alignment with the FDA on its Phase 2/3 protocol for FPI-2265 in patients with mCRPC with progressive disease who have previously been treated with a 177Lu-based PSMA radiotherapy. The development plan includes a Phase 2 dose optimization lead-in, which
aims to evaluate whether there are added safety and/or efficacy benefits of various dosing regimens in comparison to the validated regimen of 100kBq/kg every eight weeks, expected to be initiated in the second quarter of 2024. This Phase 2 portion is expected to complete enrollment of approximately 60 patients by the end of 2024. Following analysis of the Phase 2 data and an end of Phase 2 meeting to determine the recommended Phase 3 dosing regimen with the FDA, a Phase 3 global registrational trial in approximately 550 patients is expected to begin in 2025.
•
Fusion is also pursuing the opportunity to potentially develop this product candidate into earlier lines of treatment with combinations of FPI-2265 and olaparib. Fusion expects to initiate a combination trial in the second quarter of 2024.

FPI-1434: Targeting insulin growth factor 1 receptor (IGF1R)

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In January 2024, Fusion announced encouraging early findings from Cohort 2 in the cold/hot dosing arm of its ongoing Phase 1, multi-center, open-label clinical trial. The trial is designed to investigate the safety, tolerability, and pharmacokinetics of FPI-1434 in patients with solid tumors expressing IGF-1R. The trial is also designed to establish the maximum tolerated dose for FPI-1434 and the recommended Phase 2 dose. No dose limiting toxicities (DLTs) were observed to date in the 25 kBq/kg dose cohort. Two out of three patients completed the DLT period, and one pancreatic cancer patient discontinued treatment due to disease progression. Evidence of anti-tumor activity was observed in a heavily pre-treated patient with Ewing sarcoma after a single dose and a second patient receiving four cycles of therapy demonstrated stable disease as best response.
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Fusion plans to complete and further evaluate results from Cohort 2 and hold a Safety Review Committee (SRC) meeting to evaluate the emerging data. Fusion plans to share more details on the data and the FPI-1434 development program in mid-2024.

FPI-2059: Targeting neurotensin receptor 1 (NTSR1)

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Patient enrollment and dosing is ongoing in the Phase 1, multi-center, open-label clinical trial designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics of FPI-2059 as well as preliminary anti-tumor activity in participants with NTSR1 expressing advanced metastatic solid tumors.

FPI-2068: A bispecific, IgG-based, EGFR-cMET targeted radioconjugate.

•
FPI-2068 is currently being evaluated in a Phase 1 trial and is jointly developed with AstraZeneca. The investigational new drug application has been cleared and the trial is currently open and recruiting. FPI-2068 is a bispecific IgG-based TAT designed to deliver actinium-225 to various solid tumors that express EGFR-cMET. EGFR and cMET are both validated targets that are co-expressed in multiple tumor types, including head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma.

First Quarter 2024 Financial Results

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Cash and Investments: As of March 31, 2024, Fusion held cash, cash equivalents and investments of $283.1 million, compared to cash, cash equivalents and investments of $247.3 million as of December 31, 2023. The increase was primarily attributed to proceeds from sales of common shares under the Company’s at-the-market equity offering program received in the first quarter, as well as net proceeds from a draw down under the Company’s existing debt facility. Fusion expects its existing cash, cash equivalents and investments as of March 31, 2024 will be sufficient to fund operations into the fourth quarter of 2025.
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Collaboration Revenue: For the first quarter of 2024, Fusion did not record any revenue under the AstraZeneca collaboration agreement. For the same period in 2023, Fusion recorded less than $0.1 million of revenue under the AstraZeneca collaboration agreement.
•
R&D Expenses: Research and development expenses for the first quarter of 2024 were $21.3 million, compared to $15.9 million for the same period in 2023. The increase was primarily due to an increase in FPI-2265 program-related costs for our Phase 2 clinical trial of FPI-2265 in patients with mCRPC, and an increase in manufacturing-related costs.
•
G&A Expenses: General and administrative expenses for the first quarter of 2024 were $14.5 million, compared to $9.0 million for the same period in 2023. The increase was primarily due to an increase in professional fees due to higher legal and consulting expenses incurred in connection with the definitive agreement to be acquired by AstraZeneca.
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Net Loss: For the first quarter of 2024, Fusion reported a net loss of $33.7 million, or $0.40 per share, compared with a net loss of $24.3 million, or $0.45 per share, for the same period in 2023.

On May 07, 2024 FibroGen, Inc. reported that the company’s management will participate in the following investor conferences (Press release, FibroGen, MAY 7, 2024, View Source [SID1234642771]):

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Bank of America Health Care Conference
Format: 1×1 investor meetings
Date: Tuesday, May 14, 2024
Location: Las Vegas, NV

H.C. Wainwright 2nd Annual Bioconnect Investor Conference
Format: Fireside Chat and 1×1 investor meetings
Date: Monday, May 20, 2024
Fireside Chat Time: 5:00 – 5:30 PM ET
Location: New York, NY

The live audio webcast of the H.C. Wainwright Fireside Chat will be available to investors and other interested parties on the "Events & Presentations" section of the FibroGen Investor webpage at www.fibrogen.com. A replay will be available for 30 days.

On May 7, 2024– Exelixis, Inc. reported that members of the company’s management team will participate in fireside chats at the following investor conferences in May (Press release, Exelixis, MAY 7, 2024, View Source [SID1234642770]):

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BofA Securities 2024 Health Care Conference: Exelixis is scheduled to present at 2:20 p.m. ET / 11:20 a.m. PT on Tuesday, May 14 in Las Vegas.
Citizens JMP Life Sciences Conference: Exelixis is scheduled to present at 9:30 a.m. ET / 6:30 a.m. PT on Tuesday, May 14 in New York City.
RBC Capital Markets 2024 Global Healthcare Conference: Exelixis is scheduled to present at 2:35 p.m. ET / 11:35 a.m. PT on Tuesday, May 14 in New York City.
To access the webcast links, log onto www.exelixis.com and proceed to the Event Calendar page under the Investors & News heading. Replays will also be available at the same location for at least 30 days.

On May 7, 2024 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported that Joseph J. Ferra, Chief Executive Officer of Elevation Oncology, will participate in a fireside chat at the Citizens JMP Life Sciences Conference on Tuesday, May 14, 2024, at 11:30 am ET (Press release, Elevation Oncology, MAY 7, 2024, View Source;utm_medium=rss&utm_campaign=elevation-oncology-to-present-at-the-citizens-jmp-life-sciences-conference [SID1234642769]).

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A live webcast and replay of the event will be available on the Events page of the Company’s Investor Relations website at View Source