Aclaris Therapeutics to Participate in Two March Healthcare Conferences

On March 4, 2025 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, reported that the Company will participate in two upcoming healthcare conferences in March (Press release, Aclaris Therapeutics, MAR 4, 2025, View Source [SID1234650871]).

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On Tuesday March 11, 2025, at 3:00 PM EDT, Aclaris’ Chief Executive Officer Dr. Neal Walker and other members of Aclaris’ senior leadership team will participate in a fireside chat during the Leerink Partners Global Healthcare Conference in Miami, Florida.

On Thursday March 27, 2025, at 9:00 AM EDT, Dr. Walker and other members of Aclaris’ senior leadership team will participate in a virtual fireside chat during the H.C. Wainwright 3rd Annual Autoimmune & Inflammatory Disease

Virtual Conference
A live and archived webcast of both events will be accessible on the Events page of View Source The webcasts will be available on the Aclaris website for at least 30 days.

AC Immune to Participate in Upcoming Investor Conferences

On March 4, 2025 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, reported that the company’s management will participate in the following investor conferences in March (Press release, AC Immune, MAR 4, 2025, View Source [SID1234650888]):

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Leerink Partners 2025 Global Healthcare Conference,
Management will participate in investor meetings on March 10, 2025

Barclays 27th Annual Global Healthcare Conference,
Management will participate in investor meetings on March 11, 2025

Please contact your Leerink or Barclays representative or AC Immune to request a one-on-one meeting with AC Immune’s management team at the conferences.

Agios to Present at Upcoming Investor Conferences

On March 4, 2025 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, reported that its management team is scheduled to present at the following conferences (Press release, Agios Pharmaceuticals, MAR 4, 2025, View Source [SID1234650872]):

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Leerink Global Healthcare Conference 2025: Fireside chat on Tuesday, March 11, 2025, at 10:50 a.m. ET
Barclays 27th Annual Global Healthcare Conference: Fireside chat on Wednesday, March 12, 2025, at 12:30 p.m. ET

The live webcast for each event will be accessible on the Investors section of the company’s website (www.agios.com) under the "Events & Presentations" tab. Replays of the webcasts will be archived on the company’s website for at least two weeks following the presentation.

TYPE D MEETING OUTCOME WITH US FOOD AND DRUG ADMINISTRATION

On March 3, 2025 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), reported a regulatory update on its planned US clinical trial following its Type D meeting with the United States Food and Drug Administration (FDA) (Press release, Amplia Therapeutics, MAR 3, 2025, View Source [SID1234650784]).

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The Company has previously disclosed plans for a clinical trial in the US of its best-in-class FAK inhibitor narmafotinib, in combination with the chemotherapy regime FOLFIRINOX, in advanced pancreatic cancer patients. FOLFIRINOX, which is a mixture of four different drugs, is the preferred first-line treatment option for advanced pancreatic cancer in the US. The Company has previously reported1 that narmafotinib enhances the activity of FOLFIRINOX in preclinical models of pancreatic cancer.

A Type D meeting is an opportunity for a company to seek feedback from the FDA for specific questions regarding clinical development activities. The Company sought the FDA’s feedback regarding modifications to the clinical trial protocol previously submitted as part of the Investigational New Drug application cleared by the FDA in January 20242 . Specifically, the Company was seeking commentary regarding changes to the dose-escalation and dose-optimization phase of the study and concerning removal of a pharmacokinetic assessment of FOLFIRINOX in the trial. In the written response received by the Company, the FDA noted that the proposed changes ‘appear reasonable’ clearing the way for the Company to finalise the study protocol and initiate the final stages of trial planning prior to commencing the study.

Amplia CEO and MD Dr Chris Burns commented: "We are grateful for the thoughtful input from the FDA regarding the modifications to our clinical trial protocol. These changes will allow the Company to progress the trial in a more time-efficient and capital-efficient manner, and we are now in the final planning stages to start the trial in the coming months."

Dr Burns continued: "Positive data from this clinical study, combined with promising data from the current ACCENT trial – where narmafotinib is combined with gemcitabine and Abraxane – will position narmafotinib as the preferred drug to combine with the two main chemotherapy regimes used for the treatment of pancreatic cancer across the globe."

EMERGENT BIOSOLUTIONS REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS

On March 3, 2025 Emergent BioSolutions Inc. (NYSE: EBS) reported financial results for the quarter and year ended December 31, 2024 (Press release, Emergent BioSolutions, MAR 3, 2025, View Source [SID1234650833]).

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"As we close out 2024, I’m proud to share we delivered favorable full-year financial results driven by our core products, all the while, completing a series of strategic stabilization actions to strengthen our financial position ahead of plan," said Joe Papa, president and chief executive officer of Emergent. "This strong foundation enables Emergent to focus on profitable revenue growth and cash generation as we move forward with turnaround activities, a critical phase in our multi-year transformation plan. Our results and progress are a testament to the hard work and dedication of our entire team, and we believe Emergent’s future will be defined by the durability of our business, opportunities for new markets and innovation, and a steadfast commitment to protecting and saving lives."

FINANCIAL HIGHLIGHTS(1)
Q4 2024 vs. Q4 2023
($ in millions, except per share amounts) Q4 2024 Q4 2023 % Change
Total Revenues $ 194.7 $ 276.6 (30) %
Net Loss $ (31.3) $ (49.5) 37 %
Net Loss per Diluted Share $ (0.58) $ (0.95) 39 %
Adjusted Net Income (Loss)(2)
$ 2.6 $ (40.0) 107 %
Adjusted Net Income (Loss) per Diluted Share(2)
$ 0.05 $ (0.77) 106 %
Adjusted EBITDA(2)
$ 21.0 $ 3.4 518 %
Total Segment Gross Margin %(2)
29 % 25 %
Total Segment Adjusted Gross Margin %(2)
40 % 32 %

Year to Date ("YTD") 2024 vs. YTD 2023
($ in millions, except per share amounts) YTD 2024 YTD 2023 % Change
Total Revenues $ 1,043.6 $ 1,049.3 (1) %
Net Loss $ (190.6) $ (760.5) 75 %
Net Loss per Diluted Share $ (3.60) $ (14.85) 76 %
Adjusted Net Loss(2)
$ (12.1) $ (319.0) 96 %
Adjusted Net Loss per Diluted Share(2)
$ (0.23) $ (6.23) 96 %
Adjusted EBITDA(2)
$ 183.1 $ (22.3) 921 %
Total Segment Gross Margin %(2)
26 % 25 %
Total Segment Adjusted Gross Margin %(2)
45 % 33 %

1

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SELECT 2024 FULL YEAR BUSINESS UPDATES
•Appointed industry leader Joseph C. Papa as President, CEO and Director
•Appointed Dr. Simon Lowry as Chief Medical Officer and Head of Research and Development
•Received approximately $550 million of Medical Countermeasure Contract Modification Awards
•Awarded procurement contract valued up to $235.8 million to supply BioThrax (Anthrax Vaccine Adsorbed) to the U.S. Department of Defense
•FDA approved sBLA for expansion of the indication for ACAM2000 to include prevention of mpox disease in individuals determined to be at high risk

•Repaid $168 million of debt and extended maturities to 2029 with new $250 million secured term loan and $100 million asset-backed revolving credit facility
•Completed $117 million of targeted asset divestitures and streamlined manufacturing footprint
•Resolved legacy legal disputes including receipt of $50 million settlement payment from Janssen
•Received $30 million in development milestone payments from Bavarian Nordic as part of the sale of the Travel Health Business
•Returned to strong, positive operating cash flow
FOURTH QUARTER 2024 FINANCIAL PERFORMANCE(1)
Revenues
The Company uses the following categories in discussing product/service level revenues:
•NARCAN — comprises contributions from NARCAN Nasal Spray
•Anthrax MCM — comprises contributions from CYFENDUS, previously known as AV7909, BioThrax, Anthrasil and Raxibacumab
•Smallpox MCM — comprises contributions from ACAM2000, VIGIV CNJ-016 and TEMBEXA
•Other Products — comprises contributions from BAT and RSDL
•Bioservices — comprises service and lease revenues from the Bioservices business
($ in millions) Q4 2024 Q4 2023 % Change
Product sales, net:(3)
NARCAN
$ 65.1 $ 111.0 (41) %
Anthrax MCM 32.5 111.6 (71) %
Smallpox MCM 76.5 11.5 565 %
Other Products 7.8 15.0 (48) %
Total Product sales, net $ 181.9 $ 249.1 (27) %
Bioservices:
Services $ 6.8 $ 20.6 (67) %
Leases 0.6 0.2 200 %
Total Bioservices revenues $ 7.4 $ 20.8 (64) %
Contracts and grants $ 5.4 $ 6.7 (19) %
Total revenues $ 194.7 $ 276.6 (30) %

2

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Product Sales, net
NARCAN
For Q4 2024, revenues from NARCAN (naloxone HCl) Nasal Spray decreased $45.9 million, or 41%, as compared with Q4 2023. The decrease was primarily driven by lower sales of over-the-counter ("OTC") NARCAN, coupled with lower revenues for Canadian retail sales.
Anthrax MCM
For Q4 2024, revenues from Anthrax MCM products decreased $79.1 million, or 71%, as compared with Q4 2023. The decrease reflects the impact of timing of sales related to CYFENDUS, Anthrasil, and BioThrax. Anthrax vaccine product sales are primarily made under annual purchase options exercised by the U.S. government (the "USG"). Fluctuations in revenues result from the timing of USG purchases and the exercise of annual purchase options, the availability of governmental funding and the Company’s delivery of orders that follow.
Smallpox MCM
For Q4 2024, revenues from Smallpox MCM products increased $65.0 million, or 565%, as compared with Q4 2023. The increase was primarily due higher ACAM2000 sales to non-U.S. customers and timing of USG purchases of VIGIV CNJ-016. Fluctuations in revenues result from the timing of USG purchases and the exercise of annual purchase options in existing procurement contracts, the availability of governmental funding and Company delivery of orders that follow.
Other Products
For Q4 2024, revenues from Other Product sales decreased $7.2 million, or 48%, as compared with Q4 2023. The decrease was due to lower sales of RSDL, which was sold to SERB during the third quarter of 2024, and lower product sales of BAT, due to timing of deliveries.
Bioservices Revenues
Services
For Q4 2024, revenues from Bioservices services decreased $13.8 million, or 67%, as compared with Q4 2023. The decrease was primarily attributable to the sale of the Camden facility to Bora Pharmaceuticals Injectables Inc., a subsidiary of Bora Pharmaceuticals Co., Ltd ("Bora"), during the third quarter of 2024, coupled with lower revenue from the Company’s Bayview facility as a result of the prior year resolution of a customer’s outstanding obligation, partially offset by higher production from the Company’s Winnipeg facility.
Leases
For Q4 2024, revenues from Bioservices leases increased $0.4 million, or 200%, as compared with Q4 2023. The increase was attributable to an increase in lease revenue associated with SERB at our Winnipeg facility.
Contracts and Grants
For Q4 2024, revenues from contracts and grants decreased $1.3 million, or 19%, as compared with Q4 2023. The decrease was primarily attributable to the wind-down of various development initiatives.