Be Biopharma Announces New Preclinical Data for BE-102, a B Cell Medicine for the Potential Treatment of Hypophosphatasia




Be Biopharma Announces New Preclinical Data for BE-102, a B Cell Medicine for the Potential Treatment of Hypophosphatasia

• Preclinical research demonstrates that a single administration of BE-102 provides continuous secretion of active alkaline phosphatase (ALP) in vivo out to 6 months
• No safety findings observed in long-term pharmacology studies
• Data presented at the American Society of Gene and Cell Therapy (ASGCT) 28^th Annual Meeting

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Be Biopharma, Inc. (“Be Bio”), a clinical-stage company pioneering the discovery and development of engineered B Cell Medicines (BCMs), today presented results from new preclinical research demonstrating a single administration of BE-102, a BCM for the potential treatment for Hypophosphatasia (HPP), produces continuous levels of active ALP long-term in vivo. The findings will be presented during an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) 28^th Annual Meeting on Saturday, May 17, at 10:45 AM CT.

HPP is a genetic disease caused by deficient ALP activity, resulting from pathogenic mutations in the ALPL gene, which leads to multi-systemic clinical complications including deficient bone mineralization. Enzyme replacement therapy (ERT) is the only approved treatment for HPP which requires frequent lifelong injections, and is only available for perinatal/infantile- and juvenile-onset forms of HPP. BE-102 was developed to address these limitations by providing continuous secretion of active ALP from a single infusion, with the flexibility to be titratable and re-dosable as needed. BE-102 is manufactured from primary human B cells by isolating, activating, and precision engineering with CRISPR/Cas9 followed by AAV-mediated delivery of a DNA donor template for the insertion of human ALPL gene into the CCR5 locus (a safe harbor locus) followed by expansion and differentiation in culture into ALP-secreting B lymphocyte lineage cells.

“These studies demonstrate the potential of our B cell medicine platform to deliver B cell derived active ALP with durability out to six months,” said Rick Morgan, Chief Scientific Officer of Be Biopharma. “BE-102 offers a novel and durable approach that may overcome the limitations of current enzyme therapy and does not require pre-conditioning, offering flexibility for re-dosing.”

The presentation highlights both in vivo and in vitro data supporting the target product profile for BE-102. In vivo studies were conducted in immune-deficient NOG-hIL6 mice, confirming long-term engraftment and continuous production of B cell derived active ALP (>175 days) following a single IV administration of BE-102. No BE-102 related adverse events have been observed across multiple in vivo studies. In vitro pharmacology data presented today demonstrates that BE-102 secretes active ALP, which is capable of rescuing calcium deposit inhibited by inorganic pyrophosphate (PPi), a potent inhibitor of bone mineralization and an ALP substrate which accumulates in people with HPP. Be Bio’s in vitro and in vivo pharmacology and safety data established preclinical proof-of-concept that BE-102 has the potential to be a disease-modifying therapy for people with HPP by providing continuous secretion of ALP, with the flexibility to be titratable and re-dosable as needed. A robust package of preclinical studies is planned in anticipation of submission of an IND for a first-in-human clinical trial for people with HPP.

About BE-102

BE-102 is a first-in-class BCM that has been engineered using artificial intelligence-guided protein design to modify primary human B cells to produce ALP, an enzyme deficient in people living with HPP. A single infusion of BE-102 has the potential to provide continuous secretion of therapeutic ALP with the flexibility to be titrated and/or re-dosed, if needed, and without the need for pre-conditioning. BE-102 has been selected as a Development Candidate and has the potential to transform the standard of care for people living with HPP.

About Engineered B Cell Medicines – A New Class of Cellular Medicines

The B cell is a powerful cell that produces thousands of proteins per cell per second at constant levels, and over decades. Precision genome editing can now be used to engineer B Cells that produce therapeutic proteins of interest, driving a new class of cellular medicines – Engineered B Cell Medicines (BCMs) – with the potential to be durable, allogeneic, re-dosable, and administered without pre-conditioning. The promise of BCMs could transform therapeutic biologics with broad application — across protein classes, patient populations and therapeutic areas.

About Be Biopharma

Be Biopharma (“Be Bio”) is pioneering Engineered B Cell Medicines (BCMs) to dramatically improve the lives of patients who are living with Hemophilia B and other genetic diseases, cancer, and other serious conditions. With eyes locked on the patient, our team of purpose-driven scientists, technologists, manufacturing experts and business builders collaborate to create a bold new class of cell therapies. Be Bio was founded in October 2020, and is backed by ARCH Venture Partners, Atlas Venture, RA Capital Management, Nextech, Alta Partners, Longwood Fund, Bristol Myers Squibb, Takeda Ventures, Seattle Children’s Research Institute, Pathway to Cures (the venture philanthropy fund for the National Bleeding Disorders Foundation) and others to re-imagine medicine based on the power of Engineered B cells. For more information, please visit us at Be.Bio and our LinkedIn page.

Contacts

Investor Contact:
ir@be.bio

Media Contact:
media@be.bio

AMVUTTRA® (vutrisiran) Significantly Reduces Mortality and a Range of Important Cardiovascular Events in Patients with ATTR Amyloidosis with Cardiomyopathy: Additional Data from HELIOS-B




AMVUTTRA® (vutrisiran) Significantly Reduces Mortality and a Range of Important Cardiovascular Events in Patients with ATTR Amyloidosis with Cardiomyopathy: Additional Data from HELIOS-B

– Analysis Presented at the Heart Failure 2025 Congress Supports Primary Findings, Highlighting Impact of AMVUTTRA, which Delivers Rapid Knockdown of Transthyretin –

– Additional 42-Month Data Reinforce Vutrisiran’s Impact on the Risk of All-Cause Mortality and Further Underscore the Effect on Cardiovascular Mortality –

– Vutrisiran Demonstrated Substantial Benefit Across a Range of Cardiovascular Events, Notably Reducing Urgent Heart Failure Visits by 46% in the Overall Patient Population During the Double-Blind Period –

– Findings Simultaneously Published in JACC –

– Details of TRITON-CM Phase 3 Study Evaluating Alnylam’s Investigational Next-Generation TTR Silencer, Nucresiran, to be Presented at Congress –

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today presented the most contemporary analysis of the HELIOS-B Phase 3 study of vutrisiran for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM) as a late-breaking abstract at the Heart Failure 2025 Congress, a scientific congress of the European Society of Cardiology, taking place May 17-20 in Belgrade, Serbia. The results demonstrate that vutrisiran, which rapidly knocks down transthyretin, reduces key cardiovascular (CV) events such as CV hospitalizations, and heart failure (HF) hospitalizations. Additionally, in the analysis, urgent HF visits were reduced by 46% (95% CI: 0.30, 0.98; p = 0.041) in the overall population during the double-blind period, compared to placebo. These CV events often precede all-cause mortality (ACM) and are key indicators of disease progression.

Importantly, results from the November 2024 data cut, including further follow up through up to 42 months, reinforce the primary HELIOS-B analysis showing vutrisiran’s effect on ACM, and further demonstrate that vutrisiran reduces CV mortality. Through 42 months, the risk of ACM was reduced by 36% (95% CI: 0.46, 0.88; p = 0.007) and the risk of CV mortality was reduced by 33% (95% CI: 0.47, 0.96; p = 0.038) in the overall population, compared to placebo. For both the primary analysis and the current analysis, vital status through 42 months was ascertained for over 99% of all randomized patients from the HELIOS-B study, underscoring the robustness of the results.

The study was conducted in a contemporary patient population with patients receiving robust background therapy, inclusive of treatment with a TTR stabilizer and SGLT2 inhibitors. The analysis of the HELIOS-B Phase 3 study, including mortality data through up to 42 months, was simultaneously published in JACC.

“From the primary analysis of HELIOS-B, we know that AMVUTTRA profoundly impacts all-cause mortality, while preserving patients’ functional capacity and quality of life,” said Pushkal Garg, M.D., Chief Medical Officer of Alnylam. “These new data—including the impact on mortality, on cardiovascular events and on urgent heart failure visits, the latter of which was reduced by nearly half—add to the story of consistency and magnitude of benefit. I remain impressed by the HELIOS-B results, which are noteworthy given the substantial use of heart failure treatments in the study population, and I believe they continue to reinforce AMVUTTRA as a clinically differentiated, first-line option for patients with ATTR-CM.”

The results from the analysis underscore the rapid and sustained benefits of vutrisiran in treating ATTR-CM across key endpoints:

In a separate presentation on Tuesday, May 20, Alnylam will share findings from a subgroup analysis of HELIOS-B evaluating the impact of vutrisiran on ACM and recurrent CV events among patients identified by investigators as having experienced disease progression while being treated with tafamidis.

Also at the Heart Failure 2025 Congress, Alnylam will present the study design and rationale for TRITON-CM, a Phase 3, randomized, double-blind, study of nucresiran in patients with ATTR-CM. Nucresiran is an investigational next-generation RNAi therapeutic targeting TTR that has been shown to deliver rapid knockdown of TTR greater than 95% with twice-annual dosing in a Phase 1 study. TRITON-CM is an event-driven CV outcomes trial with a primary endpoint of composite ACM and CV events. The study is on track to initiate in the first half of 2025 and will enroll approximately 1,200 patients with wild-type or variant TTR and confirmed cardiomyopathy, including those receiving background stabilizer therapy. Additional details of the study’s secondary endpoints and key inclusion and exclusion criteria will be shared on Monday, May 19.

AMVUTTRA^® (vutrisiran) was approved by the U.S. Food and Drug Administration (FDA) and the Brazilian Health Regulatory Agency (ANVISA) for treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of vutrisiran for the same indication. A formal regulatory decision by the European Commission of the EMA is expected by the third quarter of 2025. Vutrisiran is currently under review for the treatment of ATTR-CM by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Alnylam remains on track to proceed with additional global regulatory submissions for vutrisiran in 2025 and beyond.

For additional information on Alnylam’s presentations at the Heart Failure 2025 Congress, please visit Capella.

Indications and Important Safety Information

Indications Approved by the U.S. FDA

AMVUTTRA^® (vutrisiran) is indicated for the treatment of the:

• cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits.
• polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.

Important Safety Information

Reduced Serum Vitamin A Levels and Recommended Supplementation

AMVUTTRA treatment leads to a decrease in serum vitamin A levels.

Supplementation at the recommended daily allowance (RDA) of vitamin A is advised for patients taking AMVUTTRA. Higher doses than the RDA should not be given to try to achieve normal serum vitamin A levels during treatment with AMVUTTRA, as serum vitamin A levels do not reflect the total vitamin A in the body.

Patients should be referred to an ophthalmologist if they develop ocular symptoms suggestive of vitamin A deficiency (e.g., night blindness).

Adverse Reactions

In a study of patients with hATTR-PN, the most common adverse reactions that occurred in patients treated with AMVUTTRA were pain in extremity (15%), arthralgia (11%), dyspnea (7%), and vitamin A decreased (7%).

In a study of patients with ATTR-CM, no new safety issues were identified.

For additional information about AMVUTTRA, please see the full U.S. Prescribing Information (revised March 2025)

About AMVUTTRA^® (vutrisiran)

AMVUTTRA^® (vutrisiran) is an RNAi therapeutic that delivers rapid knockdown of variant and wild-type transthyretin (TTR), addressing the underlying cause of transthyretin (ATTR) amyloidosis. Administered quarterly via subcutaneous injection, vutrisiran is approved and marketed in more than 15 countries for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults. In Europe, it is administered as a subcutaneous injection once every three months, either by a healthcare professional, or self-administered by patients or their caregivers. Vutrisiran is also in development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM), which encompasses both wild-type and hereditary forms of the disease.

About ATTR

Transthyretin amyloidosis (ATTR) is an underdiagnosed, rapidly progressive, debilitating and fatal disease caused by misfolded transthyretin (TTR) proteins, which accumulate as amyloid deposits in various parts of the body, including the nerves, heart and gastrointestinal tract. Patients may present with polyneuropathy, cardiomyopathy, or both manifestations of disease. There are two different forms of ATTR – hereditary ATTR (hATTR), which is caused by a TTR gene variant and affects approximately 50,000 people worldwide, and wild-type ATTR (wtATTR), which occurs without a TTR gene variant and impacts an estimated 200,000 – 300,000 people worldwide.^1-4

About RNAi

RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. By harnessing the natural biological process of RNAi occurring in our cells, a new class of medicines known as RNAi therapeutics is now a reality. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, function upstream of today’s medicines by potently silencing messenger RNA (mRNA) – the genetic precursors – that encode for disease-causing or disease pathway proteins, thus preventing them from being made. This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases.

About Alnylam Pharmaceuticals

Alnylam (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and prevalent diseases with unmet need. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach yielding transformative medicines. Since its founding in 2002, Alnylam has led the RNAi Revolution and continues to deliver on a bold vision to turn scientific possibility into reality. Alnylam has a deep pipeline of investigational medicines, including multiple product candidates that are in late-stage development. Alnylam is executing on its “Alnylam P⁵x25” strategy to deliver transformative medicines in both rare and common diseases benefiting patients around the world through sustainable innovation and exceptional financial performance, resulting in a leading biotech profile. Alnylam is headquartered in Cambridge, MA.

Alnylam Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements other than historical statements of fact regarding Alnylam’s expectations, beliefs, goals, plans or prospects including, without limitation, Alnylam’s expectations regarding the safety and efficacy of vutrisiran for the treatment of ATTR-CM, including the ability of vutrisiran to reduce mortality and cardiovascular events in ATTR-CM patients and to preserve patients’ functional capacity and quality of life; the potential for vutrisiran to become a first-line therapy for ATTR-CM; the timing of the initiation of the TRITON-CM study and the number of patients who will be enrolled in that study; the timing of additional global regulatory submissions for vutrisiran; the timing or receipt of any additional regulatory approvals for vutrisiran for ATTR-CM; Alnylam’s ability to execute on its “Alnylam P⁵x25” strategy and to deliver transformative medicines in both rare and common diseases benefit patients around the world through sustainable innovation and exceptional financial performance; and Alnylam’s ability to have a leading biotech profile should be considered forward-looking statements.

Actual results and future plans may differ materially from those indicated by these forward-looking statements as a result of various important risks, uncertainties and other factors, including, without limitation, risks and uncertainties relating to Alnylam’s ability to successfully execute on its “Alnylam P⁵x25” strategy; Alnylam’s ability to discover and develop novel drug candidates and delivery approaches and successfully demonstrate the efficacy and safety of its product candidates; the pre-clinical and clinical results for Alnylam’s product candidates; actions or advice of regulatory agencies and Alnylam’s ability to obtain and maintain regulatory approval for its product candidates, as well as favorable pricing and reimbursement; successfully launching, marketing and selling Alnylam’s approved products globally; delays, interruptions or failures in the manufacture and supply of Alnylam’s product candidates or its marketed products; obtaining, maintaining and protecting intellectual property; Alnylam’s ability to manage its growth and operating expenses through disciplined investment in operations and its ability to achieve a self-sustainable financial profile in the future; Alnylam’s ability to maintain strategic business collaborations; Alnylam’s dependence on third parties for the development and commercialization of certain products; the outcome of litigation; the potential risk of future government investigations; and unexpected expenditures; as well as those risks more fully discussed in the “Risk Factors” filed with Alnylam’s 2024 Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC), as may be updated from time to time in Alnylam’s subsequent Quarterly Reports on Form 10-Q, and in other filings that Alnylam makes with the SEC. In addition, any forward-looking statements represent Alnylam’s views only as of today and should not be relied upon as representing Alnylam’s views as of any subsequent date. Alnylam explicitly disclaims any obligation, except to the extent required by law, to update any forward-looking statements.

¹ Hawkins PN, Ando Y, Dispenzeri A, et al. Ann Med. 2015;47(8):625-638.

² Gertz MA. Am J Manag Care. 2017;23(7):S107-S112.

³ Conceicao I, Gonzalez-Duarte A, Obici L, et al. J Peripher Nerv Syst. 2016;21:5-9.

⁴ Ando Y, Coelho T, Berk JL, et al. Orphanet J Rare Dis. 2013;8:31.

Contacts

Alnylam Pharmaceuticals, Inc.


Christine Regan Lindenboom

(Investors and Media)

+1-617-682-4340

Josh Brodsky

(Investors)

+1-617-551-8276

Atara Biotherapeutics Appoints James Huang and Nachi Subramanian to Board of Directors




Atara Biotherapeutics Appoints James Huang and Nachi Subramanian to Board of Directors

THOUSAND OAKS, Calif.–(BUSINESS WIRE)–Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, announced the appointment of James Huang and Nachi Subramanian to its Board of Directors, effective following the completion the Company’s previously announced $16 million offering that was announced on May 15, 2025. The offering closed on May 16, 2025.

Mr. Huang has over 37 years of biotech experience and is the Founder and Managing Partner of Panacea Venture. Prior to Panacea Venture, Mr. Huang was a Managing Partner at Kleiner Perkins (KPCB) China where he focused on the firm’s life sciences practice, and a managing partner at Vivo Ventures where he led numerous investments in China. He was also the president of Anesiva, Inc., a biopharmaceutical company focused on pain-management treatments. Earlier in his career, he held senior roles in business development, sales, marketing, and research and development with Tularik Inc. (acquired by Amgen), GlaxoSmithKline LLC, Bristol-Myers Squibb and ALZA Corp. (acquired by Johnson & Johnson). Additionally, Mr. Huang serves as a member of the board of directors of Kindstar Globalgene Technology, Inc., Connect Biopharma Holdings Limited, Lee’s Pharmaceutical Holdings Limited and several private companies. He received an M.B.A. from the Stanford Graduate School of Business and a B.S. degree in chemical engineering from the University of California, Berkeley.

Nachi Subramanian has served as a Managing Director at the Redmile Group since December 2021. He previously spent fourteen years at J.P. Morgan, where he held senior roles across the Private Markets and Global Cash Equities businesses. Nachi began his career in Institutional Equities at Bear Stearns. He holds a B.A. in Political Science and Economics from the University of California, Irvine.

About Atara Biotherapeutics, Inc.

Atara is a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr Virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases. Atara is headquartered in Southern California.

Contacts

Investor and Media Relations
Amber Daugherty

Sr. Director, Strategy and Operations

adaugherty@atarabio.com

IFF Announces Pricing of Tender Offers For Certain Outstanding Series of Notes




IFF Announces Pricing of Tender Offers For Certain Outstanding Series of Notes

NEW YORK–(BUSINESS WIRE)–IFF (NYSE: IFF) announced today the Total Consideration (as defined below) payable in connection with its previously announced tender offers to purchase for cash: (i) up to $1,100,000,000 aggregate purchase price, excluding accrued and unpaid interest (the “Amended Pool 1 Maximum Amount”), of its 1.230% Senior Notes due 2025 (the “2025 Notes”), 1.832% Senior Notes due 2027 (the “2027 Notes”), 4.450% Senior Notes due 2028 (the “2028 Notes”) and 2.300% Senior Notes due 2030 (the “2030 Notes” and collectively with the 2025 Notes, the 2027 Notes and the 2028 Notes, the “Pool 1 Notes”) and (ii) up to $900,000,000 aggregate purchase price, excluding accrued and unpaid interest (the “Amended Pool 2 Maximum Amount” and, together with the Amended Pool 1 Maximum Amount, the “Amended Maximum Amounts”), of its 3.268% Senior Notes due 2040 (the “2040 Notes”), 4.375% Senior Notes due 2047 (the “2047 Notes”), 5.000% Senior Notes due 2048 (the “2048 Notes”) and 3.468% Senior Notes due 2050 (the “2050 Notes” and collectively with the 2040 Notes, the 2047 Notes and the 2048 Notes, the “Pool 2 Notes” and, together with the Pool 1 Notes, the “Notes”), subject to prioritized acceptance levels listed in the table below (“Acceptance Priority Levels”), Series Tender Caps (as defined below), if applicable, and the terms and conditions of the tender offers.

The table below sets forth, among other things, the aggregate principal amount of each series of Notes validly tendered and not validly withdrawn as of 5:00 p.m., New York City time, on May 15, 2025 (the “Early Tender Date”) and expected to be accepted for purchase in each tender offer, the approximate proration factor for such Notes and the Total Consideration for each series of such Notes, as calculated at 10:00 a.m., New York City time, today, May 16, 2025.

The tender offers are being made upon the terms, and subject to the conditions, previously described in the Offer to Purchase dated May 2, 2025, as amended and supplemented by IFF’s news release on May 16, 2025 (as so amended, the “Offer to Purchase”). IFF refers investors to the Offer to Purchase for the complete terms and conditions of the tender offers.

Withdrawal rights for the Notes expired at 5:00 p.m., New York City time, on the Early Tender Date. The tender offers for the Notes will expire at 5:00 p.m., New York City time, on June 2, 2025, or any other date and time to which IFF extends the applicable tender offer, unless earlier terminated. As previously announced, IFF expects to elect to exercise its right to make payment on May 20, 2025 (the “Early Settlement Date”) for Notes that were validly tendered prior to or at the Early Tender Date and that are accepted for purchase. IFF intends to fund the purchase of validly tendered and accepted Notes with the cash proceeds from the sale of its Pharma Solutions business, which was completed on May 1, 2025.

Because the Pool 1 Notes validly tendered and not validly withdrawn prior to or at the Early Tender Date have an aggregate purchase price, excluding accrued and unpaid interest, that exceeds the Amended Pool 1 Maximum Amount, IFF does not expect to accept for purchase all Pool 1 Notes that have been validly tendered and not validly withdrawn prior to or at the Early Tender Date. Rather, subject to the Amended Pool 1 Maximum Amount, the Series Tender Caps and the Acceptance Priority Levels set forth in the table above, in each case as further described in the Offer to Purchase, IFF expects to accept for purchase $500,000,000 aggregate principal amount of the 2025 Notes and $400,000,000 aggregate principal amount of 2027 Notes validly tendered and not validly withdrawn prior to or at the Early Tender Date. IFF expects to accept for purchase $266,678,000 aggregate principal amount of the 2030 Notes validly tendered and not validly withdrawn prior to or at the Early Tender Date on a prorated basis using a proration factor of approximately 50.90%. IFF does not expect to accept for purchase any amount of the 2028 Notes. Because the aggregate principal amount of the 2025 Notes and the 2027 Notes validly tendered and not validly withdrawn prior to or at the Early Tender Date exceeds the 2025 Series Tender Cap and Amended 2027 Series Tender Cap, IFF expects to accept for purchase an amount equal to the applicable Series Tender Cap in each case validly tendered and not validly withdrawn prior to or at the Early Tender Date on a prorated basis using a proration factor of approximately 58.91% and 73.97%, respectively. As described further in the Offer to Purchase, Notes tendered and not accepted for purchase will be promptly credited to the tendering holder’s account. Additionally, because the Pool 1 Notes validly tendered and not validly withdrawn prior to or at the Early Tender Date have an aggregate purchase price, excluding accrued and unpaid interest, that exceeds the Amended Pool 1 Maximum Amount, IFF does not expect to accept for purchase any Pool 1 Notes tendered after the Early Tender Date on a subsequent settlement date.

Because the Pool 2 Notes validly tendered and not validly withdrawn prior to or at the Early Tender Date have an aggregate purchase price, excluding accrued and unpaid interest, that exceeds the Amended Pool 2 Maximum Amount, IFF does not expect to accept for purchase all Pool 2 Notes that have been validly tendered and not validly withdrawn prior to or at the Early Tender Date. Rather, subject to the Amended Pool 2 Maximum Amount, the Series Tender Caps and the Acceptance Priority Levels set forth in the table above, in each case as further described in the Offer to Purchase, IFF expects to accept for purchase $649,114,000 aggregate principal amount of 2050 Notes, $417,599,000 aggregate principal amount of 2040 Notes, and $103,796,000 aggregate principal amount of 2047 Notes validly tendered and not validly withdrawn prior to or at the Early Tender Date. Because the aggregate principal amount of the 2050 Notes validly tendered and not validly withdrawn prior to or at the Early Tender Date is equal to the Amended 2050 Series Tender Cap, IFF expects to accept for purchase all of the 2050 Notes validly tendered and not validly withdrawn prior to or at the Early Tender Date. IFF expects to accept for purchase all of the 2040 Notes and 2047 Notes validly tendered and not validly withdrawn prior to or at the Early Tender Date. IFF expects to purchase an aggregate principal amount of $115,138,000 of the 2048 Notes validly tendered and not validly withdrawn prior to or at the Early Tender Date on a prorated basis using a proration factor of approximately 39.11%. As described further in the Offer to Purchase, Notes tendered and not accepted for purchase will be promptly credited to the tendering holder’s account. Additionally, because the Pool 2 Notes validly tendered and not validly withdrawn prior to or at the Early Tender Date have an aggregate purchase price, excluding accrued and unpaid interest, that exceeds the Amended Pool 2 Maximum Amount, IFF does not expect to accept for purchase any Pool 2 Notes tendered after the Early Tender Date on a subsequent settlement date.

The applicable Total Consideration listed in the table above (the “Total Consideration”) will be paid per $1,000 principal amount of each series of Notes validly tendered and accepted for purchase pursuant to the applicable tender offer on the Early Settlement Date. Only holders of Notes who validly tendered and did not validly withdraw their Notes prior to or at the Early Tender Date are eligible to receive the applicable Total Consideration for Notes accepted for purchase. Holders will also receive accrued and unpaid interest on Notes validly tendered and accepted for purchase from the applicable last interest payment date up to, but not including, the Early Settlement Date.

All Notes accepted for purchase will be retired and cancelled and will no longer remain outstanding obligations of IFF.

IFF’s obligation to accept for payment and to pay for Notes validly tendered and not validly withdrawn in the tender offers is subject to the satisfaction of certain conditions described in the Offer to Purchase. IFF reserves the right, subject to applicable law, to (i) waive any and all conditions to any of the tender offers, (ii) extend or terminate any of the tender offers, (iii) further increase or decrease either of the Amended Maximum Amounts and/or increase, decrease or eliminate any of the Series Tender Caps (other than the 2040 Series Tender Cap), or (iv) otherwise further amend any of the tender offers. IFF may take any action described in clauses (i) through (iv) above with respect to one or more tender offers without having to do so for all tender offers.

Information relating to the tender offers

Barclays Capital Inc., BNP Paribas Securities Corp. and BofA Securities, Inc. are the lead dealer managers for the tender offers. The other dealer managers for the tender offers are Citigroup Global Markets Inc., Mizuho Securities USA LLC, Wells Fargo Securities, LLC, ING Financial Markets LLC, U.S. Bancorp Investments, Inc. and SMBC Nikko Securities America, Inc. Investors with questions regarding the terms and conditions of the tender offers may contact Barclays Capital Inc. at (800) 438-3242 or by email at us.lm@barclays.com, BNP Paribas Securities Corp. at (888) 210-4358 or by email at dl.us.liability.management@us.bnpparibas.com or BofA Securities, Inc. at (888) 292-0070 or (980) 387-3907 or by email at debt_advisory@bofa.com. D.F. King & Co., Inc. is the tender and information agent for the tender offers. Investors with questions regarding the procedures for tendering Notes may contact the tender and information agent by email at IFF@dfking.com, or by phone at (212) 269-5550 (for banks and brokers only) or (877) 478-5045 (for all others, toll-free). Beneficial owners may also contact their broker, dealer, commercial bank, trust company or other nominee for assistance.

The full details of the tender offers, including complete instructions on how to tender Notes, are included in the Offer to Purchase. Holders are strongly encouraged to read carefully the Offer to Purchase, including materials incorporated by reference therein, because they contain important information. The Offer to Purchase may be obtained from D.F. King & Co., Inc., free of charge, by calling (212) 269-5550 (for banks and brokers only) or (877) 478-5045 (for all others, toll-free).

This news release does not constitute an offer to purchase, or a solicitation of an offer to sell, or the solicitation of tenders with respect to the Notes. No offer, solicitation, purchase or sale will be made in any jurisdiction in which such an offer, solicitation or sale would be unlawful. The tender offers are being made solely pursuant to the Offer to Purchase made available to holders of the Notes. None of IFF or its affiliates, their respective boards of directors, the dealer managers, the tender and information agent or the trustee, with respect to any series of Notes, is making any recommendation as to whether or not holders should tender or refrain from tendering all or any portion of their Notes in response to the tender offers. Holders are urged to evaluate carefully all information in the Offer to Purchase, consult their own investment and tax advisors and make their own decisions whether to tender Notes in the tender offers, and, if so, the principal amount of Notes to tender.

Cautionary Statement Under The Private Securities Litigation Reform Act of 1995

This press release contains “forward-looking statements” within the meaning of the federal securities laws, including Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements often address expected future business and financial performance and financial condition, and often contain words such as “”plan”, “expect,” “anticipate,” “intend,” “believe,” “seek,” “see,” “will,” “would,” “target,” similar expressions, and variations or negatives of these words. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. The forward-looking statements included in this release are made only as of the date hereof, and we undertake no obligation to update the forward-looking statement to reflect subsequent events or circumstances.

Welcome to IFF

At IFF (NYSE: IFF), we make joy through science, creativity and heart. As the global leader in flavors, fragrances, food ingredients, health and biosciences, we deliver groundbreaking, sustainable innovations that elevate everyday products—advancing wellness, delighting the senses and enhancing the human experience. Learn more at iff.com, Linkedln, Instagram and Facebook.

© 2025 by International Flavors & Fragrances Inc. IFF is a Registered Trademark. All Rights Reserved.

Contacts

Media Relations:

Paulina Heinkel

332.877.5339

Media.request@iff.com

Investor Relations:

Michael Bender

212.708.7263

Investor.Relations@iff.com

SmithRx Named to Modern Healthcare’s Best Places to Work in Healthcare in 2025 List




SmithRx Named to Modern Healthcare’s Best Places to Work in Healthcare in 2025 List

Modern pharmacy benefits leader has grown headcount by 450% in 3 years

SAN FRANCISCO–(BUSINESS WIRE)–SmithRx, a modern pharmacy benefits manager (PBM) committed to transparency and a universal pass-through model, has been recognized by Modern Healthcare as one of the 2025 Best Places to Work in Healthcare. The award is based largely on employee feedback from a confidential survey administered by a third-party organization, and measures employee sentiment on key issues including growth opportunities, benefits, company culture, and more.

Founded in 2018, SmithRx has intentionally built a mission-driven and collaborative culture that drives employees to do their best work for clients and each other. Each SmithRx team member strongly believes in the company’s mission of transforming U.S. healthcare and its transparent, universal pass-through model, which helps significantly lower pharmacy costs for employer clients. Paired with its innovative savings programs, SmithRx’s approach to pharmacy benefits drives cost reduction for clients by an average of 30% or more.

“The people behind SmithRx have always been our secret sauce, with their contributions supporting our efforts to pioneer a smarter, fairer healthcare system in this country,” said Jake Frenz, Founder and CEO of SmithRx. “It is our highest priority to empower our employees as they grow their careers, collaborate on complex problems, and find satisfaction in the work. We’re so pleased that our team feels supported at SmithRx.”

SmithRx has experienced extensive growth since its inception. The company brought its total customer base to over 4,000 clients in 2024, and achieved more than $200M in savings for clients with minimal member disruption. This momentum has required an expanded team as well; SmithRx has grown its headcount by 450% over the past three years.

Modern Healthcare’s Best Places to Work in Healthcare awards program identifies and recognizes outstanding employers in the healthcare industry nationwide. Modern Healthcare partners with Workforce Research Group on the assessment process, which includes an extensive employee survey. The complete list of this year’s winners, in alphabetical order, is available at modernhealthcare.com/bestplaceslist.

“Being recognized as a 2025 Best Place to Work in Healthcare is a powerful testament to how these organizations value their people,” said Dan Peres, President of Modern Healthcare. “In a time of constant change and challenge, this year’s winners have shown a deep commitment to creating environments where employees feel supported, heard, and inspired to do their best work. That kind of culture doesn’t happen by accident — it’s intentional, and it’s worth celebrating.”

About SmithRx

SmithRx is a modern PBM dedicated to reducing the cost and complexity of pharmacy benefits. The company empowers organizations of all sizes to take control of their pharmacy spend with a radically transparent, universal pass-through model, innovative cost-saving programs, and intuitive technology. Unlike legacy PBMs, SmithRx eliminates hidden fees, passes through 100% of rebates and discounts, and provides real-time prescription pricing and detailed savings reports. This gives clients the insights they need to make informed decisions and achieve meaningful savings for both their business and their employees. Experience the difference transparency, trust, and fairness can make in building a more equitable healthcare system. Learn more at www.smithrx.com.

About Modern Healthcare

Modern Healthcare is the most trusted business news and information brand in the healthcare industry. Modern Healthcare empowers healthcare leaders and influencers to make timely and informed business decisions. To learn more or subscribe, go to www.modernhealthcare.com/subscriptions

Contacts

Media Contact:
Claire Schillings

claire.schillings@smithrx.com

Omeros Corporation to Announce First Quarter Financial Results on May 15, 2025




Omeros Corporation to Announce First Quarter Financial Results on May 15, 2025

SEATTLE–(BUSINESS WIRE)–Omeros Corporation (NASDAQ: OMER), today announced that the company will issue its financial results for the quarter ended March 31, 2025, on Thursday, May 15, 2025, after the market closes. Omeros management will host a conference call and webcast that same day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

Conference Call Details

For online access to the live webcast of the conference call, go to Omeros’ website at https://investor.omeros.com/upcoming-events.

To access the live conference call via phone, participants must register at this link to receive a unique PIN. Once registered, you will have two options: (1) Dial in to the conference line provided at the registration site using the PIN provided to you, or (2) choose the “Call Me” option, which will instantly dial the phone number you provide. Should you lose your PIN or registration confirmation email, simply re-register to receive a new PIN.

A replay of the call will be made accessible online at https://investor.omeros.com/archived-events.

About Omeros Corporation

Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing first-in-class small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders, including complement-mediated diseases and cancers, as well as addictive and compulsive disorders. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application under review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Omeros’ long-acting MASP-2 inhibitor OMS1029 has successfully completed Phase 1 single- and multiple-ascending dose clinical studies. Zaltenibart, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in clinical development for treatment of paroxysmal nocturnal hemoglobinuria and complement 3 glomerulopathy. Funded by the National Institute on Drug Abuse, Omeros’ lead phosphodiesterase 7 inhibitor OMS527 is in clinical development for the treatment of cocaine use disorder. Omeros also is advancing a broad portfolio of novel cellular and molecular immuno-oncology programs. For more information about Omeros and its programs, visit www.omeros.com.

Contacts

Jennifer Cook Williams

Cook Williams Communications, Inc.

Investor and Media Relations

IR@omeros.com

Darling Ingredients and Tessenderlo Group Agree to Form New Company to Accelerate Growth in Attractive Collagen-Based Health, Wellness and Nutrition Sector




Darling Ingredients and Tessenderlo Group Agree to Form New Company to Accelerate Growth in Attractive Collagen-Based Health, Wellness and Nutrition Sector

• Creates ~$1.5 billion revenue company in fast-growing collagen-based health, nutrition and food sectors
• 85% owned and consolidated by Darling Ingredients
• Non-cash transaction, combining assets, capabilities
• Strengthens foundation around serving food and pharma customers
• Provides a platform for accelerated product development and growth
• Creates an opportunity to unlock significant shareholder value

IRVING, Texas–(BUSINESS WIRE)–$DAR—Darling Ingredients Inc. (NYSE: DAR) today announced the signing of a non-binding term sheet with Tessenderlo Group (XBRU: TESB) to combine the collagen and gelatin segments of their companies into a new company called Nextida™, requiring no cash or initial investment from either party. This strategic partnership aims to create a top-tier, collagen-based health, wellness and nutrition products company positioned to capitalize on global collagen growth. The transaction is subject to negotiation and execution of definitive documentation by the parties.

Pending regulatory approvals, Nextida will operate as a joint venture, with Darling Ingredients holding a majority, 85% ownership stake and Tessenderlo Group holding the remaining 15%. Nextida will combine Darling Ingredients’ collagen and gelatin business, branded as Rousselot, with Tessenderlo Group’s PB Leiner business. The combination will result in a new company, initially with expected annual revenue of approximately $1.5 billion, and total gelatin and collagen capacity of about 200,000 metric tons across 23 facilities located in South America, North America, Europe and Asia. Over time, the integration of the two companies provides significant opportunities to realize synergies and develop the Nextida portfolio of products, delivering targeted health benefits and providing a significant opportunity to increase earnings.

“By working with Tessenderlo Group over the last several months, we have developed a great opportunity that will allow us to establish a new company that provides a strong platform for accelerated product development and growth,” said Randall C. Stuewe, Chairman and Chief Executive Officer of Darling Ingredients. “Collagen has represented the fastest-growing area of Darling Ingredients’ food segment business over the past several years, and with the addition of PB Leiner’s people, assets and products, we are well positioned to increase scale and focus in this rapidly growing segment.”

Luc Tack, Chief Executive Officer, Tessenderlo Group, added, “With this combination, we will have the best new ownership possible. We will benefit from each other by sharing technology expertise and providing a complementary offering for our global customer base. This includes many in-demand products, such as gelatin and collagen peptides.”

The integration of these businesses provides further infrastructure and geographical reach to meet the growing demand for collagen products, minimizing the need for additional infrastructure investment, while realizing significant synergies through commercial and logistical optimization and operational efficiencies.

Pending regulatory approvals, the transaction is expected to close in 2026.

This strategic partnership is expected to create new opportunities for growth, while expanding options to enhance shareholder value.

Darling Ingredients will host a conference call and webcast for investors at 9 a.m. Eastern Time (8 a.m. Central Time) today, May 12, 2025, to discuss this announcement. Prior to the call, a presentation will be available at darlingii.com/nextida.

To access the call as a listener, please register for the audio-only webcast.

To join the call as a participant to ask a question, please register in advance to receive a confirmation email with the dial-in number and PIN for immediate access on May 12 or call 833-470-1428 (United States) or 404-975-4839 (international) using access code 780865.

A replay of the call will be available online via the webcast registration link two hours after the call ends. A transcript will be posted at darlingii.com/nextida within 24 hours.

About Darling Ingredients

A pioneer in circularity, Darling Ingredients Inc. (NYSE: DAR) takes material from the animal agriculture and food industries, and transforms them into valuable ingredients that nourish people, feed animals and crops, and fuel the world with renewable energy. The company operates over 260 facilities in more than 15 countries and processes about 15% of the world’s animal agricultural by-products, produces about 30% of the world’s collagen (both gelatin and hydrolyzed collagen), and is one of the largest producers of renewable energy. To learn more, visit darlingii.com. Follow us on LinkedIn.

About Tessenderlo Group

Tessenderlo Group is an industrial group that focuses on agriculture, valorizing bio-residuals, machinery, mechanical engineering, electronics, energy, and providing industrial solutions with a focus on water. With its headquarters in Belgium, the group is active in over 100 countries and has a global team of more than 7,000 employees.

Cautionary Statements Regarding Forward-Looking Information:

This release may contain “forward-looking statements,” which include information concerning the Company’s financial performance, plans, objectives, goals, strategies, future earnings, cash flow, performance and other information that is not historical information. When used in this release, the words “expects,” “anticipates,” “projects,” “plans,” “intends,” “believes,” “will” and variations of such words or similar expressions are intended to identify forward-looking statements. All forward-looking statements are based upon current expectations and beliefs and various assumptions. There can be no assurance that the Company will realize these expectations or that these beliefs will prove correct. There are a number of risks and uncertainties that could cause actual results to differ materially from the results expressed or implied by the forward-looking statements contained in this release. Numerous factors, many of which are beyond the Company’s control, could cause actual results to differ materially from those expressed as forward-looking statements. These include factors which could preclude the Company from closing the proposed transaction or realizing the anticipated benefits of the proposed transaction. Other risk factors include those that are discussed in the Company’s filings with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it is made, and the Company undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date on which it is made or to reflect the occurrence of anticipated or unanticipated events or circumstances.

Contacts

Darling Ingredients Contacts
Media: Jillian Fleming

Director, Global Communications

(972) 541-7115; jillian.fleming@darlingii.com

Investors: Suann Guthrie

Senior VP, Investor Relations, Sustainability & Communications

(469) 214-8202; suann.guthrie@darlingii.com

MaaT Pharma Announces Promising Final Data Readout for Phase 1b Evaluating MaaT033 in Amyotrophic Lateral Sclerosis (ALS)




MaaT Pharma Announces Promising Final Data Readout for Phase 1b Evaluating MaaT033 in Amyotrophic Lateral Sclerosis (ALS)

LYON, France–(BUSINESS WIRE)–$MAAT #ALS–Regulatory News:

MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, announced additional findings following full data readout for the exploratory single-arm, open-label Phase 1b clinical trial named IASO (NCT05889572) evaluating MaaT033 in Amyotrophic Lateral Sclerosis (ALS).

In November 2024, the Company announced that the trial had met its primary endpoint assessing the safety and tolerability of MaaT033 with multiple doses, following the independent Data Safety and Monitoring Board (DSMB) conclusion. As a reminder, the exploratory Phase 1b trial enrolled a total of 15 participants across two centers in France Hôpital de la Pitié-Salpêtrière – AP-HP and the University Hospital of Lille. An external Scientific Advisory Committee took place at the end of March 2025 to review the full data. Below are the key takeaways from the Committee’s review:

• MaaT033 demonstrated a favorable safety and tolerability profile, supported by biomarker and microbiome analyses.
• A rapid and sustained engraftment of bacterial species from MaaT033 was observed, mostly occurring within the first month and maintained during the 1-month follow-up period.
• A slower rate of disease progression (based on ALSFRS-R slopes) was noted to be interpreted with caution given the short follow up, limited sample size and single-arm Phase 1b design. The ALSFRS-R is a standard functional scale in ALS trials to track the progression of the disease. The slope reflects how many points are “lost” (=disease progression) per month. In the final data readout for the IASO trial, the following was observed for the ALSFRS-R Total score slope:
  • From first symptoms to baseline, the median slope was –0.7 points/month (range: –1.2 to –0.3)
  • From baseline to Day 84 (D84), the median slope slowed to –0.3 points/month (range: –2.4 to +1.0)
• No variation at D84 in the levels of neurofilaments, a marker associated with neuronal injury in ALS.

In addition, the Scientific Advisory Committee provided insights regarding the best population to target in a Phase 2 trial.

“These encouraging findings from the IASO Phase 1b trial confirm the favorable safety and tolerability profile of MaaT033 in ALS patients. They also highlight the therapeutic potential of microbiome modulation beyond oncology and open new avenues for development in neurodegenerative diseases, as evidence continues to grow around the gut-brain connection,” said Gianfranco Pittari, MD, PhD, Chief Medical Officer of MaaT Pharma.

The study was conducted in close collaboration with the French patient association Tous en Selles contre la SLA (TECS), highlighting the essential role of patients and their advocates in advancing science, and with the support of experts from the French academic networks FILSLAN and ACT4ALS-MND.

“Recognizing the significant unmet medical need in ALS and with the will to support those affected, we applied our discovery platform to this new disease area, demonstrating its potential beyond our primary focus in oncology with encouraging Phase 1 data. In light of the Company’s strict financial discipline, and considering the recent successes achieved in oncology, we are actively seeking partners with a focus on ALS and the financial capacity to support new options to fight this disease,” stated Hervé Affagard, CEO and co-founder of MaaT Pharma.

––

About MaaT033

MaaT033, a standardized, donor-derived, high-richness, high-diversity oral Microbiome Ecosystem Therapy^TM containing anti-inflammatory Butycore^TM species, is currently being developed as an adjunctive therapy to improve overall survival in patients receiving HSCT and other cellular therapies. MaaT033 is developed with the “pooling” technology, which allows pooling donations from multiple donors to create a standardized product with high microbial richness and diversity. It aims to ensure optimal microbiota function and to address a larger patient population in a chronic setting. MaaT033 has been granted Orphan Drug Designation by the European Medicines Agency (EMA).

About Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s disease in the US and Charcot’s disease in Europe, is a progressive neurodegenerative disorder affecting motor neurons in the brain and spinal cord. This leads to muscle weakness, loss of voluntary movement, and eventually, paralysis and on an average lead to death in 3 to 5 years. ALS could affect up to 60,000 patients in US and EU by 2040 and has currently no curative treatment and few symptomatic treatments.

About MaaT Pharma

MaaT Pharma is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France.

As a pioneer, MaaT Pharma is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, MaaT Pharma develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. MaaT Pharma has been listed on Euronext Paris (ticker: MAAT) since 2021.

Forward-looking Statements

All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim”, “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.

Contacts

MaaT Pharma – Investor Relations

Guilhaume DEBROAS, Ph.D.

Head of Investor Relations

+33 6 16 48 92 50

invest@maat-pharma.com

MaaT Pharma – Media Relations

Pauline RICHAUD

Senior PR & Corporate Communications Manager

+33 6 14 06 45 92

media@maat-pharma.com

Rx Communications Group – U.S. Investor Relations
Michael Miller

Managing Director

+1-917-633-6086

mmiller@rxir.com

Catalytic Agency – U.S. Media Relations
Heather Shea

Media relations for MaaT Pharma
+1 617-286-2013
heather.shea@catalyticagency.com

Almirall Q1 2025 Results




Almirall Q1 2025 Results

Almirall delivers a strong start to 2025: growing Q1 overall sales by 15%, and 23.4% in its European Dermatology business YoY, aligned with the company’s sustained growth trajectory

• Continued strong growth trajectory with 15% Net Sales increase to a total of €284.6 MM with key products delivering high double-digit YoY growth and general medicines business aided by Q1 2025 out-licensing transaction.
• EBITDA increase of 35.0% YoY in line with expectations to a total of €70.9 MM driven by continued strong operational execution including out-licensing income realized in Q1 2025.
• Performance was driven by the biologics portfolio, with Ilumetri® showing 12.7% increase in sales vs Q1 2024 (total of €55.1 MM), and Ebglyss® delivering €19.4 MM quarterly sales – mainly achieved by the continued positive launch dynamics in Germany and growing contributions from recent launched countries.
• The broad dermatology product portfolio continues its sustained growth including performance in line with expectations of key products Wynzora® (22.2%, total of €7.7 MM) and Klisyri® (25.5%, total of €6.9 MM), further driving relevance of Almirall with patients and HCPs in Europe and other regions.
• Guidance for the full year confirmed based on the strong performance in Q1 2025, and scrip dividend of €0.19 per share approved by the AGM on 9^th May 2025.

BARCELONA, Spain–(BUSINESS WIRE)–Almirall, S.A. (ALM) a global pharmaceutical company based in Barcelona, today announced its financial results from the first quarter 2025. Almirall continued to deliver strong sales growth in the first quarter of the year – in line with expectations and with the longer-term growth trajectory set out by the company. Almirall’s performance continues to be driven by its dermatology business in Europe, and by delivering advanced therapies and a broad portfolio of relevant and impactful products to more patients across markets.

Net Sales increased by 15% YoY to a total of €284.6 MM, EBITDA was €70.9 MM (increase of 35% YoY) driven by higher sales growth and recent out-licensing activities that also positively impacted that gross margin (66.9%). Dermatology sales in Europe increased by 23.4% to a total of €139.4 MM in Q1 2025.

The growth of Ebglyss® (lebrikizumab for the systemic treatment of moderate-to-severe atopic dermatitis) continues to further gain momentum delivering total Net Sales of €19.4 MM mainly based on the growth in its first launch market Germany and supported by growing contributions from recent launched countries. Including the launches in Q1 2025, Ebglyss is now available in 13 markets (Germany, Norway, UK, Spain, Denmark, Czechia, The Netherlands, Italy, Austria, Belgium, Sweden, Switzerland, and France in Q1) and the launch plans are on track with availability in all countries per plan expected to be achieved by end of 2025 (Portugal, Ireland, and Poland).

Ilumetri® (tildrakizumab for the systemic treatment of moderate-to-severe psoriasis) delivered double digit growth in Q1 2025 (12.7% increase YoY) and delivered solid Net Sales of €55.1 MM despite growing competition in the psoriasis market and some quarterly phasing impacts. Anti-IL-23 antibodies remain the leading class in advanced psoriasis treatments now and in the foreseeable future.

The biologics growth drivers were complemented by the strong performance of the broad portfolio of dermatology products leading to the dermatology portfolio overall growing 23.4% YoY in Q1 2025 in Europe to a total of €139.4 MM. Almirall’s key products Wynzora® (psoriasis), and Klisyri® (actinic keratosis) grew double-digit in sales in Q1 2025 YoY.

Wynzora® continued to grow in its main markets and delivered total Net Sales of €7.7 MM representing a 22.2% increase vs Q1 2024. The strong double-digit growth performance of Klisyri® in Q1 2025 (€6.9 MM +25.5% YoY) is aligned with expectations of its increasing market share in key regions and was further supported by the US large field launch following the approval of the label extension by the FDA in 2024.

The overall performance in Q1 was supported by the strategic out-licensing and divestment of two products in the Spanish market in January 2025 (Sekisan and Algidol).

“We started the year with a continued strong business performance that is aligned with the long-term trajectory of sustained growth we have outlined for Almirall. Therefore, we are pleased to confirm our full year guidance for 2025 as we are delivering relevant and impactful treatments to more patients and physicians in medical dermatology. Our strong results across are driven by our advanced biologic treatments for patients with moderate to severe atopic dermatitis and psoriasis, and the consistent growth of our broader dermatology portfolio. Almirall is well positioned as European leader in medical dermatology, and we continue to invest to progress our early and late-stage pipeline, and to drive our commercial excellence to deliver sustained growth in the years to come.”

Carlos Gallardo, Almirall Chairman and CEO

Financial highlights (€ rounded million)

2025 Full Year Guidance

Full year guidance for 2025: double-digit net Sales growth of 10-13% and total EBITDA between €220 MM – €240 MM.

R&D pipeline

Almirall’s continued investment in its leading R&D capabilities, and the medical dermatology pipeline are closely aligned with the company’s long-term view on its contributions and commitment to positively impacting patients and society. Key milestones across the early and late-stage pipeline are expected to be delivered in 2025 including the progress of early-stage pipeline assets through clinical testing. Efinaconazole was authorized for launch in Italy on 20^th March following its previous completion of the decentralized regulatory procedure in the EU. The interim phase I data for Anti-IL1RAP mAb were presented at the AAD 2025. A Phase II study to explore this antibody in patients suffering from Hidradenitis suppurativa is planned to start later this year.

Lifecycle management activities will further strengthen Almirall’s key priority products with several ongoing clinical studies supporting our biologics in AD and PSO respectively as part of ongoing collaborative programs with its partners Lilly and Sun Pharma, respectively, to grow patient access & product value.

Partnership with the dermatology community

Almirall’s close collaboration with dermatologists and life-science experts continue to be a key cornerstone for the company’s dedication to medical dermatology. These partnerships expand Almirall’s focus on fostering scientific exchange and to advance the understanding of skin diseases, treatment options, and their impact on patients.

In March, at the 2025 AAD congress, Almirall presented new data analysis from phase IV studies and real-world evidence with tirbanibulin for the treatment of actinic keratosis (AK) that showed consistently high levels of treatment response as well as patient satisfaction.

From 21^st to 22^nd March, Almirall hosted the 16^th edition of its Skin Academy in Barcelona which is a unique opportunity for collaboration in medical dermatology as it – again – brought together leading experts from across the globe to advance science and innovative approaches for the treatment of skin diseases. The conference focused on the latest advancements in medical dermatology, including the holistic and personalized treatment of atopic dermatitis and psoriasis. It also covered a broad range of other skin diseases such as actinic keratosis, androgenetic alopecia, onychomycosis and chronic spontaneous urticaria – advancing the understanding of these diseases and treatment options to support better patient outcomes.

Dividend and Investor Calendar 2025

On 9^th May, the Annual General Shareholder Meeting approved the distribution of a dividend charged to unrestricted reserves, for the amount of €0.19 per share. This will be applied using the scrip dividend shareholder remuneration system that has been applied in previous years.

• H1 2025 Financial Results – 25^th July 2025
• 9M 2025 Financial Results – 10^th November 2025

About Almirall

Almirall is a global pharmaceutical company dedicated to medical dermatology. We closely collaborate with leading scientists, healthcare professionals, and patients to deliver our purpose: to transform the patients’ world by helping them realize their hopes and dreams for a healthy life. We are at the forefront of science to deliver ground-breaking, differentiated medical dermatology innovations that address patients’ needs.

Almirall, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM, total revenue in 2024: €990 MM, over 2000 employees globally). Almirall products help to improve the lives of patients every day and are available in over 100 countries.

For more information, please visit almirall.com

Disclaimer

This document includes only summary information and does not intend to be comprehensive. Facts, figures and opinions contained herein, other than historical, are “forward-looking statements”. These statements are based on currently available information and on best estimates and assumptions believed to be reasonable by the Company. These statements involve risks and uncertainties beyond the Company’s control. Therefore, actual results may differ materially from those stated by such forward-looking statements. The Company expressly disclaims any obligation to review or update any forward-looking statements, targets or estimates contained in this document to reflect any change in the assumptions, events or circumstances on which such forward-looking statements are based unless so required by applicable law.

Contacts

Corporate Communications
corporate.communication@almirall.com
Phone: +34 93 291 35 08

Investor Relations
investors@almirall.com
Phone: +34 93 291 30 87

Number of Shares and Voting Rights of Innate Pharma as of May 5, 2025




Number of Shares and Voting Rights of Innate Pharma as of May 5, 2025

MARSEILLE, France–(BUSINESS WIRE)–#ANKET–Regulatory News:

Pursuant to the article L. 233-8 II of the French “Code de Commerce” and the article 223-16 of the French stock-market authorities (Autorité des Marchés Financiers, or “AMF”) General Regulation, Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) releases its total number of shares outstanding as well as its voting rights as at May 5, 2025:

(1) The total number of theoretical voting rights (or “gross” voting rights) is used as the basis for calculating the crossing of shareholding thresholds. In accordance with Article 223-11 of the AMF General Regulation, this number is calculated on the basis of all shares to which voting rights are attached, including shares whose voting rights have been suspended. The total number of theoretical voting rights includes voting rights attached to AGAP 2016, i.e. 130 voting rights for the AGAP 2016-1 and 111 voting rights for the AGAP 2016-2. No voting rights attached to AGAP 2017.

(2) The total number of exercisable voting rights (or “net” voting rights) is calculated without taking into account the shares held in treasury by the Company, with suspended voting rights. It is released so as to ensure that the market is adequately informed, in accordance with the recommendation made by the AMF on July 17, 2007.

About Innate Pharma

Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through therapeutic antibodies and its ANKET^® (Antibody-based NK cell Engager Therapeutics) proprietary platform.

Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, as well as ANKET^® multi-specific NK cell engagers to address multiple tumor types.

Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients.

Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.

Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X.

Information about Innate Pharma shares

Disclaimer on forward-looking information and risk factors

This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including “believe,” “potential,” “expect” and “will” and similar expressions, is intended to identify forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties which could cause the company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2023, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public, by the Company.

This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

Contacts

For additional information, please contact:

Investors
Innate Pharma
Henry Wheeler

Tel.: +33 (0)4 84 90 32 88

Henry.wheeler@innate-pharma.fr

Media Relations
NewCap
Arthur Rouillé

Tel.: +33 (0)1 44 71 00 15

innate@newcap.eu