Hydration solutions company, The Hydration Pharmaceuticals Company Limited (ASX: HPC) (“Hydralyte North America” or “the Company”), is pleased to report on its activities and cash flows for the 12 months ending 31 December 2023 (FY2023).
IMPORTANT NOTE: Unless otherwise designated, the consolidated financial statements and this associated analysis are presented in USD ($), which is The Hydration Pharmaceuticals Company Limited's functional and presentation currency.
Results for Announcement to the Market for Year Ending 31 December 2023:
Highlights
Financial Results
Net Sales
The Company achieved net revenue of $10,041,184 during FY23, which represented a 10% or $0.9 million increase on the previous 12-month period (FY22: $9,099,968). The Company faced inventory shortages due to high demand combined with supplier delays from September through December 2023, which resulted in unfilled orders worth approximately $877,576 in net sales. The Company’s inventory situation has since recovered with best selling products back in stock and meeting demand from key retailers. After adjusting for inventory shortages, the YoY growth rate increases to 20%.
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This article includes content from The Hydration Pharmaceuticals Company Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
Issues Open Letter to Atea's Stockholders Outlining the Case for Boardroom Change Based on Years of Stock Price Underperformance, Poor Decision-Making and Entrenchment Maneuvers
Believes its Three Highly Qualified Director Candidates Possess the Necessary Ownership Perspectives, Scientific Credibility and Public Company Board Experience to Create Value for Stockholders
Bradley L. Radoff and Michael Torok (together with certain of their affiliates, the "Radoff-JEC Group"), who collectively own approximately 5.4% of the outstanding stock of Atea Pharmaceuticals, Inc. (NASDAQ: AVIR) ("Atea" or the "Company"), today announced that they have nominated three highly qualified director candidates Howard H. Berman, James Flynn and Mr. Torok for election to the Company's Board of Directors (the "Board") at the 2025 Annual Meeting of Stockholders (the "Annual Meeting"). In connection with its nomination, the Radoff-JEC Group issued the following open letter to stockholders outlining the urgent need for boardroom change:
***
Fellow Stockholders,
Over the past four months, we have expressed concerns to Atea's Board about the Company's stock price performance, strategy, capital allocation and governance practices. Specifically, we have highlighted several key facts:
In addition to highlighting the above fundamental issues, we have also made suggestions to the Board that we believe would ensure proper governance and management of the business while resulting in significant and immediate value for stockholders. The Board has ignored or rejected our ideas.
Accordingly, and with all stockholders' interests in mind, we have nominated three highly qualified director candidates – Howard H. Berman, James Flynn and Michael Torok – for election to the Board at the Annual Meeting. Our nominees collectively possess corporate governance expertise, an ownership mindset and biotechnology backgrounds. We believe they have the right skillsets and experience to address the issues plaguing Atea today.
With a refreshed Board that is committed to objectively overseeing management and focused on creating stockholder value, we believe Atea can immediately return up to $250 million in cash to stockholders while it continues to evaluate strategic alternatives for its only asset. We look forward to providing stockholders with the opportunity to add fresh perspectives and relevant expertise to the Board at this critical time for the Company. We'll be in touch over the coming weeks with more details on how to vote for change.
Sincerely,
Bradley L. Radoff and Michael Torok
***
DIRECTOR NOMINEE BIOGRAPHIES
Howard H. Berman, Ph.D.
Dr. Berman brings a unique combination of business acumen and scientific credibility with successful company exits coupled with his experience as Co-Founder, CEO and Chairman of a public biotechnology company.
James Flynn
Mr. Flynn possesses extensive public board service experience at several biopharmaceutical companies, alongside deep business development and financial expertise.
Michael Torok
Mr. Torok is a stockholder of the Company with significant financial, accounting and capital markets expertise, as well as experience as a c-suite executive and as a director of publicly traded companies in the biopharmaceutical industry.
***
CERTAIN INFORMATION CONCERNING THE PARTICIPANTS
Bradley L. Radoff and Michael Torok, together with the other participants named herein (collectively, the "Radoff-JEC Group"), intends to file a preliminary proxy statement and accompanying BLUE universal proxy card with the Securities and Exchange Commission ("SEC") to be used to solicit votes for the election of its slate of highly qualified director nominees at the 2025 annual meeting of stockholders of Atea Pharmaceuticals, Inc., a Delaware corporation (the "Company").
THE RADOFF-JEC GROUP STRONGLY ADVISES ALL STOCKHOLDERS OF THE COMPANY TO READ THE PROXY STATEMENT AND OTHER PROXY MATERIALS, INCLUDING A PROXY CARD, AS THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. SUCH PROXY MATERIALS WILL BE AVAILABLE AT NO CHARGE ON THE SEC'S WEB SITE AT HTTP://WWW.SEC.GOV . IN ADDITION, THE PARTICIPANTS IN THIS PROXY SOLICITATION WILL PROVIDE COPIES OF THE PROXY STATEMENT WITHOUT CHARGE, WHEN AVAILABLE, UPON REQUEST. REQUESTS FOR COPIES SHOULD BE DIRECTED TO THE PARTICIPANTS' PROXY SOLICITOR.
The participants in the anticipated proxy solicitation are expected to be The Radoff Family Foundation ("Radoff Foundation"), Bradley L. Radoff, JEC II Associates, LLC ("JEC II"), The MOS Trust ("MOS Trust"), MOS PTC, LLC ("MOS PTC"), Michael Torok, Nerium Partners LP ("Nerium Partners"), Nerium Capital LLC ("Nerium Capital"), James Flynn and Howard H. Berman.
As of the date hereof, Radoff Foundation directly beneficially owns 175,000 shares of Common Stock, $0.001 par value per share, of the Company ("Common Stock"). As of the date hereof, Mr. Radoff directly beneficially owns 2,900,100 shares of Common Stock. As of the date hereof, 30,000 shares of Common Stock are held in a certain donor advised charitable account advised by Mr. Radoff (the "Charitable Account"). Mr. Radoff, as a director of Radoff Foundation, may be deemed to beneficially own the 175,000 shares of Common Stock directly beneficially owned by Radoff Foundation, and as an advisor to the Charitable Account, may be deemed to beneficially own the 30,000 shares of Common Stock held in the Charitable Account, which, together with the 2,900,100 shares of Common Stock he directly beneficially owns, constitutes an aggregate of 3,105,100 shares of Common Stock beneficially owned by Mr. Radoff. As of the date hereof, JEC II directly beneficially owns 1,300,000 shares of Common Stock. As of the date hereof, MOS Trust directly beneficially owns 100,000 shares of Common Stock. MOS PTC, as the trustee of MOS Trust, may be deemed to beneficially own the 100,000 shares of Common Stock directly beneficially owned by MOS Trust. As of the date hereof, Mr. Torok directly beneficially owns 100,000 shares of Common Stock. Mr. Torok, as the Manager of JEC II and a Manager of MOS PTC, may be deemed to beneficially own the 1,400,000 shares of Common Stock directly beneficially owned in the aggregate by JEC II and MOS Trust, which, together with the 100,000 shares of Common Stock he directly beneficially owns, constitutes an aggregate of 1,500,000 shares of Common Stock beneficially owned by Mr. Torok. As of the date hereof, Nerium Partners directly beneficially owns 54,000 shares of Common Stock. Nerium Capital, as the general partner of and investment advisor to Nerium Partners, may be deemed to beneficially own the 54,000 shares of Common Stock directly beneficially owned by Nerium Partners. Mr. Flynn, as the Chief Investment Officer of Nerium Partners and the Managing Member of Nerium Capital, may be deemed to beneficially own the 54,000 shares of Common Stock directly beneficially owned by Nerium Partners. As of the date hereof, Mr. Berman does not beneficially own any shares of Common Stock.
1 Company press release dated May 30, 2023 ( link ). | |
2 Company's cash burn for the six reported quarters since it rejected Tang Capital's bid (beginning July 1, 2023 through December 31, 2024). | |
3 Form 4 filed by Mr. Berger, dated December 12, 2024 ( link ). Company press release dated December 16, 2024 ( link ). | |
View source version on businesswire.com: https://www.businesswire.com/news/home/20250326447983/en/
Greg Lempel
greg@fondrenlp.com
News Provided by Business Wire via QuoteMedia
Allergan Aesthetics, an AbbVie company, the industry leader in aesthetics globally, demonstrates how to elevate the patient experience and achieve optimal treatment outcomes with new AA Signature program at the Anti-Aging and Aesthetics Medicine World Congress (AMWC) in Monaco from Thursday, March 27Saturday, March 29, 2025 .
Activities will center around the new AA Signature program - an innovative approach to treatment planning harnessing the power of Allergan Aesthetics advanced portfolio to address different patient needs, including Lift, Definition and Skin Quality , and a celebration of 10 years of MD Codes™, which has revolutionized aesthetic medicine with innovative methodology to guide injectors' technique and elevate patient outcomes.
AMI Symposia
Meetings will take place as follows:
The first AMI symposium, ' Design your patients' look with the NEW Signature approach by Allergan Aesthetics ' , will include:
Day two will open with ' MD Codes™ and Allergan Aesthetics: a decade of excellence and a signature of success for the future' . Highlights will include:
Beyond the AMI Symposia
Events will take place as follows:
Exclusive Science of Aging TM Symposium: 'Bold scientific advances for a new age' brings together world-class experts to present the bold scientific advances within the field of aging. Dr. Stephanie Manson Brown, Vice President of R&D, Head of Clinical Development at Allergan Aesthetics, and Dr. Patricia Ogilvie ( Germany ) will open the event, followed by the discussion of key topics including skin longevity, genomics of aging, epigenetics of skin and mitraclock with Dr. Anne Chang from Stanford University (US), Dr. Howard Jacob from AbbVie (US) and Dr. Cristiana Banila of Mitra Bio (UK). The event will conclude with an engaging Q&A led by event chair Dr. Patricia Ogilvie.
Global Aesthetics Medical Affairs Symposium : ' Socially Transformative Aesthetic Medicine Impacting Emotion and Social Perception ' will explore the multidimensional aspects of aesthetic medicine, and how aesthetic treatments not only enhance physical appearance but can also significantly impact emotional well-being and social perception. Chaired by Dr. Steven Dayan (US) alongside Dr. Sarah Boxley ( Australia ), Dr. Mitchell Brin (US), Prof. Dr. Dario Bertossi ( Italy ), and Dr. Ligia Colucci (Brazil), the expert panel will discuss the scientific data and provide clinical insights with transformative patient stories.
Meet the Experts
Meet the Experts sessions will be live from the Allergan Aesthetics booth, showcasing:
Across three days, the Allergan Aesthetics immersive booth (P3) will be a discovery hub for exploring the new AA Signature Program, where visitors can get hands-on with the portfolio, meet industry experts, experience the latest innovation in AA digital applications, and sign up to AMI Digital World.
E-Poster Sessions
Allergan Aesthetics' commitment to driving industry with advancing science and clinical data is demonstrated with the acceptance of 11 E-posters. The E-Posters will showcase the latest data and science supporting Allergan Aesthetics brand portfolio, looking specifically at the Skin Quality Lexicon and the multimodal approach of the Eye Impact Study.
Titles and named authors for the 11 posters to be showcased at AMWC:
Presentation Topic | Poster Title | Authors |
HArmonyca Int'l Study - Interim ABS | An International, Multicenter, Evaluator-blinded, Randomized, Parallel-Group, Controlled Study of the Safety and Effectiveness of HArmonyCa Lidocaine Injectable Gel for Mid Face Soft Tissue Augmentation | Andreas Nikolis, Nestor Demosthenous, Shannon Humphrey, Fernando Urdiales, Malka Salomon, Andrew Schumacher |
HArmonyca MDR Final ABS AMWC Monaco | Prospective, Open-label, Post Marketing Study of the Safety and Effectiveness of HArmonyCa Injectable Gel for Mid Face Soft Tissue Augmentation | Alessandro Gritti, Andrew Schumacher, Malka Salomon, Graeme Kerson |
SQ Attribute Definitions Part 2 ABS | Establishing a Vocabulary for Skin Quality: Working Toward Consensus Skin Attribute Definitions From the Patient and Physician Perspective | Shannon Humphrey, Derek Jones, Heather Woolery-Lloyd, Angeline Yong, Stephanie Manson Brown, Heather Lampel, Julie Garcia, Sherket Peterson |
MMP Psychosocial Impact HEOR - AMWC Monaco 2025 ABS | Psychosocial Impact of Masseter Muscle Prominence: Patient Perspectives Across Multiple Regions | Catherine Foley, Julia Garcia, Martha Gauthier, Greg J Goodman, Shannon Humphrey, Taro Kono, Elisabeth Lee, Grace Pan, Yan Wu |
Platysma Integrated Ph3 PRO 309/310 AMWC Monaco 2025 ABS | OnabotulinumtoxinA for the Treatment of Platysma Prominence: Patient-Reported Outcomes From 2 Phase 3 Multicenter, Randomized, Double-blind, Placebo-Controlled Studies | Joely Kaufman, William P. Coleman, Amir Moradi, Steven Dayan, Patricia Ogilvie, Ava Shamban, Steve Yoelin, Warren Tong, Sandhya Shimoga |
Platysma Ph3 323 OL Extension AMWC Monaco 2025 ABS | Repeat Treatments of Moderate to Severe Platysma Prominence With OnabotulinumtoxinA Has a Favorable Safety Profile in a Long-term, Phase 3, Open-label Extension Study | Terrence Keaney, Kenneth Beer, William Hanke, Ira Papel, Deanne Mraz, Rodney Rohrich, Susan Weinkle, Steven Yoelin, Warren Tong, Rene Hopfinger |
Platysma Ph3 323 OL PRO AMWC Monaco 2025 ABS | Patient-Reported Outcomes Across Repeat Treatments for Moderate to Severe Platysma Prominence in a Long-term, Phase 3, Open-label Extension Study | Shannon Humphrey, Sue Ellen Cox, Roy Geronemus, Terrence Keaney, Deanne Mraz, Jennifer Nash, James Pehoushek, Rodney Rohrich, Rene Hopfinger, Sandhya Shimoga |
Natural Look Satisfaction Scale Botox AWMC Monaco 2025 ABS | Development of the Natural Look Satisfaction Scale for the Treatment of Upper Facial Lines With Neurotoxin | Tanya Brandstetter, Annaliza Dominguez, Julia Garcia, Julie Whyte, Martha Gauthier, Kian Karimi, Steve Yoelin, Carmen Kavali |
Vycross Botox Eye Impact - Upper / Midface Tx ABS | Improving Infraorbital Hollow Severity and Volume Through Mid- and Upper-Face Treatment With Hyaluronic Acid (HA)-Fillers and OnabotulinumtoxinA | Gregory J Goodman, Samira Baharlou, Sarah Boxley, Pierre Cuvelier, Cara McDonald, Joan Vandeputte, Ivar Van Heijningen, Julia Garcia, Traci Baker, Smita Chawla, Carola de la Guardia, Frank Lin |
Vycross Botox Eye Impact PRO ABS | Improvements in Age Perception and Psychological Well-Being After Rejuvenation of the Eye Area Using Hyaluronic Acid-Based Fillers and OnabotulinumtoxinA in the Mid- and Upper-Face | Gregory J Goodman, Samira Baharlou, Sarah Boxley, Pierre Cuvelier, Cara McDonald, Joan Vandeputte, Ivar Van Heijningen, Julia Garcia, Traci Baker, Smita Chawla, Carola de la Guardia, Frank Lin |
Vit C&E after Picosecond Laser Treatment | Improvement in Skin Quality Using Vitamin C+E Complex Antioxidant Serum After Picosecond Laser Treatment | Yang Qui, Caroline Aguilar, Johnny Chen, Kate Huang, Elizabeth T. Makino, Monica Zhu, Huangde Li |
Notes to Editors
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X (formerly Twitter) , and YouTube
About Allergan Aesthetics
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.allerganaesthetics.com
Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
Global Media: Michael Salzillo michael.salzillo1@allergan.com U.S. Media: Adelle Infante Adelle.infante@allergan.com | Investors: Liz Shea liz.shea@abbvie.com |
*AA Signature, by Allergan Aesthetics, is a new program that Internationally in February 2025 and will be considered for roll out across International markets, as appropriate, over the next year.
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SOURCE AbbVie
News Provided by PR Newswire via QuoteMedia
AbbVie (NYSE: ABBV) today announced the final analysis of the confirmatory Phase 3 MIRASOL trial evaluating the efficacy and safety of ELAHERE ® (mirvetuximab soravtansine-gynx) in women with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC) compared to chemotherapy. At 30.5 months median follow-up, treatment with ELAHERE continued to show significant improvements in progression-free survival (PFS) and overall survival (OS) compared to investigator's choice (IC) chemotherapy. 1 Ovarian cancer patients often present with late-stage disease and are historically first treated with platinum-based chemotherapy, which they may become resistant to and require another therapy, such as ELAHERE. 2
"Ovarian cancer can be devastating, and when cancer cells stop responding to chemotherapy patients may feel hopeless about their journey. The data presented today reinforce the importance of ELAHERE as a transformative therapy for patients with limited options," said Svetlana Kobina , MD, PhD, vice president, oncology medical affairs, AbbVie. "We remain steadfast in our commitment to bring forward innovative therapies that improve the lives of patients with difficult-to-treat cancers."
In the United States , ovarian cancer is the leading cause of death from gynecological cancers. 3 Each year, approximately 20,000 women are diagnosed. 4 Unfortunately, most patients develop platinum-resistant disease, which is difficult to treat. 5 In this setting, single-agent chemotherapies are associated with minimal survival benefit while adding significant toxicity burden. 6
The Phase 3 MIRASOL study included 453 patients with high-grade serous epithelial PROC whose tumors express high levels of FRα and had been treated with up to three prior therapies. 1 Key findings from the 30.5-month median follow-up include:
The most common treatment-emergent adverse events (TEAEs) occurring in at least 20% of patients in the ELAHERE arm were blurred vision, keratopathy, abdominal pain, fatigue, diarrhea, dry eye, constipation, nausea and peripheral neuropathy. Compared with IC chemotherapy, treatment with ELAHERE was overall associated with lower rates of grade ≥3 TEAEs, serious AEs and discontinuations due to AEs.
"The final data showcase the significant improvement in overall survival benefit of treatment with ELAHERE compared to standard of care chemotherapy," said investigator and presenter, Toon Van Gorp, MD, PhD, Professor of Gynecologic Oncology, University of Leuven. "The significant improvements in survival, along with the well-characterized safety profile, reinforce ELAHERE as an emerging standard of care for difficult-to-treat ovarian cancer and warrants further study of this medicine in earlier treatment settings."
A separate analysis from the Phase 3 MIRASOL study evaluating the impact of [ELAHERE] treatment-emergent ocular events on patient-reported health-related quality of life (HRQoL), will be shared during an oral presentation March 17 at the SGO Annual Meeting scientific plenary session.
ELAHERE was granted full approval by the U.S. Food and Drug Administration in March 2024 and was approved by the European Commission in November 2024 . Marketing Authorization Applications for ELAHERE are also under review in multiple other countries.
About the Phase 3 MIRASOL Trial
MIRASOL is a randomized Phase 3 trial of ELAHERE versus investigator's choice (IC) of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan). Eligibility criteria include patients with PROC whose tumors express high levels of FRα, using the Ventana FOLR1 RxDx Assay, and who have been treated with up to three prior regimens. The primary endpoint of this trial is progression-free survival (PFS) by investigator assessment. Key secondary endpoints include objective response rate (ORR) and overall survival (OS). The trial enrolled 453 patients. Patients were stratified by number of prior lines of therapy (14% had one prior line of therapy, 39% had two prior lines of therapy, and 47% had three prior lines of therapy) and by IC chemotherapy, with paclitaxel as the most commonly chosen (41%), followed by PLD (36%) and topotecan (23%). Sixty-two percent of patients received prior bevacizumab; 55% received a prior PARP inhibitor.
More information can be found on www.clinicaltrials.gov (NCT04209855) .
About ELAHERE
ELAHERE (mirvetuximab soravtansine-gynx) is a first-in-class antibody-drug conjugate (ADC) comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells. Patients requiring access support may call 1-833-ELAHERE or visit www.elahere.com .
ELAHERE U.S. USE and IMPORTANT SAFETY INFORMATION 7
What is ELAHERE?
ELAHERE is a prescription medicine used to treat adults with folate receptor-alpha positive ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who:
Your healthcare provider will perform a test to make sure that ELAHERE is right for you.
It is not known if ELAHERE is safe and effective in children.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ELAHERE?
ELAHERE can cause serious side effects, including:
Eye problems. Eye problems are common with ELAHERE and can also be severe. Tell your healthcare provider right away if you develop any eye problems during treatment with ELAHERE, including blurred vision, dry eyes, sensitivity to light, eye pain, eye redness, or new or worsening vision changes.
What should I tell my healthcare provider before receiving ELAHERE?
Tell your healthcare provider about all of your medical conditions, including if you:
Patients who are able to become pregnant:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking certain other medicines during treatment with ELAHERE may cause side effects.
What are the possible side effects of ELAHERE?
ELAHERE can cause serious side effects, including:
The most common side effects and abnormal labs of ELAHERE include:
• increased liver enzymes in the blood • feeling tired • blurred vision • nausea • diarrhea • stomach-area (abdominal) pain • changes in the cornea (part of the eye) • peripheral neuropathy • muscle, bone, or joint pain • decreased red or white blood cell counts | • decreased platelets • decreased magnesium level in the blood • dry eye • constipation • vomiting • decreased albumin level in the blood • decreased appetite |
Your healthcare provider may change your dose of ELAHERE, delay treatment, or completely stop treatment if you have certain side effects.
These are not all of the possible side effects of ELAHERE. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.
Please see Full Prescribing Information , including Boxed WARNING and Medication Guide .
About AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care for patients living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), Immuno-Oncology-based therapeutics, multi-specific antibody and in situ CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines.
Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood and solid tumors. We are evaluating more than 20 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit http://www.abbvie.com/oncology .
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X (formerly Twitter) , and YouTube.
AbbVie Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
Disclosure: Dr. Van Gorp has financial interests related to AbbVie.
References:
U.S. Media: | Investors: | |
Stephanie Tennessen | Liz Shea | |
+1 (224) 214-8638 | +1 (847) 935-2211 | |
Global Media: | ||
Marianne Ostrogorski | ||
+1 (224) 240-6336 | ||
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SOURCE AbbVie
News Provided by PR Newswire via QuoteMedia
Phase 1 clinical trial of ADI-001 in autoimmune diseases ongoing; on track to report preliminary clinical data from lupus nephritis (LN) patient cohort in 1H25
Additional LN clinical data and preliminary clinical data from other autoimmune patient cohorts anticipated in 2H25
Initiation of ADI-001 Phase 1 clinical trial patient enrollment in systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS) expected in 2Q25; anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis (AAV) patient enrollment expected to be initiated in 2H25
Advancing patient enrollment in ADI-270 Phase 1 clinical trial in patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC); plan to report preliminary data in 1H25
$176.3 million in cash, cash equivalents and short-term investments as of December 31, 2024
Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today reported financial results and operational highlights for the fourth quarter and year ended December 31, 2024.
"In 2025 we plan to continue advancing our gamma delta 1 CAR T cell therapy programs, achieving key milestones and reporting preliminary data in autoimmune and oncology indications," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "The recent FDA Fast Track Designation for ADI-001 in refractory SLE with extrarenal involvement and in SSc highlights the significant unmet need for innovative, off-the-shelf therapies to treat autoimmune diseases. We are continuing to enroll LN patients in our ongoing Phase 1 trial in autoimmune diseases and look forward to sharing preliminary clinical data in the first half of 2025 and additional data in the second half of 2025. We expect to initiate enrollment for SLE, SSc, IIM and SPS patients in the second quarter and for AAV in the second half of the year, and to report clinical data from these additional cohorts in the second half as well."
Mr. Schor continued: "In addition, we are continuing to enroll patients in our Phase 1 trial of ADI-270 in relapsed or refractory metastatic/advanced ccRCC patients and remain on track to announce preliminary clinical data in the first half of 2025. With a strong clinical foundation and growing momentum, Adicet is well-positioned to transform treatment paradigms for patients battling autoimmune diseases and solid tumors."
Fourth Quarter 2024 and Recent Operational Highlights:
Autoimmune diseases
Solid tumor indications
Corporate updates
Financial Results for Fourth Quarter and Full Year 2024:
Three months ended December 31, 2024
Twelve Months Ended December 31, 2024
About Adicet Bio, Inc.
Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of "off-the-shelf" gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com .
Forward-Looking Statements
This press release contains "forward-looking statements" of Adicet within the meaning of the Private Securities Litigation Reform Act of 1995 relating to the business and operations of Adicet. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: clinical development of Adicet's product candidates, including future plans or expectations for ADI-001 in autoimmune diseases and ADI-270 in ccRCC and the potential safety, tolerability and efficacy for the treatment of autoimmune diseases and cancer; ADI-001's potential to be an off-the-shelf treatment option for autoimmune indications; ADI-270's potential to be the first gamma delta CAR T cell therapy to address solid tumors; timing and success of the Phase 1 clinical trial of ADI-001 in LN, SLE, SSc, AAV, IIM and SPS, including timing and expectations for enrollment and future data releases; timing and success of the Phase 1 clinical trial of ADI-270 in ccRCC, including expectations for future data releases; and expectations regarding Adicet's uses of capital, expenses and financial results, including the expected cash runway.
Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including without limitation, the effect of global economic conditions and public health emergencies on Adicet's business and financial results, including with respect to disruptions to our preclinical and clinical studies, business operations, employee hiring and retention, and ability to raise additional capital; Adicet's ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; that positive results, including interim results, from a preclinical or clinical study may not necessarily be predictive of the results of future or ongoing studies; clinical studies may fail to demonstrate adequate safety and efficacy of Adicet's product candidates, which would prevent, delay, or limit the scope of regulatory approval and commercialization; and regulatory approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable; and Adicet's ability to meet production and product release expectations. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Adicet's actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Adicet's most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in Adicet's other filings with the U.S. Securities and Exchange Commission, including its quarterly report on Form 10-Q. All information in this press release is as of the date of the release, and Adicet undertakes no duty to update this information unless required by law.
ADICET BIO, INC. | ||||||||||||||||
Consolidated Statements of Operations and Comprehensive Income | ||||||||||||||||
(in thousands, except share and per share amounts) | ||||||||||||||||
Three Months Ended | Years Ended | |||||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 23,273 | $ | 24,759 | $ | 99,323 | $ | 106,043 | ||||||||
General and administrative | 7,470 | 6,807 | 28,292 | 26,533 | ||||||||||||
Goodwill impairment | — | — | — | 19,462 | ||||||||||||
Total operating expenses | 30,743 | 31,566 | 127,615 | 152,038 | ||||||||||||
Loss from operations | (30,743 | ) | (31,566 | ) | (127,615 | ) | (152,038 | ) | ||||||||
Interest income | 2,067 | 2,178 | 10,714 | 9,978 | ||||||||||||
Interest expense | (1 | ) | — | (4 | ) | (25 | ) | |||||||||
Other expense, net | (50 | ) | (101 | ) | (217 | ) | (573 | ) | ||||||||
Loss before income tax provision | (28,727 | ) | (29,489 | ) | (117,122 | ) | (142,658 | ) | ||||||||
Income tax provision | — | — | — | — | ||||||||||||
Net loss | $ | (28,727 | ) | $ | (29,489 | ) | $ | (117,122 | ) | $ | (142,658 | ) | ||||
Net loss per share, basic and diluted | $ | (0.32 | ) | $ | (0.69 | ) | $ | (1.33 | ) | $ | (3.31 | ) | ||||
Weighted-average common shares used in computing net loss per share, basic and diluted | 90,846,293 | 43,035,315 | 87,866,435 | 43,042,405 | ||||||||||||
Other comprehensive income | ||||||||||||||||
Unrealized (loss) gain on treasury securities, net of tax | (105 | ) | — | 16 | — | |||||||||||
Total other comprehensive income | (105 | ) | — | 16 | — | |||||||||||
Comprehensive loss | $ | (28,832 | ) | $ | (29,489 | ) | $ | (117,106 | ) | $ | (142,658 | ) | ||||
ADICET BIO, INC. | ||||||||
Consolidated Balance Sheets Information | ||||||||
(in thousands) | ||||||||
December 31, | December 31, | |||||||
2024 | 2023 | |||||||
Cash, cash equivalents and short-term investments in treasury securities | $ | 176,303 | $ | 159,711 | ||||
Working capital | 160,744 | 142,985 | ||||||
Total assets | 220,219 | 207,295 | ||||||
Accumulated deficit | (497,894 | ) | (380,772 | ) | ||||
Total stockholders' equity | 186,609 | 170,175 | ||||||
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Adicet Bio, Inc.
Investor and Media Contacts
Investors:
Anne Bowdidge
abowdidge@adicetbio.com
Janhavi Mohite
Precision AQ
212-362-1200
janhavi.mohite@precisionaq.com
Media:
Kerry Beth Daly
kbdaly@adicetbio.com
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