On February 27, 2025 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported its financial results for the fourth quarter and full year ended 2024 and provided a corporate update (Press release, Aclaris Therapeutics, FEB 27, 2025, View Source [SID1234650685]).

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"2024 was a transformative year that has positioned Aclaris with multiple clinical catalysts expected in 2025 across our expanded pipeline," stated Dr. Neal Walker, Chief Executive Officer and Chair of the Board of Directors of Aclaris. "We are particularly excited about the upcoming Phase 2 data for bosakitug in both severe asthma and chronic rhinosinusitis with nasal polyps anticipated from our partner CTTQ, which we expect will provide important insights into our future development of bosakitug in respiratory diseases. We also anticipate top-line data from our Phase 2a trial of ATI-2138 in atopic dermatitis in the first half of 2025. With multiple clinical catalysts expected throughout 2025 across our pipeline of differentiated assets with mechanisms shown to have proven activity in the diseases we are addressing, we look to drive continued innovation for the patients we seek to treat."

Fourth Quarter 2024 Highlights and Recent Updates

Pipeline:

Announced Exclusive, Global License Agreement with Biosion, Inc., Adding Potential Best-in-Class Biologic Assets to Pipeline: Aclaris acquired worldwide rights (excluding Greater China) to bosakitug (ATI-045), a potential best-in-class, clinical-stage, novel anti-TSLP monoclonal antibody, and ATI-052, a potential best-in-class, pre-clinical stage, novel bispecific antibody that is directed against both TSLP and IL4R. As a result of this license agreement, the Company recorded a one-time $86.9 million in-process research and development charge. (press release here)
Confirmed Expectation of Phase 2 Data in the First Half of 2025 for Bosakitug in Chinese Patients with Certain Pulmonary Disorders: Aclaris’ regional partner, Chia Tai Tianqing Pharmaceutical Group, Co., Ltd. (CTTQ), is conducting concurrent Phase 2 studies in China for patients with severe asthma, CRSwNP, and chronic obstructive pulmonary disease. Data from trials in severe asthma and CRSwNP expected in first half of 2025 to inform internal development programs.
Initiated Clinical Trial Activities for a Phase 2b Trial of Bosakitug in Atopic Dermatitis (AD); Enrollment Expected to Begin in the First Half of 2025: This trial will investigate the safety, tolerability, pharmacokinetics, efficacy, and pharmacodynamics of bosakitug in patients with moderate to severe AD.
Confirmed Expectation of Top Line Results in the First Half of 2025 for Phase 2a Trial in AD of ATI-2138, an Investigational Oral Covalent ITK/JAK3 Inhibitor: This ongoing Phase 2a open-label trial is being conducted to investigate the safety, tolerability, pharmacokinetics, efficacy, and pharmacodynamics of ATI-2138 in patients with moderate to severe AD.
Announced Plan to File an Investigational New Drug (IND) Application for ATI-052 in the First Quarter of 2025: Following allowance of the IND, Aclaris expects to initiate a Phase 1 clinical trial evaluating single ascending doses and multiple ascending doses of ATI-052.
Announced New Publication Highlighting the Unique Properties of ATI-2138: New publication provides important clinical and non-clinical evidence of the potential for ATI-2138 to be a best-in-class inhibitor of key signal transduction kinases due to its unique mechanism of action. (press release here)
Corporate:

Completed $80 Million Private Placement in November 2024 to Bolster Cash Runway: Aclaris’ cash runway expected into 2028. (press release here)
Provided Update on Senior Leadership:
Dr. Neal Walker, formerly interim Chief Executive Officer, has been named Chief Executive Officer. Dr. Walker is a co-founder of Aclaris and has served as a member of the Board of Directors since its inception. He previously served as Aclaris’ Chief Executive Officer until 2022 before being appointed as interim Chief Executive Officer in January 2024. Dr. Walker serves as Chair of the Board of Directors of Aclaris.
Hugh Davis, Ph.D. joined Aclaris as President and Chief Operating Officer. Dr. Davis brings over 35 years of experience in biologics development, clinical pharmacology, and business development to Aclaris. He most recently served as Biosion’s Chief Business & Development Officer and President.
William Roberts has been appointed as Senior Vice President, Corporate Communications and Investor Relations. Mr. Roberts brings 30 years of corporate communications, investor relations, and scientific experience in the biotech/biopharma industry to the Company. He most recently served as the Communications Officer of G1 Therapeutics, which was recently acquired by Pharmacosmos Group.
Fourth Quarter and Full Year 2024 Financial Results

As of December 31, 2024, Aclaris had aggregate cash, cash equivalents and marketable securities of $203.9 million compared to $181.9 million as of December 31, 2023. The Company believes that its cash, cash equivalents and marketable securities as of December 31, 2024 will be sufficient to fund its operations into 2028, without giving effect to any potential business development transactions or financing activities.

Net loss was $96.6 million for the fourth quarter of 2024 compared to $1.5 million for the fourth quarter of 2023. Net loss was $132.1 million for the year ended December 31, 2024 compared to $88.5 million for the year ended December 31, 2023.

Total revenue was $9.2 million for the fourth quarter of 2024 compared to $17.6 million for the fourth quarter of 2023. The decrease was primarily driven by a one-time upfront payment under the license agreement with Sun Pharmaceutical Industries, Inc. received in the fourth quarter of 2023, offset by the achievement of a commercial milestone under the license agreement with Eli Lilly and Company in the fourth quarter of 2024. Total revenue was $18.7 million for the year ended December 31, 2024 compared to $31.2 million for the year ended December 31, 2023.

Research and development (R&D) expenses were $9.0 million for the quarter ended December 31, 2024 compared to $26.6 million for the prior year period. The $17.6 million decrease was primarily the result of lower zunsemetinib development expenses, lepzacitinib preclinical and clinical development activities, and compensation-related expenses. For the year ended December 31, 2024, R&D expenses were $33.6 million compared to $98.4 million for the year ended December 31, 2023.

General and administrative (G&A) expenses were $5.0 million for the quarter ended December 31, 2024 compared to $8.2 million for the corresponding prior year period. The decrease was primarily due to a reduction in personnel and stock-based compensation expenses. For the year ended December 31, 2024, G&A expenses were $22.2 compared to $32.4 million for the year ended December 31, 2023, primarily due to lower compensation-related costs.

Licensing expenses were $8.6 million for the quarter ended December 31, 2024 compared to $5.7 million for the prior year period. The increase was primarily attributable to a milestone achieved during the fourth quarter of 2024, the entirety of which was payable to a third party. For the year ended December 31, 2024, licensing expenses were $12.7 million compared to $14.7 million for the year ended December 31, 2023.

Revaluation of contingent consideration resulted in a $1.3 million gain for the quarter ended December 31, 2024 compared to a $26.3 million gain for the prior year period. For the year ended December 31, 2024, revaluation of contingent consideration resulted in a charge of $2.5 million compared to a $26.9 million gain for the year ended December 31, 2023.

During the quarter and year ended December 31, 2024, the Company recorded $86.9 million of in-process research and development expenses, representing the fair value of consideration expensed in connection with the in-license of bosakitug (ATI-045) and ATI-052, as well as transaction costs incurred. During the quarter ended December 31, 2023, the Company recorded an intangible asset impairment charge of $6.6 million representing the full balance of its in-process research and development intangible asset.

On February 27, 2025 ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, reported the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for ANKTIVA and CAR-NK (PD-L1 t-haNK) for the reversal of Lymphopenia in Patients Receiving Standard-of-Care Chemotherapy/Radiotherapy and in Multiply Relapsed Locally Advanced or Metastatic Pancreatic Cancer (Press release, ImmunityBio, FEB 27, 2025, View Source [SID1234650704]).

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The complete blood count (CBC) is a standard assay widely used by oncologist to assess the status of the immune system following chemotherapy and radiation. To date, information of the cellular elements in the CBC assay provide information to the physician for the treatment of anemia, neutropenia and reduced platelet counts associated with the adverse events of chemotherapy and radiotherapy. Anemia, neutropenia and reduced platelet counts can be treated with currently approved therapies including EPOGEN, NEUPOGEN and platelet transfusion, respectively.

However, chemotherapy and radiation has also caused a reduction in the very cells necessary to kill cancer cells. This reduction in the lymphocytes by our standard of care also inhibits the induction of T cell memory in the absence of CD4+, CD8+ T cells. A treatment for the reversal of these adverse events of lymphopenia, induced by current standard-of-care, has eluded the industry for the past 50 years. ImmunityBio and its Founder Dr. Patrick Soon-Shiong developed a vision over the past decades that activation and proliferation of these key lymphocytes was necessary if we were to win the war against cancer and indeed even prevent cancer in subjects at high-risk such as with lynch syndrome with a cancer vaccine. The founder’s vision reflecting the pursuit of addressing lymphopenia over the past decades will be updated in March.

"RMAT designation for ANKTIVA combined with NK cells was applied for by the Founder in the initial 2017 IND. With the clinical results of the QUILT trials across multiple tumor types from 2017 to 2024, validating the hypothesis that high-dose chemotherapy and radiation induces lymphopenia and can be reversed by ANKTIVA together with off-the-shelf CAR-NK cells (PD-L1 t-haNK) resulting in prolongation of overall survival (OS), and enabling ImmunityBio to reapply for RMAT in 2025,"1 said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific & Medical Officer of ImmunityBio. "I am so grateful for the FDA to have recognized the evolution of science and the need for adoption of 21st century medicine and cell therapy, particularly the role of NK cell therapy in our war against cancer as a universal therapy in cancer, and in the potential treatment of infectious diseases such as HIV, HPV and COVID. Today’s designation of ANKTIVA and the first CAR-NK (PD-L1 T-haNK), both first-in-class molecules to activate lymphocytes within the body (via subcutaneous injection of ANKTIVA) and via ex-vivo infusion of off-the-shelf PD-L1 NK cells, is an inflection point and a paradigm change of how we could treat patients with cancer and viral infections. The absolute lymphocyte count (ALC) which has been largely ignored by physicians, since no therapy existed to address lymphopenia, could now be both a prognostic biomarker but more importantly, the potential as a therapeutic biomarker."

"Multiple publications in the last five years have shown that patients with low lymphocyte counts especially those with severe lymphopenia have a statistically lower survival rate regardless of the tumor types.2-5 With this RMAT designation and the attributes of a RMAT designation including all Breakthrough Therapy Designation features and statutory ways to support Accelerated Approval, we will move rapidly to file the BLA for these authorized indications provided by the RMAT designation," said Soon-Shiong. "In addition, per the requirement under section 561A(f)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), ImmunityBio will make publicly available the Expanded Access Policy of ANKTIVA and PD-L1 t-haNK in combination with standard-of-care chemotherapy/radiotherapy within 15 days."

In the authorization letter, the FDA has committed to work closely with ImmunityBio to provide guidance and advice on generating the evidence needed to "support approval" of the indication above "in an efficient manner."

About ANKTIVA
The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response.

ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.

ANKTIVA was approved by the FDA in 2024 for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors. For more information, visit ImmunityBio.com (Founder’s Vision) and Anktiva.com.

About CAR-NK (PD-L1 t-haNK)

PD-L1 t-haNK is a human, allogeneic, stable clonal NK cell line generated from the parental aNK cell line (NK-92), manufactured by the Sponsor under cGMP conditions.

Based on the demonstrated therapeutic efficacy of CAR targeting and on the important role of FcgR-mediated ADCC in the effectiveness of therapeutic IgG1 monoclonal antibodies, we hypothesized that modification of the parental aNK cell line to stably express both a PD-L1–targeted CAR and the high-affinity variant of CD16 would result in potent and selective antitumor activity. Myeloid-derived suppressor cells (MDSCs) express PD-L1 in concert with MHC-I loss to induce immune escape of tumors resistant or relapsed from chemo-immunotherapy including checkpoint inhibitors. Thus, there is a rationale for the combination of Anktiva (converting a cold tumor to hot tumor and rescuing T cells by re-expressing MHC-I) and PD-L1 t-haNK to overcome the immunosuppressive effect of TGFb secreted by MDSCs. The ability to target both the tumor and MDSCs with off-the-shelf, outpatient based safe infusion of allogeneic CAR-NKs targeting PD-L1, was the basis for the development of this CAR-NK. Preclinical studies published in the J Immunotherapy Cancer 2020 "PD-L1 targeting high-affinity NK (t-haNK) cells induce direct antitumor effects and target suppressive MDSC populations" (Fabian et al. 2020) demonstrate that PD-L1 targeting of high affinity NK cells (PD-L1 t-haNK) induced direct anti-tumor effects in TNBC tumor cell lines and target suppressive MDSCs populations.

On February 27, 2025 Medigene AG (Medigene, FSE: MDG1, Prime Standard) and EpimAb Biotherapeutics, Inc. (EpimAb), reported that the companies have entered a strategic co-development agreement to research and develop off-the-shelf T cell receptor (TCR)-guided T Cell Engagers (TCR-TCEs) for the treatment of immune-related disorders, such as solid tumors (Press release, MediGene, FEB 27, 2025, View Source [SID1234650725]).

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The multi-target collaboration combines the respective expertise of each company with Medigene’s 3S (sensitive, specific and safe) TCR generation and characterization capabilities and EpimAb’s proprietary CD3 antibody and T-FIT (TCR-Fab in tandem) platform. The resultant bispecific therapeutics are expected to provide highly specific targeted immune responses with minimized off-target effects and thus, improved patient outcomes.The companies aim to co-develop TCR-TCE constructs, which will be owned equally by both partners.

"We are delighted to partner with EpimAb and their proprietary T-FIT platform, which is well validated with strong clinical data and a number of prominent recent partnering deals, to develop potential best-in-class TCR-TCEs, leveraging our expert 3S TCR generation capabilities," said Selwyn Ho, CEO of Medigene AG. "This co-development agreement further expands the application of Medigene’s TCRs into off-the-shelf TCR-guided modalities and underscores our commitment to forging value-driven partnerships that expand our pipeline in areas of high unmet patient need."

"EpimAb is looking forward to discover new TCR-TCEs with Medigene’s unique TCRs," said Chengbin Wu, CEO and Founder of EpimAb. "Together we can open up new possibilities for our T-FIT and CD3 binding platforms to develop novel targeted therapies for cancer patients."

The market for bispecific therapies represents a significant opportunity in the fight against cancer, addressing the critical unmet need in both solid and hematologic tumors. Annually, over 5 million cancer patients worldwide, suffering from solid and hematologic cancers, face low five-year survival rates, highlighting the urgent demand for innovative treatments. Bispecific TCR-TCEs offer a promising solution, leveraging the body’s immune system to target and eradicate cancer cells with heightened precision.

The market for these therapies is projected to experience compound annual growth rate of 40.9% from 2023 to 2030, underscoring the robust and accelerating interest in this field. By 2030, the market is estimated to exceed USD80 billion (Source: KBV Research), reflecting its substantial potential to improve patient outcomes and revolutionize treatment of cancer and other diseases.

On February 27, 2025 Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, reported financial results for the fourth quarter and full year ended December 31, 2024, and provided business highlights.

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"We are starting 2025 with momentum in TNG462, our lead PRMT5 program, with fulsome data focused on pancreatic and lung cancer expected before the end of the year," said Barbara Weber, M.D., President and Chief Executive Officer of Tango Therapeutics. "PRMT5 is a clinically well-validated target, and we believe that TNG462 and TNG456 are both potentially best-in-class oral small molecules for multiple MTAP-deleted cancers. We expect that the TNG462 data we plan to disclose in 2025 will provide meaningful differentiation and solidify our clinical development plan, with a goal of initiating our first TNG462 monotherapy registrational study in pancreatic cancer next year."

Pipeline Update

TNG462, a potentially best-in-class MTA-cooperative PRMT5 inhibitor

The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to TNG462 in November 2024 for the treatment of pancreatic cancer. ODD is granted to investigational therapies addressing medical diseases or conditions that affect fewer than 200,000 people per year in the United States. This designation provides for a seven-year marketing exclusivity period upon regulatory approval, as well as certain incentives, including federal grants and tax credits.
Patients are being enrolled in the TNG462 monotherapy Phase 1/2 clinical trial, with an emphasis on patients with pancreatic and lung cancers.
In November 2024, the Company reported positive early data for TNG462, demonstrating durable clinical responses across multiple cancer types, including RECIST partial responses in pancreatic and lung cancer, with a safety and tolerability profile that the Company believes is superior to competitors. Additional clinical data are expected in 2025 with a focus on pancreatic and lung cancer.
Based on these promising early clinical data, the Company plans to initiate multiple targeted and standard of care combination studies with TNG462, including with daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor and zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor (Revolution Medicines) and pembrolizumab. These trials are expected to begin enrolling in the first half of 2025.
TNG456, a next-generation brain-penetrant MTA-cooperative PRMT5 inhibitor

In January 2025, the FDA cleared the TNG456 IND. Preclinical studies suggest that TNG456 will have improved activity to treat glioblastoma compared to TNG908 based on increased exposure in the brain afforded by the increased potency and MTAP-selectivity. The Company expects to begin enrolling patients in a phase 1/2 trial in 1H 2025.
In the fourth quarter of 2024, the Company entered into a clinical collaboration with Eli Lilly and Company (Lilly) for the supply of the CDK4/6 inhibitor abemaciclib for use in combination with TNG456 for treatment of patients with MTAP-deleted solid tumors, with a focus on glioblastoma. The agreement provides that Lilly will supply abemaciclib at no cost to Tango and that Tango will be the sponsor of the combination trials. Each company will retain commercial rights to their respective compounds and the agreement is mutually non-exclusive.
In February 2025, the FDA granted Fast Track Designation (FTD) to TNG456 for the treatment of solid tumors with MTAP deletion, as well as TNG456 in combination with abemaciclib for the treatment of NSCLC with MTAP deletion. FTD is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need, with the potential to allow important new drugs to reach patients earlier.
TNG260, a first-in-class, highly selective CoREST complex inhibitor

Proof-of-mechanism has been established for TNG260 based on pharmacodynamic data from on-treatment patient biopsies, with favorable safety, tolerability and pharmacokinetic profiles shown at the expansion dose of 80 mg QD to date.
The dose expansion phase of the TNG260 phase 1/2 trial is ongoing in lung cancer. The study is evaluating the pharmacokinetics, pharmacodynamics, safety and efficacy of TNG260 in combination with pembrolizumab in patients with an STK11 loss-of-function mutation.
The Company plans to provide a clinical update on TNG260 in 2025.
Upcoming Milestones

TNG462 clinical data update expected in 2025
Enrollment in multiple TNG462 combination trials expected to begin 2025
TNG456 phase 1/2 trial enrollment expected to begin 1H 2025
TNG260 clinical data update expected in 2025
Financial Results

As of December 31, 2024, the Company held $257.9 million in cash, cash equivalents and marketable securities, which the Company expects to be sufficient to fund operations into the third quarter of 2026.

Collaboration revenue was $4.1 million for the three months ended December 31, 2024, compared to $5.4 million for the same period in 2023, and $30.0 million for the twelve months ended December 31, 2024 compared to $31.5 million for the same period in 2023. Collaboration revenue decreased due to lower research costs incurred under the collaboration during the three and twelve months ended December 31, 2024.

License revenue was $0 and $12.1 million for the three and twelve months ended December 31, 2024, respectively, compared to $0 and $5.0 million for the three and twelve months ended December 31, 2023, respectively. The year-to-date increase is primarily due to licensing a drug discovery program to Gilead for $12.0 million during the second quarter of 2024 as compared to Gilead licensing an earlier stage program for $5.0 million during the year ended December 31, 2023.

Research and development expenses were $33.9 million for the three months ended December 31, 2024, compared to $31.3 million for the same period in 2023, and $143.9 million for the twelve months ended December 31, 2024 compared to $115.2 million for the same period in 2023. The increase is due to the advancement of TNG462 and TNG456 and personnel-related costs to support our research and development activities.

General and administrative expenses were $11.1 million for the three months ended December 31, 2024, compared to $9.1 million for the same period in 2023, and $43.7 million for the twelve months ended December 31, 2024 compared to $35.5 million for the same period in 2023. The changes were primarily due to increases in personnel-related costs.

Net loss for the three months ended December 31, 2024 was $37.7 million, or $0.35 per share, compared to a net loss of $30.8 million, or $0.32 per share, in the same period in 2023. Net loss for the twelve months ended December 31, 2024 was $130.3 million, or $1.19 per share, compared to a net loss of $101.7 million, or $1.08 per share, in the same period in 2023.

(Press release, Tango Therapeutics, FEB 27, 2025, View Source [SID1234662364])

On February 27, 2025 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported that Daniel Faga, president and chief executive officer of Anaptys, and/or other members of its executive leadership team, are scheduled to participate in multiple upcoming investor conferences (Press release, AnaptysBio, FEB 27, 2025, View Source [SID1234650686]):

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TD Cowen 45th Annual Healthcare Conference, Boston, MA

Format – Fireside chat and one-on-one investor meetings
Date and Time – Tuesday, Mar. 4, 2025 at 1:10pm ET / 10:10am PT
Leerink Partners 2025 Global Healthcare Conference, Miami, FL

Format – Fireside chat and one-on-one investor meetings
Date and Time – Tuesday, Mar. 11, 2025 at 10:40am ET / 7:40am PT
Barclays 27th Annual Global Healthcare Conference, Miami, FL

Format – Presentation and one-on-one investor meetings
Date and Time – Wednesday, Mar. 12, 2025 at 8:30am ET / 5:30am PT
Live webcasts of the fireside chats and presentation will be available on the investor section of the Anaptys website at View Source Replays of the webcasts will be available for at least 30 days following the events.