On November 2, 2023 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, reported its consolidated financial results for the third quarter ended September 30, 2023 and reviewed recent business highlights (Press release, Alnylam, NOV 2, 2023, View Source [SID1234636728]).

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"We continued to deliver strong commercial results in the third quarter, with the successful launch of AMVUTTRA contributing to 35% year-over-year growth in net product revenues," said Yvonne Greenstreet, MBChB, Chief Executive Officer of Alnylam. "While we were disappointed by the recent Complete Response Letter for ONPATTRO for the treatment of the cardiomyopathy of ATTR amyloidosis, we remain confident in the HELIOS-B Phase 3 study of vutrisiran, which is on track to deliver topline results in early 2024. We’re also excited about advancements across our broad pipeline of RNAi therapeutics, including recent positive topline results from the KARDIA-1 Phase 2 study of zilebesiran, as well as upcoming Phase 1 results for ALN-TTRsc04 and ALN-KHK by year-end. With this continued execution we remain on track to meet our Alnylam P5x25 goals of becoming a top-tier biotech company delivering sustained innovation and exceptional financial results."

Third Quarter 2023 and Recent Significant Corporate Highlights

Commercial Performance

Total TTR: ONPATTRO (patisiran) & AMVUTTRA (vutrisiran)

Achieved global net product revenues for ONPATTRO and AMVUTTRA for the third quarter of $82 million and $149 million, respectively, representing 35% total TTR reported year-over-year growth compared to Q3 2022.
Attained over 3,790 hATTR amyloidosis patients with polyneuropathy worldwide on commercial treatment with ONPATTRO or AMVUTTRA as of September 30, 2023.
Total Ultra-Rare: GIVLAARI (givosiran) & OXLUMO (lumasiran)

Achieved global net product revenues for GIVLAARI and OXLUMO for the third quarter of $54 million and $29 million, respectively, representing 33% total Ultra-Rare reported year-over-year growth compared to Q3 2022.
Attained over 625 patients worldwide on commercial GIVLAARI treatment as of September 30, 2023.
Attained over 375 patients worldwide on commercial OXLUMO treatment as of September 30, 2023.
Leqvio (inclisiran)

Leqvio launch in the U.S. and other markets is ongoing, with focus on patient on-boarding, removing access hurdles and enhancing medical education. In the U.S., Leqvio is covered at or near label for 76% of patients. More than 55% of Leqvio source of business in the U.S. is now through "Buy and Bill" acquisition mode. FDA expanded the label to include primary hyperlipidemia (patients at increased risk of ASCVD) and the removal of four adverse reactions from the safety section as well as Limitations of Use. In Q3 2023, Leqvio was approved in China and in Japan and is now approved in 93 countries.
R&D Highlights

Reported positive topline results from the KARDIA-1 Phase 2 dose-ranging study of zilebesiran, an investigational RNAi therapeutic in development to treat hypertension in patients at high cardiovascular risk.

Published results from Phase 1 study of zilebesiran in the New England Journal of Medicine.

Reported updated positive interim results for the ongoing single ascending dose portion of the Phase 1 study of ALN-APP in patients with early-onset Alzheimer’s disease at the 2023 Alzheimer’s Association International Conference and at the 16th Clinical Trials on Alzheimer’s Disease conference.

Based on the achievement of specified clinical proof-of-principle criteria for the Phase 1 ALN-APP program, Alnylam received a $100 million milestone payment from Regeneron.
Presented new 24-month results from an interim analysis of the open-label extension period of the APOLLO-B Phase 3 study of patisiran in patients with the cardiomyopathy of transthyretin-mediated amyloidosis at the Heart Failure Society of America Annual Scientific Meeting 2023.

Published results from Phase 3 APOLLO-B study of patisiran in the New England Journal of Medicine.

Sanofi reported positive data for fitusiran, in development for the treatment of hemophilia A or B, with or without inhibitors, from the Phase 3 open-label extension study (ATLAS-OLE).

Sanofi is currently in discussions with the FDA regarding filing in 2024.
Additional Business Updates

Entered into a global strategic collaboration with Roche for the co-development and co-commercialization of zilebesiran.
Recognized by Science magazine as a Top Employer for the fifth consecutive year.
Upcoming Events

Alnylam announces today that it will present a review of its RNAi platform and pipeline progress at a virtual R&D Day on December 13, 2023.

Alnylam announces today that results from the KARDIA-1 Phase 2 dose-ranging study of zilebesiran will be presented as a Late-Breaker at the American Heart Association Scientific Sessions 2023 on November 11, 2023, in Philadelphia, Pennsylvania.

In addition, in late 2023:

Alnylam intends to report topline results from the Phase 1 study of ALN-TTRsc04.
Alnylam intends to report topline results from the Phase 1 study of ALN-KHK.
Vir is conducting multiple trials evaluating the potential for ALN-HBV02 (VIR-2218) and VIR-3434 to achieve a functional cure for chronic hepatitis B. Phase 2 data readouts are on track for Q4 2023.
Vir also announced that initial Phase 2 data readouts for the SOLSTICE trial evaluating ALN-HBV02 (VIR-2218) and VIR-3434 as monotherapy and in combination for the treatment of people living with chronic hepatitis delta, the most aggressive form of viral hepatitis, are expected in Q4 2023.

On November 2, 2023 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported a corporate update and reported financial results for the quarter ended September 30, 2023 (Press release, Allogene, NOV 2, 2023, View Source [SID1234636727]).

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"Our experience continues to deepen as we successfully execute across our platform, creating a code for allogeneic cell therapy that can be applied not just in the industry’s first potentially pivotal trial of an allogeneic CAR T product candidate, but in other harder modes such as earlier line trials, solid tumors, and next-generation products and indications," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "We look forward to the months ahead and sharing these insights, potentially unlocking new opportunities and broadening patient access to CAR T therapy."

Pipeline Updates

Anti-CD19 AlloCAR T Program
ALPHA2 is the industry’s first potentially pivotal Phase 2 allogeneic CAR T clinical trial. This global trial for the ALLO-501A product candidate will enroll approximately 100 patients who have received at least two prior lines of therapy and have not received prior anti-CD19 therapy.

The single-arm ALPHA2 trial in relapsed/refractory (R/R) large B cell lymphoma (LBCL) utilizes a single dose of ALLO-501A (120 million CAR+ cells) following lymphodepletion with FCA90 (fludarabine, 30 mg/m2; cyclophosphamide 300 mg/m2; and investigational ALLO-647 30 mg, daily for 3 days). The primary endpoint is overall response rate (ORR), and the key secondary endpoint is duration of response (DoR). Patients may receive treatment as an outpatient at the investigator’s discretion. Enrollment is expected to be completed by the 1H 2024 with the first data readout by the end of 2024.

The Company announced it will have two poster presentations from the ALPHA/ALPHA2 trials focused on lymphodepletion in allogeneic cell therapy at the 65th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) December 2023.

The first poster is a comprehensive safety review of all 85 patients treated in the Phase 1 ALPHA/ALPHA2 studies in relapsed/refractory (r/r) Large B Cell Lymphoma (LBCL) and follicular lymphoma (FL) to characterize the overall safety profile when ALLO-647 is added to standard lymphodepletion.

The second poster showcases translational results from ALPHA2 generated through a collaboration with The University of Texas MD Anderson Cancer Center. This study compared expansion kinetics among 11 allogeneic CAR T recipients treated with the ALLO-501A product candidate in the ALPHA2 trial. The study revealed the impact of recipient alloreactive CD8+ T cells in allogeneic CAR T rejection. Results of this study could help define strategies to improve allogeneic CAR T expansion, persistence and efficacy.

Long-term follow up data was previously presented from the Phase 1 ALPHA/ALPHA2 trials in LBCL and has been extensively characterized in presentations earlier this year at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, European Hematology Association (EHA) (Free EHA Whitepaper) Congress, and International Conference on Malignant Lymphoma (ICML) in Lugano.

The Phase 1 trials enrolled heavily pre-treated patients with a median of three prior lines of therapy. Data from 33 CAR T-naïve LBCL patients receiving Alloy cell product, including 12 patients treated with the Phase 2 regimen, are the first to demonstrate the potential for an investigational allogeneic CAR T product to induce complete responses at rates and durability similar to approved autologous therapies. Treatment with the ALLO-501/501A product candidates was generally well tolerated with no incidence of Grade 3 or greater cytokine release syndrome, and no cases of immune effector cell-associated neurotoxicity syndrome or graft versus host disease. Cytopenia and infections were manageable and comparable to the experience with autologous CAR T cell therapies in patients with r/r LBCL.

The EXPAND trial, enrolling in the United States and Europe, is expected to support licensure of ALLO-647, the Company’s investigational anti-CD52 monoclonal antibody used in conjunction with standard low-dose FC (fludarabine, 30 mg/m2 and cyclophosphamide 300 mg/m2, daily for 3 days) lymphodepletion regimens. The trial will enroll approximately 70 patients with r/r LBCL who will be randomized to lymphodepletion with FCA90 (which includes 90 mg of ALLO-647) versus FC alone before receiving a single 120 million cell dose of ALLO-501A. The primary endpoint of the study is progression free survival (PFS).

Anti-CD70 AlloCAR T Program
The Phase 1 dose escalation TRAVERSE trial in patients with advanced or metastatic renal cell carcinoma (RCC) who have progressed on standard therapies including an immune checkpoint inhibitor and a VEGF-targeting therapy is ongoing. Dose escalation in the TRAVERSE trial is expected to be completed by early 2024. The Company intends to target an academic forum in early 2024 to provide an update from this trial.

Next Generation Technologies and Targets

Cloak and Dagger Platform Technologies

The Company recently announced three poster presentations from its next generation AlloCAR T Platform at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The meeting will spotlight its novel, targeted Cloak and Dagger platform technologies designed to enhance engraftment, expansion and persistence of AlloCAR T cells.

These innovative approaches are intended to simplify lymphodepletion for allogeneic CAR T products and may provide a path to further expand the potential of off-the-shelf CAR T products beyond current targets and indications.

The Cloak platform technology is designed to prevent AlloCAR T cells from being recognized by host T cells without triggering substantial natural killer (NK) cell rejection while preserving CAR T cell function.

The Dagger platform technology, a feature of our ALLO-316 candidate, is designed to engineer AlloCAR T cells to selectively eliminate CD70 positive, alloreactive host immune cells, thereby mitigating potential premature rejection of AlloCAR T cells by the patient’s immune system. Translational results shared at AACR (Free AACR Whitepaper) suggest this unique immunomodulatory effect of ALLO-316 contributed to robust AlloCAR T cell expansion and persistence, and clinical remissions.

Based on preclinical results demonstrating the ability to combine anti-CD19 and other AlloCARs with the Dagger technology, the Company intends to explore this approach to potentially enhance the activity of next generation AlloCAR T products candidates, including those that target other hematological and solid tumors.

ALLO-182

SITC will also include a review of research which provided early validation of ALLO-182, an AlloCAR T candidate currently in the IND-enabling phase of development targeting Claudin18.2 for the treatment of patients with gastric and pancreatic cancers.

Corporate Updates
The Company has recently announced two new appointments to the leadership team. In August, the Company announced Earl Douglas as General Counsel, overseeing all aspects of the Company’s legal function. Following the close of the third quarter, the Company announced Geoffrey Parker as Executive Vice President, Chief Financial Officer, overseeing the Company’s financial operations and business development activities.

Third Quarter Financial Results

The Company had $497.7 million in cash, cash equivalents, and investments as of September 30, 2023.
Research and development expenses were $46.0 million for the third quarter of 2023, which includes $6.7 million of non-cash stock-based compensation expense.
General and administrative expenses were $17.0 million for the third quarter of 2023, which includes $8.6 million of non-cash stock-based compensation expense.
Net loss for the third quarter of 2023 was $61.3 million, or $0.37 per share, including non-cash stock-based compensation expense of $15.4 million.
2023 Financial Guidance

As previously provided, the Company expects a decrease in cash, cash equivalents, and investments of approximately $230 million in 2023. Based on current assumptions, the Company continues to expect its cash runway to fund operations into 2H 2025. GAAP Operating Expenses are expected to be approximately $340 million, including estimated non-cash stock-based compensation expense of approximately $80 million. These estimates exclude any impact from potential business development activities.

Conference Call and Webcast Details

Allogene will host a live conference call and webcast today at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss financial results and provide a business update. If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. The listen-only webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

On November 2, 2023 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that it will have two poster presentations focused on the importance of lymphodepletion in allogeneic cell therapy at the 65th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) taking place December 9-12, 2023 in San Diego, CA (Press release, Allogene, NOV 2, 2023, View Source [SID1234636726]).

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"All CAR T cells require lymphodepletion to support the expansion and persistence needed to eradicate malignant cells. Because of the risk of allorejection by the patient’s immune system, creating the necessary window of persistence for an off-the-shelf, allogeneic CAR T product may require an enhanced approach to lymphodepletion. These results reinforce our belief that Allogene’s strategy of adding ALLO-647, an anti-CD52 monoclonal antibody candidate, to the standard fludarabine/cyclophosphamide (flu/cy) lymphodepletion regimen in our ALPHA/ALPHA2 studies can safely achieve this," said Zachary Roberts, M.D., Ph.D., Executive Vice President of Research & Development and Chief Medical Officer of Allogene. "Our unique and proprietary lymphodepletion regimen that includes ALLO-647 has been shown to potentially induce deep and durable remissions in relapsed and treatment-refractory cancers."

The first poster is a comprehensive safety review of all 85 patients treated in the Phase 1 ALPHA/ALPHA2 studies in relapsed/refractory (r/r) Large B Cell Lymphoma (LBCL) and follicular lymphoma (FL) to characterize the overall safety profile when ALLO-647 is added to standard lymphodepletion.

In June 2023 at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland, the Company presented updated data from the Phase 1 ALPHA/ALPHA2 trials of investigational ALLO-501/501A in 33 CAR T naïve patients with r/r LBCL treated with the Alloy manufacturing process material across different CAR T dosing and lymphodepletion regimens. Data from the 12 patients, a subset of these 33 CAR T naïve patients, who received the regimen being utilized in ongoing Phase 2 trials was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. These data demonstrated that administration of the anti-CD19 allogeneic CAR T product candidate following a 3-day lymphodepletion regimen that includes fludarabine 30 mg/m2 and cyclophosphamide 300-500 mg/m2 (FC) and 39, 60, or 90 mg of ALLO-647 in divided doses can potentially yield durable responses and an acceptable safety profile in line with approved autologous CAR T therapies.

Title: ALLO-647 for Lymphodepletion in the Allogeneic CAR T Setting: Safety Experience with ALLO-501/501A in Patients (Pts) with Relapsed/Refractory (r/r) Large B-Cell and Follicular Lymphomas
Session: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster I
Abstract: 2095
Presenter: Dr. Frederick Locke, M.D., Chair, Department of Blood and Marrow Transplant and Cellular Immunotherapy; program co-leader, Immuno-Oncology, Moffitt Cancer Center
Tampa, Florida
Session Date & Time: Saturday, December 9, 2023, 5:30 PM – 7:30 PM PT
Location: San Diego Convention Center, Halls G-H

The second poster showcases translational results from ALPHA2 generated through a collaboration with researchers from The University of Texas MD Anderson Cancer Center. This study compared expansion kinetics among 11 allogeneic CAR T recipients treated with investigational ALLO-501A in the ALPHA2 trial. The study revealed the impact of recipient alloreactive CD8+ T cells in allogeneic CAR T rejection. Results of this study could help define strategies to improve allogeneic CAR T expansion, persistence, and efficacy.

Title: Cellular Mechanisms Affecting Allogeneic CAR T Cell Expansion and Rejection in Large B-cell Lymphoma
Session: 703. Cellular Immunotherapies: Basic and Translational: Poster III
Abstract: #4832
Presenter: Andrew P. Jallouk, M.D., Ph.D,Vanderbilt / MD Anderson
Session Date & Time: Monday, December 11, 2023 6:00pm – 8:00pm PT
Location: San Diego Convention Center, Halls G-H

About ALLO-501 and ALLO-501A
ALLO-501 and ALLO-501A are anti-CD19 AlloCAR T investigational products for the treatment of large B cell lymphoma. ALLO-501A, a next-generation anti-CD19 AlloCAR T, eliminates the rituximab recognition domains in ALLO-501, which could allow for use in a broader patient population, including NHL patients with recent rituximab exposure. This product candidate is currently being studied in an ongoing potentially pivotal Phase 2 trial. In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-501A in r/r LBCL.

On November 2, 2023 Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, reported recent business progress and financial results for the third quarter 2023 (Press release, Aligos Therapeutics, NOV 2, 2023, View Source [SID1234636725]).

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"Over this quarter, we raised approximately $92 million in a private placement financing allowing the advancement of our NASH THR-ß and CHB CAM-E programs. Additionally, we successfully received clearance for Aligos’ first US IND (for ALG-055009) and secured an $8.5 million contract with the NIAID to advance our coronavirus protease inhibitor into Phase 2 clinical trials. We are proud to have achieved these critical milestones," noted Lawrence Blatt, Ph.D., MBA, Chairman & CEO of Aligos Therapeutics. "With these achievements in hand, our team is well positioned to execute on our priorities, which include conducting a Ph2a MRI-PDFF study in NASH with ALG-055009, conducting Phase 2 enabling activities for our promising CAM-E, ALG-000184, in CHB, and advancing our potentially best-in-class coronavirus protease inhibitor, ALG-097558. Over the next quarter our research team will continue to identify promising novel small molecule drug candidates as backup molecules for our lead clinical programs as well as discover new small molecules targeting novel molecular pathways in viral and liver diseases."

Recent Business Progress

Aligos Portfolio of Drug Candidates

NASH (THR-ß; ALG-055009)

The US IND was cleared by the FDA, which now enables execution of a planned Phase 1 statin drug-drug interaction study in Q4 2023, prior to filing the Phase 2a protocol to the IND in Q4 2023
In the meantime, Phase 2a startup activities were initiated and are now underway
A preliminary Phase 2a study design was formulated in close collaboration with the study’s Principal Investigator, Dr. Stephen Harrison. The final study design is subject to feedback from the FDA which is expected in early Q1 2024
The final Phase 1 FIH study data were accepted as a poster presentation (Poster #2900-A) at the AASLD Liver Meeting in November 2023
CHB (CAM-E, ALG-000184)

Dosing and enrollment in ongoing Study ALG-000184-201 continues. The total dosing duration now exceeds 48 weeks in some subjects in this Phase 1a/1b study
Data from long term dosing cohorts in Study ALG-000184-201, including a late breaking poster
(Poster #5028-C) summarizing the effects of ALG-000184 on various viral markers, will be presented at the AASLD Liver Meeting in November 2023
With the recent completion of the PIPE, we plan to initiate Ph2 enabling activities, including manufacturing of drug supply, in the near future
Coronavirus (PI, ALG-097558)

Dosing continues in the ongoing first in human study, ALG-097558-701. Dosing is ongoing in the single ascending dose portion of the study and is due to start soon in the multiple ascending dose portion. We continue to project having topline data from this important safety and pharmacokinetics study in H1 2024
The NIAID awarded Aligos an $8.5M contract to conduct Phase 2 enabling activities, which includes multiple nonclinical and clinical studies. These studies will be initiated in H1 2024 and topline data are expected in H2 2025. The ALG-097558 program has been awarded over $11M across two NIH grants and contracts and we plan to seek additional external funding from both public and private sources to further advance this important program
Financial Results for the Third Quarter 2023

Cash, cash equivalents and investments totaled $70.4 million as of September 30, 2023, compared with $125.8 million as of December 31, 2022. Additionally, we raised in private placement financing approximately $92 million in gross proceeds, before deducting placement agent’s fees and other expenses, in October 2023. Including the expected net proceeds from the private placement, we believe our cash balance provides sufficient cash to fund planned operations through the end of 2025.

Net losses for the three months ended September 30, 2023 were $18.0 million or basic and diluted net loss per common share of $(0.41), compared to net losses of $18.6 million or basic and diluted net loss per common share of $(0.44) for the three months ended September 30, 2022.

Research and development (R&D) expenses for the three months ended September 30, 2023 were $15.9 million, compared with $17.8 million for the same period of 2022. The decrease was primarily due to employee-related costs and other costs including facility expenses, partially offset by an increase in third party expenses due to the milestone payments made as a result of dosing the first patient in a clinical trial. Total R&D stock-based compensation expense incurred for the three months ended September 30, 2023 was $1.6 million, compared with $1.9 million for the same period of 2022.

General and administrative (G&A) expenses for the three months ended September 30, 2023 were $6.4 million, compared with $5.3 million for the same period of 2022. The increase in G&A expenses for this comparative period is primarily attributable to an increase in legal and related costs. Total G&A stock-based compensation expense incurred for the three months ended September 30, 2023 was $1.6 million, compared with $1.5 million for the same period of 2022.

On November 2, 2023 Alentis Therapeutics ("Alentis"), a clinical-stage biotechnology company developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, reported participation in four business conferences during the Month of November including company presentations at the LSX Inv€$tival Showcase in London, UK and the Piper Sandler Annual Healthcare Conference in New York, NY (Press release, Alentis Therapeutics, NOV 2, 2023, View Source [SID1234636724]).

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Bio Europe
Alentis will take part in the conference November 6–8, 2023 at the Messe München, Munich, Germany.

LSX Inv€$tival Showcase
Roberto Iacone, CEO of Alentis will give a company presentation at 13:00 GMT on Stage 3: Biotech Late Growth. The conference will be held at Old Billingsgate in London, UK on November 13, 2023.

Jefferies London Healthcare Conference
Alentis management will join the conference held on November 14-16, 2023 at the Waldorf Hilton in London, UK.

Piper Sandler Healthcare Conference
Roberto Iacone is scheduled to give a presentation on November 30, 2023 at 2:10 pm ET in the Staten Island Track, Kennedy 1, 4th Floor. Alentis management will attend the conference at the Lotte New York Palace in New York City on November 28 – December 2, 2023.