On March 29, 2022 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported financial results for the fourth quarter and full year ended December 31, 2021, and provided a corporate update (Press release, Vincerx Pharma, MAR 29, 2022, View Source [SID1234611094]).
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"We are excited to report the recent dosing of the first patient in the VIP152 and pembrolizumab combination arm of our ongoing Phase 1b trial. Additionally, in December, we dosed the first patient in our Phase 1b dose-escalation study of VIP152 in relapsed or refractory chronic lymphocytic leukemia or Richter Syndrome, marking the initiation of the second Vincerx-sponsored clinical trial in 2021," said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx. "While we have experienced challenges to patient enrollment in our two ongoing Phase 1b trials similar to those faced by many of our peers due to the effect of the ongoing pandemic, we are proactively taking steps to address this with the addition of multiple new trial sites globally and are encouraged by an acceleration in recruitment to start the year. Moreover, on a strategic level, we are aligning our clinical trial design with the FDA’s Project Optimus initiative (View Source), which strives to reform the dose optimization and dose selection paradigm in oncology drug development. While we believe we have identified the recommended Phase 2 dose of VIP152, we are planning a dose optimization cohort to position VIP152 for success as we move forward with our clinical trials. We remain on track to initiate Phase 2 studies of VIP152 in the second half of this year."
"In parallel, we continue to advance our preclinical bioconjugation pipeline, comprising our diverse, modular platform of linkers and payloads that can be conjugated with typical antibodies, bispecifics, and small molecules, creating the potential for novel drugs with improved efficacy and safety compared with current antibody-drug conjugates. We recently announced the publication of key preclinical data for our small molecule-drug conjugate, VIP236, in the journal Cancers, which highlighted VIP236’s potential to direct a potent cancer chemotherapy to tumors while sparing healthy tissues. We are on-target to file an IND for VIP236 in the second half of the year," continued Dr. Hamdy.
"Our balance sheet, strengthened by the proceeds from our successfully completed private placement last September, positions us to continue to execute on our upcoming clinical and regulatory milestones," concluded Dr. Hamdy.
Recent Corporate Highlights
Received Investigational New Drug (IND) Application approval for Phase 1/2 study of VIP152, venetoclax, and prednisone (VVIP) in relapsed or refractory lymphoid malignancies in collaboration with the NIH
Dosed first patient in the VIP152 and pembrolizumab combination arm of the Company’s ongoing Phase 1b study (VNC-152-101)
Announced dosing of first patient in the Company’s Phase 1 dose-escalation study of VIP152 in relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or Richter Syndrome (RS) (VNC-152-102)
Received Orphan Drug Designation from European Commission for VIP152 for the Treatment of Diffuse Large B-Cell Lymphoma (DLBCL)
Announced poster presentation, "VIP152, a selective CDK9 inhibitor, demonstrates sensitivity in gynecologic cell lines that are cisplatin sensitive or resistant and delivers in vivo antitumor efficacy," at upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2022
Hosted key opinion leader webinar and presented data on VIP152 in high-grade B-cell lymphoma (HGBL) and CLL at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2021
Completed GLP toxicity studies of VIP236 in rats; initiating additional GLP toxicity studies in dogs to continue preclinical advancement of VIP236 towards IND filing in 2H22
Approved for research grant program from the German government providing for tax refunds/reimbursements of up to EUR 1 million per year over six years
Several key publications:
Publication of a peer-reviewed article titled, "A Small Molecule–Drug Conjugate (SMDC) Consisting of a Modified Camptothecin Payload Linked to an αVß3 Binder for the Treatment of Multiple Cancer Types," in the special issue, "The Role of Tumor Microenvironment in Solid Tumors: The New Frontier of Cancer Research" of the journal Cancers
Publication of a peer-reviewed article titled, "First-in-human dose escalation study of cyclin-dependent kinase-9 inhibitor VIP152 in patients with advanced malignancies shows early signs of clinical efficacy," in the journal Clinical Cancer Research
Publication of article titled "New frontiers in ADCs and SMDCs" in the journal Nature
Publication of book chapter titled, "Protease-sensitive linkers," co-authored by Vincerx’s Chief Scientific Officer, Hans-Georg Lerchen, Ph.D., in the e-Book, Chemical Linkers in Antibody-Drug Conjugates (ADCs)
Publication of book chapter titled, "IL3RA-Targeting Antibody-Drug Conjugate BAY-943 with a Kinesin Spindle Protein Inhibitor Payload Shows Efficacy in Preclinical Models of Hematologic Malignancies," co-authored by Vincerx’s Chief Scientific Officer, Hans-Georg Lerchen, Ph.D. and Chief Development Officer, Beatrix Stelte-Ludwig, Ph.D., in the e-Book, Therapeutic Monoclonal Antibodies and Antibody Products, Their Optimization and Drug Design in Cancers
Fourth Quarter and Full Year 2021 Financial Results
Vincerx Pharma had $111.5 million in cash as of December 31, 2021, as compared to $61.8 million as of December 31, 2020. Based on its current business plans and assumptions, Vincerx believes its available cash will be sufficient to meet its operating requirements through 2023.
Research and development (R&D) expenses for the fourth quarter and full year 2021 were $12.3 million and $40.1 million, respectively, as compared to $2.1 million for each of the same periods in 2020. The quarterly and annual increases were primarily driven by increases in stock-based compensation expense, third party preclinical, clinical and manufacturing services in connection with our preclinical studies and clinical trials and new employee salaries.
General and administrative (G&A) expenses for the fourth quarter and full year 2021 were $5.4 million and $22.6 million, respectively, as compared to $3.3 million and $3.6 million for the same periods in 2020. The quarterly and annual increases were primarily driven by increases in legal (both general and patent protection and filings), insurance and accounting and other professional services in support of our operations as a public company, stock-based compensation expense and new employee salaries.
For the fourth quarter and full year 2021, Vincerx reported a net loss of $6.5 million, or $0.31 per share, and a net loss of $39.3 million, or $2.29 per share, respectively. For the fourth quarter and full year 2020, Vincerx reported a net loss of $16.3 million, or $2.74 per share, and a net loss of $16.6 million, or $3.16 per share, respectively.