Vincerx Pharma Reports Third Quarter 2024 Financial Results
Continued enrollment and dose escalation in Phase 1 study of VIP943, a potentially best-in-class anti-CD123 antibody-drug conjugate $(ADC)$; additional data expected by early 2025
Completed Phase 1 dose-escalation studies of small molecule drug-conjugate (SMDC), VIP236, and CDK9 inhibitor, enitociclib, and identified the maximum tolerated dose
Expected cash runway into early 2025
PALO ALTO, Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today reported financial results for the third quarter of 2024 and provided an overview of its clinical programs and anticipated milestones.
"As we direct our efforts and resources toward our ADC technologies and programs, we are committed to advancing VIP943 based on the encouraging safety, efficacy, and tolerability results observed to date. We look forward to presenting additional data from patients at efficacious dose cohorts by early next year," said Ahmed Hamdy, M.D., Chief Executive Officer. "Securing the funding necessary to advance our programs remains a priority. Alongside exploring financing options, we remain focused on strategic partnerships, particularly as pharmaceutical companies intensify their search for truly differentiated and transformative technologies."
THIRD QUARTER 2024 CLINICAL PROGRAM HIGHLIGHTS AND ANTICIPATED MILESTONES
VIP943
-- VIP943 is a novel CD123-targeted ADC developed with the Company's
next-generation VersAptx platform.
-- VIP943 has shown promising safety, efficacy, and tolerability in an
ongoing Phase 1 dose-escalation study for patients with
relapsed/refractory acute myeloid leukemia $(AML.UK)$, myelodysplastic
syndrome (MDS), and B-cell acute lymphoblastic leukemia (B-ALL)
(NCT06034275). In October, the Company reported two complete responses in
this Phase 1 study: one out of four patients with relapsed AML in the 1
mg/kg dose cohort achieved complete remission with incomplete hematologic
recovery (CRi), and one out of one patient with higher-risk MDS in the
1.3 mg/kg dose cohort achieved complete remission with limited count
recovery $(CRL)$.
-- VIP943 has shown effective target engagement and elimination of CD123+
malignant cells, with pharmacodynamic data demonstrating decreases in
CD123+ blasts after dosing. Preliminary pharmacokinetic data indicates
minimal payload release (<=1% in plasma), signifying a stable linker.
-- Given the favorable safety and tolerability observed for VIP943, the
Company continues dose escalation to assess potential for additional
efficacy. Enrollment in the once-weekly and twice-weekly (as an induction
therapy) dosing schedules is ongoing.
-- Vincerx expects to share additional Phase 1 study data for VIP943 by
early 2025.
Enitociclib
-- Enitociclib is a highly selective CDK9 inhibitor designed to block the
activation of RNA polymerase II, leading to inhibition of oncogenes,
including MYC and MCL1.
-- Enitociclib is currently in a Phase 1 dose-escalation study (NTC05371054)
evaluating the combination of enitociclib, venetoclax, and prednisone in
diffuse large B-cell lymphoma (DLBCL) and peripheral T-cell lymphoma
(PTCL). This study is being conducted in collaboration with the National
Institutes of Health (NIH). As of September 2024, the study reported four
partial responses (PRs) in seven patients (57% overall response rate),
including one patient with double hit lymphoma (DH-DLBCL) and three
patients with PTCL.
-- Enitociclib has successfully completed its Phase 1 dose-escalation study
as a monotherapy (NCT02635672), enrolling 63 patients across
dose-escalation and expansion cohorts. The treatment demonstrated a
favorable safety profile, dose-proportional pharmacokinetics, and
on-target pharmacodynamic activity. Clinical benefits included durable
complete metabolic remissions in two patients with DH-DLBCL, lasting 3.7
and 2.3 years, with both remissions continuing more than two years after
treatment cessation. In addition, a transformed follicular (tFL) patient
achieved a PR with a 63% tumor reduction after nearly two years, a
meaningful outcome given the historically poor prognosis of tFL.
Furthermore, 13 patients with solid tumors achieved stable disease as
their best response, including five ovarian cancer patients--indicating a
promising path for future combination studies in this indication.
-- The Company is actively focused on finding a strategic partner to
continue the development of this asset.
VIP236
-- VIP236 is a <ALPHA>V<BETA>3 SMDC conjugated to an optimized camptothecin
$(CPT)$ payload developed with the Company's VersAptx platform.
-- VIP236 has completed its Phase 1 dose-escalation study (NCT05712889),
identifying the maximum tolerated dose that could be utilized in future
studies. As reported in October, a total of 29 patients were enrolled in
the Phase 1 study, resulting in a 45% disease control rate. The drug
demonstrated a favorable safety profile, distinguishing itself from other
CPTs by showing no instances of common dose-limiting side effects such as
life-threatening diarrhea, severe stomatitis/mucositis, or interstitial
lung disease.
-- The Company intends to identify a partner to champion VIP236 through
further development.
THIRD QUARTER 2024 FINANCIAL RESULTS
-- Vincerx had approximately $10.1 million in cash, cash equivalents, and
marketable securities as of September 30, 2024, as compared to
approximately $16.3 million as of June 30, 2024. Based on its current
business plans and assumptions, Vincerx believes its available capital
will be sufficient to meet its operating requirements into early 2025.
-- Research and development expenses for the third quarter ended September
30, 2024, were approximately $3.9 million, as compared to approximately
$6.1 million for the same period in 2023. This decrease is primarily the
result of decreases in research services of approximately $2.4 million
and personnel-related expenses of approximately $0.8 million, offset by
an increase in clinical-related expenses of approximately $0.9 million.
-- General and administrative expenses for the third quarter ended September
30, 2024, were approximately $3.9 million, as compared to approximately
$3.5 million for the same period in 2023. This increase was due to a $0.5
million increase in professional services, partially offset by a decrease
in personnel-related expenses of $0.1 million.
-- For the third quarter ended September 30, 2024, Vincerx reported a net
loss of approximately $7.8 million, or $0.17 per share. For the third
quarter ended September 30, 2023, Vincerx reported a net loss of
approximately $9.0 million, or $0.42 per share.
About Vincerx Pharma, Inc.
Vincerx Pharma, Inc. is a clinical-stage biopharmaceutical company committed to developing differentiated and novel therapies to address the unmet medical needs of patients with cancer. Vincerx has assembled a seasoned management team with a proven track record of successful oncology drug development, approvals, and value creation.
Vincerx's diverse pipeline consists of the next-generation ADC VIP943, currently in Phase 1; SMDC VIP236, which has completed its Phase 1; CDK9 inhibitor enitociclib, which has completed a Phase 1 monotherapy study and continues in a Phase 1 study in collaboration with the NIH; preclinical ADC VIP924; and VersAptx, a versatile, next-generation bioconjugation platform.
Vincerx is based in Palo Alto, California, and has a research subsidiary in Monheim, Germany.
For more information, please visit www.vincerx.com and follow Vincerx on LinkedIn.
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the "safe harbor" created by those sections. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, expectations and events, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "would," "could," "suggest," "seek," "intend," "plan," "goal," "potential," "on-target," "on track," "project," "estimate," "anticipate," or other comparable terms. All statements other than statements of historical facts included in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, Vincerx's business model, cash runway, pipeline, strategy, timeline, product candidates and attributes, and preclinical and clinical development, timing, and results. Forward-looking statements are neither historical facts nor assurances of future performance or events. Instead, they are based only on current beliefs, expectations, and assumptions regarding future business developments, future plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict, many of which are outside Vincerx's control.
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