On August 7, 2023 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 second quarter ended June 30, 2023 and provided a corporate update (Press release, Vincerx Pharma, AUG 7, 2023, View Source [SID1234633885]).

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"I am excited to report that the Investigational New Drug (IND) application for our first antibody-drug conjugate (ADC), VIP943, was filed and is under review by the U.S. Food and Drug Administration (FDA)," said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx. "We believe that our next-generation ADC technology represents a significant step forward in the treatment of cancer by potentially overcoming the safety and efficacy challenges associated with many ADCs. Our unique combination of internalizing antibodies, selective and stable linkers, novel payloads, and exclusive CellTrapper technology allows for greater intracellular accumulation of the payload, potentially leading to higher efficacy while limiting unwanted side effects. We currently expect to dose our first patient with VIP943 in the fourth quarter."

"We also continue enrolling patients in our Phase 1 dose escalation study for VIP236, our first-in-class small molecule drug-conjugate (SMDC). VIP236 is designed to deliver an optimized camptothecin payload to tumors expressing αvβ3, which is found in advanced and metastatic tumors. Encouragingly, VIP236 preclinical data shows enhanced efficacy—independent of HER2 status— in patient-derived xenograft (PDX) and cell line-derived gastric cancer models compared with the ADC ENHERTU. Given the first-in-class nature of this program, we are evaluating several dosing approaches and expect to provide preliminary results by late 2023 or early 2024."

"On the business development front, we are thrilled to welcome Mr. Steve Bloom as our new Chief Business Officer. With Steve on board, we believe we are positioned to accelerate our ongoing business development activities and capitalize on the burgeoning industry enthusiasm for bioconjugates."

"As we enter the latter half of the year, we are strategically focusing our resources on VIP943 and VIP236, along with exploring potential research and other collaborations that can bolster the advancement of these two lead programs, as well as leverage the strength of our next-generation modular bioconjugation platform," concluded Dr. Hamdy.

Second Quarter 2023 Corporate Highlights

VIP943, CD123-KSPi ADC: for Leukemias and Myelodysplastic Syndrome:

IND for VIP943 filed; anticipate enrolling the first patient in a Phase 1 dose escalation study in Q4 2023
Presented preclinical data at ASH (Free ASH Whitepaper) 2022 demonstrating superiority with significantly improved safety in monkeys and better efficacy in a mouse model of acute leukemia when compared with Mylotarg
VIP236, an αvβ3 Integrin Binder Linked to an optCPT Payload SMDC:

Phase 1 first-in-human dose-escalation study with VIP236 monotherapy ongoing (ClinicalTrials.gov NCT05712889)
Presented compelling preclinical data at AACR (Free AACR Whitepaper) 2023 demonstrating that VIP236 had potent and durable tumor growth inhibition in multiple mouse models for non-small cell lung cancer (NSCLC), colorectal carcinoma (CRC), triple negative breast cancer (TNBC), and gastric cancers
VIP924, CXCR5-KSPi ADC: for B-cell Malignancies:

Presented promising preclinical data at AACR (Free AACR Whitepaper) 2023 demonstrating significant tumor growth inhibition in a panel of lymphoma cell lines and cell line-derived and PDX lymphoma models
Pacing investment as we focus resources on lead programs (VIP236 and VIP943)
Additional Platform Updates

Presented preclinical data at AACR (Free AACR Whitepaper) 2023 on synthesis and characterization of novel SMDCs with different payloads, highlighting the breadth and potential of our SMDC platform
Enitociclib, Positive Transcription Elongation Factor b (P-TEFb)/CDK9 Inhibitor:

Focused on Phase 1 study with the National Institutes of Health (NIH) evaluating combination of enitociclib and venetoclax and prednisone (VVIP) in diffuse large B-cell lymphoma (DLBCL) and peripheral T Cell Lymphoma (PTCL); enrollment ongoing (ClinicalTrials.gov NTC05371054)
Additional combination studies will be determined based on further financing/partnering support
Proof-of-concept monotherapy efficacy has been generated in early-stage clinical studies:
Hematologic malignancies: 2 patients with double-hit DLBCL achieved complete metabolic responses after 10 cycles of treatment and remain in remission, off treatment, for >4 years; 1 patient with transformed follicular lymphoma remains on treatment for >13 months with a maximum 43% reduction in target lesions
Solid tumors: 13 patients achieved stable disease, including durable disease control, in patients with ovarian, pancreatic cancer, and salivary gland cancer
Strong preclinical evidence for additional indications (eg, multiple myeloma) and pediatric indications
Second Quarter 2023 Financial Results

Vincerx had approximately $27.4 million in cash, cash equivalents and marketable securities as of June 30, 2023, as compared to approximately $52.5 million as of December 31, 2022. Vincerx expects its burn rate to decrease as a result of completing Chemistry, Manufacturing, and Controls (CMC) activities and prioritizing resources toward advancing Phase 1 studies for VIP236 and VIP943, its lead programs. Based on its current business plans and assumptions, Vincerx believes its available capital will be sufficient to meet its operating requirements into late 2024.
Research and development (R&D) expenses for the three- and six-months ended June 30, 2023 were approximately $7.9 million and $18.5 million, as compared to approximately $13.7 million and $29.7 million for the same periods in 2022. The decrease for the three-months ended June 30, 2023 compared with the same period in 2022 is primarily the result of decreases in stock-based compensation expense of approximately $2.0 million, payroll related costs of approximately $0.9 million as a result of our headcount reduction in June 2022, clinical services of approximately $1.1 million, and third party research and preclinical work of approximately $1.1 million. The decrease for the six-months ended June 30, 2023 compared with the same period in 2022 is primarily the result of decreases in stock-based compensation expense of approximately $5.0 million, payroll related costs of approximately $2.1 million as a result of the headcount reduction, clinical services of approximately $1.8 million, and manufacturing services associated with our ADC program of approximately $1.4 million.

General and administrative (G&A) expenses for the three- and six-months ended June 30, 2023 were approximately $3.8 million and $8.3 million, as compared to approximately $4.7 million and $10.4 million for the same periods in 2022. These decreases are primarily due to declines in stock-based compensation expense of approximately $0.7 million and $1.8 million for the three- and six-months ended June 30, 2023, respectively.
For the second quarter ended June 30, 2023, Vincerx reported a net loss of approximately $11.2 million, or $0.52 per share. For the second quarter ended June 30, 2022, Vincerx reported a net loss of approximately $18.4 million, or $0.88 per share. For the six-months ended June 30, 2023, Vincerx reported a net loss of $25.5 million, or $1.20 per share, as compared to a net loss of $34.8 million, or $1.66 per share for the same period in 2022.