Vincerx Pharma Reports Second Quarter 2023 Financial Results and Provides Corporate Update
IND Application filed for potential best-in-class ADC, VIP943; Phase 1 trial expected to begin Q4 2023
Enrollment continues in Phase 1 dose escalation study for VIP236, a first-in-class SMDC
Cash balance expected to support planned operations into late 2024
“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
“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.
“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
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 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 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 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 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 millionin cash, cash equivalents and marketable securities as of June 30, 2023, as compared to approximately $52.5 millionas 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, 2023were approximately $7.9 millionand $18.5 million, as compared to approximately $13.7 millionand $29.7 millionfor the same periods in 2022. The decrease for the three-months ended June 30, 2023compared 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, 2023compared 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, 2023were approximately $3.8 millionand $8.3 million, as compared to approximately $4.7 millionand $10.4 millionfor the same periods in 2022. These decreases are primarily due to declines in stock-based compensation expense of approximately $0.7 millionand $1.8 millionfor 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 $0.52per share. For the second quarter ended June 30, 2022, Vincerx reported a net loss of approximately $18.4 million, or $0.88per 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.
Vincerx is based in
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, expected 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 and many of which are outside of our control.
Actual results, conditions and events may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results, conditions, and events to differ materially from those indicated in the forward-looking statements include, but are not limited to: general economic, financial, legal, political, and business conditions; the potential effects of health epidemics and pandemics, including COVID-19; risks associated with preclinical or clinical development and trials, including those conducted prior to Vincerx’s in-licensing; failure to realize the benefits of Vincerx’s license agreement with Bayer; risks related to the rollout of Vincerx’s business and the timing of expected business and product development milestones; changes in the assumptions underlying Vincerx’s expectations regarding its future business or business model; Vincerx’s ability to successfully develop and commercialize product candidates; Vincerx’s capital requirements and availability, uses of capital, and cash runway; and the risks and uncertainties set forth in Form 10-Q for the quarter ended
Vincerx and the Vincerx logo are our trademarks. This press release also contains trademarks and trade names that are the property of their respective owners.
|Vincerx Pharma, Inc.
Condensed Consolidated Balance Sheets
|Cash and cash equivalents||$||6,679||$||11,663|
|Short-term marketable securities||20,680||40,796|
|Other current assets||3,818||3,371|
|Total current assets||31,813||55,964|
|Property, plant and equipment, net||151||177|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Common stock warrant liabilities||244||144|
|Total current liabilities||9,157||9,156|
|Lease liability, net of current portion||1,932||2,412|
|Other noncurrent liabilities||50||50|
|Total stockholders' equity||24,136||47,668|
|Total liabilities and stockholders' equity||$||35,275||$||59,286|
|Vincerx Pharma, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
|For the three months ended||For the six months ended|
|General and administrative||$||3,787||$||4,722||$||8,299||$||10,378|
|Research and development||7,873||$||13,742||18,460||29,713|
|Total operating expenses||11,660||19,623||26,759||41,250|
|Loss from operations||(11,660||)||(19,623||)||(26,759||)||(41,250||)|
|Other income (expense)|
|Change in fair value of warrant liabilities||(118||)||1,202||(100||)||6,413|
|Other income (expense)||300||-||574||(8||)|
|Total other income (expense)||509||1,202||1,267||6,405|
|Net loss per common share, basic and diluted||$||(0.52||)||$||(0.88||)||$||(1.20||)||$||(1.66||)|
|Weighted average common shares outstanding, basic and diluted||21,274||20,995||21,231||20,946|
Source: Vincerx Pharma, Inc.