Bay Street News

Vincerx Pharma Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Update

VIP236, first-in-class small molecule-drug conjugate (SMDC), preliminary Phase 1 data and update on pipeline progress will be presented by management at a virtual investor event on April 8 at 2:00 PM PT

Phase 1 trial ongoing for VIP943, a best-in-class anti-CD123 antibody-drug conjugate (ADC); preliminary data anticipated on or around the 2024 European Hematology Association (EHA) Annual Meeting; in addition, pharmacokinetic data will be shared at the 2024 American Association of Cancer Research (AACR) Annual Meeting

Expected cash runway into early Q3 2024

PALO ALTO, Calif., March 29, 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 fourth quarter and full year ended December 31, 2023, and provided a corporate update.

“The last calendar year was pivotal for Vincerx,” said Ahmed Hamdy, M.D., Chief Executive Officer. “Having progressed three clinical programs, including VIP236 and VIP943, both developed with our VersAptxTM platform, and enitociclib, we firmly established ourselves as a clinical-stage cancer therapeutics company with novel product candidates that aim to improve safety and efficacy over traditional chemotherapy.”

Raquel Izumi, Ph.D., Chief Operations Officer, added, “VIP236, our first-in-class SMDC, is in a Phase 1 dose-escalation trial for advanced and metastatic solid tumors. To date, we have dosed 20 patients across two dosing schedules and results from the once every 3-week dosing schedule continue to show a strong safety profile with dose-dependent clinical activity. We are excited to share more details regarding the preliminary Phase 1 data during the 2024 AACR Annual Meeting.”

Dr. Izumi continued, “VIP943, our best-in-class anti-CD123 ADC, is in a Phase 1 dose-escalation trial in hematologic malignancies. Enrollment in the third cohort is underway with a total of 9 patients dosed. Preliminary pharmacokinetic data from the first two cohorts show very little payload in circulation, which aligns with the favorable safety profile observed in nonhuman primates in our preclinical studies. We look forward to sharing pharmacokinetic data for VIP943 during AACR and more details regarding the preliminary Phase 1 data on or around EHA. Enitociclib, our highly selective CDK9 inhibitor, in a Phase 1 dose-escalation study with the National Institutes of Health (NIH), has signaled encouraging efficacy in Phase 1 combination studies in peripheral T-cell lymphoma (PTCL) and double-hit B-cell lymphoma (DLBCL). Earlier this year, we reported partial responses at doses below expected efficacy levels, highlighting the drugs synergistic potential with other treatments.”

Dr. Hamdy concluded, “We entered 2024 with strong momentum and remain focused on aggressively advancing our programs and maximizing the value of our next-generation VersAptx platform.”

FOURTH QUARTER AND FULL YEAR 2023 CLINICAL PROGRAM HIGHLIGHTS

VersAptx™ Platform

VIP236

VIP943

Enitociclib

VIP924

FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS

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 antibody-drug conjugate, VIP943, in Phase 1; small molecule-drug conjugate, VIP236, in Phase 1; preclinical antibody-drug conjugate, VIP924; CDK9 inhibitor, enitociclib, in an NIH-sponsored Phase 1; and VersAptx, its versatile and adaptable, next-generation bioconjugation platform.
Vincerx is based in Palo Alto, California, and has a research facility 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.

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; 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 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, availability and uses of capital, and cash runway; and the risks and uncertainties set forth in Form 10-K for the year ended December 31, 2023 and other reports filed with the Securities and Exchange Commission by Vincerx. Forward-looking statements speak only as of the date hereof, and Vincerx disclaims any obligation to update any forward-looking statements.

Vincerx, the Vincerx logo, CellTrapper, and VersAptx are our trademarks. This press release also contains trademarks and trade names that are the property of their respective owners.

Contacts
Gabriela Jairala
gabriela.jairala@vincerx.com
Vincerx Pharma, Inc.

Totyana Simien
Inizio Evoke Comms
totyana.simien@inizioevoke.com  

 

  Vincerx Pharma, Inc.
Condensed Consolidated Balance Sheets
(in thousands)
 
     
    Dec 31, 2023   Dec 31, 2022  
    (Unaudited)      
  ASSETS        
  Current assets:        
  Cash and cash equivalents $ 12,782   $ 11,663  
  Restricted cash   72     70  
  Short-term marketable securities       40,796  
  Prepaid expenses   51     134  
  Grant receivable   1,044     1,372  
  Other current assets   784     1,929  
  Total current assets   14,733     55,964  
  Right-of-use assets   2,201     3,064  
  Property, plant and equipment, net   125     177  
  Other assets   1,158     81  
  Total assets $ 18,217   $ 59,286  
           
  LIABILITIES AND STOCKHOLDERS’ EQUITY        
  Current liabilities        
  Accounts payable $ 2,497   $ 4,065  
  Accrued expenses   1,755     3,923  
  Lease liability   1,162     1,024  
  Common stock warrant liabilities   191     144  
  Total current liabilities   5,605     9,156  
  Lease liability, net of current portion   1,340     2,412  
  Other noncurrent liabilities   50     50  
  Total liabilities   6,995     11,618  
           
  Total stockholders’ equity   11,222     47,668  
  Total liabilities and stockholders’ equity $ 18,217   $ 59,286  
           

 

  Vincerx Pharma, Inc.
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except per share amounts)
 
           
    For the three months ended   For the year ended  
    December 31,   December 31,  
      2023       2022       2023       2022    
  Operating expenses:                
  General and administrative $ 1,820     $ 4,015     $ 13,636     $ 18,885    
  Research and development   3,713       11,536       28,973       49,837    
  Restructuring                     2,469    
  Total operating expenses   5,533       15,551       42,609       71,191    
  Loss from operations   (5,533 )     (15,551 )     (42,609 )     (71,191 )  
  Other income (expense)                
  Change in fair value of warrant liabilities   (59 )     (31 )     (47 )     6,303    
  Interest income   198       460       1,251       664    
  Other income (expense)   444       1,351       1,248       1,240    
  Total other income (expense)   583       1,780       2,452       8,207    
  Net loss $ (4,950 )   $ (13,771 )   $ (40,157 )   $ (62,984 )  
                   
  Net loss per common share, basic and diluted $ (0.23 )   $ (0.65 )   $ (1.89 )   $ (3.00 )  
  Weighted average common shares outstanding, basic and diluted   21,370       21,138       21,295       21,029    
                   


Bay Street News