false 0001796129 0001796129 2024-11-12 2024-11-12

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 12, 2024

 

 

Vincerx Pharma, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-39244   83-3197402
(State or Other Jurisdiction
of Incorporation)		   (Commission
File Number)		   (I.R.S. Employer
Identification No.)

 

260 Sheridan Avenue, Suite 400

Palo Alto, California

   94306
(Address of principal executive offices)   (Zip Code)

(650) 800-6676

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report.)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

  

Trading
symbol(s)

  

Name of each exchange
on which registered

Common Stock, $0.0001 par value per share   VINC   The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

Item 2.02

Results of Operations and Financial Condition.

On November 12, 2024, Vincerx Pharma, Inc. (the “Company”) issued a press release announcing financial results for its fiscal quarter ended September 30, 2024. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01

Financial Statements and Exhibits.

 

  (d)

Exhibits.

 

Exhibit
No.		    Description
99.1    Press Release dated November 12, 2024
104    Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated: November 12, 2024

 

VINCERX PHARMA, INC.
By:  

/s/ Alexander A. Seelenberger

Name:   Alexander A. Seelenberger
Title:   Chief Financial Officer

Exhibit 99.1

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 — 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), 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 αVb3 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. 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, Vincerx’s capital requirements, availability and uses of capital, ability to raise additional capital and cash runway; risks associated with preclinical or clinical development and studies; 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; general economic, financial, legal, political, and business conditions; and the risks and uncertainties set forth in the Form 10-Q for the quarter ended June 30, 2024 and subsequent 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, and VersAptx are our trademarks.

Contacts

Gabriela Jairala

Vincerx Pharma, Inc.

gabriela.jairala@vincerx.com

Totyana Simien

Inizio Evoke Comms

totyana.simien@inizioevoke.com

Vincerx Pharma, Inc.

Condensed Consolidated Balance Sheets

(in thousands)

 

     September 30,
2024		      December 31,
2023		  
     (unaudited)         

ASSETS

      

Current assets:

      

Cash and cash equivalents

    $ 2,942      $ 12,782  

Short-term marketable securities

      7,144        —   

Prepaid expenses

      283        51  

Grant receivable

      1,063        1,044  

Other current assets

      316        856  
  

 

 

     

 

 

  

Total current assets

      11,748        14,733  

Right-of-use assets

      1,431        2,201  

Property, plant and equipment, net

      85        125  

Other assets

      1,683        1,158  
  

 

 

     

 

 

  

Total assets

    $ 14,947      $ 18,217  
  

 

 

     

 

 

  

LIABILITIES AND STOCKHOLDERS’ EQUITY

      

Current liabilities

      

Accounts payable

    $ 1,963      $ 2,497  

Accrued expenses

      1,724        1,755  

Lease liability

      1,274        1,162  

Common stock warrant liabilities

      463        191  
  

 

 

     

 

 

  

Total current liabilities

      5,424        5,605  

Lease liability, net of current portion

      365        1,340  

Other noncurrent liabilities

      50        50  
  

 

 

     

 

 

  

Total liabilities

      5,839        6,995  
  

 

 

     

 

 

  

Total stockholders’ equity

      9,108        11,222  
  

 

 

     

 

 

  

Total liabilities and stockholders’ equity

    $ 14,947      $ 18,217  
  

 

 

     

 

 

  

Vincerx Pharma, Inc.

Condensed Consolidated Statements of Operations

(unaudited)

(in thousands, except per share amounts)

 

     For the three months ended
September 30,		     For the nine months ended
September 30,		  
     2024     2023     2024     2023  

Operating expenses:

         

General and administrative

    $ 3,885     $ 3,508     $ 10,419     $ 11,816  

Research and development

      3,908       6,101       12,218       25,260  
  

 

 

    

 

 

    

 

 

    

 

 

  

Total operating expenses

      7,793       9,609       22,637       37,076  
  

 

 

    

 

 

    

 

 

    

 

 

  

Loss from operations

      (7,793 )      (9,609 )      (22,637 )      (37,076 ) 
  

 

 

    

 

 

    

 

 

    

 

 

  

Other income (expense)

         

Change in fair value of warrant liabilities

      (331 )      112       (272 )      12  

Interest income

      154       260       410       1,053  

Other income (expense)

      127       230       419       804  
  

 

 

    

 

 

    

 

 

    

 

 

  

Total other income (expense)

      (50 )      602       557       1,869  
  

 

 

    

 

 

    

 

 

    

 

 

  

Net loss

    $ (7,843 )    $ (9,007 )    $ (22,080 )    $ (35,207 ) 
  

 

 

    

 

 

    

 

 

    

 

 

  

Net loss per common share, basic and diluted

    $ (0.17 )    $ (0.42 )    $ (0.63 )    $ (1.66 ) 
  

 

 

    

 

 

    

 

 

    

 

 

  

Weighted average common shares outstanding, basic and diluted

      45,672       21,345       35,175       21,269  
  

 

 

    

 

 

    

 

 

    

 

 

  
v3.24.3
Document and Entity Information
Nov. 12, 2024
Cover [Abstract]  
Amendment Flag false
Entity Central Index Key 0001796129
Document Type 8-K
Document Period End Date Nov. 12, 2024
Entity Registrant Name Vincerx Pharma, Inc.
Entity Incorporation State Country Code DE
Entity File Number 001-39244
Entity Tax Identification Number 83-3197402
Entity Address, Address Line One 260 Sheridan Avenue
Entity Address, Address Line Two Suite 400
Entity Address, City or Town Palo Alto
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94306
City Area Code (650)
Local Phone Number 800-6676
Written Communications false
Soliciting Material false
Pre Commencement Tender Offer false
Pre Commencement Issuer Tender Offer false
Security 12b Title Common Stock, $0.0001 par value per share
Trading Symbol VINC
Security Exchange Name NASDAQ
Entity Emerging Growth Company true
Entity Ex Transition Period false
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