8-K

 

 

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): May 17, 2021

 

 

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 May 17, 2021, Vincerx Pharma, Inc. (the “Company”) issued a press release announcing financial results for its fiscal quarter ended March 31, 2021. 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.

 

99.1    Press release dated May 17, 2021.


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: May 17, 2021

 

Vincerx Pharma, Inc.
By:  

/s/ Raquel E. Izumi

  Raquel E. Izumi
  President and Chief Operations Officer
EX-99.1

Exhibit 99.1

Vincerx Pharma Reports First Quarter 2021 Financial Results

and Provides a Corporate Update

Phase 1b dose escalation study of VIP152 in patients with CLL relapsed/refractory to venetoclax and

BTK inhibitors on track to initiate in 2H2021

First patient in Phase 1b Study of VIP152 in MYC-driven R/R aggressive lymphomas and advanced solid tumors expected 2Q 2021

Phase 1 VIP152 dose-escalation safety and efficacy data in double-hit lymphoma to be presented at ASCO

PALO ALTO, California, May 17, 2021 — 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 first quarter ended March 31, 2021 and provided a corporate update.

“The clearance of Vincerx’s first company-sponsored IND is an important milestone that paves the way for the initiation of our planned Phase 1b dose escalation study of VIP152 in patients with relapsed/refractory chronic lymphocytic leukemia and Richter syndrome in the second half of the year,” said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx. “This rapid execution is a testament to our team’s capabilities, and builds upon our Phase 1b expansion study in patients with MYC-driven hematologic malignancies and solid tumors, expected to begin patient dosing in the second quarter. Both studies are part of our comprehensive clinical program, which leverages early signals of Phase 1 clinical activity to evaluate the potential of VIP152 in challenging oncology populations. We look forward to continued progress across these important milestones in the clinic, which will also include the presentation of Phase 1 data in patients with double-hit lymphoma at ASCO.”

Dr. Hamdy continued, “For our preclinical assets, we were pleased to present compelling preclinical data on VIP236 at the AACR Annual Meeting, highlighting that VIP236 has the potential to provide potent, highly targeted antitumor activity to address the needs of patients with advanced and aggressive cancers. We remain focused on rapidly advancing our pipeline from a clinical and regulatory standpoint and look forward to providing further updates.”

Recent Highlights

 

   

Announced U.S. Food and Drug Administration (FDA) clearance of Investigational New Drug (IND) Application to initiate a Phase 1b dose escalation study evaluating VIP152, a highly selective PTEFb/CDK9 inhibitor, in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and Richter syndrome (RS)

 

   

Presented preclinical data on VIP236, a novel small molecule drug conjugate (SMDC), at the American Association for Cancer Research (AACR) Annual Meeting 2021

 

   

Hosted Key Opinion Leader (KOL) event on bioconjugation and CDK9 inhibitors, featuring presentations by Brian Druker, M.D., Knight Cancer Institute, and Anthony W. Tolcher, M.D., NEXT Oncology

 

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Announced that Phase 1 safety and efficacy dose escalation data from patients with double-hit lymphoma will be presented at the 2021 American Society of Clinical Oncology Annual Meeting

 

   

Announced formation of Scientific Advisory Board (SAB) composed of world leading academics and industry leaders in cancer research and therapeutics

 

   

Announced completion of public warrant redemption and receipt of cash proceeds of approximately $37.3 million.

First Quarter 2021 Financial Results

 

   

Vincerx Pharma ended the first quarter with $53.4 million in cash and cash equivalents, which does not include the proceeds from the public warrant redemption noted above, compared to $61.8 million at December 31, 2020.

 

   

Net loss for the first quarter ended March 31, 2021 was $6.3 million, or $0.46 per share, basic and diluted.

 

   

Research and development (R&D) expenses were $4.8 million for the quarter ended March 31, 2021, consisting primarily of $2.7 million in stock-based compensation expense, $1.3 million in new employee salaries and $0.8 million of outside services in preparation for our anticipated clinical trials.

 

   

General and administrative (G&A) expenses were $4.8 million for the quarter ended March 31, 2021, consisting primarily of $2.0 million in stock-based compensation expense, $0.9 million related to new employee salaries and $1.5 million of legal, accounting and other professional services in support of our intellectual property protection and operations as a newly formed public company.

About Vincerx Pharma, Inc. Vincerx Pharma, Inc. (“Vincerx”) is a recently formed clinical-stage life sciences company focused on leveraging its extensive development and oncology expertise to advance new therapies intended to address unmet medical needs for the treatment of cancer. Vincerx’s executive team has assembled a management team of biopharmaceutical experts with extensive experience in building and operating organizations that develop and deliver innovative medicines to patients. Vincerx’s current pipeline is derived from an exclusive license agreement with Bayer and includes a clinical-stage and follow-on small molecule drug program and a preclinical stage bioconjugation/next-generation antibody-drug conjugate platform.

Cautionary 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,” “seek,” “intend,” “plan,” “goal,” “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, pipeline, strategy, timeline, product candidates and preclinical and clinical development and results. Forward-looking statements are neither historical

 

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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 and changes in domestic and foreign markets; the potential effects of the COVID-19 pandemic; risks associated with preclinical or clinical development conducted prior to Vincerx’s in-licensing; failure to realize the anticipated benefits of the business combination with LifeSci Acquisition Corp.; failure to realize the benefits of the Bayer license; risks related to the rollout of Vincerx’s business and the timing of expected business milestones; changes in the assumptions underlying Vincerx’s expectations regarding its future business or business model; Vincerx’s ability to develop and commercialize product candidates; the availability and uses of capital; the effects of competition on Vincerx’s future business; and the risks and uncertainties set forth in reports on Forms 10-K, 10-Q and 8-K filed with or furnished to the SEC from time to time by Vincerx. Forward-looking statements speak only as of the date hereof, and Vincerx disclaims any obligation to update any forward-looking statements.

Contact Information

Bruce Mackle

LifeSci Advisors, LLC

646-889-1200

bmackle@lifesciadvisors.com

 

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Vincerx Pharma, Inc.

Condensed Consolidated Balance Sheets

 

     March 31,
2021
     December 31,
2020
 
     (Unaudited)         

ASSETS

     

Current assets:

     

Cash and cash equivalents

   $ 53,355      $ 61,792  

Prepaid expenses

     1,053        1,104  

Other current assets

     —          214  
  

 

 

    

 

 

 

Total current assets

     54,408        63,110  

Right-of-use assets

     3,372        —    

Other assets

     220        82  
  

 

 

    

 

 

 

Total assets

   $ 58,000      $ 63,192  
  

 

 

    

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

     

Current liabilities

     

Accounts payable, accrued expenses and other

     1,947        505  

License payable

     —          5,000  

Common stock warrant liabilities*

     27,224        32,308  
  

 

 

    

 

 

 

Total current liabilities

     29,171        37,813  

Lease liability, net of current portion

     3,276        —    
  

 

 

    

 

 

 

Total liabilities

     32,447        37,813  
  

 

 

    

 

 

 

Total stockholders’ equity

     25,553        25,379  
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

   $ 58,000      $ 63,192  
  

 

 

    

 

 

 

 

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Vincerx Pharma, Inc.

Condensed Consolidated Statements of Operations

 

     For the three
months ended
March 31,
 
     2021     2020  
     (Unaudited)  

Operating expenses:

    

General and administrative

   $ 4,791     $ 4  

Research and development

     4,834        
  

 

 

   

 

 

 

Total operating expenses

     9,625       4  
  

 

 

   

 

 

 

Loss from operations

     (9,625     (4
  

 

 

   

 

 

 

Other income

    

Change in fair value of warrant liabilities*

     3,349        
  

 

 

   

 

 

 

Total other income

     3,349        
  

 

 

   

 

 

 

Net loss

   $ (6,276   $ (4
  

 

 

   

 

 

 

Net loss per common share, basic and diluted

   $ (0.46   $ (0.00
  

 

 

   

 

 

 

Weighted average common shares outstanding, basic and diluted

     13,735       4,968  
  

 

 

   

 

 

 

 

*

The common stock warrant liabilities as of December 31, 2020 and change in fair value of warrant liabilities reflect the effects of the change in accounting treatment of certain of our private warrants in order to align with recent SEC guidance and the resulting restatement of our consolidated financial statements for the year ended December 31, 2020. These warrants were recorded as liabilities in our condensed consolidated balance sheet as of December 31, 2020 at fair value, with changes in fair value recognized in our condensed consolidated statement of operations for the three-month period ended March 31, 2021.

 

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