GlobeNewswire Inc | Nov 12, 2021 08:00AM EST

November 12, 2021

Advancing Phase 1b study of VIP152 in MYC-driven relapsed or refractory aggressive lymphomas and advanced solid tumors

Phase 1b dose escalation study of VIP152 in patients with CLL relapsed/refractory to venetoclax and BTK inhibitors on track to initiate in 2H2021

Strengthened balance sheet with $50M private placement

PALO ALTO, Calif., Nov. 12, 2021 (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 third quarter ended September 30, 2021 and provided a corporate update.

Our Phase 1b study of VIP152 continues to enroll across diverse indications per our development plan. Despite the recent COVID surge, we remain on-track with our goal to initiate Phase 2 studies in the second half of 2022, saidAhmed Hamdy M.D., Chief Executive Officer of Vincerx. We are also on-track to expand our clinical program with the initiation of our Phase 1 dose escalation study in patients with CLL relapsed/refractory to venetoclax and BTK inhibitors and Richter Syndrome by the end of the year.

Dr. Hamdy continued, Our balance sheet, strengthened by the proceeds from our recent private placement, provides us with additional resources to execute on our upcoming clinical and regulatory milestones, which will include the further diversification of our clinical pipeline with planned combination regimen studies to enable our entry into earlier lines of therapy. In parallel, we continue to progress our earlier stage bioconjugation programs and, with IND-enabling work ongoing, expect our small molecule drug conjugate (SMDC) candidate, VIP236, to enter first-in-human studies in the second half of 2022.

Recent Highlights

-- Advanced Phase 1b study of VIP152, a potent and selective inhibitor of CDK9, in MYC-driven relapsed or refractory aggressive lymphomas and advanced solid tumors. Ongoing Phase 1b expansion, first-in-human study is in patients with advanced cancer and consists of two expansion arms: Arm 1 will enroll up to 40 patients with relapsed/refractory aggressive lymphoma, including DLBCL, transformed follicular lymphoma, and mantle cell lymphoma.Arm 2 will enroll up to 40 patients with advanced solid tumors, including patients with ovarian cancer, triple negative breast cancer, castration-resistant neuroendocrine prostate cancer, and any other solid tumor with MYC aberration.The Company is also evaluating the safety of pembrolizumab in combination with VIP152 in patients with advanced solid tumors. Other combinations studies are in planning.

-- Announced upcoming presentations at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition. -- Advanced SMDC and antibody drug conjugate (ADC) bioconjugation pipeline manufacturing capabilities. Toxicology and Investigational New Drug (IND)-enabling studies are ongoing for VIP236, which selectively targets the tumor microenvironment and is activated by the tumor stroma, with an IND filing with U.S. Food and Drug Administration expected in the second half of 2022. -- Strengthened balance sheet with $50 million private placement led by new and existing investors, with proceeds intended to support the clinical evaluation of VIP152 in additional indications and combination regimens, as well as, to advance the Companys bioconjugation platform.

Third Quarter 2021 Financial Results

-- Vincerx Pharmaended the third quarter with$122.8 millionin cash and cash equivalents, which includes the proceeds from the private placement completed in September, compared to$61.8 millionatDecember 31, 2020. -- Net loss for the third quarter ended September 30, 2021, was $24.5 million, or $1.39 per share, basic and diluted. The third quarter net loss includes a charge of $6.6M related to the change in fair value of its warrant liabilities. -- Research and development (R&D) expenses were $12.2 million for the quarter ended September 30, 2021, consisting primarily of $2.7millionin headcount related costs,$5.5 millionof third party preclinical, clinical and manufacturing services in connection with its preclinical studies and clinical trials and$4.0million in stock-based compensation expense. -- General and administrative (G&A) expenses were $5.7 million for the quarter ended September 30, 2021, consisting primarily of$2.1millionin headcount related costs,$1.5 millionof outside services in support of its operations as a public company and$2.1million in stock-based compensation expense.

About Vincerx Pharma, Inc. Vincerx Pharma, Inc.(Vincerx) is a 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 has assembled a management team of biopharmaceutical experts with extensive experience in building and operating organizations that develop and deliver innovative medicines to patients. Vincerxs 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 platform, which includes next-generation antibody-drug conjugates and innovative small molecule drug conjugates. For more information, please visitwww.vincerx.com.

Cautionary StatementThis 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: Vincerxs business model, pipeline, strategy, timeline, product candidates, preclinical and clinical development and results and future capital requirements. 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 and changes in domestic and foreign markets; the potential effects of the COVID-19 pandemic; risks associated with preclinical or clinical development and trials, including those conducted prior to Vincerxs in-licensing; failure to realize the benefits of Vincerxs license agreement with Bayer; risks related to the rollout of Vincerxs business and the timing of expected business milestones; changes in the assumptions underlying Vincerxs expectations regarding its future business or business model; Vincerxs ability to develop and commercialize product candidates; the availability and uses of capital; the effects of competition on Vincerxs future business; and the risks and uncertainties set forth in Forms 10-K, 10-Q and 8-K filed with or furnished to theSECfrom 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 MackleLifeSci Advisors, LLC646-889-1200bmackle@lifesciadvisors.com

VincerxPharma,Inc.Condensed Consolidated Balance Sheets

(inthousands)

September 30, December 31, 2021 2020 (Unaudited) ASSETS Current assets: Cash and cash equivalents $ 122,796 $ 61,792Prepaid expenses 452 1,104Other current assets - 214Total current assets 123,248 63,110Right-of-use assets 4,169 -Property plant and equipment 250 -Other assets 1,758 82Total assets $ 129,425 $ 63,192 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable $ 2,259 $ 505Accrued expenses 4,668 -Lease liability 532 -License payable - 5,000Common stock warrant liabilities 17,703 32,308Total current liabilities 25,162 37,813Lease liability, net of current portion 3,637 -Total liabilities 28,799 37,813 Total stockholders' equity 100,626 25,379Total liabilities and stockholders' equity $ 129,425 $ 63,192

VincerxPharma,Inc.Condensed Consolidated Statements of Operations

(unaudited)(inthousands,exceptpershareamounts)

For the three months ended For the nine months ended September 30, September 30, 2021 2020 2021 2020 Operating expenses:General and $ 5,720 $ 305 $ 17,206 $ 342 administrativeResearch and 12,211 - 27,743 - developmentTotal operating 17,931 305 44,949 342 expensesLoss from (17,931 ) (305 ) (44,949 ) (342 )operationsOther income (expense)Change in fairvalue of warrant (6,606 ) - 12,102 - liabilitiesOther income 13 (2 ) 13 (2 )(expense)Total other income (6,593 ) (2 ) 12,115 (2 )(expense)Net loss $ (24,524 ) $ (307 ) $ (32,834 ) $ (344 ) Net loss percommon share, $ (1.39 ) $ (0.06 ) $ (2.06 ) $ (0.07 )basic and dilutedWeighted averagecommon shares 17,694 5,076 15,941 5,018 outstanding, basicand diluted