GlobeNewswire Inc | Aug 12, 2021 04:05PM EDT

August 12, 2021

First patient dosed in 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

PALO ALTO, Calif., Aug. 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 second quarter ended June 30, 2021 and provided a corporate update.

During the past quarter, we achieved an important milestone in dosing the first patient in our Phase 1b study of VIP152, our selective PTEFb/CDK9 inhibitor, in MYC-driven indications, building upon the compelling signals of monotherapy activity observed in the dose-escalation study and exploratory cohort in double-hit lymphoma, saidAhmed Hamdy M.D., Chief Executive Officer of Vincerx. Looking ahead, we intend to continue our strong execution in the clinic with the initiation of our Phase 1 dose escalation study in CLL relapsed/refractory to venetoclax and BTK inhibitors in the second half of this year. Our balance sheet provides us with a solid foundation to continue to execute on our clinical and regulatory goals.

Recent Highlights

-- Announced first patient dosed in 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 (FIH) study is in patients with advanced cancer and consists of two expansion arms. Arm 1 will enroll up to 30 patients with relapsed/refractory aggressive lymphoma, including DLBCL, transformed follicular lymphoma, and blastoid 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. All patients must have confirmed MYC overexpression or translocation. -- Presented clinical data in a poster presentation entitled Safety and efficacy of VIP152, a PTEFb / CDK9 inhibitor, in patients with double-hit lymphoma at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting -- Published an article entitled Changing for the Better: Discovery of the Highly Potent and Selective CDK9 Inhibitor VIP152 Suitable for Once Weekly Intravenous Dosing for the Treatment of Cancer, in the Journal of Medicinal Chemistry -- Announced inclusion in the Russell 3000 and Microcap Indexes

Second Quarter 2021 Financial Results

-- Vincerx Pharmaended the second quarter with$85.6 millionin cash and cash equivalents, which includes the proceeds from the recent public warrant redemption, compared to$61.8 millionatDecember 31, 2020. -- Net loss for the second quarter ended June 30, 2021 was $2.0 million, or $0.12 per share, basic and diluted. -- Research and development (R&D) expenses were $10.7 million for the quarter ended June 30, 2021, consisting primarily of $3.0 millionin headcount related costs,$3.3 millionof outside services in preparation for and support of our clinical trials and $4.4million in stock-based compensation expense. -- General and administrative (G&A) expenses were $6.7 million for the quarter ended June 30, 2021, consisting primarily of $1.2 millionin headcount related costs,$3.3 millionof outside services in support of our operations as a public company and $2.2million 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 conducted prior to Vincerxs in-licensing; failure to realize the anticipated benefits of the business combination withLifeSci Acquisition Corp.; 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 InformationBruce MackleLifeSci Advisors, LLC646-889-1200bmackle@lifesciadvisors.com



Vincerx Pharma, Inc.Condensed ConsolidatedBalance Sheets

(in thousands) June 30, December 31, 2021 2020 (Unaudited) ASSETS Current assets: Cash and cash equivalents $ 85,623 $ 61,792Prepaid expenses 882 1,104Other current assets - 214Total current assets 86,505 63,110Right-of-use assets 4,217 -Other assets 415 82Total assets $ 91,137 $ 63,192 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable 1,830 505Accrued expenses 2,397 -Lease liability 360 -License payable - 5,000Common stock warrant liabilities 11,097 32,308Total current liabilities 15,684 37,813Lease liability, net of current portion 3,858 -Total liabilities 19,542 37,813 Total stockholders' equity 71,595 25,379Total liabilities and stockholders' equity $ 91,137 $ 63,192

Vincerx Pharma, Inc.Condensed ConsolidatedStatements of Operations

(unaudited)(in thousands, except per share amounts) For the three months ended For the six months ended June 30, June 30, 2021 2020 2021 2020Operating expenses:General and $ 6,695 $ 33 $ 11,486 $ 37 administrativeResearch and 10,698 - 15,532 - developmentTotal operating 17,393 33 27,018 37 expensesLoss from (17,393 ) (33 ) (27,018 ) (37 )operationsOther income Change in fairvalue of 15,359 - 18,708 - warrantliabilitiesTotal other 15,359 - 18,708 - incomeNet loss $ (2,034 ) $ (33 ) $ (8,310 ) $ (37 ) Net loss percommon share, $ (0.12 ) $ (0.01 ) $ (0.55 ) $ (0.01 )basic anddilutedWeightedaverage commonshares 16,350 5,009 15,050 4,988 outstanding,basic anddiluted