On 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, reported financial results for the first quarter ended March 31, 2021 and provided a corporate update (Press release, Vincerx Pharma, MAY 17, 2021, View Source [SID1234580147]).

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"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 (Free ASCO Whitepaper)."

Dr. Hamdy continued, "For our preclinical assets, we were pleased to present compelling preclinical data on VIP236 at the AACR (Free AACR Whitepaper) 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) (Free AACR Whitepaper) 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

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 (ASCO) (Free ASCO Whitepaper) 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.

On May 17, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that the company will present at Biomarkers Week Online 2021 (Press release, Personalis, MAY 17, 2021, View Source [SID1234580163]).

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The presentation, titled "ImmunoID NeXT Platform for comprehensive tumor immunogenomics and advanced biomarker discovery," will describe the Personalis universal cancer immunogenomics platform, ImmunoID NeXT. Erin Newburn, MS, PhD, will present for Personalis. Dr. Newburn will provide an overview of the platform, which combines highly sensitive, exome-scale DNA and RNA sequencing with advanced analytics to provide a multidimensional view of the tumor and the tumor microenvironment (TME) from a single sample preparation. Dr. Newburn will review a case study in a cohort of 51 late-stage melanoma patients that demonstrates how the integration of neoantigen burden, HLA LOH, and Antigen Presentation Machinery (APM) mutational data formed a composite biomarker that more accurately predicted response to checkpoint blockade than other markers. Additionally, Dr. Newburn will highlight our NeXT Liquid Biopsy, an exome-wide liquid biopsy approach combined with ImmunoID NeXT, to further explore critical areas of tumor biology.

ImmunoID NeXT is the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample. The ImmunoID NeXT Platform can be used to investigate the key tumor- and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one and maximizing the biological information that can be generated from a precious tumor specimen.

Personalis is a co-sponsor of Biomarkers Week and will have representatives available to answer questions about the company’s cancer immunogenomics capabilities.

On May 17, 2021 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create product candidates that address unmet medical needs, reported that the company will hold a conference call and live webcast on Thursday, May 27, 2021 at 4:30 p.m. Eastern Time (ET) to review its first quarter 2021 financial results and provide a business update (Press release, Ascendis Pharma, MAY 17, 2021, View Source [SID1234580108]).

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Conference Call Details

Date Thursday, May 27, 2021
Time 4:30 p.m. ET/1:30 p.m. Pacific Time
Dial In (U.S.) 844-290-3904
Dial In (International) 574-990-1036
Access Code 4986247
A live webcast of the conference call will be available on the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will be available on this website shortly after conclusion of the event for 30 days.

On May 17, 2021 Genmab A/S (Nasdaq: GMAB) reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, MAY 17, 2021, View Source [SID1234580124]).

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The share buy-back program is expected to be completed no later than June 30, 2021 and comprises up to 200,000 shares.

The following transactions were executed under the program from May 10, 2021 to May 14, 2021:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 240,306 shares as treasury shares, corresponding to 0.37% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 11 dated February 23, 2021.

On May 17, 2021 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, reported its financial results for the first quarter of 2021 (Press release, NexImmune, MAY 17, 2021, View Source [SID1234580148]).

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"With a strong cash position following our successful IPO in February, we remain focused on completing enrollment in our clinical trials for NEXI-001 and NEXI-002, and we expect to present additional clinical data at scientific conferences during 2021 for each," said Scott Carmer, Chief Executive Officer. "We are also advancing new cell therapy programs targeting solid tumors and have initiated IND-enabling pre-clinical experiments that will support the initial application of our ‘AIM Injectable’ modality. We look forward to providing further updates as these important programs mature."

Select 1Q 2021 Business Highlights

On February 17, 2021, NexImmune completed a successful IPO and raised gross proceeds of $126M. The IPO was oversubscribed and priced at the top of the range.
NexImmune announced the appointments of Robert Knight, MD as Chief Medical Officer; Jerome Zeldis, MD, PhD as Executive Vice President, Research and Development; Jeffery Weber, MD, PhD as Chief Scientific Advisor and Scientific Advisory Board Chair; Chad Rubin as SVP of Corporate Affairs; and Grant Verstandig as a member of its Board of Directors.
NEXI-001 and NEXI-002 are both in Phase 1/2 clinical trials. The Company will share preliminary data from the initial safety cohorts of both trials at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting and EHA (Free EHA Whitepaper)2021 Virtual Congress for NEXI-001 and NEXI-002, respectively, with additional results for each trial in Q421.
Select 1Q 2021 Financial Highlights

Cash and cash equivalents for the company as of March 31, 2021 were $118.1M, compared to $5.0M at December 31, 2020. Based upon its current operating plans and cash and cash equivalents the Company expects to have sufficient capital to fund its operating expenses and capital expenditure requirements through the second quarter of 2022.

Research and development expenses were $6.0M in the first quarter of 2021, compared to $4.3M for the same period in the prior year. The increase in R&D expenses were mainly attributable to costs for the two clinical trials as well as personnel-related expenses driven by increased headcount, offset partially by reduced preclinical and regulatory-related spending.

General and administrative expenses were $4.1M, compared to $2.1M for the same period the prior year. The increase was due primarily to increases in headcount and fees related to professional and consulting services.

Net loss, according to generally accepted accounting principles in the U.S. (GAAP), was $8.5M for the quarter, or a basic and diluted GAAP loss per share of $0.71. This compared to a net loss of $6.3M for the same period the prior year.