On May 11, 2021 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, reported that John Climaco, Chief Executive Officer of CNS Pharmaceuticals, will present at the Q2 Virtual Investor Summit on Tuesday, May 18th at 12:30 PM ET (Press release, CNS Pharmaceuticals, MAY 11, 2021, View Source [SID1234579724]).

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In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website.

A live video webcast will be accessible on the Events page in the Investors section of the Company’s website (www.cnspharma.com) and will be archived for 90 days following the event.

On May 11, 2021 Nuvalent, Inc., a biotechnology company creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the completion of a $135 million Series B financing (Press release, Nuvalent, MAY 11, 2021, https://www.nuvalent.com/nuvalent-completes-135-million-series-b-financing-to-advance-portfolio-of-novel-precisely-targeted-kinase-inhibitors-for-treatment-resistant-cancers/ [SID1234580619]). The round was led by Bain Capital Life Sciences with participation from sole founding investor, Deerfield Management, and additional new investors Fidelity Management and Research Company LLC, Wellington Management Company, Viking Global Investors, Janus Henderson Investors, Avoro Capital Advisors, Boxer Capital of Tavistock Group, Venrock Healthcare Capital Partners, Fairmount Funds Management LLC, Driehaus Capital Management LLC, and Logos Capital. Andrew Hack, M.D., Ph.D., a Managing Director of Bain Capital Life Sciences, will join the Nuvalent Board of Directors.

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"We are encouraged by the support of this exceptional group of investors and their shared belief in our mission to develop precisely targeted therapies for patients with cancer," said Alex Balcom, Chief Financial Officer at Nuvalent. "With this financing, we are well positioned to efficiently advance our parallel lead programs into clinical development and to accelerate the discovery of additional novel, selective compounds to meet medical needs in treatment-resistant cancers."

Proceeds from the Series B financing will support the clinical advancement of Nuvalent’s parallel lead programs, NVL-520 (previously NUV-520), a potential best-in-class ROS1-selective kinase inhibitor, and NVL-655 (previously NUV-655), a potential best-in-class ALK-selective kinase inhibitor. The financing is also expected to support further expansion and accelerated development of Nuvalent’s discovery research pipeline of novel, selective small molecule kinase inhibitors.

New preclinical data leading to the selection of NVL-520 and NVL-655 for clinical advancement were recently presented at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting. These parallel lead compounds have been designed to address the identified clinical needs of kinase selectivity, brain penetrance, and activity against drug-resistance mutations in ROS1- and ALK-driven tumors, respectively. The preclinical data support the potential for NVL-520 and NVL-655 to remain active in tumors that have developed resistance mutations and to minimize off-target adverse events, including TRK-related adverse events affecting the central nervous system (CNS), in order to drive more durable responses for patients.

"Nuvalent’s focused approach to drug development has led to a promising pipeline of novel drug candidates with specific, rational designs and opportunity for meaningful clinical impact," said Dr. Hack. "I am pleased to join the company’s Board of Directors and look forward to working with this talented team as they continue to apply their internal expertise in chemistry and structure-based drug design towards addressing real-world medical needs identified in close collaboration with leading clinical advisors."

Nuvalent also recently announced several additions to its leadership and advisory team, including precision oncology expert Christopher Turner, M.D., as Chief Medical Officer, and leading scientific advisors with deep expertise in targeted therapies for oncology.

"We welcome Andrew to our Board of Directors, who draws from a breadth of experience across early- to late-stage companies in the biotechnology and life sciences sectors to bring a valuable, multi-faceted perspective to our growing team of distinguished leaders and advisors," said James Porter, Ph.D., Nuvalent Chief Executive Officer. "The milestones that we announced today support our significant achievements since our public launch in January 2021, and the tremendous potential that we believe Nuvalent has. With the support of this investor syndicate, we confidently move forward to develop therapies that drive deep, durable responses for patients with cancer."

On May 11, 2021 Cellectis S.A. (NASDAQ: CLLS – Euronext Growth: ALCLS), a clinical-stage biotechnological company employing its core proprietary technologies to develop best-in-class products based on gene-edited allogeneic CAR T-cells ("UCART") in the field of immuno-oncology, and Sanofi (Euronext: SAN – NYSE: SNY), reported that entered into a partnership agreement and a supply agreement regarding alemtuzumab, an anti-CD52 monoclonal antibody, to be used as part of a lymphodepleting regimen in certain Cellectis sponsored UCART clinical trials (Press release, Cellectis, MAY 11, 2021, View Source [SID1234579661]).

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Cellectis is the inventor of the combination of CD52 knockout UCART cells with a lymphodepleting regimen with an anti-CD52 antibody such as alemtuzumab. The CD52 knockout renders its UCART product candidates resistant to alemtuzumab as part of the lymphodepleting regimen. Patients’ lymphodepleting regimens reduce host immune cells and should improve allogeneic CAR T-cell expansion and persistence. In Cellectis sponsored trials, alemtuzumab is currently used as part of the lymphodepleting regimen for UCART22 in the BALLI-01 clinical trial in relapsed/refractory ALL, and for UCART123 in the AMELI-01 clinical trial in relapsed/refractory AML, but not for UCARTCS1 which has a self-lymphodepleting activity. Both Cellectis’ UCART22 and UCART123 candidate products have the CD52 gene inactivated by TALEN gene editing technology.

As part of the agreement, Sanofi will supply alemtuzumab to support Cellectis’ clinical trials and the parties agreed to enter into discussions to execute a commercial supply of alemtuzumab under pre-agreed financial conditions.

On May 11, 2021 Anticancer Bioscience (ACB), pioneers in synthetic lethal approaches to precision oncology, reported that progress in its MYC-synthetic lethal (MYC-SL) program (Press release, Anticancer Bioscience, MAY 11, 2021, View Source [SID1234579676]). The Company has identified three classes of novel small molecule compounds that demonstrate robust anti-cancer activity in preclinical studies, acting through interfering with mitosis and blocking cytokinesis. ACB is progressing through optimization and final candidate selection with the goal of progressing at least one of these MYC-SL compounds into clinical trials by 2022.

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The MYC family oncogene, encoding a transcription factor Myc, is deregulated in over 50% of human cancers, and this deregulation is frequently associated with poor prognosis and unfavorable patient survival. Myc has a central role in almost every aspect of the oncogenic process, orchestrating proliferation, apoptosis, differentiation, and metabolism. Direct targeting of Myc has been a challenge for decades owing to its "undruggable" protein structure, with a lack of a drug binding pocket. The synthetic lethality associated with Myc overexpression is being explored for its potential in the development of novel anti-cancer therapies.

Commenting on the progress and pre-clinical data, Dun Yang PhD, Founder, President, and CEO of ACB said:

"We are excited by our early in vitro and in vivo pre-clinical studies and in our molecular biology work to identify the target that our novel compounds hit. In animal models, data consistent with the in vitro studies has confirmed that the MYC-SL compounds act through interfering mitosis and blocking cytokinesis. We have filed patents on our compounds and are progressing rapidly through optimization to candidate selection and IND enabling studies."

The novel target for ACB’s MYC-SL compounds has been identified and will be subject to peer review publication in due course.

ACB has developed an innovative and proprietary general utility new scaffold-drug fragment (GUNS-DF) library approach to small molecule drug discovery. It is constructing 10 types of pilot GUNS-DF libraries, each of which contains a distinct core scaffold. Twenty compounds with excellent drug-like properties have been identified from three types of GUNS-DF libraries with a potency of less than 20 nM in a cell-based assay for MYC-SL agents. This potency was achieved after synthesizing and screening approximately 350 analogs during lead optimization.

At low nM concentrations, these compounds elicited potent cytotoxicity in a panel of 50 cell lines representing a variety of human malignancies. With adequate bioavailability, many of these compounds also suppressed the growth of various cancer cell lines that grew as xenografts in immunocompromised mice.

Having raised CNY131m (~USD21m) in seed finance to fund its discovery research, ACB is currently pursuing a Series A financing to progress at least one of its MYC-SL compounds into clinical trials.

ACB will be showcasing its innovative drug discovery platforms and pipeline at ChinaBio and BioEquity in May, and at BIO in June.

On May 11, 2021 ASLAN Pharmaceuticals (Nasdaq:ASLN), a clinical-stage immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, reported financial results for the first quarter ended March 31, 2021 and provided an update on its clinical development activities (Press release, ASLAN Pharmaceuticals, MAY 11, 2021, View Source [SID1234579692]).

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Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: "We have continued to make solid progress in 2021 and we are on track to complete the expansion cohort in our multiple ascending dose trial for ASLAN004 with an additional 27 patients expected to be enrolled by mid-2021 followed by the announcement of topline data expected in the third quarter of 2021. We are excited to expand our senior management team with two highly experienced executives, Dr Karen Veverka, who will be leading our clinical development program, and Joseph Suttner to lead clinical operations. In addition, we are preparing for our Phase 2b trial for ASLAN004, which we expect to initiate in the second half of 2021. Our robust financial position provides the resources to fund development activities and achieve additional value creating milestones for shareholders."

First quarter 2021 and recent business highlights

Clinical development

ASLAN004

Positive interim data from the three dose cohorts of the ongoing Phase 1 randomised, double-blind placebo controlled multiple ascending dose (MAD) study of ASLAN004 for the treatment of moderate to severe atopic dermatitis (AD) were announced in March. ASLAN004, a novel, first-in-class antibody, was well tolerated across all doses and showed improvements compared to placebo in all efficacy endpoints, supporting its potential as a differentiated treatment for AD. Additional data from the expansion cohort is planned for the third quarter of 2021.
New data from the Single Ascending Dose study that demonstrate ASLAN004’s favourable tolerability profile as an IL-13Rα1 inhibitor and as a differentiated treatment method for atopic dermatitis patients were accepted for poster presentation at the 2021 Society for Investigative Dermatology virtual meeting on 6 May. The data will also be published in the fall edition of the Journal of Investigative Dermatology.
Corporate updates

Appointed Dr Karen Veverka as Vice President, Medical to lead ASLAN’s clinical medical development program for new products, including Phase 2 and 3 trials. Dr Veverka brings more than 20 years of experience in the pharmaceutical industry, as well as significant preclinical and clinical research and development (R&D) experience in immunology and dermatology. Prior to joining ASLAN, Dr Veverka was Senior Medical Director and Medical Head for the Innovative Portfolio at LEO Pharma, a leader in global dermatology. At LEO she led the development of brand medical strategy and execution of medical affairs activities for products in the AD and psoriasis therapeutic areas, including tralokinumab. Dr Veverka has also held leadership roles at Novartis and GTx. Dr Veverka earned her PhD in Pharmacology at The Mayo Clinic Graduate School of Biomedical Sciences and completed a postdoctoral research fellowship at St Jude Children’s Research Hospital.
Appointed Joseph Suttner as Vice President, Clinical Operations. Mr Suttner brings more than 20 years in clinical operations and R&D, including more than 8 years in dermatology. Mr Suttner has successfully led clinical operations teams at Dermira, PellePharm and several other biotechnology companies through Phase 2b trials in AD, Gorlin syndrome, and actinic keratosis, among other conditions.
Anticipated upcoming milestones

Completion of MAD clinical study of ASLAN004 in moderate-to-severe AD patients with clinical results expected in third quarter of 2021.
Initiation of Phase 2b study of ASLAN004 for AD expected in the second half of 2021.
First quarter 2021 financial highlights

Cash used in operations for the first quarter of 2021 was US$7.6 million compared to US$5.2 million in the same period in 2020.
Research and development expenses were US$3.8 million in the first quarter of 2021 compared to US$2.4 million in the first quarter of 2020. The increase was driven by manufacturing expenses incurred in preparation for the Phase 2b trial of ASLAN004.
General and administrative expenses were US$3.1 million in the first quarter of 2021 compared to US$1.0 million in the first quarter of 2020. The increase was due to the increase in headcount and staffing costs in preparation for the Phase 2b trial of ASLAN004 and additional corporate costs incurred to support the fundraising activities that were concluded in the first quarter of 2021.
Net loss for the first quarter of 2021 was US$6.7 million compared to a net loss of US$3.0 million for the first quarter of 2020.
Cash, cash equivalents and short-term investments totalled US$100.8 million as of 31 March 2021 compared to US$14.3 million as of 31 December 2020. Following the financing activities in the first quarter of 2021, which raised combined gross proceeds of approximately US$101 million, management believes that its cash and cash equivalents will be sufficient to fund operations into 2023.
The weighted-average number of American Depository Shares (ADSs) outstanding in the computation of basic loss per share for the first quarter of 2021 was 51.4 million (representing 257.2 million ordinary shares) compared to 38.0 million (representing 190.0 million ordinary shares) for the first quarter of 2020. Following the financing activities in the first quarter of 2021, the number of ADSs outstanding on 31 March 2021 was 69.5 million (representing 347.6 million ordinary shares). One ADS is the equivalent of five ordinary shares.