Vincerx Pharma Announces Redemption of Public Warrants

On April 5, 2021 Vincerx Pharma, Inc. (Nasdaq: VINC) (the "Company"), reported that it will redeem all of its outstanding public warrants (the "Public Warrants") to purchase shares of the Company’s common stock, $0.0001 par value per share ("Common Stock"), that were issued under the Warrant Agreement, dated as of March 5, 2020 (the "Warrant Agreement"), by and between the Company and Continental Stock Transfer & Trust Company, as warrant agent (the "Warrant Agent"), and that remain outstanding at 5:00 p.m. New York City time on May 5, 2021 (the "Redemption Date") for a redemption price of $0.01 per Public Warrant (the "Redemption Price") (Press release, Vincerx Pharma, APR 5, 2021, View Source [SID1234577573]). Prior to the Redemption Date, the Company’s units, listed on the Nasdaq Capital Market under the symbol "LSACU," will each be separated into one share of Common Stock and one Public Warrant, and be traded on the Nasdaq Capital Market under the symbols "LSAC" and "LSACW," respectively.

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Warrants to purchase Common Stock that were issued under the Warrant Agreement in a private placement and still held by the initial holders thereof or their permitted transferees are not subject to this redemption.

Under the terms of the Warrant Agreement, the Company is entitled to redeem all the outstanding Public Warrants if the last sale price of the Common Stock is at least $16.50 per share for any 20 trading days within any 30-day trading period ending on the third business day prior to the date on which a notice of redemption is given. This share price performance target has been met. At the direction of the Company, the Warrant Agent has delivered a notice of redemption to each of the registered holders of the outstanding Public Warrants.

Each Public Warrant may be exercised by the holders thereof until 5:00 p.m. New York City time on the Redemption Date, to purchase one-half (1/2) of a fully paid and non-assessable share of Common Stock underlying such warrant, at the exercise price of $11.50 per whole share of Common Stock. Pursuant to the Warrant Agreement, a holder may exercise its warrants only for a whole number of shares. This means that only an even number of Public Warrants may be exercised at any given time by a holder. Any Public Warrants that remain unexercised following 5:00 p.m. New York City time on the Redemption Date will be void and no longer exercisable, and the holders of those Public Warrants will be entitled to receive only the redemption price of $0.01 per warrant. 6,563,767 Public Warrants were initially issued by the Company, exercisable for an aggregate of 3,281,883 shares of Common Stock at a price of $11.50 per share, representing a total of approximately $37.7 million in potential proceeds to the Company.

None of the Company, its board of directors or employees has made or is making any representation or recommendation to any holder of the Public Warrants as to whether to exercise or refrain from exercising any Public Warrants.

The shares of Common Stock underlying the Public Warrants have been registered by the Company under the Securities Act of 1933, as amended, and are covered by a registration statement on Form S-1 filed with, and declared effective by, the Securities and Exchange Commission (File No. 333-252589).

Questions concerning redemption and exercise of the Public Warrants can be directed to Continental Stock Transfer & Trust Company, 1 State Street, 30th Floor, New York, New York 10004, Attention: Compliance Department, telephone number (212) 509-4000.

No Offer or Solicitation

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any offer of any of the Company’s securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

PROTHENA ANNOUNCES APPOINTMENT OF HIDEKI GARREN, MD, PHD, AS CHIEF MEDICAL OFFICER

On April 5, 2021 Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical company with expertise in protein dysregulation and a pipeline of investigational therapeutics for rare peripheral amyloid and neurodegenerative diseases, reported the appointment of Hideki Garren, MD, PhD, as Chief Medical Officer (Press release, Prothena, APR 5, 2021, View Source [SID1234577627]). Dr. Garren will lead the clinical and medical organizations to advance Prothena’s clinical pipeline.

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"Hideki brings valuable experience and expertise to our team as we look ahead towards transitioning to a fully integrated research, development and commercial biotechnology company," said Gene Kinney, PhD, President and Chief Executive Officer. "His experience leading several late-stage development programs in neurology and rare disease indications through registration and launch is particularly relevant as we advance our pipeline of programs in these areas. We are delighted to welcome him to the team as we prepare for our next stage of growth."

"Prothena’s impressive scientific platform has advanced a rich pipeline of potentially transformational therapeutics, including several programs that have demonstrated benefit on meaningful clinical endpoints in diseases with highly significant unmet medical needs," commented Dr. Garren. "I am excited to join the company during this dynamic period of growth and look forward to working as part of this exceptional team with a rich scientific heritage."

Dr. Garren joins Prothena from F. Hoffmann-La Roche Ltd. (Roche) & Genentech Inc. where he was Vice President, Global Head of Neuroimmunology, leading Roche’s Neuroimmunology franchise team. A neurologist by training, Dr. Garren was most recently responsible for the Phase 3 clinical programs for Ocrevus for Multiple Sclerosis and Enspryng for Neuromyelitis Optica Spectrum Disorder. Dr. Garren also held the role of Executive Director, Translational Medicine Expert in Neuroscience with Novartis Pharma. Prior to Novartis, Dr. Garren served as Co-Founder, Executive Vice President, Chief Scientific Officer, and Chief Operating Officer of Bayhill Therapeutics, Inc., a company he started in 2002 based on a technology platform he co-invented while at Stanford University.

Dr. Garren earned his Bachelor of Science from the California Institute of Technology and his MD and PhD from the University of California, Los Angeles (UCLA). He completed his internship in internal medicine at UCLA, and his residency in neurology and fellowship in neuroimmunology at Stanford University.

HTG Molecular Diagnostics Reports Preliminary First Quarter 2021 Financial Results

On April 5, 2021 HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company whose mission is to advance precision medicine, reported certain preliminary financial results for the first quarter ended March 31, 2021 (Press release, HTG Molecular Diagnostics, APR 5, 2021, View Source [SID1234577574]).

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As discussed during HTG’s earnings conference call on March 25, the company believes its full year 2021 revenue could grow 30% to 40% over 2020 levels as it navigates a resurgence of COVID-19, which impacted the first quarter and is expected to continue to impact at least the first half of 2021. HTG expects to report unaudited total revenue for the first quarter ended March 31, 2021 of approximately $1.4 million, and cash, cash equivalents and short-term marketable securities of approximately $30.8 million as of March 31, 2021.

"After seeing many of our customers begin to return to work in the fourth quarter of 2020, we were cautiously optimistic that we were starting to pull out of the COVID-19-related revenue impact that we experienced throughout most of 2020. However, a second round of COVID-19-related closures, especially in Europe, have again impacted our core business, delaying planned studies and product sales," said John Lubniewski, CEO of HTG. "While we remain confident in the main drivers and underlying demand for our products, and still believe that full year 2021 revenue could grow 30% to 40% over 2020 levels, we believe regional and company level closures will continue to add turbulence to our revenue recovery throughout the first half of 2021."

Mr. Lubniewski continued, "We continue to see a fundamental macro trend of personalized medicine driving an increased use of biomarkers, especially RNA-based biomarkers. We believe our technology continues to be an ideal tool to address deployable alternatives for measuring gene expression, advance clinical trials, and lower false discovery rates in preclinical screening. We plan to continue to focus on diversifying our customer base and further expanding into markets outside of oncology for sales of existing HTG EdgeSeq products. In addition, we are in the final development phase of our planned transcriptome panel and the related Early Adopter Program, which we believe will move us toward our planned commercial launch in the third quarter of 2021."

The preliminary results set forth above are based on management’s initial review of the company’s results as of and for the quarter ended March 31, 2021 and are subject to revision based upon the company’s quarter-end closing procedures and the completion and review by the company’s external auditors of the company’s quarter‑end financial statements. Actual results may differ materially from these preliminary results as a result of the completion of quarter-end closing procedures, final adjustments, and other developments arising between now and the time that the company’s financial results are finalized. In addition, these preliminary results are not a comprehensive statement of the company’s financial results for the quarter ended March 31, 2021, should not be viewed as a substitute for complete financial statements prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the company’s results for any future period.

The company expects to announce full March 31, 2021 financial results in advance of its quarterly conference call in May 2021.

CELSION CORPORATION ANNOUNCES CLOSING OF $15 MILLION REGISTERED DIRECT OFFERING

On April 5, 2021 Celsion Corporation (NASDAQ: CLSN) ("Celsion" or the "Company"), reported the closing of its previously announced registered direct offering of 11,538,462 shares of common stock at a purchase price of $1.30 per share, resulting in net proceeds of $13.9 million, after deducting placement agents’ fees but before expenses payable by the Company (Press release, Celsion, APR 5, 2021, View Source [SID1234577628]).

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A.G.P./Alliance Global Partners acted as the lead placement agent for the offering.

JonesTrading Institutional Services LLC and Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as co-placement agents for the offering.

Celsion intends to use the net proceeds for general corporate purposes, including research and development activities, capital expenditures and working capital.

This offering was made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-254515), previously filed with the Securities and Exchange Commission (the "SEC") on March 19, 2021 and declared effective on March 30, 2021. The offering of the shares of common stock were made by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering are filed with the SEC and are available on the SEC’s website at View Source or by contacting A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Legend Biotech, J&J finish off rolling submission for CAR-T hopeful, approach finish line

On April 5, 2021 China’s Legend Biotech and Janssen reported that they have finished off the rolling submission to the FDA for their partnered cell therapy hopeful cilta-cel (Press release, Legend Biotech, APR 5, 2021, View Source [SID1234577717]).

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The closely watched asset, the star of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s meeting a few years’ back, saw Johnson & Johnson’s U.S. submission for adults with relapsed and/or refractory multiple myeloma completed in the first quarter, according to a new form filed with the Securities and Exchange Commission from Legend.

Analysts at Jefferies said this is a "critical first step" toward nabbing an approval for the therapy by year-end. There’s another two months for the biologics license application to be accepted and then, if its nabs a priority review, another six months for approval, meaning it could be given the green light toward the end of 2021, for which it has been previously guided.

This comes just a few weeks after Bristol Myers Squibb and partner bluebird bio nabbed an approval for Abecma—formerly known as idecabtagene vicleucel, or ide-cel—to treat adults whose multiple myeloma has progressed after at least four previous rounds of treatment.

The March approval was the first CAR-T med approved in multiple myeloma and the first CAR-T in the B-cell maturation antigen-targeted class. J&J and Legend are now hoping to be close behind.

In recent data out late last year at the annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), the pair unveiled the first phase 2 readout for its prospect, which banished multiple myeloma in two-thirds of patients and shrank tumors in 97% of patients.

RELATED: ASH (Free ASH Whitepaper): J&J, Legend’s anti-BCMA CAR-T keeps it consistent in phase 2 as FDA filing looms

The data, presented virtually at ASH (Free ASH Whitepaper)’s annual meeting in December, came from 97 patients whose cancer had returned after a median of six prior treatments or had not responded to treatment in the first place.

The investigators followed the patients for a median of one year after treatment. J&J’s Janssen unit previously reported data from 29 patients from the phase 1b part of the trial, showing the treatment—ciltacabtagene autoleucel, or cilta-cel—eliminated tumors in 86% of patients and shrank tumors in all 29 of them for a 100% overall response rate.

Jefferies said in a note to clients that, while the duo won’t be first, "We think round 8-9 months difference in the timing of market arrival does not offer much first mover advantage for [BMS/bluebird bio’s] ide-cel given its inferior clinical profile to cilta-cel."