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.

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.

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."

On April 5, 2021 Invitae (NYSE: NVTA), a leading medical genetics company, reported that a small group of investors, led by SB Management, a subsidiary of Softbank Group Corp., will make an investment of $1.15 billion in convertible senior notes to support the Company’s future growth initiatives (Press release, Invitae, APR 5, 2021, View Source [SID1234577575]).

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"Invitae’s mission is to deliver genetic information to improve healthcare for billions of people at all stages of life. With the support of our long-term shareholders, we’re creating the platform to support the routine use of genetics in mainstream medicine to result in better healthcare for everyone," said Sean George, co-founder and chief executive officer of Invitae. "This investment will help us continue to fuel our growth, including expanding our platform, services and menu through both in-house development and the addition of complementary companies and technologies as we work to build a differentiated platform uniquely capable of driving the transition to personalized medicine."

"Invitae has a definitive head start in the rapidly expanding market for clinical genetic sequencing. Their comprehensive diagnostic products are well positioned to further grow the global understanding of how genomics predispose populations for certain diseases. These datasets will inform treatment and dramatically improve patient outcomes," said Akshay Naheta, chief executive officer of SB Management, a subsidiary of SoftBank Group Corp.

Under the terms of the investment, the participating investors, including SB Management, will purchase a total aggregate principal amount of $1.15 billion in Convertible Senior Notes due 2028 (the "Notes"). The Notes will have an initial conversion price of $43.18 per share of the Company’s common stock, subject to customary anti-dilution and other adjustments. The initial conversion price of $43.18 represents a 20% premium to the Company’s average 5-day trailing volume-weighted average price as of April 1, 2021. The Notes will mature on April 1, 2028, unless earlier converted, redeemed or repurchased. The Notes will bear 1.5% interest per year. Upon conversion, the Company will have the right to elect settlement in cash, shares, or any combination thereof in its sole discretion.

Additional information regarding this announcement may be found in a Current Report on Form 8-K that the Company intends to file today with the U.S. Securities and Exchange Commission.

J. Wood Capital Advisors LLC and Perella Weinberg Partners LP acted as financial advisors and J.P. Morgan acted as placement agent to Invitae on the transaction.

On April 5, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ) and TOA EIYO Ltd. (President: Atsuo Takahashi, Ph.D., "TOA EIYO") reported that the both companies have agreed to terminate the distribution agreement on March 31, 2022 (Press release, Astellas, APR 5, 2021, View Source [SID1234577557]). In accordance with this agreement, after April 1, 2022, TOA EIYO will independently sell and provide information on all 18 products such as Bisono tape, a transdermal patch of β1 blocker, for treatment of hypertension and atrial fibrillation and Frandol tablets and tape for treatment of ischemic heart disease, which TOA EIYO obtained Marketing Authorization in Japan, that are currently sold on consignment by Astellas.

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Astellas and TOA EIYO has collaborated for sales and marketing for a long time. Astellas currently sells most of the products which TOA EIYO obtained Marketing Authorization in Japan, and TOA EIYO provides their product information to medical institutions. The both companies have discussed and agreed to terminate the distribution agreement on March 31, 2022.

Astellas is continuously working on optimizing the allocation of management resouces in order to maximize the value of each product, and the termination of the distribution agreement is part of this effort. As a specialty pharmaceutical company in the field of cardiovascular medicine, TOA EIYO has decided that it is necessary to establish its own sales structure of products in order to meet the diverse needs of cardiovasculartreatment.

Astellas and TOA EIYO will work closely during the sales transfer process to ensure stable supply of the relevant products and a smooth continuation of activities, including the provision/collection of product information and the promotion of their proper use.