On April 26, 2021 NanOlogy, LLC, a clinical-stage interventional oncology drug therapy company, reported the first patient has been enrolled in a clinical trial of intratumoral (IT) NanoPac(large surface area microparticle [LSAM] paclitaxel) for suspension via endobronchial ultrasound-guided transbronchial needle injection (EBUS-TBNI) in lung cancer (Press release, NanOlogy, APR 26, 2021, View Source [SID1234578482]). A second patient is scheduled for enrollment in early May.

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The trial will evaluate safety and preliminary efficacy of up to 3 monthly IT injections of NanoPac in patients with primary or recurrent nonoperable lung cancer. Tissue and blood will be collected pre/post NanoPac administration to analyze pharmacokinetics (PK) and immune effect by multiplex immunofluorescence and flow cytometry analysis. Preclinical and clinical data indicate the long tumor residence and therapeutic drug release of several weeks enabled by LSAMs result in prolonged direct tumor cell death and favorable immunogenic effect. Notably, NanOlogy has demonstrated both clinically after administration of its investigational drugs in patients with locally advanced pancreatic cancer and high risk nonmuscle invasive bladder cancer. The current trial expects to enroll patients on immune checkpoint inhibitors (ICIs) like Keytruda, Opdivo, or Tecentriq, which will allow for assessment of immune effect of NanoPac in combination with ICIs.

Six INDs have been established for NanOlogy investigational drugs allowing clinical trials via multiple routes of solid tumor-directed administration in patients with pancreatic, prostate, ovarian, peritoneal, bladder, and lung cancer. More than 145 patients have been administered NanOlogy drugs with no confirmed drug-related severe adverse events because of gradual, subtoxic clearance of drug from site of administration as demonstrated by clinical PK analysis.

Please visit the NanOlogy website (www.nanology.us) for more information on the company and its programs.

On April 26, 2021 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology company pioneering the development of monoclonal antibodies targeting treatment of various cancers and viral infections, reported that It has paid off and eliminated a major convertible debt note, pre-emptively preventing a dilutive conversion (Press release, Nascent Biotech, APR 26, 2021, View Source [SID1234578481]).

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The note, which was held by JSJ Investments, LLC ("JSJ"), represented over $186k in debt carried pre-conversion on the Company’s balance sheet. Under the terms associated with the note, JSJ had the right to convert the value of the note into common shares at a substantial discount to current average trading levels in NBIO shares, which would have represented a significant dilutive event.

Instead, to prevent such an event and to reinforce its commitment to preserving shareholder value, the Company has paid off the full value of the note.

Nascent’s CEO Sean Carrick stated, "We value our shareholders and our reputation as a shareholder friendly Company above all else. We have our sights set on some very big long-term objectives. And we won’t get there by working against the interests of our common equity holders. Paying off this JSJ note reduces uncertainty and lightens the balance sheet. We look forward to identifying other opportunities to defend our shareholders’ interests and avoid unnecessary dilution in financing our progress as we move toward full commercialization of monoclonal antibody solutions in the cancer and viral treatment markets."

On April 26, 2021 MannKind Corporation (Nasdaq: MNKD) reported that on April 22, 2021 it and MidCap Financial Trust, as agent, entered into an amendment of the credit and security agreement dated August 6, 2019 (the "MidCap Credit Facility") (Press release, Mannkind, APR 26, 2021, View Source [SID1234578480]). In addition, MannKind and Mann Group, LLC entered into an amendment of the terms of the Mann Group convertible note and repaid in full outstanding amounts under the Mann Group non-convertible note on April 22, 2021. In connection with these transactions, MannKind reduced its outstanding amount of indebtedness, yet retained flexibility to borrow additional amounts under tranche 3 of the MidCap Credit Facility, which is available to borrow until June 30, 2022, subject to the satisfaction of certain milestone conditions associated with Tyvaso DPI.

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The MidCap Credit Facility was amended to modify several terms, including: (i) increasing the funds available in tranche 3, if drawn by the Company, from $25.0 million to $60.0 million; (ii) revising the conditions to drawing tranche 3, including milestone conditions associated with Tyvaso DPI; (iii) providing for an exit fee of $1.0 million in connection with the prepayment described below in lieu of the existing prepayment penalty and exit fees; (iv) removing the requirement to issue a warrant to purchase shares of MannKind’s common stock upon the drawdown of tranche 3; (v) decreasing the interest rate on the remaining outstanding debt; (vi) extending the interest-only period and maturity of term loans under the MidCap Credit Facility; (vii) reducing the minimum cash covenant from $30.0 million to $10.0 million, effective immediately, and eliminating such covenant in the event that Tyvaso DPI is approved by the FDA; (viii) eliminating the requirement to test compliance with the minimum Afrezza net revenue covenant so long as the Company has $90.0 million or more of unrestricted cash; (ix) permitting the Company to make certain acquisitions subject to certain conditions; and (x) permitting the Company to make investments of up to an additional $9.0 million so long as the Company has $90.0 million or more of unrestricted cash following such investment. In connection with the amendment of the MidCap Credit Facility, MannKind prepaid $10.0 million in cash to reduce the principal balance under the MidCap Credit Facility from $50.0 million to $40.0 million.

The Mann Group convertible note was amended to lower the interest rate to 2.5% (from 7.0%), effective April 22, 2021, and to extend the maturity to December 2025 (from November 2024). In addition, MannKind repaid the entire principal amount of $35.1 million outstanding, together with accrued and unpaid interest thereon, under the Mann Group non-convertible note and paid all accrued and unpaid interest outstanding under the Mann Group convertible note.

MannKind also announced that it is evaluating the considerations underlying a potential sale-leaseback of its manufacturing facility in Connecticut, which is being negotiated under a previously announced letter of intent. The Company will update investors regarding its plans for the facility at a future date.

MannKind’s Chief Financial Officer, Steven B. Binder commented, "Starting with the convertible debt offering in March and ending with these debt reductions and restructurings, we have positioned the Company with ample cash and a manageable debt load to fund our near-term priorities, enabling us to focus on the development of our product pipeline, investing behind growing Afrezza and supporting our collaborations."

Further details about both transactions will be provided in a Current Report on Form 8-K filed with the Security and Exchange Commission.

TYVASO DPI is a trademark of United Therapeutics Corporation.

On April 26, 2021 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS) and Boston Pharmaceuticals reported that the companies have entered into an exclusive product license agreement to develop PRS-342, a 4-1BB/GPC3 preclinical immuno-oncology Anticalin-antibody bispecific fusion protein (Press release, Pieris Pharmaceuticals, APR 26, 2021, View Source [SID1234578470]). Under the terms of the agreement, Boston Pharmaceuticals has exclusively licensed worldwide rights to PRS-342. Pieris will receive an upfront payment of $10 million and is further entitled to receive up to approximately $353 million in development, regulatory, and sales-based milestone payments, and tiered royalties on sales of PRS-342. Pieris will also contribute an undisclosed amount toward manufacturing activities.

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"Based on the encouraging preclinical data from PRS-342, as well as data demonstrative of the 4-1BB mechanism of action we have seen from Pieris’ other immuno-oncology programs, we are excited to have the opportunity on a global scale to progress this program into clinical development in areas of significant unmet need," said Robert Armstrong, Chief Executive Officer of Boston Pharmaceuticals. "We look forward to working with Pieris, benefiting from both their strong early-stage development expertise and their deep understanding of immuno-oncology bispecifics."

"Our recent presentations at AACR (Free AACR Whitepaper) for our HER2- and PD-L1-targeting 4-1BB bispecifics demonstrate the potency of our costimulatory approach, especially our bispecific antibodies’ ability to achieve clinical benefit, including in patients who have failed checkpoint therapy. It is therefore rewarding to see another one of our 4-1BB-based Anticalin bispecifics for immuno-oncology moving towards the clinic," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "Boston Pharmaceuticals has a strong leadership team and proven track record of developing a broad range of assets, including in oncology, and we look forward to the advancement of this next-generation bispecific and to directly supporting some crucial next steps towards clinical initiation."

On April 26, 2021 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported that Brian M. Culley, Chief Executive Officer, will be presenting at the B. Riley Securities’ Neuroscience Conference in a virtual fireside chat hosted by B. Riley Equity Research on Wednesday, April 28, 2021 at 1:30 p.m. ET (Press release, Lineage Cell Therapeutics, APR 26, 2021, View Source [SID1234578469]).

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Interested investors can access the live and archived webcast on the Events and Presentations section of Lineage’s website. Additional videos are available on the Media page of the Lineage website.