Nascent Biotech Continues to Reduce Liabilities by Over $2.0 Million Dollars

On October 1, 2020 Nascent Biotech, Inc. (OTCQB:NBIO) reported that It has continued to reduce its liabilities through stock conversion and payment of accounts payable and accrued liabilities (Press release, Nascent Biotech, OCT 1, 2020, View Source [SID1234567885]). The reduction was achieved through the conversion of debt to equity and the reduction of liabilities, including its last convertible note. The convertible note’s principal is now $11,250 down from $161,250, a reduction of $150,000.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Nascent’s CEO Sean Carrick states," The reduction of debt puts Nascent in a stronger position to move forward with the clinical trials which are to begin soon. Further liability management is a primarily objective of the Company."

Teneobio Announces US FDA Clearance of Investigational New Drug Application for TNB-486 and the Initiation of Phase I Clinical Studies in Patients with B-cell Malignancies

On October 1, 2020 Teneobio, Inc. and its affiliate TeneoTwo, Inc. reported that their investigational new drug application (IND) for TNB-486, a bispecific T-cell engaging antibody for the treatment of B-Cell Non-Hodgkin’s lymphoma (B-NHL) was cleared for the initiation of Phase I clinical studies by the US Food and Drug Administration (FDA) on September 30, 2020 (Press release, TeneoBio, OCT 1, 2020, View Source;utm_medium=rss&utm_campaign=teneobio-announces-us-fda-clearance-of-investigational-new-drug-application-for-tnb-486-and-the-initiation-of-phase-i-clinical-studies-in-patients-with-b-cell-malignancies [SID1234567881]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

TNB-486 is a fully human bispecific antibody that binds CD19 with one arm and incorporates a unique anti-CD3 on the other. In preclinical studies, TNB-486 induced T-cell dependent killing of CD19-positive B-cell leukemia and lymphoma cells while inducing minimal cytokine secretion, a feature that could limit immune mediated toxicities while retaining cytotoxic activity.

Benjamin Buelow, CMO of Teneobio, Inc., added, "We are excited to bring our differentiated T-cell engager therapy to relapsed and/or refractory lymphoma patients, for whom a safe and effective therapeutic option remains an unmet need. The unique anti-CD3 arm in Teneobio’s T-cell engagers uncouples toxic cytokine release from tumor cell killing and is designed to maximize the therapeutic window for this class of therapies. TNB-486 also has a predicted half-life of over two weeks that enables a patient- and provider-focused dosing schedule. An off-the-shelf CD19-targeted therapy with a convenient dosing regimen will be a tremendous boon to the fight against this terrible disease."

Bicycle Therapeutics Announces Gross Proceeds of $50.0 Million from its At-the-Market Offering Program and Enters into Debt Financing from Hercules Capital

On October 1, 2020 Bicycle Therapeutics plc (Nasdaq: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that it has completed its at-the-market (ATM) offering program initiated during the third quarter, generating gross proceeds of $50.0 million (Press release, Bicycle Therapeutics, OCT 1, 2020, View Source [SID1234567869]). Cantor Fitzgerald & Co. and Oppenheimer & Co. Inc. acted as placement agents for the offering.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In addition, Bicycle announced that it has closed a financing with Hercules Capital, Inc. (NYSE: HTGC) for a term loan of up to $40.0 million in two tranches. Under the terms of the loan and security agreement, an initial tranche of $30.0 million will be fully available at the loan closing, with a minimum draw of $15.0 million.

"I am pleased to announce the successful utilization of our ATM program and our flexible financing with Hercules, which have further strengthened our balance sheet as we prepare for multiple clinical catalysts in the coming year. Over the course of 2020, we have continued to execute on our financing strategy, generating approximately $120 million, over half of which was non-dilutive and the remainder was pursuant to our ATM program," said Lee Kalowski, President and Chief Financial Officer of Bicycle Therapeutics. "These financings allow us to continue progressing our three clinical programs, support clinical development of our lead immuno-oncology candidate BT7480, expected to start next year, and extend our cash runway well into the first half of 2023. We believe we have the financial resources to advance our clinical and pre-clinical oncology pipeline with the aim of potentially shifting the treatment paradigm for patients with cancer who have limited therapeutic options."

Bicycle plans to use the proceeds of the financings to advance its oncology pipeline of Bicycle Toxin Conjugates and immuno-oncology candidates through multiple clinical milestones expected in 2021, including interim updates from the ongoing Phase IIa trial of BT1718, Phase I/II trial of BT5528 and Phase I/II trial of BT8009, as well as the initiation of a Phase I/II trial of BT7480 and advancement of IND-enabling studies for BT7455.

The securities described above were offered by Bicycle pursuant to a shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (the "SEC"), which the SEC declared effective on June 15, 2020. A final prospectus supplement related to the offering was filed with the SEC and is available on the SEC’s website located at View Source Additional information about the debt facility with Hercules will be contained in a future Current Report on Form 8-K to be filed by the Company with the U.S. Securities and Exchange Commission.

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor may there be any sale of Bicycle’s common stock in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of any state or jurisdiction.

Kaleido Biosciences Appoints Daniel Menichella as President and Chief Executive Officer

On October 1, 2020 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a chemistry-driven approach to targeting the microbiome to treat disease and improve human health, reported that Daniel Menichella has been appointed President and Chief Executive Officer and a member of the company’s Board of Directors, effective October 13, 2020 (Press release, Kaleido Biosciences, OCT 1, 2020, View Source [SID1234567867]). Mr. Menichella succeeds Alison Lawton, who stepped down to attend to a family health matter but continued to work with the Company in the Office of the CEO alongside Executive Chair Mike Bonney.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"I’m excited to welcome Dan to Kaleido and am confident his extensive experience helping companies advance product candidates, execute meaningful business development partnerships, and build strong cultures will help Kaleido fulfill its great potential," said Mike Bonney. "I look forward to working closely with Dan to ensure a smooth transition as I return to my role as an active and involved Board Chair."

Mr. Menichella is an experienced Chief Executive Officer, having been hired as CEO of CureVac Inc.’s US subsidiary in January 2017 before taking over as CEO of the international company in June of 2018. Prior to that, Mr. Menichella was Chief Business Officer at several companies, including Bamboo Therapeutics from 2015-2016, Applied Genetic Technologies Corporation (AGTC) from 2013-2015 and Zyngenia, Inc. from 2011-2013. Mr. Menichella also led Business Development and Corporate Strategy functions at Talecris Biopharmaceuticals from 2007-2011 and at Merck KGaA from 2002-2007. He earned his Bachelor of Arts from Harvard University and his Master of Business Administration from the University of North Carolina at Chapel Hill.

"I am thrilled to join Kaleido at such an exciting time in its evolution," said Mr. Menichella. "With a strong product platform and multiple key milestones anticipated between now and the end of 2021, I look forward to continuing to build upon our leadership in the microbiome space and finding new ways to treat disease and improve human health."

"On behalf of the Board of Directors and employees of Kaleido, we want to recognize Alison’s meaningful contributions over her near three years leading the Company," said Mike Bonney. "Alison will be stepping down from the Board coincident with Dan’s start, and has agreed to be available to Dan for advice and counsel, as he moves into the CEO role."

About Microbiome Metabolic Therapies (MMT)

Kaleido’s Microbiome Metabolic Therapies, or MMTs, are designed to drive the function and distribution of the microbiome’s existing microbes in order to decrease or increase the production of metabolites, or to advantage or disadvantage certain bacteria in the microbiome community. The Company’s initial MMT candidates are targeted, synthetic glycans that are orally administered, have limited systemic exposure, and are selectively metabolized by enzymes in the microbiome. Kaleido utilizes its discovery and development platform to study MMTs in microbiome samples to rapidly advance MMT candidates rapidly into clinical studies in healthy subjects and patients. These human clinical studies are conducted under regulations supporting research with food, evaluating safety, tolerability and potential markers of effect. For MMT candidates that are further developed as therapeutics, the Company conducts clinical trials under an Investigational New Drug (IND) or regulatory equivalent outside the U.S., in Phase 2 or later development.

Replimune to Participate at the Chardan Virtual 4th Annual Genetic Medicines Conference

On October 1, 2020 Replimune Group Inc. (Nasdaq: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported that members of its senior management team will present in a fireside chat and host investor meetings at the Chardan Virtual 4th Annual Genetic Medicines Conference being held on October 6, 2020 at 4:45 p.m. ET (Press release, Replimune, OCT 1, 2020, View Source [SID1234567866]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!