SOPHIA GENETICS RAISES $110 MILLION IN OVERSUBSCRIBED NEW FUNDING ROUND

On October 1, 2020 SOPHiA GENETICS, global leader in Data-Driven Medicine, reported the closing of a $110 million financing round to enter into the next stage of its expansion, with a focus on supporting the growing clinical and biopharma demand for Data-Driven Medicine worldwide (Press release, Sophia Genetics, OCT 1, 2020, View Source [SID1234567888]).

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This Series F round was led by aMoon, a leading health-tech & life sciences venture fund based in Israel, and Hitachi Ventures, a venture arm of Japanese Hitachi Group. The company also received the trust of prime financial institutions Credit Suisse and the Pictet group. Existing investors Swisscom Ventures, Endeavour Vision, Generation Investment Management, Alychlo, and Eurazeo Growth participated in the round, as well as newcomers ACE & Company and Famille C Invest.

Having established the world’s largest Data-Driven Medicine community network through its universal and collaborative AI platform, SOPHiA GENETICS supports healthcare professionals by translating multiple sources of complex medical data into valuable clinical insights. The SOPHiA Platform is used by over 1’000 healthcare institutions and has analyzed 600’000 genomic profiles; up to 17’000 new profiles a month. Through continual learning and network effects, experts worldwide are empowered to act with confidence for better patient management.

The new funding round will boost the company’s penetration in both the US and Asian markets. Proceeds will also be dedicated to increasing the platform multimodal capabilities and its adoption by healthcare institutions worldwide. Leveraging this momentum, SOPHiA GENETICS will be best positioned to power biopharma’s effort to optimize and accelerate the development of new targeted therapies.

As SOPHiA enters this new phase of rapid expansion, Didier Hirsch, former CFO at Agilent, joins the company’s Board of Directors. He will also chair the company’s Audit Committee, ushering SOPHiA GENETICS toward its next important milestones.

"The overall demand for Data-Driven Medicine is rapidly growing, and the next step is to successfully combine multiple sources of data to better address clinicians’ needs," said Dr. Tomer Berkovitz, Partner & CFO of aMoon. "With this shift, more complex data will be generated, and we believe that SOPHIA’s decentralized model will play a pivotal role in empowering health organizations to offer better patient care".

Keiji Kojima, Executive Vice President and General Manager of Hitachi’s Smart Life Business Division, added: "Over the years, SOPHiA GENETICS has emerged as a leader in Data-Driven Medicine and we look forward to supporting the company expand its footprint in the Japanese market and beyond."

"SOPHiA has established an impressive track record of disrupting healthcare and enabling a decentralized approach. This new funding round will further strengthen SOPHiA’s already unique offering, performance, and life-changing impact on patients and targeted therapies," said Troy Cox, Chairman of the Board of Directors of SOPHiA GENETICS.

"Since inception, we knew that leveraging a wide range of data modalities powered by cutting-edge technologies was key to sustainably deliver better outcomes to the global healthcare community", concluded Jurgi Camblong, CEO and Founder at SOPHiA GENETICS. "Now, with this new funding round, we can embark on the next stage of our development and take our collaborative approach further, delivering intelligent medicine, together."

Covis Group Announces Agreement to Acquire AMAG Pharmaceuticals

On October 1, 2020 Covis Group S.à r.l. ("Covis") and AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) reported that they have entered into a definitive agreement under which Covis will acquire AMAG for $13.75 per share in cash, or approximately $498 million on a fully diluted basis and approximately $647 million on an enterprise basis, including debt obligations expected to be assumed or repaid net of cash (Press release, AMAG Pharmaceuticals, OCT 1, 2020, View Source [SID1234567886]). The offer represents a premium of approximately 46% to the closing price of AMAG’s common stock on September 30, the last full trading day prior to the announcement.

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Commenting on the transaction, Covis CEO Michael Porter said, "AMAG’s category leading treatments are strong strategic complements to our existing therapeutic portfolio. Through this combination, we believe we will be able to unlock value for all of our stakeholders, employees and patients through the effective and efficient management of these products, coupled with our two companies’ longstanding commitment to expanding patient access to therapy and putting patient interests first. At Covis, we never lose sight that our patients are our paramount concern. We look forward to engaging with the talented team at AMAG as we work together to plan the integration of our two organizations."

AMAG CEO Scott Myers added, "In the beginning of 2020, AMAG announced that the company had undertaken a strategic review of our product portfolio and strategy, the guiding principles of which included driving near- and long-term profitability and enhancing shareholder value. This strategic review resulted in the company pursuing and accomplishing the divestiture of its women’s health assets, and other efforts to streamline and strengthen the core business to position AMAG for the future. Following this initial transformation, our Board of Directors and management team, together with independent legal and financial advisors, thoroughly evaluated the transaction with Covis as well as other strategic options and concluded that it represents the most compelling opportunity for shareholders, providing them certain and immediate cash value. We believe Covis is the right partner for AMAG, especially in light of Covis’ shared commitment to ensuring that our therapies will reach patients in need. We are confident the work we’ve done will continue to thrive under Covis’ leadership."

The completion of the tender offer is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of AMAG’s common stock, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other customary conditions. Following the successful completion of the tender offer, an indirect, wholly owned subsidiary of Covis will merge with AMAG (the "merger") and the outstanding AMAG shares not tendered in the tender offer will be converted into the right to receive the same $13.75 per share in cash paid in the tender offer. The tender offer is expected to commence in October 2020. Covis plans to finance the transaction with cash on hand, and a combination of committed debt and equity financing. There is no financing condition to the obligations of Covis to consummate the transaction.

As part of the transaction, Covis intends to enter into an amended and restated credit facility with its current lenders (the "Lenders"), pursuant to which the Lenders will provide up to a $460 million senior secured incremental term loan and a $55 million secured revolver (the "Covis Debt Financing"). The proceeds from the Covis Debt Financing, plus equity commitments from Covis’ equity sponsor, will be used to pay the cash purchase price for the transaction and repay any of the existing AMAG debt that is not assumed. The Covis Debt Financing amount will be added to Covis’ current $450 million term loan facility with the Lenders. As the merger will result in a change of control under the terms of AMAG’s Indenture governing its 3.25% Convertible Senior Unsecured Notes Due 2022 (the "Convertible Notes"), the holders of the Convertible Notes will have the right to put at par the Convertible Notes held by them for a period of twenty business days following the closing of the merger.

All Board members and executive officers of AMAG have agreed to tender their shares in favor of the transaction. The transaction, which has been unanimously approved by the Board of Directors of each company, is expected to close in November 2020, pending Hart-Scott-Rodino (HSR) approval and the conditions to the tender offer being satisfied.

Goldman Sachs & Co. LLC is acting as exclusive financial advisor, and Goodwin Procter LLP is acting as legal advisor to AMAG. Paul, Weiss, Rifkind, Wharton and Garrison LLP is acting as legal advisor to Covis.

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.

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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]).

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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.

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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.