On March 3, 2021 Herantis Pharma Plc ("Herantis"), an innovative clinical stage biotech company pioneering new disease modifying and regenerative biologic and gene therapies, reported its Full Year Report for January – December 2020. It is available on Herantis’ website (Financial information) (Press release, Herantis Pharma, MAR 3, 2021, View Source,c3300578 [SID1234577483]).

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"2020 was a fast-paced, purpose-driven, and transitional year for Herantis as we enter the next chapter of development for our fascinating science and innovative disease modifying treatments for patients suffering from debilitating neurological and lymphatic diseases. The year was notable for favorable data in our key programs, a new strategy for our Parkinson’s program, and significant funds raised.

For CDNF, a natural biological molecule, we were very pleased to announce data in August confirming the drug successfully achieved its primary endpoint of safety and tolerability in a First-in-Human Phase I-II study in Parkinson’s disease patients. This was a momentous achievement successfully taking the drug into human subjects. Going forward, we will focus on new routes of administration including nose-to-brain (nasal spray) and skin injection (subcutaneous). This strategy is expected to expand the target population to earlier stage patients, accelerate clinical development, and increase the attractiveness of our CDNF asset to partners.

For xCDNF, an engineered peptide using only the smallest most potent fragments of CDNF, we generated impressive data confirming the potency of the compound plus its ability to cross the blood brain barrier to reach the brain tissue, both of which are critical elements for the success for this therapy. Importantly, as with the new CDNF administration routes above, xCDNF is administered via a simple skin injection without the need for surgery.

It is exciting to have two such compelling assets in our portfolio, and we very much look forward to developing these two programs with their respective merits.

For Lymfactin, our gene therapy product, we were very pleased to announce in November favorable 24-month follow-up review from Phase I Lymfactin trial in Breast Cancer Related Lymphedema (BCRL). Post the FY 2020 financial reporting period, results from Phase II study with Lymfactin in BCRL have been announced separately 2nd March.

We raised a total of approximately EUR 15 million during 2020 with two direct share issues in May and December. 2020 has been a year of considerable progress for Herantis, and we enter 2021 with an optimised foundation, solid business fundamentals, and exciting milestones planned for the year ahead. I am very proud of the accomplishments and the significant advancements Herantis has made this past year to shape its future."

On March 3, 2021 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS), reported that the Company has entered into amended and restated credit facilities in the aggregate principal amount of $175 million, consisting of a $150 million term loan, which includes a cashless conversion of $25 million in existing term loans, and a $25 million revolving credit facility (Press release, Radius, MAR 3, 2021, View Source [SID1234576152]). The amended and restated credit facilities also provide for an additional $25 million term loan at the lenders’ discretion. The transaction represents a significant upsize from the Company’s prior senior $95 million loan facilities, which consisted of a $55 million term loan ($25 million of which had been drawn) and a $20 million revolving credit facility that also included an additional $20 million of potential incremental availability. The amended and restated loan is expected to close on or about March 11.

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Jim Chopas, the Company’s Principal Finance and Accounting Officer said "this transaction demonstrates the Company’s improved financial strength and ability to access the debt capital markets on what we see as favorable terms to fund its corporate objectives. We expect the increase in cash interest expense to be absorbed by the Company’s cash flow."

Proceeds from the transaction are expected to be used in the following three ways:

Repurchase $112.2 million of aggregate principal amount of the Company’s existing 3.00% Convertible Senior Notes due September 1, 2024
Rollover the existing $25 million term loan into the new loan
Add $14.2 million of cash to the balance sheet, increasing liquidity as of 12/31/2020 on a pro forma basis from $114.7 million to $128.9 million, subject to change based on adjustments to the aggregate repurchase price of the 2024 Notes over the VWAP Period
The expected aggregate repurchase price of the 2024 Notes is $105.7 million, inclusive of accrued interest, which represents a discount of 6% to face value and convertible debt cancellation of $6.7 million. The aggregate repurchase price is subject to adjustment based in part on the daily volume-weighted average prices per share of the Company’s common stock during a ten-trading day pricing period ("VWAP Period") following execution of the Repurchase Agreements. As a result of the transaction, the Company’s annual cash interest expense will increase by approximately $6.3 million, driven by the higher term loan interest rate relative to the 2024 Notes.

The 2024 Notes repurchase is expected to close on March 18, 2021, subject to customary closing conditions.

J. Wood Capital Advisors LLC was the exclusive advisor to Radius in the financing transaction and in the repurchase of the 2024 Notes.

TRANSACTION OVERVIEW AND RATIONALE

Balance Sheet

Eliminates approximately 2.3 million shares of potential future dilution upon conversion of the notes
Reduces the risk of a convertible note reissuance at a lower strike price to extend the maturity
Provides an additional $14.2 million of liquidity to the balance sheet, subject to change based on adjustments to the aggregate repurchase price of the 2024 Notes over the VWAP Period
Demonstrates access to the secured debt market at scale and at a manageable cost
Creates a tranche of prepayable debt that allows the company to reduce debt ahead of stated maturities in 2024
Pro forma, Radius will have $150 million of prepayable debt and $192.8 million of non-prepayable debt
Initial step in optimizing the Company’s capital structure and balance sheet in the intermediate term
Income Statement and Cash Flow

Incremental cash interest expense from the transaction is approximately $6.3 million on an annual basis and is expected to be manageable given the Company’s anticipated improvement in cash flow
Radius reaffirms 2021 financial guidance of generating $10 million of positive EBITDA
The Company views the increased interest expense as modest relative to the benefits of the transaction
Peter Schwartzman, the Company’s Capital and Strategy Officer, added "the financing demonstrates the Company’s dedication to strategic management of its capital structure. This transaction reduces future potential equity dilution, adds incremental liquidity, and represents an initial phase of a long-term balance sheet strategy to enhance both operating and financing flexibility." Mr. Schwartzman continued, "the completion of the transaction is a significant advancement of the Company’s financial position, which will enable Radius to achieve both short and intermediate term objectives. We would like to thank MidCap and its partners for their participation and for enabling this transaction."

Source: 2020 10-K and financing documents
1 Subject to change based on adjustments to the aggregate repurchase price of the 2024 Notes over the VWAP Period
2 Face value, refer to notes in 10-K

ABOUT THE TRANSACTION

The Company and certain of its subsidiaries (the "Borrowers") amended and restated its existing senior secured facilities ("Facilities") with MidCap Financial and MidCap Funding IV Trust, as agents under the term loan credit agreement and revolving loan credit agreement, respectively, and the lenders thereunder.

The term loan credit agreement provides for, among other things:

An initial term loan of $150 million, including the cashless conversion of $25 million in existing term loans (the "Initial Term Loan")
An additional $25 million term loan, which the lenders may make available in their discretion within one year of the closing of the Initial Term Loan
Interest at a rate of LIBOR plus 5.75%, subject to a 2.00% LIBOR floor
The amended and restated revolving loan agreement provides for, among other things:

A revolving credit facility of up to $25 million, made available based on a borrowing base calculated based on percentages of
the net collectable value of certain of the Borrowers’ domestic accounts receivable, and
domestic eligible inventory,
minus certain reserves
Interest at a rate of LIBOR plus 3.50%, subject to a 2.00% LIBOR floor
The Facilities have a maturity date of June 1, 2024. They are guaranteed and secured by substantially all of the assets of the Borrowers and any future subsidiaries of the Borrowers that become borrowers or guarantors under the Facilities, subject to certain exceptions. The Borrowers may be required to make mandatory prepayments prior to maturity under certain circumstances.

The foregoing description of the amended and restated credit agreements and facilities is qualified in its entirety by reference to the full text of the Credit Agreements, which will be filed as exhibits to our corresponding Current Report on Form 8-K, to be filed within four business days of the date hereof.

On March 3, 2021 Bio-Techne Corporation (NASDAQ: TECH), a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities, reported it has reached an agreement to acquire Asuragen, Inc. for initial consideration of $215 million in cash plus contingent consideration of up to $105 million upon the achievement of certain future milestones (Press release, Bio-Techne, MAR 3, 2021, View Source [SID1234576105]). The transaction will be financed through a combination of cash on hand and an existing revolving line of credit. Bio-Techne anticipates the acquisition to close in the fourth quarter of its fiscal 2021.

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Founded in 2006, Asuragen is headquartered in Austin, Texas and is a leader in the development, manufacturing and commercialization of genetic carrier screening and oncology testing kits. Asuragen’s products leverage proprietary chemistries which can be used on widely available platforms including, PCR, qPCR, capillary electrophoresis, and next-generation sequencing instruments. This platform agnostic approach enables its clinical laboratory customers to solve complex molecular diagnostic challenges and empowers hospital and regional labs to expand in-house testing capabilities, furthering the decentralization of the molecular diagnostics market, enabling quicker turn-around times and ultimately delivering better patient care. Asuragen’s headquarters includes a scalable, Good Manufacturing Practice (GMP)-compliant 50,000 square foot manufacturing facility as well as a CLIA-certified laboratory. In 2020, Asuragen generated greater than $30 million in revenue globally and its Chief Executive Officer, Matt McManus, will join the Bio-Techne team to continue to lead the legacy Asuragen business as well as the integration process.

Asuragen brings a leading portfolio of best-in-class molecular diagnostic and research products, including its FDA-cleared AmplideX Fragile X Diagnostic and Carrier Screening kit for the screening of prospective parents as potential carriers of Fragile X chromosomal abnormalities as well as its Quantitidex qPCR IS BCR-ABL kit to enable the monitoring of leukemia patients for minimal residual disease. In addition to its existing portfolio of innovative and enabling technologies, Asuragen’s pipeline includes expanded carrier screening panels for various pathologies recognized by The American College of Obstetricians and Gynecologists (ACOG) as areas of concern for prospective new parents. Bio-Techne sees multiple growth synergies following the closing of the transaction, including Asuragen’s capabilities and proven track record in productizing lab-developed tests and commercializing innovative molecular products for broader market adoption.

"Asuragen is very complimentary with Bio-Techne’s existing diagnostics franchise and the addition of this business is expected to drive growth synergies throughout the expanded portfolio," said Chuck Kummeth, President and Chief Executive Officer of Bio-Techne. "We are not only acquiring a financially strong and scalable business, building our diagnostic portfolio and expanding our bandwidth with an additional CLIA-certified and GMP compliant laboratory, but are also adding a team with deep expertise in the intricacies of the global regulatory environment and a proven track record of opening new market channels. This critical mass will be very beneficial to the Genomics and Diagnostics Segment as we commercialize our pipeline of liquid biopsy tests through our Exosome Diagnostics business and also opens the possibility of approaching the market with kitted versions of these products. We anticipate continued traction with Asuragen’s leading portfolio of molecular diagnostic kits for both clinical and research uses and see significant potential in its pipeline of expanded carrier screening panels. Asuragen is a great addition to the Bio-Techne team."

"The Asuragen team is extremely excited to be joining Bio-Techne at this point in our growth trajectory," said Matt McManus, Chief Executive Officer of Asuragen. "Bio-Techne’s global presence, reputation and relationships within the clinical diagnostic and research communities will enable Asuragen to broaden our reach and accelerate penetration into the high-growth molecular diagnostic markets addressed by our portfolio. I am honored to continue to lead the Asuragen team as a part of Bio-Techne. I would like to thank all of the great people of Asuragen for their committed efforts growing our company to this point and am looking forward to the next stage of growth under the Bio-Techne umbrella."

Fredrickson & Byron, P.A. is serving as Bio-Techne’s legal counsel. Perella Weinberg Partners LP is the financial advisor and Vinson & Elkins LLP is serving as legal counsel to Asuragen.

On March 3, 2021 Vaxalto Biotherapeutics, Inc. (www.vaxalto.com), a pre-clinical stage biotechnology company focused on developing and commercializing novel engineered immunotherapeutic oncolytic viruses, and Mount Sinai Innovation Partners (MSIP), part of the Icahn School of Medicine at Mount Sinai, reported that they have partnered to develop novel cancer immunotherapies (Press release, Vaxalto Biotherapeutics, MAR 3, 2021, View Source [SID1234576057]). Mount Sinai has granted an exclusive, worldwide license to Vaxalto covering intellectual property and technology related to an avian paramyxovirus (APMV) oncolytic virus platform and novel immuno-modulator targeting the lymphatic system. This technology forms the core of Vaxalto’s proprietary, multimodal therapeutic approach utilizing direct destruction of cancer cells, vascular and immune system activation.

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"We are delighted to be partnering with Mount Sinai to develop our novel viral immunotherapy, which eliminates tumors following intra-tumoral administration and leads to long-term protection from cancer recurrence based on animal studies," said Dr. Mihaela Skobe, Vaxalto co-founder and Director, Laboratory for Metastasis and Lymphatic Research, Department of Oncological Sciences at Mount Sinai.

Skobe is joined by Dr. Peter Palese and Dr. Adolfo Garcia-Sastre, also from the Icahn School of Medicine at Mount Sinai, to form Vaxalto’s scientific leadership team.

"We look forward to this collaboration between Mount Sinai and Vaxalto, in an effort to advance potential breakthrough therapies using a novel approach to treating a range of cancers," said Dr. Erik Lium, President, Mount Sinai Innovation Partners and Executive Vice President and Chief Commercial Innovation Officer, Mount Sinai Health System

On March 3, 2021 Oblato, Inc. (the Company), a wholly owned U.S. subsidiary of the Korean biotech company GtreeBNT Co., Ltd.,reported that the FDA granted Fast Track Designation of OKN-007, the proprietary drug for Diffuse Intrinsic Pontine Glioma (DIPG) (Press release, Oblato, MAR 3, 2021, View Source [SID1234576047]).

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The FDA Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

With the Fast Track Designation of OKN-007 for the treatment of DIPG, Oblato is eligible for Accelerated Approval and Priority Review and for Rolling Review that allows the Company to submit completed sections of its New Drug Application (NDA) for review by FDA before the entire application can be reviewed. The Company expects that the period of the regulatory approval process will be reduced.

DIPG is a rare pediatric brainstem cancer with limited treatment options. After a DIPG diagnosis, ninety percent of the patients die within 24 months, and the overall 5-year survival is less than one percent.

In addition to the Fast Track Designation, Oblato has already received Rare Pediatric Disease designation for DIPG. The Company is eligible for a rare pediatric disease priority review voucher from the FDA that can be redeemed for a priority review of a marketing application of a different product and is transferrable, when the Company receives NDA approval.

"We anticipate that the Fast Track Designation for DIPG will shorten the NDA review process. The Company will make every effort to develop this treatment for this rare pediatric disease," stated an official from the Company.