On February 23, 2021 AbbVie and Caribou Biosciences, Inc reported that the companies have entered into a collaboration and license agreement for the research and development of chimeric antigen receptor (CAR) T-cell therapeutics (Press release, Caribou Biosciences, FEB 23, 2021, View Source [SID1234575782]).

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The terms of the multi-year agreement will allow AbbVie to utilize Caribou’s next-generation Cas12a clusters of regularly interspaced short palindromic repeats (CRISPR) hybrid RNA-DNA (chRDNA) genome editing and cell therapy technologies to research and develop 2 new CAR T-cell therapies. AbbVie will be given exclusive rights to Cas12a for the targets of their choosing. Caribou will perform certain pre-clinical research, development, and manufacturing activities for the collaboration programs, while AbbVie will handle development, commercialization, and other manufacturing efforts.1,2

A $40 million upfront cash payment and equity investment will be directed to Caribou, as well as up to $300 million in future development, regulatory, and launch milestones. Additionally, there will be the potential for Caribou to receive additional payments for commercial milestones and global tiered royalties. AbbVie has the option to expand the collaboration to include an additional 2 CAR T -cell therapies for a fee.1

"Caribou’s next-generation CRISPR genome editing technologies hold broad promise for new therapy development," Rachel Haurwitz, PhD, president and CEO of Caribou said in an interview with OncLive. "A partnership with AbbVie allows Caribou to increase the number of targets and diseases addressable by these technologies. It’s an important opportunity to expand upon what we hope to do for patients. The collaboration is also an important validation of Caribou’s differentiated next-generation CRISPR genome editing technologies."

CRISPR gene editing technology utilizes modular, biological tools to induce DNA changes in living cells. The 2 basic components of CRISPR systems are the nuclease proteins and the RNA molecules. The nuclease proteins cut DNA while the RNA molecules guide the nuclease to generate a site-specific, double-stranded break, which result in editing at the targeted genomic site. CRISPR systems are differentiated by the presence of a class 1 multiprotein effector complex or a class 2 single effector protein.2,3

CRISPR systems have been shown to achieve several different types of genetic modifications in different types of cells. CRISPR techniques have achieved recombination, engineered immunity, mutagenesis, and donor-mediated gene disruption in bacteria, yeast, and filamentous fungi cells. The technique has also been used to achieve RNA-guided gene editing in multiple human cell lines with high specify and efficiencies of up to approximately 50%.3,4

CRISPR systems can sometimes unintentionally edit certain genomic sites, leading to harmful effects on cellular function. Caribou’s chRDNAs are highly specific RNA-DNA hybrid guides that are used in combination with CRISPR to direct more precise genome editing.2

"Caribou utilizes CRISPR hybrid RNA-DNA guides that contain both DNA and RNA nucleotides," Haurwitz explained. "These hybrid guides drive much more specific genome editing than all RNA guides. Caribou uses chRDNA guides in concert with a CRISPR enzyme to develop complex immune cell therapies."

By using CRISPR technology to engineer CAR T-cells to withstand host immune attack, Caribou hopes to develop "off-the-shelf" cellular therapies aimed at benefitting a broad patient population. The company is currently focusing on genome-edited off-the-shelf allogenic CAR T-cell and natural killer cell therapies for the treatment of patients with intractable malignancies.5

Current programs in the discovery phase include CB-011 and CB-012 which use T cells to target BCMA and CD371 for patients with hematologic malignancies, respectively. Another product, CB-020, focuses on using natural killer cells therapies for an undisclosed target for patients with solid tumors. The CB-010 program, currently in phase 1 exploration, uses T cells to target CD19 and for patients with relapsed/refractory B-cell non-Hodgkin lymphoma.5

"I am excited about the opportunity for our companies to collaboratively develop 2 additional CAR T- [cell products], expanding upon the total number of therapies Caribou’s technologies underpin," Haurwitz concluded.

On February 23, 2021 XOMA Corporation (NASDAQ: XOMA) reported its Chief Executive Officer, Jim Neal, will present at the following upcoming investor conferences (Press release, Xoma, FEB 23, 2021, View Source [SID1234575745]):

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The Cowen 41st Annual Virtual Health Care Conference. Mr. Neal will be featured in a panel session entitled, "Blazing New Paths in Clinical Development and Structure" on Tuesday, March 2, 2021 at 2:10 PM ET. The session will be available via live webcast to conference attendees.
H.C. Wainwright Global Life Science s Conference. The presentation will be available on demand beginning March 9, 2021 at 7:00 AM ET and can be accessed at http://bit.ly/3k8O9yj. The presentation can also be accessed by visiting the investor relations section of the Company’s website at www.xoma.com. A replay of the presentation will be available and archived on the site for 90 days after the event.

On February 23, 2021 Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) ("Biofrontera" or the "Company"), an international biopharmaceutical company, reported the pricing of a U.S. underwritten public offering of 1,334,002 American Depositary Shares, or ADSs, at an offering price of $6.68 per ADS (Press release, Biofrontera, FEB 23, 2021, View Source [SID1234575548]). Each ADS represents two of Biofrontera’s ordinary shares, nominal value €1.00 per share.

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The Company expects to receive aggregate gross proceeds of approximately $8.9 million from this offering, before deducting underwriting discounts, commissions and other related expenses. The offering is expected to close on or about February 26, 2021, subject to completion of the capital increase, which has to be recorded in the commercial register of the Company.

This offer is part of a concurrent preemptive rights offering by Biofrontera of its ordinary shares pursuant to German law to its existing holders of ordinary shares, under which Biofrontera offers a total of 8,969,870 ordinary shares at an offering price of €2.75 per share (or approximately $3.34 per share, representing the same per share price as the one used in the ADS offering).

Proceeds from these offerings will be used to conduct clinical studies aimed at improving the market positioning of Biofrontera’s lead product Ameluz, in particular to seek FDA or other applicable regulatory approval for the extension of the indications in the United States to basal cell carcinoma, acne and actinic keratoses on body areas other than the face and scalp, as well as to complete the development of a larger BF-RhodoLED lamp, invest in the procurement of the necessary materials for it and to seek any FDA or other regulatory approvals required to launch the new lamp, and for general corporate purposes.

The Benchmark Company, LLC is acting as the managing underwriter with Lake Street Capital Markets acting as co-manager and as the "qualified independent underwriter" in connection with this offering.

A registration statement on Form F-3 relating to this U.S. offering has been filed with, and declared effective by, the Securities and Exchange Commission ("SEC"). The U.S. offering of these securities is being made only by means of a prospectus supplement, forming a part of the effective registration statement and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement relating to the U.S. offering, when available, may be obtained from Biofrontera, with an address of Hemmelrather Weg 201, D-51377, Leverkusen, Germany Telephone: +011 49 214 876 00, emailing: [email protected]. In addition, the registration statement, including the prospectus supplement, is available to the public at www.sec.gov or www.biofrontera.com. In addition, you may contact The Benchmark Company by calling 212-312-6700 or [email protected].

McGuireWoods LLP is acting as U.S. legal counsel to Biofrontera.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, the securities described above, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to their registration or qualification under the securities laws of any such state or jurisdiction.

On February 23, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported the signing of a license agreement with Luminary Therapeutics for the use of TcBuster for the manufacturing of gene-modified cell therapies (Press release, Bio-Techne, FEB 23, 2021, View Source [SID1234575503]). TcBuster is Bio-Techne’s proprietary non-viral transposon-based gene delivery system used to advance cell therapy manufacturing.

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Under the terms of this agreement, Bio-Techne grants Luminary Therapeutics a non-exclusive license for TcBuster. Luminary Therapeutics will use TcBuster in their LMY-920 program, a BAFF-CAR-T product. Luminary Therapeutics plans to file an IND with the FDA later this calendar year.

"This agreement with Luminary Therapeutics brings Bio-Techne’s cutting-edge TcBuster system one step closer to delivering gene-modified cell therapies," said Dave Eansor, President of Bio-Techne’s Protein Sciences Segment. "With this license agreement, Bio-Techne will increase its presence as a key player in the cell and gene therapy market."

"The use of TcBuster during the manufacturing process provides significant benefits over the current viral approaches allowing for delivery of larger cargo with safe integration profiles," said John Hurley, Luminary Therapeutics’ COO. "We are excited to utilize GMP grade TcBuster reagents to provide our patients with a cutting-edge next generation CAR-T therapy."

On February 23, 2021 Medtronic plc (NYSE:MDT) reported financial results for its third quarter of fiscal year 2021, which ended January 29, 2021 (Press release, Medtronic, FEB 23, 2021, View Source [SID1234575499]).

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The company reported third quarter worldwide revenue of $7.775 billion, an increase of 0.8 percent as reported and a decrease of 1.0 percent on an organic basis, which adjusts for the $136 million benefit of foreign currency translation. Unless otherwise stated, all revenue growth rates in this press release are stated on an organic basis, which adjusts for the impact of foreign currency translation. There were no acquisitions made in the last year that had a significant impact on the company’s or any individual segment’s third quarter revenue growth.

As reported, third quarter GAAP net income and diluted earnings per share (EPS) were $1.270 billion and $0.94, respectively. As detailed in the financial schedules included through the link at the end of this release, third quarter non-GAAP net income and non-GAAP diluted EPS were $1.753 billion and $1.29, respectively, both decreases of 10 percent. Adjusting for the negative 6 cent impact from foreign currency, third quarter non-GAAP diluted EPS decreased 6 percent.

Third quarter U.S. revenue of $3.939 billion represented 51 percent of company revenue and decreased 2 percent. Non-U.S. developed market revenue of $2.522 billion represented 32 percent of company revenue and increased 6 percent as reported and was flat organic. Emerging Markets revenue of $1.314 billion represented 17 percent of company revenue and was flat as reported and increased 1 percent organic.

"Our Q3 results reflect that our business is well on the way to returning to growth, with sequential improvements in both revenue and earnings, despite the impact of the COVID resurgence on procedure volumes in late December and January. We’re outperforming our end markets, as new products are driving share gains in an increasing number of our businesses," said Geoff Martha, Medtronic chairman and chief executive officer. "Looking ahead, we’re positioning ourselves for long-term success as we implement our new operating model and execute on a number of large opportunities to win share and create and disrupt big markets."

Cardiac and Vascular Group
The Cardiac and Vascular Group (CVG) includes the Cardiac Rhythm & Heart Failure (CRHF), Coronary & Structural Heart (CSH), and Aortic, Peripheral & Venous (APV) divisions. CVG third quarter revenue of $2.707 billion decreased 4.0 percent as reported and 5.9 percent organic. CVG’s revenue reflected the impact of the COVID-19 resurgence on procedure volumes in the third quarter in late December and January. CVG’s organic performance reflected mid-single digit declines in CRHF, high-single digit declines in CSH, and mid-single digit declines in APV.

Cardiac Rhythm & Heart Failure third quarter revenue of $1.371 billion decreased 1.6 percent as reported and decreased 3.7 percent organic. Arrhythmia Management revenue declined in the mid-single digits. This included mid-sixties growth globally and mid-seventies growth in the United States in Leadless Pacemakers, on the continued global adoption of the company’s Micra transcatheter pacing systems. Heart Failure declined low-single digits, as low-single digit declines in Cardiac Resynchronization Therapy Pacemakers (CRT-Ps) and mid-twenties declines in Left Ventricular Assist Devices (LVADs) were partially offset by low-single digit growth in cardiac resynchronization therapy defibrillators (CRT-Ds) from the recent launch of Cobalt and Crome.
Coronary & Structural Heart third quarter revenue of $873 million decreased 7.9 percent as reported and 9.5 percent organic, reflecting low-double digit declines in drug-eluting stents (DES). The company experienced a continued impact to DES sales in China as a result of the national tender announcement in mid-October. While transcatheter aortic valves (TAVR) declined mid-single digits versus the prior year, the company estimates it gained share sequentially.
Aortic, Peripheral & Venous third quarter revenue of $463 million decreased 3.1 percent as reported and 5.0 percent organic. Aortic declined in the low-single digits, Peripheral declined in the mid-single digits, and Venous declined in the low-double digits. Sales of the company’s IN.PACT drug-coated balloons increased high-single digits.
Minimally Invasive Therapies Group
The Minimally Invasive Therapies Group (MITG) includes the Surgical Innovations (SI) and the Respiratory, Gastrointestinal & Renal (RGR) divisions. MITG third quarter revenue of $2.313 billion increased 6.3 percent as reported and 4.6 percent organic. MITG’s revenue reflected the increased demand for COVID-19 related diagnostics and therapies, offset by the impact of the COVID-19 resurgence on procedure volumes in late December and January. RGR’s mid-twenties organic growth was partially offset by SI’s mid-single digit organic decline.

Surgical Innovations third quarter revenue of $1.423 billion decreased 3.5 percent as reported and 5.3 percent organic. Advanced Surgical declined mid-single digits and General Surgery declined in the high-single digits, both reflecting the deceleration of worldwide surgical procedure recovery due to the resurgence of the COVID-19 pandemic.
Respiratory, Gastrointestinal & Renal third quarter revenue of $890 million increased 26.8 percent as reported and 25.4 organic. Respiratory Interventions increased mid-seventies organic, with sales of ventilators increasing nearly three-fold to meet global demand as a result of the COVID-19 pandemic. Patient Monitoring increased in the low-double digits on strength of the company’s Nellcor pulse oximetry products.
Restorative Therapies Group
The Restorative Therapies Group (RTG) includes the Cranial and Spinal Technologies, Specialty Therapies, and Neuromodulation divisions. RTG third quarter revenue of $2.126 billion increased 0.7 percent as reported and decreased 0.8 percent organic. RTG’s revenue reflected the impact of the COVID-19 resurgence on procedure volumes in the third quarter in late December and January, partially offset by growth from new products. RTG’s organic performance this quarter included mid-single-digit declines in Cranial and Spinal Technologies and low-single digit organic growth in Specialty Therapies and Neuromodulation.

Cranial and Spinal Technologies third quarter revenue of $1.081 billion decreased 3.2 percent as reported and 4.5 percent organic, including mid-single digit declines in Spine and low-single digit declines in Enabling Technology. The company had solid sales of capital equipment in the U.S., with sales growth in Mazor robotics, O-arm imaging, and Midas-Rex powered surgical instruments.
Specialty Therapies third quarter revenue of $618 million increased 5.1 percent as reported and 3.2 percent organic. Neurovascular increased in the mid-single digits and Pelvic Health increased in the mid-teens, partially offset by mid-single digit declines in ENT.
Neuromodulation third quarter revenue of $426 million increased 4.9 percent as reported and 3.4 percent organic, with new products driving low-single digit growth in Pain Therapies and mid-single digit growth in DBS.
Diabetes Group
Diabetes Group third quarter revenue of $630 million increased 3.3 percent as reported and 0.8 percent organic. Diabetes Group revenue performance reflected mid-single digit growth in durable pumps and CGM due to the launch of MiniMed 780G in international markets and the MiniMed 770G launch in the U.S.

Guidance
Given the uncertainty on near-term financial results caused by the COVID-19 pandemic, the company is not providing formal annual or quarterly financial guidance at this time.

Webcast Information
Medtronic will host a webcast today, February 23, at 8:00 a.m. EST (7:00 a.m. CST) to provide information about its businesses for the public, investors, analysts, and news media. This quarterly webcast can be accessed by clicking on the Investor Events link at investorrelations.medtronic.com and this earnings release will be archived at news.medtronic.com. Medtronic will be live tweeting during the webcast on its Newsroom Twitter account, @Medtronic. Within 24 hours of the webcast, a replay of the webcast and transcript of the company’s prepared remarks will be available by clicking on the Investor Events link at investorrelations.medtronic.com.

Medtronic plans to report its fiscal year 2021 fourth quarter results on May 27, 2021, and its fiscal year 2022 first, second, and third quarter results on August 24, 2021, November 23, 2021, and February 22, 2022, respectively. Confirmation and additional details will be provided closer to the specific event.

Financial Schedules
To view the third quarter financial schedules and non-GAAP reconciliations, click here. To view the third quarter earnings presentation, click here. Both documents can also be accessed by visiting news.medtronic.com.