On November 9, 2021 Inhibrx, Inc. (Nasdaq: INBX), a biotechnology company with four clinical programs in development and a strong emerging pipeline, reported financial results for the third quarter of 2021 and provided an update on recent corporate highlights (Press release, Inhibrx, NOV 9, 2021, https://www.prnewswire.com/news-releases/inhibrx-reports-third-quarter-2021-financial-results-and-recent-corporate-highlights-301420241.html [SID1234594914]).

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Recent Corporate Highlights

On October 12, 2021, Inhibrx announced interim results from a Phase 1 clinical trial evaluating the safety and pharmacokinetics of INBRX-101, an optimized recombinant human AAT-Fc fusion protein, in patients with alpha-1 antitrypsin deficiency, or AATD. The data from the single ascending dose cohorts revealed the potential to achieve normal AAT levels with monthly dosing and also showed a favorable safety and tolerability profile with no drug-related severe or serious adverse events at doses up to and including 120 mg/kg single dose and 80 mg/kg multi-dose administered intravenously.
On October 28, 2021, Inhibrx announced the appointment of three executives: David Matly, M.B.A., as Chief Commercial Officer; David Kao, PharmD, M.B.A., RPh, as Vice President of Regulatory Affairs; and Jack Tsai, M.D., M.B.A., as Vice President of Business Development. Additionally, the Company announced the appointment of Kristiina Vuori, M.D., Ph.D. to its Board of Directors.
On November 1, 2021, Inhibrx announced it will be presenting at the Connective Tissue Oncology Society (CTOS) 2021 Virtual Annual Meeting taking place November 10-13, 2021. This presentation will provide an update on the Phase 1 expansion cohort for INBRX-109 in patients with conventional chondrosarcoma. Inhibrx will also present a poster on preclinical data that will guide the planned Phase 1 expansion cohort for INBRX-109 in Ewing Sarcoma.
On November 3, 2021, Inhibrx announced that three abstracts had been accepted for presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting, taking place November 10-14, 2021, in Washington D.C. and virtually. The three abstracts will highlight preclinical data from two of its clinical programs, INBRX-105 and INBRX-106, as well as introduce the first emerging pipeline candidate from its targeted cytokine platform, INBRX-121.
Financial Results

Cash and Cash Equivalents. As of September 30, 2021, Inhibrx had cash and cash equivalents of $112.7 million, compared to $128.7 million as of December 31, 2020. As of November 9, 2021, Inhibrx had cash and cash equivalents of $141.1 million.
R&D Expense. Research and development expenses were $18.5 million during the third quarter of 2021, compared to $19.8 million during the third quarter of 2020. This overall decrease was primarily due to the timing of work performed during 2020 by Inhibrx’s contract development and manufacturing organization partners for the formulation and manufacturing of certain of its therapeutic candidates, offset in part by an increase in clinical trial expenses based on the initiation of a Phase 2 trial in conventional chondrosarcoma and the progression of ongoing Phase 1 trials during 2021. Additionally, personnel-related costs increased during the third quarter of 2021 as compared to the same period in the prior year as a result of the continued expansion of its organization.
G&A Expense. General and administrative expenses were $2.8 million during the third quarter of 2021, compared to $1.6 million during the third quarter of 2020. This was primarily driven by increases in personnel-related costs, as well as increases in professional service fees related to Inhibrx’s expanding intellectual property portfolio and other expenses associated with operating as a public company following its initial public offering in August 2020.
Net Loss. Net loss was $20.6 million during the third quarter of 2021, or $0.54 per share, compared to $20.5 million during the third quarter of 2020, or $0.77 per share.
About the Inhibrx sdAb Platform
Inhibrx utilizes diverse methods of protein engineering in the construction of therapeutic candidates that can address the specific requirements of complex target and disease biology. A key tool for this effort is the Inhibrx proprietary sdAb platform, which enables the development of therapeutic candidates with attributes superior to other monoclonal antibody and fusion protein approaches. This platform allows the combination of multiple binding units in a single molecule, enabling the creation of therapeutic candidates with defined valency or multiple specificities that can achieve enhanced cell signaling or conditional activation. An additional benefit of this platform is that these optimized, multi-functional entities can be manufactured using the established processes that are commonly used to produce therapeutic proteins.

On November 9, 2021 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs), reported financial results for the third quarter and nine months ended September 30, 2021 and highlighted recent corporate progress (Press release, Avidity Biosciences, NOV 9, 2021, View Source [SID1234594913]).

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"This past quarter we initiated our Phase 1/2 MARINATM trial for AOC 1001, which transitions us into a clinical stage company. This trial is important for both AOC 1001 and our platform as it is expected to generate the first proof of concept data on the AOC platform’s potential to deliver RNA therapy outside of the liver – a first for the field of RNA conjugates and for Avidity," said Sarah Boyce, president and chief executive officer. "This is also an important milestone for the myotonic dystrophy community who currently have no therapeutic options. We look forward to sharing preliminary data on AOC 1001 in the second half of next year as we work to achieve our ambitious agenda of having AOCs for DM1, DMD and FSHD in the clinic by the end of 2022."

"Following completion of our successful first follow-on financing in August, we are well funded into 2024 with a cash balance of $413 million at quarter end. Given these significant financial resources, we are well positioned to complete the ongoing MARINA trial for AOC 1001, as well as initiate proof of concept clinical trials in 2022 for AOC 1044, the first of our DMD programs, and for our AOC FSHD program while we continue our investment in expanding our AOC platform," said Mike MacLean, chief financial officer.

Recent Highlights:

Initiated first clinical trial for an AOC – transitioning Avidity into a clinical stage company
Initiated the Phase 1/2 MARINA trial of AOC 1001 in adults with myotonic dystrophy type 1 (DM1)
Received clearance from the U.S. Food and Drug Administration (FDA) to proceed with the Phase 1/2 MARINA trial under Avidity’s initial new drug application (IND) in July 2021
Enrolled the first patient in the MARINA trial in October 2021, marking the first time a person has been dosed with an AOC
AOC 1001 was granted Orphan Designation by the FDA and the European Medicines Agency (EMA)
AOC 1001 was granted Fast Track Designation by the FDA in October 2021
Entered a collaboration with a key physician network for a natural history study in FSHD
Avidity is supporting the natural history study called the Motor Outcomes to Validate Evaluations Plus (MOVE+) Study run by the facioscapulohumeral muscular dystrophy (FSHD) Clinical Trial Research Network (FSHD CTRN) to enhance the understanding of how to utilize whole-body MRI and other tools to identify specific biomarkers for FSHD that can accelerate and support future clinical trial design.
Completed a follow-on financing, resulting in net proceeds of $155.1 million
Upcoming Events

Volume 3 of Avidity’s Virtual Investor and Analyst Event Series will be focused on FSHD and will be held on Thursday, December 9, 2021 at 8am PT/11am ET. To register for the live video webcast, please visit the "Events and Presentations" page in the "Investors" section of Avidity’s website. A replay of the webcast will be archived on Avidity’s website following the event.

Art Levin, Ph.D., Avidity’s chief scientific officer, and W. Michael Flanagan, Ph.D., Avidity’s chief technical officer, will discuss the scientific rationale and potential benefits of leveraging AOCs for FSHD.

The virtual event will also feature Jeffrey Statland, M.D., professor, Department of Neurology, University of Kansas Medical Center, to discuss the clinical impact of FSHD and the ongoing natural history studies. Dr. Statland is one of the principal investigators in the ongoing MOVE and MOVE+ natural history studies for people living with FSHD.

Third Quarter 2021 Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities totaled $413.0 million as of September 30, 2021, compared to $328.1 million as of December 31, 2020.
Collaboration Revenue: Collaboration revenue, including reimbursable expenses, primarily relates to Avidity’s partnership with Eli Lilly and Company and totaled $2.2 million for the third quarter of 2021 compared with $1.7 million for the third quarter of 2020, and $7.5 million for the first nine months of 2021 compared with $4.6 million for the first nine months of 2020.
Research and Development (R&D) Expenses: R&D expenses include external and internal costs associated with research and development activities. These expenses were $24.8 million for the third quarter of 2021 compared with $9.5 million for the third quarter of 2020, and $68.2 million for the first nine months of 2021 compared with $24.0 million for the first nine months of 2020. The increases were primarily driven by the advancement of AOC 1001, AOC 1044 and the AOC FSHD program, as well as costs related to the expansion of the company’s overall research capabilities.
General and Administrative (G&A) Expenses: G&A expenses primarily consist of employee-related expenses, professional fees, insurance costs and patent filing and maintenance fees. These expenses were $6.6 million for the third quarter of 2021 compared with $3.8 million for the third quarter of 2020, and $18.8 million for the first nine months of 2021 compared with $8.6 million for the first nine months of 2020. The increases were primarily due to higher personnel costs. The year-to-date increase was also due to higher professional fees and insurance costs.

On November 9, 2021 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the third quarter of 2021 and updated financial guidance for 2021 (Press release, Jazz Pharmaceuticals, NOV 9, 2021, View Source [SID1234594912]).

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"Last year, we set the ambitious corporate objective of completing five key commercial launches through 2020 and 2021. With the launch of Xywav for idiopathic hypersomnia earlier this month, we have now accomplished this goal, demonstrating our significant execution capabilities and commitment to bring important new medicines forward for patients," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "The successful integration of GW underscores our ability to deliver on transformative M&A to grow our business. While there’s more work to be done, I’m confident we have the right strategy, teams and capabilities in place to realize the blockbuster potential of Epidiolex and to discover, develop and launch additional novel, innovative medicines leveraging cannabinoid science. Our commercial execution, productive R&D engine and culture of commitment to patients and their families provide a strong foundation for significant and sustained growth."

Renée Galá, executive vice president and chief financial officer, added, "This is an exciting time of transformation for Jazz, underpinned by operational execution, financial discipline and strategic capital allocation across our business. We continue to deliver on our business and financial targets which has enabled us to rapidly reduce our net leverage ratio to 4.41 times in just five months following the close of the GW transaction. We have also delivered on revenue growth and diversification. Recently launched or acquired products now make up over 50% of net product sales, and we remain on track to meet our goal of at least 65% in 2022. In addition, our prior investments in corporate development are translating into near-term catalysts as we advance JZP385, JZP150 and Zepzelca into important new clinical trials. We will continue to prioritize disciplined capital allocation to assets and activities that drive growth and value, while remaining focused on achieving our net leverage ratio target of less than 3.51 times by the end of next year."

Key Highlights

Total revenues increased 39% to $838.1 million compared to 3Q20
52% of net product sales from recently launched or acquired products
Exceptional Xywav adoption in narcolepsy with approximately 6,000 active patients exiting 3Q21
Xywav for idiopathic hypersomnia (IH) launched November 1, 2021
Continued Epidiolex revenue growth of 21% compared to 3Q20 despite COVID-19 pressure
Top-tier launch has established Zepzelca as second-line SCLC treatment of choice
Rylaze launch progressing well; positive feedback from key stakeholders
Pipeline advancing with key trial initiations underway for JZP385, JZP150 and Zepzelca
Raising full year 2021 earnings guidance
Net leverage ratio reduced by 0.5x to 4.4×1 in the five months following GW transaction close
____________________

1.

On a pro forma, non-GAAP adjusted basis

Business Updates

Neuroscience

Oxybate (Xyrem and Xywav):

Net product sales for the combined oxybate business increased 3% to $460.4 million in 3Q21 compared to the same period in 2020.
Average active oxybate patients on therapy was approximately 16,000 in 3Q21, an increase of approximately 6% compared to the same period in 2020.
Xywav for Narcolepsy (calcium, magnesium, potassium, and sodium oxybates) oral solution:

The Company continues to drive market-leading adoption of Xywav in narcolepsy.
Xywav net product sales were $153.1 million in 3Q21.
There were approximately 6,000 active patients on Xywav exiting 3Q21.
In June 2021, FDA recognized seven years of Orphan Drug Exclusivity, through July 2027, for Xywav and published its summary of clinical superiority findings stating that "Xywav is clinically superior to Xyrem by means of greater safety because Xywav provides a greatly reduced chronic sodium burden compared to Xyrem." Further, FDA stated that "the differences in the sodium content of the two products at the recommended doses will be clinically meaningful in reducing cardiovascular morbidity in a substantial proportion of patients for whom the drug is indicated."
Xywav for Idiopathic Hypersomnia

On August 12, 2021, FDA approved Xywav for the treatment of IH in adults.
The Company launched Xywav for IH on November 1, 2021.
Xywav is the first-and-only medicine approved by FDA for the treatment of IH in adults, underscoring the Company’s patient-focused R&D strategy and concept-to-commercial capabilities.
Xywav for IH is a significant value driver, with initial launch efforts focused on the approximately 37,000 currently diagnosed patients in the U.S. who are actively seeking healthcare.
Xywav demonstrated robust clinical data with statistically significant improvements across all primary and secondary endpoints in the Phase 3 clinical trial.
Xywav has broad patent protection to 2033 and is eligible for Orphan Drug Exclusivity for IH.
Xyrem (sodium oxybate) oral solution:

Xyrem net product sales decreased 31% to $307.3 million in 3Q21 compared to the same period in 2020, reflecting the continued strong adoption of Xywav.
Epidiolex/Epidyolex (cannabidiol):

Epidiolex/Epidyolex net product sales were $160.4 million in 3Q21, an increase of 21% compared to the same period of 2020 on a pro-forma basis, despite short-term COVID-19 pressure.
Recent market research indicates approximately 40% of prescribers are moving Epidiolex up in their treatment algorithm.
The Company has made significant progress on its European rollout with launches in Spain, Italy and Switzerland in 3Q21. Epidyolex is now commercially available and fully reimbursed in four of the five key European markets: United Kingdom, Germany, Italy and Spain, with an anticipated launch in France in 2022.
The Company expects to initiate a Phase 3 pivotal trial of Epidiolex for Epilepsy with Myoclonic-Atonic Seizures (EMAS), the fourth target indication for Epidiolex, in 1H22.
The Company continues to strengthen the durability of Epidiolex, and expects a composition of matter-like patent, extending through 2039, to be issued later this year.
Sunosi (solriamfetol):

Sunosi net product sales increased by 111% to $19.3 million in 3Q21 compared to the same period of 2020.
In 3Q21, U.S. prescriptions increased by 8% compared to 2Q21.
Nabiximols:

The Company has initiated the third Phase 3 nabiximols clinical trial in multiple sclerosis (MS)-related spasticity. This is a randomized, double-blind, placebo-controlled trial with a primary endpoint of muscle tone, expected to enroll approximately 190 patients.
The Company expects data from its first Phase 3 trial in 1H22, followed by data from the two additional Phase 3 trials in late 2022 and early 2023.
The Company anticipates that if the results of the first trial are positive, there is potential for regulatory submission to FDA in the next 18-24 months.
JZP385:

The Company has initiated a Phase 2b trial and expects top-line data to read out in 1H24.
JZP385, a highly selective modulator of T-type calcium channels, is in clinical development for the potential treatment of essential tremor.
JZP150:

The Company is on track to initiate a Phase 2 trial this year.
JZP150, a fatty acid amide hydrolase (FAAH) inhibitor, is in clinical development for the potential treatment of post-traumatic stress disorder.
Oncology

Zepzelca (lurbinectedin):

Zepzelca net product sales increased 94% to $71.7 million in 3Q21 compared to the same period in 2020.
Zepzelca net product sales in 3Q21 were favorably impacted by approximately $10 million, relating to a reduction in the returns accrual rate, due to lower than estimated actual returns. Excluding this impact, net product sales in 3Q21 increased by 10% compared to 2Q21.
The Company has established Zepzelca as the treatment of choice in the second-line small cell lung cancer (SCLC) setting. Zepzelca has near-term growth opportunities, as the Company expects that it will continue to gain share among patients being re-challenged with platinum-based chemotherapies or receiving other chemotherapy regimens.
Zepzelca development program updates:
Jazz and collaborator F. Hoffmann-La Roche Ltd (Roche) have initiated a Phase 3 trial to evaluate first-line use of Zepzelca in combination with Tecentriq (atezolizumab), compared to Tecentriq alone, as maintenance therapy, in patients with extensive stage SCLC after induction chemotherapy. The trial is now listed on clinicaltrials.gov (NCT05091567); enrollment of the first patient is anticipated later this year.
The Company’s partner, PharmaMar, plans to initiate a confirmatory trial in second-line SCLC later this year. If positive, this trial would confirm the benefit of Zepzelca in the treatment of SCLC when patients progress following first-line treatment with a platinum-based regimen.
Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn):

Rylaze net product sales were $20.7 million in 3Q21, following commercial launch on July 15, 2021.
The Company has been granted Real-Time Oncology Review by FDA and plans to submit a supplemental Biologics License Application (sBLA) with additional data in support of a Monday/Wednesday/Friday (M/W/F) intramuscular dosing schedule in early 2022.
The Company is presenting data, for the first time, from the Phase 2/3 study of Rylaze in patients with ALL/LBL who developed hypersensitivity or silent inactivation to a long-acting E. coli–derived asparaginase, at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which will be held December 11-14, 2021.
The Company anticipates that data from the current development program will support regulatory filings in Europe in mid-2022, with potential for approval in 2023. The Company is also working with a partner to advance the program for potential filing, approval and launch in Japan.
Rylaze is the only recombinant Erwinia asparaginase manufactured product that maintains a clinically meaningful level of asparaginase activity throughout the entire duration of treatment. It was developed by the Company to address the needs of patients and healthcare providers for an innovative, high-quality Erwinia asparaginase with reliable supply.
Vyxeos (daunorubicin and cytarabine) liposome for injection:

Vyxeos net product sales increased 13% to $34.7 million in 3Q21 compared to the same period in 2020.
Defitelio (defibrotide sodium) / defibrotide:

Defitelio/defibrotide net product sales increased 15% to $57.7 million in 3Q21 compared to the same period in 2020.

GAAP net income (loss) for 3Q21 was ($52.8 million), or ($0.86) per diluted share, compared to $148.2 million, or $2.64 per diluted share, for 3Q20.

Non-GAAP adjusted net income for 3Q21 was $261.4 million, or $4.20 per diluted share, compared to $242.1 million, or $4.31 per diluted share, for 3Q20.

Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.

Total revenues increased 39% in 3Q21 compared to the same period in 2020.

Products launched or acquired since 2019 comprised 52% of total net product sales in 3Q21.
Neuroscience net product sales in 3Q21 increased 41% to $646.1 million compared to the same period in 2020. In 3Q21, oxybate net product sales increased to $460.4 million led by strong Xywav net product sales of $153.1 million partially offset by a decrease in Xyrem net product sales as a result of the strong adoption of Xywav by existing Xyrem patients. Epidiolex/Epidyolex net product sales in 3Q21 were $160.4 million, following the GW Acquisition in 2Q21.
Oncology net product sales in 3Q21 increased 34% to $184.8 million compared to the same period in 2020 primarily driven by an increase in Zepzelca net product sales of $34.8 million. Zepzelca launched in the U.S. in July 2020.
Operating expenses changed over the prior year period primarily due to the following:

Cost of product sales increased in 3Q21 compared to the same period in 2020, on a GAAP and on a non-GAAP adjusted basis, due to increased net product sales as a result of the GW Acquisition. In addition, an acquisition accounting inventory fair value step-up expense of $82.6 million impacted GAAP cost of product sales.
Selling, general and administrative (SG&A) expenses increased in 3Q21 compared to the same period in 2020, on a GAAP and on a non-GAAP adjusted basis, primarily due to an increase in compensation-related expenses driven by higher headcount as a result of the GW Acquisition and the addition of costs related to Epidiolex, as well as an increase in other expenses related to the expansion of our business including investments to support the Company’s recent product launches. SG&A expenses in 3Q21 on a GAAP basis also included transaction and integration related expenses of $53.4 million related to the GW Acquisition.
Research and development expenses increased in 3Q21 compared to the same period in 2020, on a GAAP and on a non-GAAP adjusted basis, primarily due to the addition of costs related to clinical programs for Epidiolex, nabiximols and cannabinoids and an increase in compensation-related expenses due to higher headcount primarily driven by the GW Acquisition.
Cash Flow and Balance Sheet

As of September 30, 2021, cash and cash equivalents were $671.8 million, and the outstanding principal balance of the Company’s long-term debt was $6.6 billion compared to $7.1 billion as of June 30, 2021. In addition, the Company had undrawn borrowing capacity under a revolving credit facility of $500.0 million.

For the nine months ended September 30, 2021, the Company generated $600.8 million of cash from operations.

During the third quarter, and aligned to its stated deleveraging target, the Company made significant debt repayments of $477.6 million which included the repayment on maturity of the remaining balance on its 1.875% exchangeable senior notes due 2021 and a voluntary payment on its term loan B.

2021 Financial Guidance1

Jazz Pharmaceuticals is updating its full year 2021 financial guidance. This guidance reflects the Company’s current and future expected operational performance, including COVID-19 related impacts, the strength of its underlying operations and the prioritization of new and ongoing value creating development projects.

The Company is raising its full-year earnings guidance, resulting in a reduced GAAP net loss and increased non-GAAP adjusted net income (ANI) on an absolute and per share basis. The updated non-GAAP ANI range exceeds the upper end of the prior range. The Company is reducing both SG&A and R&D expense guidance on a GAAP and non-GAAP adjusted basis, reflecting progress within its transformation initiatives, improved financial discipline and strategic capital allocation. The Company is narrowing its net sales guidance range for neuroscience and oncology, with a reduced mid-point for oncology net sales guidance which reflects the ongoing impacts of COVID-19 on our legacy products and the Rylaze competitive landscape at launch in 3Q21, resulting in a reduced mid-point for total revenues guidance.

Conference Call Details

Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. ET (9:30 p.m. GMT) to provide a business and financial update and discuss its 3Q21 results. The live webcast may be accessed from the Investors section of the Company’s website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary. Investors may participate in the conference call by dialing +1 855 353 7924 in the U.S., or +1 503 343 6056 outside the U.S., and entering passcode 5888822.

A replay of the conference call will be available through November 16, 2021 by dialing +1 855 859 2056 in the U.S., or +1 404 537 3406 outside the U.S., and entering passcode 5888822. An archived version of the webcast will be available for at least one week in the Investors section of the Company’s website at www.jazzpharmaceuticals.com.

On November 9, 2021 Thermo Fisher Scientific Inc. (NYSE: TMO) ("Thermo Fisher") reported that it has priced an offering of €2.8 billion aggregate principal amount (the "Offering") of the following euro-denominated notes, which will be issued by Thermo Fisher Scientific (Finance I) B.V., its indirect, wholly owned finance subsidiary (Press release, Thermo Fisher Scientific, NOV 9, 2021, View Source [SID1234594911]):

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€1,700,000,000 aggregate principal amount of its floating rate senior notes due 2023 (the "floating rate notes"), at the issue price of 100.744% of their principal amount,
€550,000,000 aggregate principal amount of its 0.000% senior notes due 2023 (the "2023 notes"), at the issue price of 100.321% of their principal amount, and
€550,000,000 aggregate principal amount of its 0.000% senior notes due 2025 (the "sustainability notes" and together with the floating rate notes and the 2023 notes, the "notes"), at the issue price of 99.868% of their principal amount.
The Offering is expected to close on or about November 18, 2021, subject to customary closing conditions. The notes will be fully and unconditionally guaranteed by Thermo Fisher. The floating rate notes will pay interest quarterly.

Thermo Fisher intends to use the net proceeds from the sale of the floating rate notes and the 2023 notes to pay a portion of the cash consideration payable for the pending acquisition of PPD, Inc. ("PPD"). Thermo Fisher may also determine to use a portion of the net proceeds from the sale of the floating rate notes and the 2023 notes for general corporate purposes, which may include the acquisition of companies or businesses, repayment and refinancing of debt, including debt of PPD, working capital and capital expenditures or the repurchase of its outstanding equity securities or it may temporarily invest the net proceeds in short-term, liquid investments until they are used for their ultimate purpose.

Thermo Fisher intends to allocate an amount equal to the net proceeds from the sale of the sustainability notes to finance or refinance, in whole or in part, certain green or social eligible projects. Pending allocation to green or social eligible projects, such net proceeds may be temporarily invested in cash, cash equivalents, short-term investments, or used to repay other borrowings.

The joint book-running managers for the Offering are Barclays Bank PLC, Morgan Stanley Europe SE, BofA Securities Europe SA, Citigroup Global Markets Europe AG and Mizuho Securities Europe GmbH. Barclays Bank PLC is also acting as the sustainability structuring agent for the sustainability notes.

The Offering is being made pursuant to an effective registration statement on Form S-3 filed with the U.S. Securities and Exchange Commission (the "SEC"). Prospective investors should read the prospectus forming a part of that registration statement and the prospectus supplement related to the Offering and the other documents that Thermo Fisher has filed with the SEC for more complete information about Thermo Fisher and the Offering. These documents are available at no charge by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, Thermo Fisher, the underwriters or any dealer participating in the Offering will arrange to send you the prospectus if you request it by calling Barclays Bank PLC at +1 888 603 5847, Morgan Stanley Europe SE at +44 (0)20 7677 4799, BofA Securities Europe SA at +33(0) 1 8770 0000, Citigroup Global Markets Europe AG at +49 69 1366 8362 or Mizuho Securities Europe GmbH at +49 69 42729 3000.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the notes, nor shall there be any offer, solicitation or sale of the notes in any jurisdiction in which such offer, solicitation or sale would be unlawful.

MiFID II and UK MiFIR – professionals/ECPs-only / No PRIIPs or UK PRIIPs KID – Manufacturer target market (MiFID II and UK MiFIR product governance) is eligible counterparties and professional clients only (all distribution channels). No PRIIPs or UK PRIIPs key information document (KID) has been prepared as not available to retail in European Economic Area ("EEA") or United Kingdom ("UK").

This press release is addressed only to specific individuals who are individuals (i) who have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order") and qualified investors falling within Article 49(2)(a) to (d) of the Order and (ii) to whom it may otherwise lawfully be communicated under the Order (all such persons together being referred to as the "relevant persons"). This press release must not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this press release relates is available only to relevant persons and will be engaged in only with relevant persons. By reading this press release, the reader acknowledges that it is a person either (i) outside the UK or (ii) falling within one of the foregoing categories.

This press release is an advertisement and is not a prospectus for the purposes of Prospectus Regulation (as defined below). A prospectus will be prepared and made available to the public as required and in accordance with the Prospectus Regulation. Investors should not subscribe for any notes referred to in this press release except on the basis of information contained in such prospectus. The prospectus, when published, will be available on the website of Euronext Dublin at https://live.euronext.com (opens in a new tab).

For these purposes, the expression "Prospectus Regulation" means either Regulation (EU) 2017/1129 or Regulation (EU) 2017/1129 as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Act 2018, as appropriate.

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On November 9, 2021 Aethlon Medical, Inc. (Nasdaq: AEMD), a company developing medical technology to treat cancer and life-threatening infectious diseases, reported financial results for its second quarter ended September 30, 2021 and provided an update on recent developments (Press release, Aethlon Medical, NOV 9, 2021, View Source [SID1234594910]).

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Company Updates

Aethlon Medical is continuing the research and clinical development of the Hemopurifier, our therapeutic blood filtration system that can bind and remove life-threatening viruses and harmful exosomes from blood. This action has potential applications in cancer, where cancer associated exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases, including removal of COVID-19 virus, associated variants, and related exosomes.

As disclosed in our last earnings release on August 9, 2021, the Aethlon Hemopurifier has demonstrated binding of SARS-CoV-2 spike protein and, as reported in a peer reviewed publication, the binding and removal from circulation of SARS-CoV-2 virus from a human patient. This is in addition to the Hemopurifier’s previously demonstrated binding of numerous pathogenic viruses. The new information about the Hemopurifier in COVID-19 has stimulated clinical researchers to express interest in joining our ongoing clinical trial investigating the Hemopurifier for the treatment of patients with SARS-CoV-2/COVID-19 infection. This trial is being conducted under the open Investigational Device Exemption (IDE) for the Hemopurifier in life threatening viral infections. The trial is designed to allow for up to 40 of these patients to be treated under an Early Feasibility Study protocol at up to 20 clinical sites in the U.S.

During the recent quarter, we entered into an agreement with PPD, Inc., a leading global contract research organization (CRO), to oversee our U.S. clinical studies investigating the Hemopurifier for critically ill COVID-19 patients.

Together with PPD, we continue to advance site readiness at Cooper Medical Center, Loma Linda Medical Center, University of California Davis, Virginia Commonwealth University Medical Center, LSU Health Shreveport, University of Miami Medical Center, and Thomas Jefferson Medical Center. Additionally, we obtained institutional research board approval and have entered into a clinical trial agreement with Stanford Hospital. We are in discussions to bring on board other key U.S. medical centers.

We also recently obtained ethics review board approval and entered into a clinical trial agreement with Medanta Medicity Hospital, a multi-specialty hospital in Delhi NCR, India, for a COVID-19 clinical trial at that location. On-site training is expected to take place in November 2021.

"The opportunity to help critically ill, ICU patients with COVID-19 continues in both the U.S. and India," said Steven LaRosa, M.D., Chief Medical Officer.

"In addition to our work with COVID-19, we remain very optimistic about the use of our Hemopurifier for the treatment of Head and Neck Cancer. We acknowledge that the enrollment of our Head and Neck Cancer trial has been delayed, primarily due to the COVID-19 pandemic. We are exploring additional avenues to investigate our Hemopurifier in patients with cancer," said Charles J. Fisher, Jr., M.D., CEO.

Financial Results for the Second Quarter Ended September 30, 2021

At September 30, 2021, Aethlon Medical had a cash balance of approximately $23.2 million.

Aethlon recorded approximately $115,000 of government contract revenue on its Phase 2 Melanoma Cancer Contract in the three months ended September 30, 2021. We also recorded approximately $17,000 of revenue related to our cost reimbursable subaward arrangement with the University of Pittsburgh in connection with an NIH contract entitled "Depleting Exosomes to Improve Responses to Immune Therapy in HNNCC." As a result, the Company recorded total government contract revenue of approximately $132,000 in the three months ended September 30, 2021. Aethlon did not record any government contract revenue in the three months ended September 30, 2020.

Consolidated operating expenses for the three months ended September 30, 2021 were approximately $2.1 million, compared to approximately $1.8 million for the three months ended September 30, 2020. This increase of approximately $300,000, or 20%, in the 2021 period was due to increases in payroll and related expenses of approximately $200,000 and in general and administrative expenses of approximately $100,000.

The $200,000 increase in payroll and related expenses was primarily due to the combination of a $101,000 increase in our research and development payroll as the result of hiring additional scientists and, a $100,000 increase in general and administrative payroll expense as the result of additional headcount.

The $100,000 increase in general and administrative expenses was primarily due to a $72,000 increase in our rent expense, a $54,000 increase in our amortization expense and a $46,000 increase in our insurance expenses, which were partially offset by a $57,000 decrease in our clinical trial expenses.

As a result of the changes in revenues and expenses noted above, the Company’s net loss before noncontrolling interests increased to approximately $2.0 million for the three months ended September 30, 2021, from approximately $1.8 million for the three months ended September 30, 2020.

The unaudited condensed consolidated balance sheet for September 30, 2021 and the unaudited condensed consolidated statements of operations for the three and six month periods ended September 30, 2021 and 2020 follow at the end of this release.

Conference Call

The Company will hold a conference call today, Tuesday, November 9, 2021 at 4:30 p.m. Eastern Time to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

Interested parties can register for the conference by navigating to View Source

Please note that registered participants will receive their dial in number upon registration.

Interested parties without internet access or unable to pre-register may dial in by calling:
PARTICIPANT DIAL IN (TOLL FREE): 1-844-836-8741
PARTICIPANT INTERNATIONAL DIAL IN: 1-412-317-5442

All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through December 9, 2021. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada Toll Free at 1-855-669-9658. The replay conference ID number is 10162862.