On April 20, 2022 Abbott (NYSE: ABT) reported financial results for the first quarter ended March 31, 2022 (Press release, Abbott, APR 20, 2022, View Source [SID1234612573]).

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First-quarter sales of $11.9 billion increased 13.8 percent on a reported basis and 17.5 percent on an organic basis, which excludes the impact of foreign exchange.
First-quarter GAAP diluted EPS1 was $1.37 and adjusted diluted EPS, which excludes specified items, was $1.73.
Global COVID-19 testing-related sales were $3.3 billion in the first quarter.
Abbott projects full-year 2022 diluted EPS on a GAAP basis of at least $3.35 and projected adjusted diluted EPS of at least $4.70 remains unchanged.
2022 guidance includes projected COVID-19 testing-related sales of approximately $4.5 billion, which Abbott expects to largely occur in the first half of the year and will update on a quarterly basis.
In February, Abbott initiated a voluntary recall of certain infant formula products manufactured at one of its U.S. facilities. Abbott is working closely with the U.S. Food and Drug Administration (FDA) and has begun implementing corrective actions and enhancements to the facility.
In February, Abbott received FDA approval for an expanded indication for its CardioMEMS HF system, a small implantable sensor and remote monitoring system that can detect early warning signs of worsening heart failure.
In March, Abbott announced its FreeStyle Libre system is the first and only continuous glucose monitoring (CGM) system to gain expanded reimbursement in Japan to now include all people with diabetes who use insulin.
In April, Abbott announced FDA approval for its Aveir single-chamber leadless pacemaker for the treatment of patients in the U.S. with slow heart rhythms. Unlike traditional pacemakers, leadless pacemakers do not require an incision in the chest to implant or leads (wires) to deliver therapy.
"Our diversified business continues to perform well in a challenging environment," said Robert B. Ford, chairman and chief executive officer, Abbott. "We’re particularly pleased with the strong performance we’re achieving in Medical Devices and Established Pharmaceuticals."

FIRST-QUARTER BUSINESS OVERVIEW
Note: Management believes that measuring sales growth rates on an organic basis is an appropriate way for investors to best understand the underlying performance of the business. Organic sales growth excludes the impact of foreign exchange.

Following are sales by business segment and commentary for the first quarter 2022:

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

First-quarter 2022 worldwide sales of $11.9 billion increased 13.8 percent on a reported basis and 17.5 percent on an organic basis.

Worldwide sales, excluding COVID-19 testing-related sales, increased 3.9 percent on a reported basis and 7.7 percent on an organic basis in the quarter.2

Worldwide Nutrition sales decreased 7.0 percent on a reported basis and 4.4 percent on an organic basis in the first quarter. During the quarter, sales were negatively impacted by a voluntary recall of certain powder formulas manufactured at one of Abbott’s U.S. plants. Excluding the U.S. sales associated with these products in the current and prior years, worldwide Nutrition sales increased 5.0 percent on a reported basis and 8.0 percent on an organic basis in the first quarter.3

In Adult Nutrition, strong performance of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading diabetes nutrition brand, led to global sales growth of 8.0 percent on a reported basis and 11.5 percent on an organic basis.

Worldwide Pediatric Nutrition sales decreased 20.6 percent on a reported basis and 18.8 percent on an organic basis. Internationally, Pediatric Nutrition sales were unfavorably impacted primarily by challenging market conditions in China.

Worldwide Diagnostics sales increased 31.7 percent on a reported basis and 35.1 percent on an organic basis in the first quarter. Global COVID-19 testing-related sales were $3.3 billion in the quarter, led by sales of rapid testing products.

Sales in Core Laboratory and Molecular Diagnostics were impacted by year-over-year declines in COVID-19 testing-related sales in these businesses. Excluding COVID-19 testing-related sales, Core Laboratory Diagnostics sales and Molecular Diagnostics sales increased 2.4 percent and 24.8 percent, respectively, on a reported basis in the first quarter and 6.6 percent and 29.0 percent, respectively, on an organic basis.4

Established Pharmaceuticals sales increased 7.1 percent on a reported basis in the first quarter and increased 13.4 percent on an organic basis.

Key Emerging Markets include several emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies increased 9.8 percent on a reported basis in the quarter and increased 17.1 percent on an organic basis, led by double-digit growth on a reported and organic basis in several geographies and therapeutic areas, including gastroenterology, respiratory and central nervous system/pain management.

Other sales decreased 1.7 percent on a reported basis and increased 1.2 percent on an organic basis in the quarter.

Worldwide Medical Devices sales increased 7.4 percent on a reported basis and 11.5 percent on an organic basis in the first quarter. Strong growth in the quarter was driven by double-digit organic growth in Electrophysiology, Heart Failure, Structural Heart and Diabetes Care.

In Diabetes Care, FreeStyle Libre sales were approximately $1.0 billion in the quarter, which represents sales growth of 20.4 percent on a reported basis and 26.2 percent on an organic basis.

ABBOTT’S EARNINGS-PER-SHARE GUIDANCE
Abbott projects full-year 2022 diluted earnings per share under GAAP of at least $3.35. Abbott forecasts specified items for the full-year 2022 of $1.35 per share primarily related to intangible amortization, costs related to a voluntary recall, expenses associated with acquisitions, restructurings and cost reduction initiatives and other net expenses. Excluding specified items, projected adjusted diluted earnings per share of at least $4.70 remains unchanged for the full-year 2022.

ABBOTT DECLARES 393RD CONSECUTIVE QUARTERLY DIVIDEND
On Feb. 18, 2022, the board of directors of Abbott declared the company’s quarterly dividend of $0.47 per share. Abbott’s cash dividend is payable May 16, 2022 to shareholders of record at the close of business on April 15, 2022.

Abbott has increased its dividend payout for 50 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

On April 20, 2022 Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company focused on discovery and development of small molecule medicines to modulate the activity and stability of pathologically altered proteins, reported that it will participate at the following conferences (Press release, Vivoryon Therapeutics, APR 20, 2022, View Source [SID1234612572]):

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Kempen Life Sciences Conference

Date: April 21, 2022, 10:30 am CEST

Venue: Amsterdam, The Netherlands

Participant: Dr. Ulrich Dauer, CEO of Vivoryon Therapeutics

HAIB Stockpicker Summit

Date: May 11-13, 2022

Venue: Berlin, Germany

Participant: Dr. Ulrich Dauer, CEO of Vivoryon Therapeutics

H.C. Wainwright Global Investment Conference

Date: May 25, 2022, 3:30 pm EDT (9:30 pm CEST)

Venue: Miami, FL, USA

Participant: Dr. Ulrich Dauer, CEO of Vivoryon Therapeutics

A webcast of the presentation will be available via the "Presentations & Webcasts" page in the Investor Relations section on the Company’s website at www.vivoryon.com and will be archived on the Company’s website for 30 days following the conference.

BIO International Convention

Date: June 13-16, 2022

Venue: San Diego, CA, USA

Participants: Dr. Ulrich Dauer, CEO, and Dr. Michael Schaeffer, CBO of Vivoryon Therapeutics

On April 20, 2022 Heat Biologics, Inc. (NYSE American: HTBX) (to be renamed "NightHawk Biosciences"), a fully-integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported it has completed the acquisition of Elusys Therapeutics, Inc. a commercial-stage biodefense company and developer of ANTHIM (obiltoxaximab), a treatment for inhalation anthrax. ANTHIM is approved for use in the U.S. and Canada, and under the brand name Obiltoxaximab SFL in Europe and the United Kingdom (Press release, NightHawk Biosciences, APR 20, 2022, View Source [SID1234612571]).

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Nighthawk acquired all outstanding shares of Elusys, which will continue to operate as a wholly-owned subsidiary of NightHawk. No stock or warrants were issued in connection with the acquisition, and Elusys had no outstanding term debt.

The strategic acquisition of Elusys significantly expands the Company’s role in the biodefense space, complementing NightHawk’s RapidVax platform, which is designed to target emerging biological threats. Pursuant to this acquisition, NightHawk also announced it plans to migrate manufacturing of ANTHIM to its planned 500,000 square foot Scorpion biomanufacturing facility in Manhattan, Kansas, which is being constructed to support development of commercial-scale biologics and large molecules.

To date, Elusys has been awarded over $350 million in research and development grants, contracts and procurement orders from the Biomedical Advanced Research and Development Authority (BARDA) and the U. S. Strategic National Stockpile (SNS). Through ongoing, multi-year partnerships with the U.S. government, Elusys has been supplying ANTHIM to the SNS – the government’s repository of critical medical supplies for biodefense preparedness.

Jeff Wolf, CEO of NightHawk, commented, "We are excited to announce the closing of this transformative acquisition, which provides us with a solid foothold in the biodefense space. Elusys has an established a successful track record collaborating with U.S. government agencies including BARDA, NIH, SNS and DOD. We plan to leverage Elusys’ existing relationships and distribution channels as a launching pad for RapidVax, our "plug and play" platform designed for rapid development and delivery of new vaccines. In addition, we look forward to leveraging our new Kansas facility, which will enable us to manufacture these therapies internally and therefore benefit from significant operating synergies, as well as enhanced oversight, quality control, and speed to market. We are also exploring opportunities to expand ANTHIM distribution abroad. This transaction is perfectly aligned with our overall vision to establish a fully-integrated ecosystem to deliver medical innovations faster, better, and more efficiently."

David Lasseter, former Deputy Assistant Secretary of Defense for Countering Weapons of Mass Destruction, and a member of NightHawk’s Biothreat Advisory Board, commented, "This transaction is extremely timely, given the global uncertainty and unprecedented threats from foreign nations and rogue actors. Anthrax is one of the most significant biological warfare threats facing our country, with real potential for mass casualties. ANTHIM represents a key medical countermeasure for the treatment of inhalation Anthrax."

A special committee of Heat’s Board of Directors negotiated and approved the transaction and Cassel Salpeter & Co. provided a fairness opinion in connection with the transaction. Blank Rome LLP acted as legal counsel to Heat. Elusys was advised by RBC Capital Markets, LLC. Additional details on the transaction are outlined in Company’s Form 8-K, which will be filed with the Securities and Exchange Commission and will be available on the Company’s website.

About ANTHIM

Anthrax is a life-threatening infectious disease caused by Bacillus anthracis. Cases of inhalational anthrax in humans can occur through intentional spread of B. anthracis spores as a biowarfare or bioterrorism agent. B. anthracis spores introduced through the lungs lead to inhalational anthrax, which is deadly in humans.

ANTHIM is a monoclonal antibody that binds to the protective antigen (PA) component of anthrax toxin. ANTHIM’s toxin neutralizing activity prevents entry of anthrax toxin into susceptible cells, avoiding further spread of the toxin throughout the body and the ensuing tissue damage that leads to death. ANTHIM is supplied as single-dose vials for IV infusion.

Indications and Usage

ANTHIM is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. ANTHIM should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis. The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax. There have been no studies of the safety or pharmacokinetics (PK) of ANTHIM in the pediatric population. Dosing in pediatric patients was derived using a population PK approach. ANTHIM does not have direct antibacterial activity. ANTHIM should be used in combination with appropriate antibacterial drugs. ANTHIM is not expected to cross the blood-brain barrier and does not prevent or treat meningitis.

IMPORTANT SAFETY INFORMATION Including BOXED WARNING

WARNING: HYPERSENSITIVITY and ANAPHYLAXIS
Hypersensitivity reactions, including anaphylaxis, have been reported during ANTHIM infusion. ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs.

WARNINGS AND PRECAUTIONS

Hypersensitivity and anaphylaxis have been reported during the IV infusion of ANTHIM. Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Monitor individuals who receive ANTHIM closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs. Pre-medication with diphenhydramine is recommended prior to administration of ANTHIM. Diphenhydramine pre-medication does not prevent anaphylaxis and may mask or delay onset of symptoms of hypersensitivity.

ADVERSE REACTIONS

The safety of ANTHIM has been studied only in healthy volunteers. It has not been studied in patients with inhalational anthrax. The most frequently reported adverse reactions were headache, pruritus, infections of the upper respiratory tract, cough, vessel puncture site bruise, infusion site swelling, urticaria, nasal congestion, infusion site pain, and pain in extremity.

USE IN SPECIFIC POPULATIONS

Pediatric Use: There have been no studies of the safety or PK of ANTHIM in the pediatric population.
To see the complete prescribing information for ANTHIM, click here.

On April 20, 2022 Immunetune, a preclinical-stage biotech developing next-generation DNA vaccines against cancer and infectious diseases, reported the upcoming presentations by members of its management team at several industry and scientific conferences during April and May 2022 (Press release, ImmuneTune, APR 20, 2022, View Source [SID1234612539]).

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"I am glad to announce that we have been selected to present at the Neoantigen Summit and the Cancer Immunotherapy meeting," said Sijme Zeilemaker, CEO of Immunetune. "As our lead program NeoVAC has recently completed GLP toxicity studies, we are looking forward to present our preclinical package and connect with other leaders in this exciting industry of immunotherapies for the treatment of cancer."

Upcoming conferences:

Innovation for Health, April 21, Amsterdam, the Netherlands

CEO Sijme Zeilemaker will be participating.
Neoantigen Summit Europe, April 26 – 28, Amsterdam, the Netherlands

CEO Sijme Zeilemaker will take part in the Industry Leader’s Fireside Chat on April 27th, 10:40 – 11:00 AM, on the great challenges and opportunities in cancer vaccine development.
CSO Jeroen van Bergen will be presenting on April 27th, 12:00 – 12:30 PM, on ‘Optimizing Vaccine Manufacturing for Targeting Neoantigens’ in the Clinical Translation & Manufacturing track.
Cancer Immunotherapy (CIMT) (Free CIMT Whitepaper) Annual Meeting, May 10-12, Mainz, Germany

CSO Jeroen van Bergen will be giving a poster presentation on May 10th between 3:30 – 6:00 PM.
CSO Jeroen van Bergen will be giving an oral presentation in the short-talk session presenting on on May 12th between 9:00 – 10:30 AM.
The selected abstract for both sessions is titled "Personalized synthetic polyepitope DNA cancer vaccines including a novel pyroptotic adjuvant synergize with checkpoint inhibitor therapy to generate effective anti-tumor T cell immunity". Abstracts will be available online prior to the start of the conference.
Knowledge for Growth, May 19, Ghent, Belgium

CEO Sijme Zeilemaker will be participating.

On April 19, 2022 Panolos Biosciences reported the results of anti-cancer research of its main pipeline, PB101, at the AACR (Free AACR Whitepaper) Annual Meeting 2022 held from the 8th (local time) to the 13th (Press release, Panolos Bioscience, APR 19, 2022, View Source [SID1234633689]).

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PB101 is an anti-cancer drug developed by Panolos and being jointly researched by Professor Hong-Jae Jeon and Chan Kim’s team at the Department of Hematology and Oncology at CHA Bundang Hospital. It has a mechanism to inhibit the growth of cancer cells by targeting all types of vascular endothelial growth factors (VEGF-A, VEGF-B, Placental Growth Factor) that are excessively produced around cancer cells.

According to the non-clinical results presented by Panolos at this AACR (Free AACR Whitepaper), PB101 not only inhibits tumor growth by blocking intratumoral angiogenesis, but also increases tumor-hostile immune cells by influencing the immune environment in the tumor microenvironment. appear. In addition, the excellent antitumor effect and survival rate were confirmed through an experiment of combination administration of PB101 with an immuno-anticancer drug, and unlike the single administration experiment group, 27.2% of subjects in the combination administration experiment group showed a complete remission effect.

In an experiment to confirm growth and lung metastasis through repetitive tumor engraftment on subjects who showed complete remission, it was confirmed that, unlike the control group, cancer did not grow. This is due to the formation of memory immune cells that remember the tumor cell line during the combination treatment process. It is estimated that it did.

Based on the results presented at this AACR (Free AACR Whitepaper), Panolos hopes that PB101’s inhibitory effect on angiogenesis in tumors and its immune-activating effect can create a synergistic effect when used in combination with existing immuno-cancer drugs, providing new treatment options to patients. is looking forward to PB101 aims to apply for a phase 1 clinical trial approval (IND) within this year.