Xeris Biopharma Enters Into Agreement for $30 Million Private Placement

Xeris Biopharma Enters Into Agreement for $30 Million Private Placement

CHICAGO–(BUSINESS WIRE)–
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS) (“Xeris” or the “Company”), a biopharmaceutical company developing and commercializing unique therapies for patient populations in endocrinology, neurology, and gastroenterology, today announced that on January 2, 2022, it entered into a securities purchase agreement in connection with a private placement (the “Private Placement”) with an affiliate of Armistice Capital, LLC (“Armistice”) for aggregate gross proceeds of approximately $30.0 million. The Private Placement is expected to close on or around January 3, 2022.

In accordance with the Purchase Agreement, the Company will issue to Armistice an aggregate of (i) 10,238,908 shares (the “Shares”) of the Company’s common stock, par value $0.0001 per share (the “Common Stock”) at a purchase price of $2.93 per Share, which was the closing price on December 31, 2021, resulting in aggregate gross proceeds of approximately $30.0 million, and (ii) warrants (the “Warrants”) to purchase an aggregate of 5,119,454 shares of Common Stock at an exercise price of $3.223 per share, resulting in aggregate gross proceeds of approximately $16.5 million if fully exercised. The Warrants will become exercisable immediately upon the closing and have a term of five years from the earliest of the date (a) of effectiveness of the Resale Registration Statement, (b) all of the Shares and the Common Stock issuable upon exercise of the Warrants (the “Warrant Shares”) have been sold pursuant to Rule 144 or may be sold pursuant to Rule 144 without the requirement for the Company to be in compliance with the current public information required under Rule 144 and without volume or manner-of-sale restrictions, (c) following the one-year anniversary of the date of closing provided that the holder of Shares or Warrant Shares is not an affiliate of the Company, or (d) all of the Shares and Warrant Shares may be sold pursuant to an exemption from registration under Section 4(a)(1) of the Securities Act without volume or manner-of-sale restrictions.

The Company expects to use the net proceeds from the Private Placement to support its operations, including for selling and marketing its three commercial products, clinical trials, working capital, and other general corporate purposes.

The securities to be issued and sold in the Private placement will not, upon issuance, be registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state securities laws, and may not be offered or sold in the United States absent registration under the Securities Act or an applicable exemption from the registration requirements of the Securities Act. The Company has agreed to file a registration statement (the “Resale Registration Statement”) with the Securities and Exchange Commission to register the resale of the Shares and the Warrant Shares described above.

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

About Xeris Biopharma

Xeris (Nasdaq: XERS) is a biopharmaceutical company developing and commercializing unique therapies for patient populations in endocrinology, neurology, and gastroenterology. Xeris has two commercially available products; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, and Keveyis®, the first and only FDA-approved therapy for primary periodic paralysis. In addition, Recorlev® was recently approved by the U.S. Food and Drug Administration for the treatment of endogenous Cushing’s syndrome. Xeris also has a robust pipeline of development programs to extend the current marketed products into important new indications and uses and bring new products forward using its proprietary formulation technology platforms, XeriSol™ and XeriJect™, supporting long-term product development and commercial success.

Xeris is headquartered in Chicago, IL. For more information, visit www.xerispharma.com or follow us on Twitter, LinkedIn, or Instagram.

Forward-Looking Statements

Any statements in this press release about future expectations, plans, and prospects for Xeris Biopharma Holdings, Inc., including statements regarding the potential sale of shares of Common Stock and Warrants in the Private Placement, the anticipated use of proceeds from the Private Placement, the timing of filing of the Resale Registration Statement, and other statements containing the words “will,” “would,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, fluctuations in Xeris’ stock price; the anticipated use of the proceeds of the Private Placement; Xeris’ ability to satisfy customary closing conditions related to the Private Placement and to consummate the Private Placement, reliance on third-party suppliers for Gvoke®, Ogluo®, Keveyis®, and Recorlev®, the regulatory approval of its product candidates, its ability to market and sell its products, the impact of the COVID-19 pandemic on Xeris, changes in global, political, economic, business, competitive, market and regulatory forces, future exchange and interest rates, changes in tax laws, regulations, rates and policies, future business acquisitions or disposals and competitive developments, and the other risks described in Xeris’ Quarterly Report on Form 10-Q and other reports we file from time to time with the SEC. These forward-looking statements are based on numerous assumptions and assessments made in light of Xeris’ experience and perception of historical trends, current conditions, business strategies, operating environment, future developments, and other factors it believes appropriate. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. The factors described in the context of such forward-looking statements in this communication could cause Xeris’ plans with respect to the Private Placement, Xeris’ plans with respect to its products and product candidates, Xeris’ actual results, performance or achievements, industry results and developments to differ materially from those expressed in or implied by such forward-looking statements. Although it is believed that the expectations reflected in such forward-looking statements are reasonable, no assurance can be given that such expectations will prove to have been correct and persons reading this communication are therefore cautioned not to place undue reliance on these forward-looking statements which speak only as at the date of this communication. Additional information about economic, competitive, governmental, technological, and other factors that may affect Xeris is set forth in Item 1A, “Risk Factors,” in Xeris’ 2020 Annual Report on Form 10-K, which has been filed with the SEC, and other important factors in Xeris’ subsequent filings with the SEC, the contents of which are not incorporated by reference into, nor do they form part of, this communication. Any forward-looking statements in this communication are based upon information available to Xeris, as of the date of this communication and, while believed to be true when made, may ultimately prove to be incorrect. Subject to any obligations under applicable law, Xeris does not undertake any obligation to update any forward-looking statement whether as a result of new information, future developments or otherwise, or to conform any forward-looking statement to actual results, future events, or to changes in expectations. All subsequent written and oral forward-looking statements attributable to Xeris or any person acting on behalf of any of them are expressly qualified in their entirety by this paragraph.

Investor Contact

Allison Wey

Senior Vice President, Investor Relations and Corporate Communications

[email protected]

(312) 736-1237

KEYWORDS: United States North America Illinois

INDUSTRY KEYWORDS: Biotechnology Pharmaceutical Health

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Anebulo Pharmaceuticals Announces Initiation of Phase 2 Clinical Study Evaluating ANEB-001 for the Treatment of Acute Cannabinoid Intoxication

Anebulo Pharmaceuticals Announces Initiation of Phase 2 Clinical Study Evaluating ANEB-001 for the Treatment of Acute Cannabinoid Intoxication

Affirms expectations for initial topline results in 1H 2022

Recent FDA pre-IND meeting provides valuable guidance on U.S. regulatory path; company expects to submit IND in 1Q 2022

AUSTIN, Texas–(BUSINESS WIRE)–Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance abuse, announces that the first patient has been dosed in a Phase 2 proof-of-concept clinical study investigating ANEB-001 as a potential treatment for acute cannabinoid intoxication.

In addition, Anebulo recently held a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) during which the company received valuable guidance regarding the clinical development of ANEB-001 in the U.S. Importantly, the FDA noted that a challenge model whereby subjects are exposed to THC in a controlled clinical setting may be acceptable to investigate primary efficacy, which would allow for the more efficient development of ANEB-001. Further, the FDA suggested that Anebulo submit a model-informed drug development (MIDD) paired-meeting request.

“The initiation of our Phase 2 study in the Netherlands represents a significant milestone for Anebulo. We continue to anticipate reporting initial topline results from Part A of this trial in the first half of 2022, as we closely monitor the impact of COVID-19. Despite the recently announced national lockdown in the Netherlands, our CRO is continuing to screen and enroll patients,” stated Daniel Schneeberger, M.D., Chief Executive Officer of Anebulo.

“Additionally, we are pleased with the guidance provided by the FDA regarding ANEB-001’s clinical and regulatory path in the U.S. We were able to rapidly incorporate the FDA’s feedback into the design of the current Phase 2 trial to make the data generated in Europe as relevant as possible for a potential future NDA submission. We expect to file an IND with the FDA during the first quarter of 2022,” he added. “There is a large and growing need to treat acute cannabinoid intoxication with 1.7 million cannabinoid-related emergency department visits in the U.S. in 2018, and we believe ANEB-001 holds potential to reverse symptoms safely and rapidly.”

The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study at a single site in the Netherlands to evaluate ANEB-001 in the inhibition of THC-induced effects. The new trial design anticipates enrolling a total of 60 patients in Part A, randomized 1:1:1 between 50mg of ANEB-001, 100mg of ANEB-001 and placebo. All participants will receive 10.5mg of THC as a challenge drug. The goal of Part A is to deliver clinical proof-of-concept that ANEB-001 can reverse the effects of THC. Part B will enroll additional cohorts and further explore the relationship between THC and ANEB-001 dose levels and clinical efficacy, and provide additional datapoints for pharmacokinetic/pharmacodynamic models. Anebulo believes the ability to quickly adapt the protocol and test additional hypotheses will save time and reduce development risk while designing future trials in 2022.

About Anebulo Pharmaceuticals, Inc.

Anebulo Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance abuse. Its lead product candidate, ANEB-001, is intended to reverse the negative effects of acute cannabinoid intoxication within one hour of administration. ANEB-001 is a competitive antagonist at the human cannabinoid receptor type 1 (CB1) with good oral bioavailability and brain penetration (rat brain:plasma ratio of approximately 1.5). Clinical trials completed to date have shown that ANEB-001 is rapidly absorbed, well tolerated, and may lead to weight loss, an effect that is consistent with CB1 antagonism in the central nervous system. For further information about Anebulo, please visit www.anebulo.com.

Forward-Looking Statements

This press release contains forward-looking statements as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements, along with terms such as “anticipate,” “expect,” “intend,” “may,” “will,” “should” and other comparable terms, involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of Anebulo Pharmaceuticals and members of its management, as well as the assumptions on which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including risks attendant to developing, testing and commercializing the company’s product candidates, and those described in Anebulo Pharmaceutical’s most recent annual report on Form 10-K and in other periodic reports filed with the SEC, and that actual results may differ materially from those contemplated by such forward-looking statements. Except as required by federal securities law, Anebulo Pharmaceuticals undertakes no obligation to update or revise forward-looking statements to reflect changed conditions.

Anebulo Pharmaceuticals, Inc.

Rex Merchant

Chief Financial Officer

(512) 598-0931

[email protected]

LHA Investor Relations

Yvonne Briggs

(310) 691-7100

[email protected]

KEYWORDS: United States North America Texas

INDUSTRY KEYWORDS: Mental Health Health Other Health General Health Clinical Trials Pharmaceutical Biotechnology

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Alnylam to Webcast Presentation at 40th Annual J.P. Morgan Healthcare Conference

Alnylam to Webcast Presentation at 40th Annual J.P. Morgan Healthcare Conference

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that management will present a company overview at the 40th Annual J.P. Morgan Healthcare Conference, being held virtually, on Monday, January 10, 2022 at 9:45 am ET. This presentation will include an update on unaudited fourth quarter and full year 2021 global net product revenues. In addition, the Company will webcast the Q&A breakout session immediately following its presentation at 10:05 am ET.

A live audio webcast of both the presentation and breakout session will be available on the Investors section of the Company’s website, www.alnylam.com/events. A replay will be available on the Alnylam website within 48 hours after the event.

About Alnylam Pharmaceuticals

Alnylam (Nasdaq: ALNY) is leading the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system (CNS)/ocular diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach for the treatment of a wide range of severe and debilitating diseases. Founded in 2002, Alnylam is delivering on a bold vision to turn scientific possibility into reality, with a robust RNAi therapeutics platform. Alnylam’s commercial RNAi therapeutic products are ONPATTRO® (patisiran), GIVLAARI® (givosiran), OXLUMO® (lumasiran), and Leqvio® (inclisiran) being developed and commercialized by Alnylam’s partner Novartis. Alnylam has a deep pipeline of investigational medicines, including six product candidates that are in late-stage development. Alnylam is executing on its “Alnylam P5x25” strategy to deliver transformative medicines in both rare and common diseases benefiting patients around the world through sustainable innovation and exceptional financial performance, resulting in a leading biotech profile. Alnylam is headquartered in Cambridge, MA. For more information about our people, science and pipeline, please visit www.alnylam.com and engage with us on Twitter at @Alnylam, on LinkedIn, or on Instagram.

Alnylam Pharmaceuticals, Inc.

Christine Regan Lindenboom

(Investors and Media)

617-682-4340

Josh Brodsky

(Investors)

617-551-8276

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: FDA Health Genetics Clinical Trials Pharmaceutical Biotechnology

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Concert Pharmaceuticals to Present at H.C. Wainwright BIOCONNECT Virtual Conference

Concert Pharmaceuticals to Present at H.C. Wainwright BIOCONNECT Virtual Conference

LEXINGTON, Mass.–(BUSINESS WIRE)–Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that it will participate at the H.C. Wainwright BIOCONNECT Virtual Conference taking place January 10-13, 2022. The on-demand presentation will be available beginning at 7:00 a.m. ET on January 10, 2022.

The webcast of the presentation may be accessed in the Investors section of the Company’s website at www.concertpharma.com. A replay of the conference webcast will be available on Concert’s website for two weeks following the presentation.

About Concert

Concert Pharmaceuticals is a clinical stage biopharmaceutical company that is developing small molecule drugs that it discovered through the application of its DCE Platform® (deuterated chemical entity platform). Selective incorporation of deuterium into known molecules has the potential, on a case-by-case basis, to provide better pharmacokinetic or metabolic properties, thereby enhancing their clinical safety, tolerability or efficacy. Concert’s lead product candidate is in late-stage development for the treatment of alopecia areata, a serious autoimmune dermatological condition. Concert is also assessing a number of earlier-stage pipeline candidates. For more information please visit www.concertpharma.comor follow us on Twitter at @ConcertPharma or on LinkedIn.

Justine Koenigsberg

(781) 674-5284

[email protected]

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Health Pharmaceutical

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4D pharma appoints John Doyle as Chief Financial Officer

4D pharma appoints John Doyle as Chief Financial Officer

LEEDS, England–(BUSINESS WIRE)–4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, today announces the appointment of John Doyle as Chief Financial Officer (CFO). Mr. Doyle brings over 15 years of experience leading and developing the financial operations, strategy and investor relations functions at public healthcare companies.

“We are delighted to welcome John to 4D pharma at this exciting stage of the company’s growth, following our NASDAQ listing in 2021,” said Duncan Peyton, Chief Executive Officer of 4D pharma. “John’s extensive financial experience in diverse healthcare organizations and transformational events will be invaluable as 4D pharma continues to make progress in the clinic on multiple fronts with our Live Biotherapeutic programs.”

“I am honored to join a company that is committed to delivering a revolutionary class of medicines by harnessing bacteria from the microbiome, said John Doyle, Chief Financial Officer of 4D pharma. “The 4D pharma team has built an impressive pipeline across key areas of high unmet need and I am excited for the opportunity to execute on the company’s growth strategy and financial goals.”

Mr. Doyle joins 4D pharma after serving as CFO at Chiasma Inc., a publicly traded biopharmaceutical company acquired by Amryt Pharma in 2021. Prior to Chiasma, John was Vice President of Finance and Investor Relations at Verastem Inc., a publicly traded biopharmaceutical company. Prior to joining Verastem in February 2018, he served as Head of Financial Planning & Analysis at SimpliVity Corp., a software company that was acquired by Hewlett Packard Enterprises in February 2017. Before that, Mr. Doyle was Director of Business Unit Financial Planning & Analysis, Early Phase Division, at PAREXEL, a publicly traded pharmaceutical contract research organization. Earlier in his career, he served in increasingly senior financial planning and analysis roles at Hologic, Inc., a publicly traded provider of medical diagnostic, surgical and imaging products. Mr. Doyle holds a B.S. in finance from the University of Massachusetts.

About 4D pharma

4D pharma is a world leader in the development of Live Biotherapeutics, a novel and emerging class of drugs, defined by the FDA as biological products that contain a live organism, such as a bacterium, that is applicable to the prevention, treatment or cure of a disease. 4D has developed a proprietary platform, MicroRx®, that rationally identifies Live Biotherapeutics based on a deep understanding of function and mechanism.

4D pharma’s Live Biotherapeutic products (LBPs) are orally delivered single strains of bacteria that are naturally found in the healthy human gut. The Company has five clinical programs, namely a Phase I/II study of MRx0518 in combination with KEYTRUDA® (pembrolizumab) in solid tumors, a Phase I study of MRx0518 in a neoadjuvant setting for patients with solid tumors, a Phase I study of MRx0518 in patients with pancreatic cancer, a Phase I/II study of MRx-4DP0004 in asthma, and Blautix® in Irritable Bowel Syndrome (IBS) which has completed a successful Phase II trial. Preclinical-stage programs include candidates for CNS disease such as Parkinson’s disease and other neurodegenerative conditions. The Company has a research collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, USA, to discover and develop Live Biotherapeutics for vaccines.

For more information, refer to https://www.4dpharmaplc.com

4D pharma

Investor Relations: [email protected]

Singer Capital Markets – Nominated Adviser and Joint Broker +44 (0)20 7496 3000

Philip Davies / James Fischer (Corporate Finance)

Tom Salvesen (Corporate Broking)

Bryan Garnier & Co. Limited – Joint Broker +44 (0)20 7332 2500

Dominic Wilson

Stern Investor Relations, Inc. +1-212-362-1200

Julie Seidel [email protected]

Image Box Communications +44 (0)20 8943 4685

Neil Hunter / Michelle Boxall

[email protected] / [email protected]

6 Degrees

Lynne Dardanell +1-336-202-9689

[email protected]

KEYWORDS: United Kingdom Europe

INDUSTRY KEYWORDS: Oncology Health Other Health Clinical Trials Pharmaceutical Biotechnology

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Garmin acquires Vesper Marine, a leading provider of marine communication equipment and services

Garmin acquires Vesper Marine, a leading provider of marine communication equipment and services

Product portfolio includes award-winning situational awareness and remote monitoring technology

SCHAFFHAUSEN, Switzerland–(BUSINESS WIRE)–
Garmin® Ltd. (NYSE:GRMN), today announced it has acquired Vesper Marine, a privately-held provider of AIS, VHF and vessel monitoring solutions for the marine industry. This acquisition is expected to bolster Garmin’s industry-leading lineup of marine products and technology designed to provide peace of mind and enhanced situational awareness for boaters.

With almost 15 years of experience, Vesper has developed a suite of communication products and solutions for power, sail and workboats, including the award-winning Cortex system. Cortex combines a state-of-the-art VHF radio with Vesper’s unique smartAIS transponder and remote vessel monitoring technology. Vesper’s smartAIS transponders incorporate built-in alarms to alert mariners of potential collisions, dragging anchors and man overboard situations. The company also offers mobile apps to monitor, view and manage a Cortex system or smartAIS transponder for iOS and Android devices.

“Vesper has pioneered a number of innovations in the marine communications space, with recognition across the industry for its emphasis on user-friendly and intuitive interfaces that make it easier to communicate on the water,” said Jarrod Seymour, Garmin vice president, marine segment leader. “Together with the Vesper team, we look forward to providing an unmatched portfolio of integrated marine communications products and services to our customers.”

“We are excited to have the support from a marine technology leader like Garmin,” said Carl Omundsen, Vesper Marine co-founder. “This combination will allow Vesper to expand its capabilities and integration into the marine communication market to make an even greater impact in the boating industry.”

Vesper Marine is headquartered in Auckland, New Zealand and will join Garmin’s existing team and facility located in Auckland. Financial terms of the acquisition will not be released.

Engineered on the inside for life on the outside, Garmin products have revolutionized life for anglers, sailors, mariners and boat enthusiasts everywhere. Committed to developing the most innovative, highest quality and easiest to use marine electronics in the industry, Garmin believes every day is an opportunity to innovate and a chance to beat yesterday. For the seventh consecutive year, Garmin was recently named the Manufacturer of the Year by the National Marine Electronics Association (NMEA). Other Garmin marine brands include Fusion® and Navionics®. For more information, visit Garmin’s virtual pressroom at garmin.com/newsroom, email [email protected], or follow us at facebook.com/garmin, twitter.com/garminnews, instagram.com/garmin or youtube.com/garmin.

About Garmin: Garmin Ltd. (NYSE: GRMN) is incorporated in Switzerland, and its principal subsidiaries are located in the United States, Taiwan and the United Kingdom. Garmin is a registered trademark of Garmin Ltd. or its subsidiaries. All other brands, product names, company names, trademarks and service marks are the properties of their respective owners. All rights reserved.

Notice on Forward-Looking Statements:

This release includes forward-looking statements regarding Garmin Ltd. and its business. Such statements are based on management’s current expectations. The forward-looking events and circumstances discussed in this release may not occur and actual results could differ materially as a result of known and unknown risk factors and uncertainties affecting Garmin, including, but not limited to, the risk factors that are described in the Annual Report on Form 10-K for the year ended December 26, 2020 and the Quarterly Report on Form 10-Q for the quarter ended September 25, 2021, filed by Garmin with the Securities and Exchange Commission (Commission file number 0-31983). A copy of Garmin’s Form 10-K and the Q3 2021 Form 10-Q can be downloaded from https://www.garmin.com/en-US/investors/sec/. No forward-looking statement can be guaranteed. Forward-looking statements speak only as of the date on which they are made and Garmin undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

Carly Hysell

913-397-8200

[email protected]

KEYWORDS: Australia/Oceania Europe Switzerland New Zealand

INDUSTRY KEYWORDS: Technology Mobile/Wireless Engineering Fishing Manufacturing Sailing Sports Telecommunications Powerboating Software Outdoors Hardware Consumer Electronics Satellite

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GOL announces approval of MAP acquisition by the CADE

PR Newswire

SÃO PAULO, Jan. 3, 2022 /PRNewswire/ — GOL Linhas Aéreas Inteligentes S.A. (NYSE: GOL and B3: GOLL4), (“GOL” or “Company”), in addition to the Material Fact disclosed on June 8, 2021 regarding the acquisition of MAP Transportes Aéreos Ltda. by the Company (“Transaction”), informs that, on December 30, 2021, the General Superintendency of the Administrative Council for Economic Defense (“CADE”) issued the Order SG No. 1929/2021 (“Order”) approving the Transaction without restrictions. In accordance with applicable law, the approval decision will become final within 15 calendar days from its publication, with no third-party appeal or summons by the CADE Court. The Order and other documents of public nature about the analysis carried out by CADE may be accessed at the autarchy’s electronic address (www.cade.gov.br).

Investor Relations

[email protected]

www.voegol.com.br/ir

+55(11) 2128-4700

About GOL Linhas Aéreas Inteligentes S.A.

GOL is Brazil’s largest airline, leader in the corporate and leisure segments. Since its founding in 2001, it has been the airline with the lowest unit cost in Latin America, which has enabled the democratization of air transportation. The Company has alliances with American Airlines and Air France-KLM, in addition to making available to Customers many codeshare and interline agreements, bringing more convenience and ease of connections to any place served by these partnerships. With the purpose of “Being First for Everyone”, GOL offers the best travel experience to its passengers, including: the largest inventory of seats and the most legroom; the most complete platform with internet, movies and live TV; and the best loyalty program, SMILES. In cargo transportation, GOLLOG delivers parcels to various regions in Brazil and abroad. The Company has a team of 15,000 highly qualified airline professionals focused on Safety, GOL’s number one value, and operates a standardized fleet of 127 Boeing 737 aircraft. GOL’s shares are traded on the NYSE (GOL) and the B3 (GOLL4). For further information, visit www.voegol.com.br/ir.

Disclaimer

The information contained in this press release has not been subject to any independent audit or review and contains “forward-looking” statements, estimates and projections that relate to future events, which are, by their nature, subject to significant risks and uncertainties. All statements other than statements of historical fact contained in this press release including, without limitation, those regarding GOL’s future financial position and results of operations, strategy, plans, objectives, goals and targets, future developments in the markets in which GOL operates or is seeking to operate, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “will”, “may”, “project”, “estimate”, “anticipate”, “predict”, “seek”, “should” or similar words or expressions, are forward-looking statements. The future events referred to in these forward-looking statements involve known and unknown risks, uncertainties, contingencies and other factors, many of which are beyond GOL’s control, that may cause actual results, performance or events to differ materially from those expressed or implied in these statements. These forward-looking statements are based on numerous assumptions regarding GOL’s present and future business strategies and the environment in which GOL will operate in the future and are not a guarantee of future performance. Such forward-looking statements speak only as at the date on which they are made. None of GOL or any of its affiliates, officers, directors, employees and agents undertakes any duty or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law. None of GOL or any of its affiliates, officers, directors, employees, professional advisors and agents make any representation, warranty or prediction that the results anticipated by such forward-looking statements will be achieved, and such forward-looking statements represent, in each case, only one of many possible scenarios and should not be viewed as the most likely or standard scenario. Although GOL believes that the estimates and projections in these forward-looking statements are reasonable, they may prove materially incorrect and actual results may materially differ. As a result, you should not rely on these forward-looking statements.

 

Cision View original content:https://www.prnewswire.com/news-releases/gol-announces-approval-of-map-acquisition-by-the-cade-301452651.html

SOURCE GOL Linhas Aéreas Inteligentes S.A.

Cardinal Health to Webcast Discussion of Second-Quarter Results for Fiscal Year 2022 on February 3

PR Newswire

DUBLIN, Ohio, Jan. 3, 2022 /PRNewswire/ — Cardinal Health (NYSE: CAH) plans to release second-quarter financial results for its fiscal year 2022 on February 3 prior to the opening of trading on the New York Stock Exchange. The company will webcast a discussion of these results beginning at 8:30 a.m. Eastern.

To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required.  Presentation slides and a webcast replay will be available until February 2, 2023.

Upcoming investor event

Mike Kaufmann, chief executive officer, will present at the 40th Annual J.P. Morgan Healthcare Conference at 10:30 a.m. Eastern, on Monday, January 10, 2022. The presentation will be followed by a Q&A session with Mike Kaufmann and Jason Hollar, chief financial officer. To access more details and to listen to a live webcast of this event, please visit the Investor Relations page at ir.cardinalhealth.com.

About Cardinal Health
Cardinal Health is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for health care facilities. With 50 years in business, operations in more than 35 countries and approximately 44,000 employees globally, Cardinal Health is essential to care. Information about Cardinal Health is available at cardinalhealth.com.

Media:

Erich Timmerman

(847) 887-1487


[email protected]  

Investors:

Kevin Moran

(614) 757-7942


[email protected]     

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/cardinal-health-to-webcast-discussion-of-second-quarter-results-for-fiscal-year-2022-on-february-3-301452019.html

SOURCE Cardinal Health

Immuneering Appoints Rimma Steinhertz, Ph.D., PMP as Vice President, Project and Alliance Management

CAMBRIDGE, Mass., Jan. 03, 2022 (GLOBE NEWSWIRE) — Immuneering Corporation (Nasdaq: IMRX), a biopharmaceutical company advancing a robust pipeline of oncology and neuroscience product candidates that are designed to uniquely disrupt cellular signaling dynamics, today announced the appointment of Rimma Steinhertz, Ph.D., PMP to the newly created position of Vice President, Project and Alliance Management, effective immediately. In this role, Dr. Steinhertz will focus on working with Immuneering’s leadership team as it advances IMM-1-104 as a monotherapy into clinical trials in 2022 and working with potential future partners to advance combination approaches with IMM-1-104 in select patient populations.

“Rimma is a highly accomplished program leader and project manager with decades of experience in preclinical and clinical development for oncology and neurology,” stated Ben Zeskind, Ph.D., Co-Founder and Chief Executive Officer of Immuneering. “We welcome Rimma to the team and look forward to leveraging her broad expertise, deep knowledge of best practices in project management for pharmaceutical R&D, and industry relationships as we steadily advance our robust pipeline of novel product candidates, including IMM-1-104.”

“Immuneering is employing a novel, differentiated approach to drug development and I look forward to supporting the company’s commitment to operational excellence as it transitions from preclinical development into human clinical trials,” noted Dr. Steinhertz.

Dr. Steinhertz joins Immuneering from Glenmark Pharmaceuticals/Ichnos Sciences, Inc., where, since 2019, she served as Executive Director, Global Program Leader, Portfolio & Program Management, Oncology. Previously, from 2016 to 2019, she was the Group Director, External Collaborations, Oncology at Merck & Co., Inc., where she led a group of more than 30 clinical scientists and project managers supporting over 250 combination Phase 1-3 studies in 30+ indications for Keytruda® in co-development with pharmaceutical and biotechnology companies, academic and U.S. government entities. Prior to that, from 2006 through 2015, Dr. Steinhertz held positions of increasing responsibility in the oncology group at Eisai, Inc., most recently serving as Director, Program & Alliance Management, Oncology Business Unit. Earlier in her career, from 2002 to 2006, she held various positions at Johnson & Johnson Pharmaceutical Research & Development, working on several pre-IND assets across multiple indications.

Dr. Steinhertz earned the equivalent of a B.S. in chemical engineering from the Moscow Technological Institute, a B.S. in chemistry from Rhode Island College, a Ph.D. in medicinal/organic chemistry from Boston College and a Project Management Professional (PMP) from the Project Management Institute. She also completed a Postdoctoral Fellowship in medicinal/organic chemistry at Harvard University.

About Immuneering Corporation

Immuneering is a biopharmaceutical company with an emerging pipeline focused on improving patient outcomes across a spectrum of debilitating oncologic and neurologic diseases by applying its deep knowledge of translational bioinformatics to every stage of the drug development process. Immuneering has more than a decade of experience in translational bioinformatics and generating insights into drug mechanisms of action and patient treatment responses. Building on this experience, Immuneering has developed a disease-agnostic platform that enables the company to utilize human data, novel biology and chemistry, and translational planning to create and advance its wholly owned pipeline. Immuneering’s current development programs in oncology are focused on providing potential treatments for patients with solid tumors caused by mutations of oncologic signaling pathways, including the MAPK pathway. Immuneering’s lead product candidate, IMM-1-104, is designed to be a highly selective dual-MEK inhibitor that further disrupts KSR for the treatment of advanced solid tumors in patients harboring RAS mutant tumors. Additionally, Immuneering has six other oncology programs in the discovery stage that are designed to target either the MAPK or mTOR pathway, and two neuroscience programs in the discovery stage.

Forward-Looking Statements

This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding Immuneering’s progress toward drugs targeting cancers driven by alterations that activate the RAS/MAPK pathway, the treatment potential of IMM-1-104, including in combination with other drugs, the timing of regulatory filings for IMM-1-104 with the FDA and commencement of clinical trials for IMM-1-104. Forward-looking statements are based on Immuneering’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, the risks inherent in oncology and neuroscience drug development, including target discovery, target validation, lead compound identification, lead compound optimization, preclinical studies and clinical trials. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the Company’s most recent Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) as well as in Immuneering’s subsequent filings it makes with the SEC. Forward-looking statements contained in this announcement are made as of this date, and Immuneering undertakes no duty to update such information except as required under applicable law.

Corporate Contact:

Rebecca Kusko, Ph.D.
Immuneering Corporation
617-500-8080
[email protected]

Investor Contact:

Susan A. Noonan
S.A. Noonan Communications
917-513-5303
[email protected]



Brown & Brown, Inc. announces the asset acquisition of HARCO Insurance Services and HARCO Financial Services

DAYTONA BEACH, Fla., Jan. 03, 2022 (GLOBE NEWSWIRE) — J. Scott Penny, chief acquisitions officer of Brown & Brown, Inc. (NYSE: BRO), and Christopher (“Chris”) L. Goff, Willis (“Josh”) J. Hargrave, III, and Geraldeen (“Gerri”) Rougeau-Eubank, the principals of HARCO Insurance Services, Inc. d/b/a HARCO Insurance Services and Lone Star Affiliates, Inc. d/b/a HARCO Financial Services (collectively, “HARCO”), today announced that Brown & Brown Lone Star Insurance Services, Inc., a subsidiary of Brown & Brown, Inc., has acquired substantially all of the assets of HARCO.

With roots dating back to 1969, HARCO is a full-service, independent retail insurance agency serving businesses and individuals throughout Texas. Following the acquisition, the HARCO team will continue operating from their existing Houston, Texas office as a branch location of Brown & Brown’s Houston, Texas retail operations. The combined offices will operate under the leadership of Ryan Beavers, executive vice president of Brown & Brown Lone Star Insurance Services, Inc.

Tommy K. Huval, a regional president in Brown & Brown’s Retail segment who oversees various offices in Texas and Louisiana, stated, “Over its long and successful history, HARCO has thrived because of its focus on delivering outstanding service with an eye toward building long-term customer and carrier relationships. We are excited to continue expanding Brown & Brown’s Texas presence and to welcome Josh, Gerri, and Chris, along with the rest of the talented HARCO team, to the Brown & Brown family. I’ve had the privilege of knowing Josh for many years and am pleased with the capabilities of our combined team.”

Hargrave stated, “Our HARCO team is looking forward to joining the Brown & Brown team to further enhance the products, resources, and continued services we provide to our customers. We share common business values and believe the relationship will be most beneficial to all parties, including our valued customers and the insurance companies with which we do business.”

About Brown & Brown, Inc.

Brown & Brown, Inc. (NYSE: BRO) is a leading insurance brokerage firm, delivering risk management solutions to individuals and businesses since 1939. With over 11,000 teammates in more than 300 locations across the U.S. and select global markets, we are committed to providing innovative strategies to help protect what our customers value most. For more information, please visit www.bbinsurance.com.

This press release may contain certain statements relating to future results which are forward-looking statements, including those associated with this acquisition. These statements are not historical facts but instead represent only Brown & Brown’s current belief regarding future events, many of which, by their nature, are inherently uncertain and outside of Brown & Brown’s control. It is possible that Brown & Brown’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements. Further information concerning Brown & Brown and its business, including factors that potentially could materially affect Brown & Brown’s financial results and condition, as well as its other achievements, is contained in Brown & Brown’s filings with the Securities and Exchange Commission. Such factors include those factors relevant to Brown & Brown’s consummation and integration of the announced acquisition, including any matters analyzed in the due diligence process, and material adverse changes in the business and financial condition of the seller, the buyer, or both, and their respective customers. All forward-looking statements made herein are made only as of the date of this release, and Brown & Brown does not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which Brown & Brown hereafter becomes aware.

For more information:

R. Andrew Watts
Chief Financial Officer
(386) 239-5770