Market Newsdesk

January 21, 2021 8:18 am

XBiotech Candidate True Human™ COVID-19 Therapy Found to Target Highly Infectious Emerging Strain

With New Infectious Strain Rapidly Spreading, XBiotech Establishes Data Indicating its Candidate True Human™ COVID-19 Therapy may be Effective for Treating New Mutant Strain

AUSTIN, Texas, Jan. 21, 2021 (GLOBE NEWSWIRE) — XBiotech Inc. (NASDAQ: XBIT) announces that its COVID-19 candidate True Human™ antibody therapy may also be used for treating the COVID-19 mutant virus that recently emerged in the UK and is now rapidly spreading across the US. The mutant COVID-19 virus has alterations to the spike protein that reportedly make the virus more contagious, and these mutations might also enable the virus to escape existing vaccines or therapies. XBiotech’s candidate therapy specifically targets the so-called spike protein of the virus and potently neutralizes the virus’ ability to infect cells. The company analyzed its candidate COVID-19 therapy for its ability to bind the spike protein of the mutant COVID-19 virus and was found to have the same high affinity for spike protein of both the original COVID-19 and mutant COVID-19 viruses. These findings provide quick and convincing evidence that XBiotech’s candidate True Human™ therapy, which was potently effective in neutralizing the original strain of COVID-19, could be expected to be similarly effective at neutralizing the mutant strain of the virus.

The new mutant COVID-19 virus has undergone changes that include small differences in the so-called spike protein of the virus. Scientists at XBiotech used a state-of-the-art method employing bio-layer interferometry to analyze binding of its COVID-19 True Human™ antibody to the spike protein of the mutant strain. These studies showed the antibody bound to the mutant spike protein with same high affinity as it does to the original COVID-19 virus.

Sushma Shivaswamy, Ph.D., XBiotech’s Chief Scientific Officer, commented, “We are extremely excited that our antibody therapy has the capability of treating this new, even more contagious, strain of the virus. I applaud the hard work and dedication of our scientists who are tirelessly working to address emerging needs of this pandemic while keeping us on track to pursue other important diseases.”

The Company previously announced that its candidate True Human™ therapy for COVID-19—isolated from an actual patient that had recovered from the infection—was found to neutralize the virus at concentrations about four-times better than antibodies currently FDA approved under emergency use authorization.

The higher rate of transmission of the mutant COVID-19 virus means that it could quickly become the dominant form of the virus in the US. The CDC in fact predicts the new variant will be the main cause of COVID infections in the USA by March, 2021. A therapy that could be used to treat both COVID-19 and the mutant strains of the virus could be of crucial importance as the mutant virus spreads. The Company has engineered production capable cell lines and is prepared to establish manufacturing processes for clinical development as necessary.

About XBiotech

XBiotech is a fully integrated, global biopharmaceutical company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies. XBiotech currently is advancing a pipeline of therapies by harnessing naturally occurring antibodies from patients with immunity to certain diseases. Utilizing natural human immunity as a source of new medicines offers the potential to redefine the standards of care for a wide range of diseases.

On December 30, 2019 XBiotech sold an IL-1⍺ blocking True Human™ antibody that had been used successfully in a number of clinical trials. The sale of the antibody generated $750 million in upfront cash and up to $600 million in potential milestone payments. The Company retained the right to pursue the development of True Human™ antibodies targeting IL-1⍺ for all areas of medicine outside of dermatology. While the Company previously was focused on a single True Human™ antibody targeting IL-1⍺, it now plans to develop multiple product candidates, which will target IL-1⍺ in specific areas of medicine.

In addition to recent sale of its anti-IL-1⍺ antibody, XBiotech now has other revenue sources. Commencing January 1, 2020 XBiotech began using its proprietary manufacturing technology to produce clinical drug product for a major Pharmaceutical Company under a two-year supply agreement. In addition, XBiotech is providing clinical trial contract research operations to conduct two large, double-blind placebo-controlled Phase II clinical studies. The financial strength generated from the sale and contract operations is enabling XBiotech to expand both its anti-IL-1⍺ product development and infectious disease programs.

To accelerate advance of the Company’s pipeline, the Company is expanding its existing manufacturing and research center, and planning to build an additional 30,000ft²infectious disease research & development center on its 48-acre property in Austin, TX which is wholly owned by the Company. The expansion and new building will be in addition to the present custom-built 33,000ft² combined manufacturing and R&D facility that currently exists on the campus. XBiotech owns the 48-acre campus—and all structures on the property—debt-free and envisions further expansion of facilities. For more information, visit www.xbiotech.com.

About True Human™ Therapeutic Antibodies

XBiotech’s True Human™ antibodies are the only available antibodies derived without modification from humans who possess natural immunity to certain diseases. (Unlike all commercially available antibodies, which are called “Humanized” or “Fully Human”, XBiotech’s True Human™ antibodies are directly sourced from the natural human immune response for specific diseases without modification, and thereby have not been shown to cause immunogenicity.) With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements, including declarations regarding management’s beliefs and expectations that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “would,” “could,” “expects,” “plans,” “contemplate,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “intend” or “continue” or the negative of such terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties are subject to the disclosures set forth in the “Risk Factors” section of certain of our SEC filings. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Contact
Ashley Otero
[email protected]
512-386-2930

January 21, 2021 8:18 am

Argos Cardiac Output Monitor Earns CE Mark Approval

VALHALLA, N.Y., Jan. 21, 2021 (GLOBE NEWSWIRE) — Retia Medical, a leading provider of minimally-invasive hemodynamic monitoring technology today announced it received CE (Conformitè Europëenne) Mark approval for its Argos Cardiac Output Monitor.

Retia’s CEO Marc Zemel stated, “Obtaining the CE mark for the Argos Cardiac Output Monitor is a significant corporate milestone and a testament to the quality of the Argos Monitor and to Retia’s compliance with all applicable European health, safety, performance and environmental requirements.”

Mr. Zemel continued “We are excited to have received this certification as it now enables Retia’s entry into the European market. The ability to distribute a CE-marked Argos Monitor is an important step in advancing care for high-risk patients. Retia’s mission is to make consistently accurate hemodynamic information affordable and available to help clinicians implement consistent care protocols to prevent serious complications such as heart attacks, strokes, acute kidney injuries and others.”

Retia’s Multi-Beat Analysis (MBA™) algorithm offers consistently accurate cardiac output measurements by analyzing multiple heartbeats for each cardiac output calculation. Other monitors use older technology and can only analyze a single beat at a time. Argos’s more consistently accurate cardiac output measurements are especially important for optimizing the care of critically-ill patients receiving fluids or vasopressor drugs in the OR and ICU.

In addition to its unique MBA™ algorithm technology, the Argos monitoring system features several leading-edge innovations, including:

No proprietary disposable sensors required. Unlike other hemodynamic monitors which require use of a costly disposable sensor for each patient, the Argos Monitor simply connects to the existing bedside multi-parameter monitor to obtain the blood pressure waveform. This approach can save each hospital hundreds of thousands of Euros annually.
A simple setup requiring only one interconnect cable to attach the Argos to the existing bedside monitor making it the easiest-to-use cardiac output monitor on the market.
Seamless connection to the hospital Electronic Medical Record (EMR). As more hospitals incorporate EMR systems, they are faced with the challenge of interfacing each separate medical device. To facilitate the transfer of Argos’s hemodynamic parameters to the hospital’s EMR system, Retia Medical recently announced a collaboration with Capsule Technologies. This collaboration will permit simple transfer across many different EMR systems.

As previously announced, the Argos Monitor received FDA 510(k) clearance in December 2018 and Retia Medical received ISO 134385:2016 certification of its quality management system in 2019.

In the United States, the Argos Cardiac Output Monitor is currently utilized in leading institutions such as Johns Hopkins Hospital, Duke University Health System, University Hospitals Cleveland Medical Center, among many others.

For more information on Retia Medical and the Argos Cardiac Output Monitor, visit http://www.retiamedical.com and follow us on Twitter @RetiaMedical and LinkedIn.

The Argos Monitor will be marketed by Metaltronica in Italy. Retia Medical is seeking distribution partnerships throughout Europe; please contact David Hebrank, Vice President of Sales and Business Development at [email protected]

For media inquiries, please contact:

Morris Nguyen
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5fff7d57-a8a5-4cf7-ba1b-2624f678c2eb

January 21, 2021 8:18 am

Establishment Labs to Host Investor Event Featuring Its Motiva Mia System

Establishment Labs to Host Investor Event Featuring Its Motiva Mia System

SANTA BARBARA, Calif.–(BUSINESS WIRE)–
Establishment Labs Holdings Inc. (NASDAQ: ESTA), a medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, today announced it will host a virtual investor event on Feb. 9, 2021 to discuss its Motiva Mia^® system for minimally invasive augmentation, which includes the Motiva Ergonomix2 Diamond^® breast implant.

The Motiva Mia system is designed to offer a minimally invasive breast enhancement procedure in less time, with faster recovery and less pain, and without the need for general anesthesia compared to a traditional breast surgery procedure. During the event, members of the Company’s management team will discuss this innovative technology, as well as the potential market opportunity and proposed commercialization timeline. The event will also feature the participation of Charles Randquist, MD; Prof. Marcos Sforza, MD and Jeffry Fassero, MD, who will share their experiences from the recently completed 30-patient Motiva Mia series in the Company’s IRB approved study.

Event Details

Date: Tuesday, Feb. 9, 2021

Time: 1:00 – 2:30 pm EST

To register: https://establishmentlabs.zoom.us/webinar/register/WN_55ESTwYRTCKbhtVrzkTzfg

After the conclusion of the program, there will be a question and answer session for investors and analysts. A recording of the event will be archived on the Company’s website.

The Motiva Mia^® system is currently not approved for commercial distribution. Motiva Implants^® are undergoing clinical investigation pursuant to U.S. FDA regulations for investigational medical devices.

About Establishment Labs

Establishment Labs Holdings Inc. is a global medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, by designing, developing, manufacturing and marketing an innovative portfolio of silicone gel-filled breast implants, branded as Motiva Implants^®, the centerpiece of the MotivaImagine^® platform. Motiva Implants^® are produced at our two manufacturing sites that are compliant with ISO13485:2016, FDA 21 CFR 820 under the MDSAP program, and are currently commercially available in more than 80 countries through exclusive distributors or the Company’s direct salesforce. In March 2018, Establishment Labs received approval for an investigational device exemption (IDE) from the FDA and initiated the Motiva Implant^® clinical trial in the United States in April 2018. In addition to Motiva Implants^®, Establishment Labs’ product and technologies portfolio includes the Divina^® 3D Simulation System and other products and services. Please visit our website for additional information at www.establishmentlabs.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). You can find many (but not all) of these statements by looking for words such as “approximates,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “would,” “may” or other similar expressions in this press release, and includes statements related to our ongoing clinical trials and our ability to commercialize Motiva Ergonomix implants. Any statements that refer to projections of our future financial or operating performance, anticipated trends in our business, our goals, strategies, focus and plans, and other characterizations of future events or circumstances, including statements related to the performance of the Motiva Mia system and commercial timelines and plans are forward-looking statements. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995. We caution investors that any forward-looking statements presented in this report, or that we may make orally or in writing from time to time, are expressions of our beliefs and expectations based on currently available information at the time such statements are made. Such statements are based on assumptions, and the actual outcome will be affected by known and unknown risks, trends, uncertainties and factors that are beyond our control. Although we believe that our assumptions are reasonable, we cannot guarantee future performance, and some will inevitably prove to be incorrect. As a result, our actual future results may differ from our expectations, and those differences may be material. Factors that could cause or contribute to these differences include, among others, those risks and uncertainties discussed in the Company’s annual report on Form 10-K filed on March 16, 2020, quarterly reports on Form 10-Q, and other filings made by the Company with the Securities and Exchange Commission. The risks included in those documents are not exhaustive, and additional factors could adversely affect our business and financial performance. We operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for us to predict all such risk factors, nor can we assess the impact of all such risk factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. We are not undertaking any obligation to update any forward-looking statements. Accordingly, investors should use caution in relying on past forward-looking statements, which are based on known results and trends at the time they are made, to anticipate future results or trends.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210121005199/en/

Investor/Media Contact:

David K. Erickson

949-447-6671

[email protected]

KEYWORDS: California New York United States North America

INDUSTRY KEYWORDS: General Health Health Surgery Medical Devices

MEDIA:

Logo

January 21, 2021 8:18 am

HOMB Raises the Bar with Best in Class Performance Metrics

CONWAY, Ark., Jan. 21, 2021 (GLOBE NEWSWIRE) — Home BancShares, Inc. (NASDAQ GS: HOMB), parent company of Centennial Bank, released record quarterly earnings today.

Highlights of the Fourth Quarter of 2020:

Metric	Q4 2020	Q3 2020	Q2 2020	Q1 2020	Q4 2019
Net Income	$81.8 million	$69.3 million	$62.8 million	$507,000	$73.3 million
Total Revenue (net)	$181.9 million	$176.1 million	$173.7 million	$162.7 million	$167.8 million
Income (loss) before income taxes	$107.7 million	$90.4 million	$82.1 million	($2.4 million)	$96.5 million
Pre-tax net income, excluding provision for credit losses and unfunded commitment expense (PPNR) (non-GAAP)⁽¹⁾	$107.7 million	$104.4 million	$102.7 million	$92.2 million	$96.5 million
Pre-tax net income to total revenue (net)	59.19%	51.32%	47.25%	-1.49	57.49%
P5_NR (Pre-tax, pre-provision, profit percentage) (PPNR to total revenue (net)) (non-GAAP)⁽¹⁾	59.19%	59.28%	59.15%	56.67%	57.49%
ROA	1.97%	1.66%	1.55%	0.01%	1.94%
ROA (pre-tax net income, excluding provision for credit losses and unfunded commitment expense) (non-GAAP)⁽¹⁾	2.60%	2.50%	2.53%	2.45%	2.56%
ROA, excluding provision for credit losses and unfunded commitment expense (non-GAAP)⁽¹⁾	1.97%	1.91%	1.92%	1.87%	1.94%
NIM	4.00%	3.92%	4.11%	4.22%	4.24%
NIM, excluding PPP loans (non-GAAP)⁽¹⁾	3.97%	3.98%	4.16%	4.22%	4.24%
Purchase Accounting Accretion	$5.7 million	$7.0 million	$7.0 million	$7.6 million	$9.1 million
ROE	12.72%	10.97%	10.27%	0.08%	11.71%
ROTCE (non-GAAP)⁽¹⁾	20.96%	18.29%	17.40%	0.14%	19.55%
Diluted Earnings Per Share	$0.50	$0.42	$0.38	$0.00	$0.44
Non-Performing Assets to Total Assets	0.48%	0.47%	0.39%	0.44%	0.43%
Common Equity Tier 1 Capital	13.4%	12.6%	12.0%	11.5%	12.4%
Leverage	10.8%	10.4%	10.3%	10.8%	11.3%
Tier 1 Capital	14.0%	13.2%	12.6%	12.1%	13.0%
Total Risk-Based Capital	17.8%	16.9%	16.2%	15.7%	16.4%
Allowance for Credit Losses to Total Loans	2.19%	2.12%	1.99%	2.01%	0.94%
Allowance for Credit Losses to Total Loans, excluding PPP loans (non-GAAP)⁽¹⁾	2.33%	2.29%	2.15%	2.01%	0.94%

⁽¹⁾ Calculation of this metric and the reconciliation to GAAP are included in the schedules accompanying this release.

“While 2020 was dark in many ways, the lights were definitely on at Home BancShares,” stated John Allison. “Q1 was an anomaly with the implementation of CECL, but it was followed up with record numbers in quarters two, three and four, and for that, I couldn’t be more pleased,” Allison continued. “Fifty cents earnings per share is a record I’m particularly proud of,” added Allison.

“Our talented team of bankers delivered record net income for the quarter of $81.8 million and our income before income taxes came in strong at $107.7 million,” said Tracy French. “During one of the hardest years for business and the economy, I’m proud of how our bankers worked to assist their customers in their time of need while still churning out impressive best in class numbers throughout the year,” continued French.

Operating Highlights

Net income and earnings per share were quarterly records for the Company. Net income increased $12.5 million, or 17.99%, to $81.8 million for the three-month period ended December 31, 2020, from $69.3 million for the three-month period ended September 30, 2020. Earnings per share increased $0.08 per share, or 19.05%, to $0.50 per share for the three-month period ended December 31, 2020, from $0.42 per share for the three-month period ended September 30, 2020.

During the fourth quarter of 2020, the Company did not record any credit loss expense. The Company’s provisioning model is closely tied to unemployment rate projections which continued to improve through the end of 2020.

Our net interest margin was 4.00% for the three-month period ended December 31, 2020 compared to 3.92% for the three-month period ended September 30, 2020. The yield on loans was 5.33% and 5.24% for the three months ended December 31, 2020 and September 30, 2020, respectively, as average loans decreased from $11.76 billion to $11.46 billion. Additionally, the rate on interest bearing deposits decreased to 0.44% as of December 31, 2020 from 0.54% as of September 30, 2020, with average balances of $9.59 billion and $9.68 billion, respectively.

As of December 31, 2020, we had $691.7 million of Paycheck Protection Program (PPP) loans outstanding. These loans are at 1.00% plus the accretion of the origination fee. Excluding PPP loans, our net interest margin (non-GAAP) for the three-month period ended December 31, 2020 was 3.97%⁽¹⁾. The PPP loans had a 6-basis point accretive impact to the yield on loans, and the PPP loans were accretive to the net interest margin by 3 basis points. This was primarily due to approximately $157.0 million of the Company’s PPP loans being forgiven during the fourth quarter of 2020 as well as the acceleration of deferred fees for the loans that were forgiven. The deferred fee income increased from $3.8 million to $6.9 million for the three-month periods ended September 30, 2020 and December 31, 2020, respectively.
______________________________
(1) Calculation of this metric and the reconciliation to GAAP are included in the schedules accompanying this release.

The COVID-19 pandemic has created a significant amount of excess liquidity in the market. As a result of this excess liquidity, we had an increase of $102.3 million of average interest-bearing cash balances in the fourth quarter of 2020 compared to the third quarter of 2020. This excess liquidity diluted the net interest margin by 3 basis points.

Purchase accounting accretion on acquired loans was $5.7 million and $7.0 million and average purchase accounting loan discounts were $49.6 million and $55.8 million for the three-month periods ended December 31, 2020 and September 30, 2020, respectively. Net amortization of time deposit premiums was $30,000 per quarter and net average remaining time deposit premiums were $146,000 and $176,000 for the three-month periods ended December 31, 2020 and September 30, 2020, respectively.

Net interest income on a fully taxable equivalent basis increased $2.1 million, or 1.4%, to $149.8 million for the three-month period ended December 31, 2020, from $147.7 million for the three-month period ended September 30, 2020. This increase in net interest income for the three-month period ended December 31, 2020 was the result of a $3.0 million decrease in interest expense, which was partially offset by a $875,000 decrease in interest income. The $3.0 million decrease in interest expense was primarily the result of a $2.6 million decrease in interest expense on deposits and a $318,000 decrease in interest expense on FHLB borrowings. The $875,000 decrease in interest income was primarily the result of a $1.4 million decrease in loan interest income, which was partially offset by a $492,000 net increase in investment income.

The Company reported $33.9 million of non-interest income for the fourth quarter of 2020. The most important components of the fourth quarter non-interest income were $10.1 million from mortgage lending income, $8.4 million from other service charges and fees, $5.5 million from service charges on deposit accounts, and $2.6 million from other income. Non-interest income for the fourth quarter of 2020 included a $4.3 million adjustment for the increase in fair market value of marketable securities.

Mortgage lending income was $10.1 million for the three-month period ended December 31, 2020, compared to $10.2 million for the three-month period ended September 30, 2020, as the Company experienced a significant increase in secondary market loan sales in 2020. The housing market continues to benefit from the current low interest rate environment.

Non-interest expense for the fourth quarter of 2020 was $74.2 million. The most important components of the fourth quarter non-interest expense were $43.0 million from salaries and employee benefits, $16.2 million in other expense and $9.8 million in occupancy and equipment expenses. For the fourth quarter of 2020, our efficiency ratio was 39.64%.
______________________________
(1) Calculation of this metric and the reconciliation to GAAP are included in the schedules accompanying this release.

Financial Condition

Total loans receivable were $11.22 billion at December 31, 2020 compared to $11.69 billion at September 30, 2020. Total deposits were $12.73 billion at December 31, 2020 compared to $12.94 billion at September 30, 2020. Total assets were $16.40 billion at December 31, 2020 compared to $16.55 billion at September 30, 2020.

During the fourth quarter 2020, the Company experienced approximately $470.7 million in organic loan decline. Centennial CFG experienced $149.0 million of organic loan decline and had loans of $1.54 billion at December 31, 2020. Our legacy footprint experienced $157.0 million in PPP loan decline and $164.7 million in organic loan decline during the quarter.

Non-performing loans to total loans was 0.66% as of December 31, 2020 compared to 0.63% as of September 30, 2020. Non-performing assets to total assets increased slightly from 0.47% as of September 30, 2020 to 0.48% as of December 31, 2020. For the fourth quarter of 2020, net charge-offs were $2.8 million compared to net charge-offs of $4.1 million for the third quarter of 2020.

Non-performing loans at December 31, 2020 were $24.1 million, $43.1 million, $530,000, $3.6 million and $2.8 million in the Arkansas, Florida, Alabama, Shore Premier Finance and Centennial CFG markets, respectively, for a total of $74.1 million. Non-performing assets at December 31, 2020 were $25.6 million, $46.0 million, $564,000, $3.6 million and $2.8 million in the Arkansas, Florida, Alabama, Shore Premier Finance and Centennial CFG markets, respectively, for a total of $78.6 million.

The Company’s allowance for credit losses on loans was $245.5 million at December 31, 2020, or 2.19% of total loans, compared to the allowance for loan losses of $248.2 million, or 2.12% of total loans, at September 30, 2020. The Company’s allowance for credit losses on loans to total loans, excluding PPP loans (non-GAAP), was 2.33%⁽¹⁾ at December 31, 2020. As of December 31, 2020 and September 30, 2020, the Company’s allowance for credit losses on loans and allowance for loan losses was 331.10% and 336.42% of its total non-performing loans, respectively.

Stockholders’ equity was $2.61 billion at December 31, 2020 compared to $2.54 billion at September 30, 2020, an increase of approximately $65.0 million. The increase in stockholders’ equity is primarily associated with the $58.7 million increase in retained earnings. Book value per common share was $15.78 at December 31, 2020 compared to $15.38 at September 30, 2020. Tangible book value per common share (non-GAAP) was $9.70⁽¹⁾ at December 31, 2020 compared to $9.30⁽¹⁾ at September 30, 2020, an increase of 17.11% on an annualized basis.
______________________________
(1) Calculation of this metric and the reconciliation to GAAP are included in the schedules accompanying this release.

Branches

The Company currently has 77 branches in Arkansas, 78 branches in Florida, 5 branches in Alabama and one branch in New York City.

Conference Call

Management will conduct a conference call to review this information at 1:00 p.m. CT (2:00 ET) on Thursday, January 21, 2021. We encourage all participants to pre-register for the conference call using the following link: https://dpregister.com/sreg/10150658/df97bab01e. Callers who pre-register will be given dial-in instructions and a unique PIN to gain immediate access to the live call. Participants may pre-register now, or at any time prior to the call, and will immediately receive simple instructions via email. The Home BancShares conference call will also be automatically scheduled as an event in your Outlook calendar.

Those without internet access or unable to pre-register may dial in and listen to the live call by calling 1-877-508-9586 and asking for the Home BancShares conference call. A replay of the call will be available by calling 1-877-344-7529, Passcode: 10150658, which will be available until January 28, 2021 at 10:59 p.m. CT (11:59 ET). Internet access to the call will be available live or in recorded version on the Company’s website at www.homebancshares.com under “Investor Relations” for 12 months.

Non-GAAP Financial Measures

This press release contains financial information determined by methods other than in accordance with generally accepted accounting principles (GAAP). The Company’s management uses these non-GAAP financial measures–including net income (earnings), as adjusted; pre-tax net income, excluding provision for credit losses and unfunded commitment expense; pre-tax, pre-provision, profit percentage; diluted earnings per common share, as adjusted; return on average assets, as adjusted; return on average assets (pre-tax net income, excluding provision for credit losses and unfunded commitment expense); return on average assets, excluding provision for credit losses and unfunded commitment expense; return on average common equity, as adjusted; return on average tangible common equity; return on average tangible common equity, as adjusted; efficiency ratio, as adjusted; net interest margin, excluding PPP loans; allowance for credit losses to total loans, excluding PPP loans; tangible book value per common share and tangible common equity to tangible assets–to provide meaningful supplemental information regarding our performance. These measures typically adjust GAAP performance measures to include the tax benefit associated with revenue items that are tax-exempt, as well as adjust income available to common shareholders for certain significant items or transactions (including the effect of the PPP loans) that management believes are not indicative of the Company’s primary business operating results. Since the presentation of these GAAP performance measures and their impact differ between companies, management believes presentations of these non-GAAP financial measures provide useful supplemental information that is essential to a proper understanding of the operating results of the Company’s business. These non-GAAP disclosures should not be viewed as a substitute for operating results determined in accordance with GAAP, nor are they necessarily comparable to non-GAAP performance measures that may be presented by other companies. Where non-GAAP financial measures are used, the comparable GAAP financial measure, as well as the reconciliation to the comparable GAAP financial measure, can be found in the tables of this release.

General

This release may contain forward-looking statements regarding the Company’s plans, expectations, goals and outlook for the future. Statements in this press release that are not historical facts should be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements of this type speak only as of the date of this news release. By nature, forward-looking statements involve inherent risk and uncertainties. Various factors could cause actual results to differ materially from those contemplated by the forward-looking statements. These factors include, but are not limited to, the following: economic conditions, credit quality, interest rates, loan demand, real estate values and unemployment; disruptions, uncertainties and related effects on our business and operations as a result of the ongoing coronavirus (COVID-19) pandemic and measures that have been or may be implemented or imposed in response to the pandemic, including the impact on, among other things, credit quality and liquidity; the ability to identify, complete and successfully integrate new acquisitions; legislative and regulatory changes and risks and expenses associated with current and future legislation and regulations, including those in response to the COVID-19 pandemic; technological changes and cybersecurity risks; the effects of changes in accounting policies and practices, including from the adoption of the current expected credit loss (CECL) model on January 1, 2020; changes in governmental monetary and fiscal policies; political instability; competition from other financial institutions; potential claims, expenses and other adverse effects related to current or future litigation, regulatory examinations or other government actions; changes in the assumptions used in making the forward-looking statements; and other factors described in reports we file with the Securities and Exchange Commission (the “SEC”), including those factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on February 26, 2020, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 5, 2020.

Home BancShares, Inc. is a bank holding company, headquartered in Conway, Arkansas. Its wholly-owned subsidiary, Centennial Bank, provides a broad range of commercial and retail banking plus related financial services to businesses, real estate developers, investors, individuals and municipalities. Centennial Bank has branch locations in Arkansas, Florida, South Alabama and New York City. The Company’s common stock is traded through the NASDAQ Global Select Market under the symbol “HOMB.”

FOR MORE INFORMATION CONTACT:
Donna Townsell
Director of Investor Relations
Home BancShares, Inc.
(501) 328-4625

Home BancShares, Inc.

Consolidated End of Period Balance Sheets

(Unaudited)

	Dec. 31,			Sep. 30,			Jun. 30,			Mar. 31,			Dec. 31,
(In thousands)	2020			2020			2020			2020			2019

ASSETS

Cash and due from banks	$	242,173		$	144,197		$	185,047		$	147,200		$	168,914
Interest-bearing deposits with other banks		1,021,615			899,140			1,030,609			424,235			321,687
Cash and cash equivalents		1,263,788			1,043,337			1,215,656			571,435			490,601
Investment securities – available-for-sale, net of allowance for credit losses		2,473,781			2,361,900			2,238,005			2,098,000			2,083,838
Loans receivable		11,220,721			11,691,470			11,955,743			11,384,982			10,869,710
Allowance for credit losses		(245,473	)		(248,224	)		(238,340	)		(228,923	)		(102,122	)
Loans receivable, net		10,975,248			11,443,246			11,717,403			11,156,059			10,767,588
Bank premises and equipment, net		278,614			280,364			279,498			281,795			280,103
Foreclosed assets held for sale		4,420			4,322			6,292			8,204			9,143
Cash value of life insurance		103,519			102,989			102,443			103,120			102,562
Accrued interest receivable		60,528			72,599			80,274			50,295			45,086
Deferred tax asset, net		70,249			75,167			74,333			77,110			44,301
Goodwill		973,025			973,025			973,025			973,025			958,408
Core deposit and other intangibles		30,728			32,149			33,569			35,055			36,572
Other assets		164,904			160,660			174,908			177,634			213,845
Total assets	$	16,398,804		$	16,549,758		$	16,895,406		$	15,531,732		$	15,032,047

LIABILITIES AND STOCKHOLDERS’ EQUITY

Liabilities
Deposits:
Demand and non-interest-bearing	$	3,266,753		$	3,207,967		$	3,413,727		$	2,425,036		$	2,367,091
Savings and interest-bearing transaction accounts		8,212,240			8,011,200			7,970,979			7,149,644			6,933,964
Time deposits		1,246,797			1,718,299			1,793,230			1,940,234			1,977,328
Total deposits		12,725,790			12,937,466			13,177,936			11,514,914			11,278,383
Federal funds purchased		–			–			–			–			5,000
Securities sold under agreements to repurchase		168,931			158,447			162,858			126,884			143,727
FHLB and other borrowed funds		400,000			403,428			531,432			951,436			621,439
Accrued interest payable and other liabilities		127,999			139,485			161,095			138,479			102,410
Subordinated debentures		370,326			370,133			369,939			369,748			369,557
Total liabilities		13,793,046			14,008,959			14,403,260			13,101,461			12,520,516

Stockholders’ equity
Common stock		1,651			1,652			1,652			1,651			1,664
Capital surplus		1,520,617			1,520,103			1,518,631			1,516,151			1,537,091
Retained earnings		1,039,370			980,699			932,856			891,498			956,555
Accumulated other comprehensive (loss) income		44,120			38,345			39,007			20,971			16,221
Total stockholders’ equity		2,605,758			2,540,799			2,492,146			2,430,271			2,511,531
Total liabilities and stockholders’ equity	$	16,398,804		$	16,549,758		$	16,895,406		$	15,531,732		$	15,032,047

Home BancShares, Inc.

Consolidated Statements of Income

(Unaudited)

	Quarter Ended													Year Ended
	Dec. 31,		Sep. 30,			Jun. 30,		Mar. 31,			Dec. 31,			Dec. 31,			Dec. 31,
(In thousands)	2020		2020			2020		2020			2019			2020			2019

Interest income
Loans	$	153,407	$	154,787		$	158,996	$	158,148		$	161,211		$	625,338		$	658,345
Investment securities
Taxable		6,900		7,227			8,693		9,776			9,707			32,596			41,406
Tax-exempt		4,979		4,367			3,698		3,114			3,260			16,158			13,015
Deposits – other banks		270		252			211		1,116			949			1,849			5,188
Federal funds sold		–		–			–		21			5			21			34
Total interest income		165,556		166,633			171,598		172,175			175,132			675,962			717,988

Interest expense
Interest on deposits		10,596		13,200			15,116		24,198			26,823			63,110			114,104
Federal funds purchased		–		–			–		13			33			13			54
FHLB borrowed funds		1,917		2,235			2,656		2,698			2,686			9,506			17,209
Securities sold under agreements to repurchase		208		237			260		462			652			1,167			2,544
Subordinated debentures		4,810		4,823			4,899		5,079			5,155			19,611			20,860
Total interest expense		17,531		20,495			22,931		32,450			35,349			93,407			154,771

Net interest income		148,025		146,138			148,667		139,725			139,783			582,555			563,217

Provision for credit loss – loans		–		14,000			11,441		76,672			–			102,113			1,325
Provision for credit loss – acquired loans		–		–			–		9,309			–			9,309			–
Provision for credit loss – investment securities		–		–			–		842			–			842			–
Total credit loss expense		–		14,000			11,441		86,823			–			112,264			1,325

Net interest income after provision for credit losses		148,025		132,138			137,226		52,902			139,783			470,291			561,892

Non-interest income
Service charges on deposit accounts		5,544		4,910			4,296		6,631			6,778			21,381			25,930
Other service charges and fees		8,425		8,539			7,666		6,056			10,636			30,686			34,086
Trust fees		420		378			397		438			390			1,633			1,566
Mortgage lending income		10,071		10,177			6,196		2,621			3,801			29,065			14,303
Insurance commissions		366		271			533		678			551			1,848			2,278
Increase in cash value of life insurance		534		548			558		560			562			2,200			2,752
Dividends from FHLB, FRB, FNBB & other		967		3,433			230		7,842			1,952			12,472			7,707
Gain on SBA loans		304		–			–		341			686			645			1,573
Gain (loss) on branches, equipment and other assets, net		217		(27	)		54		82			35			326			(3	)
Gain on OREO, net		150		470			235		277			159			1,132			757
Loss on securities, net		–		–			–		–			(2	)		–			(2	)
Fair value adjustment for marketable securities		4,271		(1,350	)		919		(5,818	)		–			(1,978	)		–
Other income		2,616		2,602			3,939		3,219			2,481			12,376			8,569
Total non-interest income		33,885		29,951			25,023		22,927			28,029			111,786			99,516

Non-interest expense
Salaries and employee benefits		43,022		41,511			40,088		39,329			38,446			163,950			154,177
Occupancy and equipment		9,801		9,566			10,172		8,873			8,729			38,412			35,452
Data processing expense		5,171		4,921			4,614		4,326			4,294			19,032			16,161
Other operating expenses		16,247		15,714			25,298		25,721			19,873			82,980			69,997
Total non-interest expense		74,241		71,712			80,172		78,249			71,342			304,374			275,787

Income (loss) before income taxes		107,669		90,377			82,077		(2,420	)		96,470			277,703			385,621
Income tax expense (benefit)		25,875		21,057			19,250		(2,927	)		23,208			63,255			96,082
Net income	$	81,794	$	69,320		$	62,827	$	507		$	73,262		$	214,448		$	289,539

Home BancShares, Inc.

Selected Financial Information

(Unaudited)

	Quarter Ended															Year Ended
	Dec. 31,			Sep. 30,			Jun. 30,			Mar. 31,			Dec. 31,			Dec. 31,			Dec. 31,
(Dollars and shares in thousands, except per share data)	2020			2020			2020			2020			2019			2020			2019

PER SHARE DATA

Diluted earnings per common share	$	0.50		$	0.42		$	0.38		$	–		$	0.44		$	1.30		$	1.73
Diluted earnings per common share, as adjusted, excluding fair value adjustment for marketable securities, special dividend from equity investment, provision for credit losses, branch write-off expense, unfunded commitment expense, outsourced special project expense, merger and acquisition expenses, FDIC Small Bank Assessment Credit, hurricane expense and BOLI redemption tax (non-GAAP)⁽¹⁾		0.48			0.47			0.47			0.43			0.44			1.85			1.74
Basic earnings per common share		0.50			0.42			0.38			–			0.44			1.30			1.73
Dividends per share – common		0.1400			0.1300			0.1300			0.1300			0.1300			0.5300			0.5100
Book value per common share		15.78			15.38			15.09			14.72			15.10			15.78			15.10
Tangible book value per common share (non-GAAP)⁽¹⁾		9.70			9.30			8.99			8.61			9.12			9.70			9.12

STOCK INFORMATION

Average common shares outstanding		165,119			165,200			165,163			166,014			166,696			165,373			167,804
Average diluted shares outstanding		165,119			165,200			165,163			166,014			166,696			165,373			167,804
End of period common shares outstanding		165,095			165,163			165,206			165,148			166,373			165,095			166,373

ANNUALIZED PERFORMANCE METRICS

Return on average assets		1.97	%		1.66	%		1.55	%		0.01	%		1.94	%		1.33	%		1.93	%
Return on average assets excluding fair value adjustment for marketable securities, special dividend from equity investment, provision for credit losses, branch write-off expense, unfunded commitment expense, outsourced special project expense, merger and acquisition expenses, FDIC Small Bank Assessment Credit, hurricane expense and BOLI redemption tax: (ROA, as adjusted) (non-GAAP)⁽¹⁾		1.90	%		1.88	%		1.93	%		1.88	%		1.94	%		1.90	%		1.94	%
Return on average assets excluding intangible amortization (non-GAAP)⁽¹⁾		2.13	%		1.80	%		1.68	%		0.05	%		2.12	%		1.45	%		2.10	%
Return on average common equity		12.72	%		10.97	%		10.27	%		0.08	%		11.71	%		8.57	%		12.01	%
Return on average common equity excluding fair value adjustment for marketable securities, special dividend from equity investment, provision for credit losses, branch write-off expense, unfunded commitment expense, outsourced special project expense, merger and acquisition expenses, FDIC Small Bank Assessment Credit, hurricane expense and BOLI redemption tax: (ROE, as adjusted) (non-GAAP)⁽¹⁾		12.23	%		12.39	%		12.77	%		11.48	%		11.68	%		12.22	%		12.11	%
Return on average tangible common equity (non-GAAP)⁽¹⁾		20.96	%		18.29	%		17.40	%		0.14	%		19.55	%		14.31	%		20.49	%
Return on average tangible common equity excluding intangible amortization (non-GAAP)⁽¹⁾		21.22	%		18.56	%		17.70	%		0.44	%		19.86	%		14.59	%		20.83	%
Return on average tangible common equity excluding fair value adjustment for marketable securities, special dividend from equity investment, provision for credit losses, branch write-off expense, unfunded commitment expense, outsourced special project expense, merger and acquisition expenses, FDIC Small Bank Assessment Credit, hurricane expense and BOLI redemption tax: (ROTCE, as adjusted) (non-GAAP)⁽¹⁾		20.15	%		20.66	%		21.63	%		19.22	%		19.51	%		20.41	%		20.67	%

(1) Calculation of this metric and the reconciliation to GAAP are included in the schedules accompanying this release.

Home BancShares, Inc.

Selected Financial Information

(Unaudited)

	Quarter Ended															Year Ended
(Dollars and shares in thousands,	Dec. 31,			Sep. 30,			Jun. 30,			Mar. 31,			Dec. 31,			Dec. 31,			Dec. 31,
except per share data)	2020			2020			2020			2020			2019			2020			2019


Efficiency ratio		39.64	%		39.56	%		44.93	%		46.82	%		41.26	%		42.63	%		40.34	%
Efficiency ratio, as adjusted (non-GAAP)⁽¹⁾		40.67	%		40.08	%		39.38	%		41.37	%		41.14	%		40.36	%		40.55	%
Net interest margin – FTE		4.00	%		3.92	%		4.11	%		4.22	%		4.24	%		4.02	%		4.29	%
Net interest margin – FTE, excluding PPP loans (non-GAAP)⁽¹⁾		3.97	%		3.98	%		4.16	%		4.22	%		4.24	%		4.04	%		4.29	%
Fully taxable equivalent adjustment	$	1,778		$	1,576		$	1,434		$	1,227		$	1,322		$	6,015		$	5,255
Total revenue (net)		181,910			176,089			173,690			162,652			167,812			694,341			662,733
Pre-tax net income, excluding provision for credit losses and unfunded commitment expense (PPNR) (non-GAAP)⁽¹⁾		107,669			104,377			102,732			92,178			96,470			406,956			386,946
Pre-tax net income to total revenue (net)		59.19	%		51.32	%		47.25	%		-1.49	%		57.49	%		40.00	%		58.19	%
P5_NR (Pre-tax, pre-provision, profit percentage) (PPNR to total revenue (net)) (non-GAAP)⁽¹⁾		59.19	%		59.28	%		59.15	%		56.67	%		57.49	%		58.61	%		58.39	%
Net income, excluding provision for credit losses and unfunded commitment expense		81,794			79,661			78,084			70,382			73,262			309,921			290,522
Return on average assets (pre-tax net income, excluding provision for credit losses and unfunded commitment expense) (non-GAAP)⁽¹⁾		2.60	%		2.50	%		2.53	%		2.45	%		2.56	%		2.52	%		2.57	%
Return on average assets, excluding provision for credit losses and unfunded commitment expense (non-GAAP)⁽¹⁾		1.97	%		1.91	%		1.92	%		1.87	%		1.94	%		1.92	%		1.93	%
Total purchase accounting accretion		5,736			6,957			7,036			7,647			9,133			27,376			35,890
Average purchase accounting loan discounts		49,563			55,835			62,822			69,365			91,869			59,406			114,521


OTHER OPERATING EXPENSES

Advertising	$	1,076		$	902		$	795		$	1,226		$	1,340		$	3,999		$	4,687
Merger and acquisition expenses		–			–			–			711			–			711			–
Amortization of intangibles		1,421			1,420			1,486			1,517			1,565			5,844			6,324
Electronic banking expense		2,282			2,426			2,054			1,715			1,870			8,477			7,525
Directors’ fees		359			429			412			424			396			1,624			1,602
Due from bank service charges		254			259			239			223			289			975			1,081
FDIC and state assessment		1,493			1,607			1,846			1,548			1,635			6,494			4,468
Hurricane expense		–			–			–			–			–			–			897
Insurance		795			766			711			746			790			3,018			2,846
Legal and accounting		790			1,235			1,278			919			1,633			4,222			5,017
Other professional fees		1,528			1,661			1,735			3,226			3,189			8,150			10,213
Operating supplies		440			460			553			535			469			1,988			2,021
Postage		315			328			313			327			327			1,283			1,266
Telephone		347			321			310			324			312			1,302			1,210
Unfunded commitments		–			–			9,214			7,775			–			16,989			–
Other expense		5,147			3,900			4,352			4,505			6,058			17,904			20,840

Total other operating expenses	$	16,247		$	15,714		$	25,298		$	25,721		$	19,873		$	82,980		$	69,997

(1) Calculation of this metric and the reconciliation to GAAP are included in the schedules accompanying this release.

Home BancShares, Inc.

Selected Financial Information

(Unaudited)

	Dec. 31,			Sep. 30,			Jun. 30,			Mar. 31,			Dec. 31,
(Dollars in thousands)	2020			2020			2020			2020			2019

BALANCE SHEET RATIOS

Total loans to total deposits		88.17	%		90.37	%		90.73	%		98.87	%		96.38	%
Common equity to assets		15.89	%		15.35	%		14.75	%		15.65	%		16.71	%
Tangible common equity to tangible assets (non-GAAP)⁽¹⁾		10.41	%		9.88	%		9.35	%		9.79	%		10.80	%

LOANS RECEIVABLE

Real estate
Commercial real estate loans
Non-farm/non-residential	$	4,429,060		$	4,342,141		$	4,325,795		$	4,357,007		$	4,412,769
Construction/land development		1,562,298			1,748,928			1,818,151			1,892,394			1,776,689
Agricultural		114,431			89,476			105,554			89,630			88,400
Residential real estate loans
Residential 1-4 family		1,536,257			1,665,628			1,730,716			1,775,610			1,819,221
Multifamily residential		536,538			491,380			482,635			411,960			488,278
Total real estate		8,178,584			8,337,553			8,462,851			8,526,601			8,585,357
Consumer		864,690			883,568			851,344			852,174			511,909
Commercial and industrial		1,896,442			2,161,818			2,228,816			1,759,752			1,528,003
Agricultural		66,869			85,365			80,023			64,582			63,644
Other		214,136			223,166			332,709			181,873			180,797
Loans receivable	$	11,220,721		$	11,691,470		$	11,955,743		$	11,384,982		$	10,869,710

Paycheck Protection Program (PPP) loans (included in total loans receivable)		691,747			848,745			848,628			–			–

ALLOWANCE FOR CREDIT LOSSES

Balance, beginning of period	$	248,224		$	238,340		$	228,923		$	102,122		$	104,304
Impact of adopting ASC 326		–			–			–			43,988			–
Allowance for credit losses on acquired loans		–			–			–			357			–
Loans charged off		3,040			4,599			2,582			4,265			2,631
Recoveries of loans previously charged off		289			483			558			740			449
Net loans (recovered)/charged off		2,751			4,116			2,024			3,525			2,182
Provision for credit loss – loans		–			14,000			11,441			76,672			–
Provision for credit loss – acquired loans		–			–			–			9,309			–
Total credit loss expense excluding provision for credit loss – investment securities		–			14,000			11,441			85,981			–
Balance, end of period	$	245,473		$	248,224		$	238,340		$	228,923		$	102,122

Net (recoveries) charge-offs to average total loans		0.10	%		0.14	%		0.07	%		0.13	%		0.08	%
Allowance for credit losses to total loans		2.19	%		2.12	%		1.99	%		2.01	%		0.94	%
Allowance for credit losses to total loans, excluding PPP loans		2.33	%		2.29	%		2.15	%		2.01	%		0.94	%

NON-PERFORMING ASSETS

Non-performing loans
Non-accrual loans	$	64,528		$	65,148		$	52,074		$	52,131		$	47,607
Loans past due 90 days or more		9,610			8,635			7,824			7,760			7,238
Total non-performing loans		74,138			73,783			59,898			59,891			54,845
Other non-performing assets
Foreclosed assets held for sale, net		4,420			4,322			6,292			8,204			9,143
Other non-performing assets		–			247			247			447			447
Total other non-performing assets		4,420			4,569			6,539			8,651			9,590
Total non-performing assets	$	78,558		$	78,352		$	66,437		$	68,542		$	64,435

Allowance for credit losses for loans to non-performing loans		331.10	%		336.42	%		397.91	%		382.23	%		186.20	%
Non-performing loans to total loans		0.66	%		0.63	%		0.50	%		0.53	%		0.50	%
Non-performing assets to total assets		0.48	%		0.47	%		0.39	%		0.44	%		0.43	%

(1) Calculation of this metric and the reconciliation to GAAP is included in the schedules accompanying this release.

Home BancShares, Inc.

Consolidated Net Interest Margin

(Unaudited)

	Three Months Ended
	December 31, 2020						September 30, 2020
	Average		Income/		Yield/		Average		Income/		Yield/
(Dollars in thousands)	Balance		Expense		Rate		Balance		Expense		Rate

ASSETS
Earning assets
Interest-bearing balances due from banks	$	1,029,047	$	270	0.10	%	$	926,754	$	252	0.11	%
Federal funds sold		5		–	0.00	%		124		–	0.00	%
Investment securities – taxable		1,615,214		6,900	1.70	%		1,618,058		7,227	1.78	%
Investment securities – non-taxable – FTE		798,402		6,550	3.26	%		672,067		5,731	3.39	%
Loans receivable – FTE		11,457,713		153,614	5.33	%		11,758,143		154,999	5.24	%
Total interest-earning assets		14,900,381		167,334	4.47	%		14,975,146		168,209	4.47	%
Non-earning assets		1,592,685						1,619,349
Total assets	$	16,493,066					$	16,594,495

LIABILITIES AND SHAREHOLDERS’ EQUITY
Liabilities
Interest-bearing liabilities
Savings and interest-bearing transaction accounts	$	8,109,111	$	5,813	0.29	%	$	7,937,412	$	6,651	0.33	%
Time deposits		1,483,049		4,783	1.28	%		1,745,279		6,549	1.49	%
Total interest-bearing deposits		9,592,160		10,596	0.44	%		9,682,691		13,200	0.54	%
Federal funds purchased		–		–	0.00	%		–		–	0.00	%
Securities sold under agreement to repurchase		156,198		208	0.53	%		157,172		237	0.60	%
FHLB borrowed funds		400,001		1,917	1.91	%		464,799		2,235	1.91	%
Subordinated debentures		370,232		4,810	5.17	%		370,038		4,823	5.19	%
Total interest-bearing liabilities		10,518,591		17,531	0.66	%		10,674,700		20,495	0.76	%
Non-interest bearing liabilities
Non-interest bearing deposits		3,279,708						3,259,501
Other liabilities		137,516						146,502
Total liabilities		13,935,815						14,080,703
Shareholders’ equity		2,557,251						2,513,792
Total liabilities and shareholders’ equity	$	16,493,066					$	16,594,495
Net interest spread					3.81	%					3.71	%
Net interest income and margin – FTE			$	149,803	4.00	%			$	147,714	3.92	%

Home BancShares, Inc.

Consolidated Net Interest Margin

(Unaudited)

	Year Ended
	December 31, 2020						December 31, 2019
	Average		Income/		Yield/		Average		Income/		Yield/
(Dollars in thousands)	Balance		Expense		Rate		Balance		Expense		Rate

ASSETS
Earning assets
Interest-bearing balances due from banks	$	921,189	$	1,849	0.20	%	$	254,548	$	5,188	2.04	%
Federal funds sold		1,330		21	1.58	%		1,421		34	2.39	%
Investment securities – taxable		1,653,159		32,596	1.97	%		1,663,512		41,406	2.49	%
Investment securities – non-taxable – FTE		577,444		21,263	3.68	%		379,232		17,026	4.49	%
Loans receivable – FTE		11,504,123		626,249	5.44	%		10,961,599		659,589	6.02	%
Total interest-earning assets		14,657,245		681,978	4.65	%		13,260,312		723,243	5.45	%
Non-earning assets		1,480,049						1,768,188
Total assets	$	16,137,294					$	15,028,500

LIABILITIES AND SHAREHOLDERS’ EQUITY
Liabilities
Interest-bearing liabilities
Savings and interest-bearing transaction accounts	$	7,686,621	$	36,085	0.47	%	$	6,674,493	$	77,194	1.16	%
Time deposits		1,756,138		27,026	1.54	%		1,972,040		36,910	1.87	%
Total interest-bearing deposits		9,442,759		63,111	0.67	%		8,646,533		114,104	1.32	%
Federal funds purchased		1,557		13	0.83	%		2,895		54	1.87	%
Securities sold under agreement to repurchase		151,573		1,167	0.77	%		149,665		2,544	1.70	%
FHLB borrowed funds		534,608		9,506	1.78	%		848,969		17,209	2.03	%
Subordinated debentures		369,943		19,611	5.30	%		369,175		20,860	5.65	%
Total interest-bearing liabilities		10,500,440		93,408	0.89	%		10,017,237		154,771	1.55	%
Non-interest bearing liabilities
Non-interest bearing deposits		2,998,560						2,489,254
Other liabilities		135,094						111,156
Total liabilities		13,634,094						12,617,647
Shareholders’ equity		2,503,200						2,410,853
Total liabilities and shareholders’ equity	$	16,137,294					$	15,028,500
Net interest spread					3.76	%					3.90	%
Net interest income and margin – FTE			$	588,570	4.02	%			$	568,472	4.29	%

Home BancShares, Inc.

Non-GAAP Reconciliations

(Unaudited)

	Quarter Ended															Year Ended
(Dollars and shares in thousands,	Dec. 31,			Sep. 30,			Jun. 30,			Mar. 31,			Dec. 31,			Dec. 31,			Dec. 31,
except per share data)	2020			2020			2020			2020			2019			2020			2019

EARNINGS, AS ADJUSTED

GAAP net income available to common shareholders (A)	$	81,794		$	69,320		$	62,827		$	507		$	73,262		$	214,448		$	289,539
Pre-tax adjustments
Fair value adjustment for marketable securities		(4,271	)		1,350			(919	)		5,818			–			1,978			–
Special dividend from equity investment		–			(3,181	)		–			(7,004	)		(861	)		(10,185	)		(2,995	)
Provision for credit losses		–			14,000			11,441			86,823			–			112,264			1,325
Branch write-off expense		–			–			981			–			–			981			–
Unfunded commitment expense		–			–			9,214			7,775			–			16,989			–
Outsourced special project expense		–			–			–			1,092			631			1,092			1,531
Merger and acquisition expenses		–			–			–			711			–			711			–
FDIC Small Bank Assessment Credit		–			–			–			–			–			–			(2,291	)
Hurricane expenses		–			–			–			–			–			–			897
Total pre-tax adjustments		(4,271	)		12,169			20,717			95,215			(230	)		123,830			(1,533	)
Tax-effect of adjustments		(1,116	)		3,181			5,414			24,884			(59	)		32,363			(396	)
Adjustments after-tax		(3,155	)		8,988			15,303			70,331			(171	)		91,467			(1,137	)
BOLI redemption tax		–			–			–			–			–			–			3,667
Total adjustments after-tax (B)		(3,155	)		8,988			15,303			70,331			(171	)		91,467			2,530
Earnings, as adjusted (C)	$	78,639		$	78,308		$	78,130		$	70,838		$	73,091		$	305,915		$	292,069

Average diluted shares outstanding (D)		165,119			165,200			165,163			166,014			166,696			165,373			167,804

GAAP diluted earnings per share: (A/D)	$	0.50		$	0.42		$	0.38		$	–		$	0.44		$	1.30		$	1.73
Adjustments after-tax: (B/D)		(0.02	)		0.05			0.09			0.43			–			0.55			0.01
Diluted earnings per common share, as adjusted, excluding fair value adjustment for marketable securities, special dividend from equity investment, provision for credit losses, branch write-off expense, unfunded commitment expense, outsourced special project expense, merger and acquisition expenses, FDIC Small Bank Assessment Credit, hurricane expense and BOLI redemption tax: (C/D)	$	0.48		$	0.47		$	0.47		$	0.43		$	0.44		$	1.85		$	1.74

ANNUALIZED RETURN ON AVERAGE ASSETS

Return on average assets: (A/G)		1.97	%		1.66	%		1.55	%		0.01	%		1.94	%		1.33	%		1.93	%
Return on average assets excluding fair value adjustment for marketable securities, special dividend from equity investment, provision for credit losses, branch write-off expense, unfunded commitment expense, outsourced special project expense, merger and acquisition expenses, FDIC Small Bank Assessment Credit, hurricane expense and BOLI redemption tax: (ROA, as adjusted) ((A+F)/G)		1.90	%		1.88	%		1.93	%		1.88	%		1.94	%		1.90	%		1.94	%
Return on average assets (pre-tax net income, excluding provision for credit losses and unfunded commitment expense): (B/G)		2.60	%		2.50	%		2.53	%		2.45	%		2.56	%		2.52	%		2.57	%
Return on average assets, excluding provision for credit losses and unfunded commitment expense: (C/G)		1.97	%		1.91	%		1.92	%		1.87	%		1.94	%		1.92	%		1.93	%
Return on average assets excluding intangible amortization: ((A+E)/(G-H))		2.13	%		1.80	%		1.68	%		0.05	%		2.12	%		1.45	%		2.10	%

GAAP net income available to common shareholders (A)	$	81,794		$	69,320		$	62,827		$	507		$	73,262		$	214,448		$	289,539
Pre-tax net income, excluding provision for credit losses and unfunded commitment expense (B)	$	107,669		$	104,377		$	102,732		$	92,178		$	96,470		$	406,956		$	386,946
Net income, excluding provision for credit losses and unfunded commitment expense (C)	$	81,794		$	79,661		$	78,084		$	70,382		$	73,262		$	309,921		$	290,522
Amortization of intangibles (D)		1,421			1,420			1,486			1,517			1,565			5,844			6,324
Amortization of intangibles after-tax (E)		1,049			1,049			1,098			1,121			1,161			4,317			4,691
Adjustments after-tax (F)		(3,155	)		8,988			15,303			70,331			(171	)		91,467			2,530
Average assets (G)		16,493,066			16,594,495			16,319,206			15,133,475			14,944,368			16,137,294			15,028,500
Average goodwill, core deposits & other intangible assets (H)		1,004,432			1,005,864			1,007,307			999,004			995,721			1,004,157			998,090

Home BancShares, Inc.

Non-GAAP Reconciliations

(Unaudited)

	Quarter Ended															Year Ended
	Dec. 31,			Sep. 30,			Jun. 30,			Mar. 31,			Dec. 31			Dec. 31,			Dec. 31,
(Dollars and shares in thousands, except per share data)	2020			2020			2020			2020			2019			2020			2019

ANNUALIZED RETURN ON AVERAGE COMMON EQUITY

Return on average common equity: (A/D)		12.72	%		10.97	%		10.27	%		0.08	%		11.71	%		8.57	%		12.01	%
Return on average common equity excluding fair value adjustment for marketable securities, special dividend from equity investment, provision for credit losses, branch write-off expense, unfunded commitment expense, outsourced special project expense, merger and acquisition expenses, FDIC Small Bank Assessment Credit, hurricane expense and BOLI redemption tax: (ROE, as adjusted) ((A+C)/D)		12.23	%		12.39	%		12.77	%		11.48	%		11.68	%		12.22	%		12.11	%
Return on average tangible common equity: (A/(D-E))		20.96	%		18.29	%		17.40	%		0.14	%		19.55	%		14.31	%		20.49	%
Return on average tangible common equity excluding intangible amortization: (B/(D-E))		21.22	%		18.56	%		17.70	%		0.44	%		19.86	%		14.59	%		20.83	%
Return on average tangible common equity excluding fair value adjustment for marketable securities, special dividend from equity investment, provision for credit losses, branch write-off expense, unfunded commitment expense, outsourced special project expense, merger and acquisition expenses, FDIC Small Bank Assessment Credit, hurricane expense and BOLI redemption tax: (ROTCE, as adjusted) ((A+C)/(D-E))		20.15	%		20.66	%		21.63	%		19.22	%		19.51	%		20.41	%		20.67	%

GAAP net income available to common shareholders (A)	$	81,794		$	69,320		$	62,827		$	507		$	73,262		$	214,448		$	289,539
Earnings excluding intangible amortization (B)		82,843			70,369			63,925			1,628			74,423			218,765			294,230
Adjustments after-tax (C)		(3,155	)		8,988			15,303			70,331			(171	)		91,467			2,530
Average common equity (D)		2,557,251			2,513,792			2,459,941			2,481,104			2,482,406			2,503,200			2,410,853
Average goodwill, core deposits & other intangible assets (E)		1,004,432			1,005,864			1,007,307			999,004			995,721			1,004,157			998,090

EFFICIENCY RATIO

Efficiency ratio: ((C-E)/(A+B+D))		39.64	%		39.56	%		44.93	%		46.82	%		41.26	%		42.63	%		40.34	%
Efficiency ratio, as adjusted: ((C-E-G)/(A+B+D-F))		40.67	%		40.08	%		39.38	%		41.37	%		41.14	%		40.36	%		40.55	%

Net interest income (A)	$	148,025		$	146,138		$	148,667		$	139,725		$	139,783		$	582,555		$	563,217
Non-interest income (B)		33,885			29,951			25,023			22,927			28,029			111,786			99,516
Non-interest expense (C)		74,241			71,712			80,172			78,249			71,342			304,374			275,787
Fully taxable equivalent adjustment (D)		1,778			1,576			1,434			1,227			1,322			6,015			5,255
Amortization of intangibles (E)		1,421			1,420			1,486			1,517			1,565			5,844			6,324

Adjustments:
Non-interest income:
Fair value adjustment for marketable securities	$	4,271		$	(1,350	)	$	919		$	(5,818	)	$	–		$	(1,978	)	$	–
Gain (loss) on OREO		150			470			235			277			159			1,132			757
Gain (loss) on branches, equipment and other assets, net		217			(27	)		54			82			35			326			(3	)
Special dividend from equity investment		–			3,181			–			7,004			861			10,185			2,995
Gain (loss) on securities		–			–			–			–			(2	)		–			(2	)
Total non-interest income adjustments (F)	$	4,638		$	2,274		$	1,208		$	1,545		$	1,053		$	9,665		$	3,747

Non-interest expense:
Branch write-off expense	$	–		$	–		$	981		$	–		$	–		$	981		$	–
Unfunded commitment expense		–			–			9,214			7,775			–			16,989			–
FDIC Small Bank Assessment Credit		–			–			–			–			–			–			(2,291	)
Merger Expenses		–			–			–			711			–			711			–
Hurricane damage expense		–			–			–			–			–			–			897
Outsourced special project expense		–			–			–			1,092			631			1,092			1,531
Total non-interest expense adjustments (G)	$	–		$	–		$	10,195		$	9,578		$	631		$	19,773		$	137

ANNUALIZED NET INTEREST MARGIN

Net interest margin: A/C		4.00	%		3.92	%		4.11	%		4.22	%		4.24	%		4.02	%		4.29	%
Net interest margin, excluding PPP loans (non-GAAP): B/D		3.97	%		3.98	%		4.16	%		4.22	%		4.24	%		4.04	%		4.29	%

Net interest income – FTE (A)	$	149,803		$	147,714		$	150,101		$	140,952		$	141,105		$	588,570		$	568,472
PPP loan interest & discount accretion income		8,841			5,943			4,450			–			–			19,234			–
Net interest income – FTE, excluding PPP loans (non-GAAP) (B)	$	140,962		$	141,771		$	145,651		$	140,952		$	141,105		$	569,336		$	568,472

Average interest-earning assets (C)	$	14,900,381		$	14,975,146		$	14,678,465		$	13,428,700		$	13,188,508		$	14,657,245		$	13,260,312
Average PPP loans		775,861			821,977			585,946			–			–			547,328			–
Average interest-earning assets, excluding PPP loans (non-GAAP) (D)	$	14,124,520		$	14,153,169		$	14,092,519		$	13,428,700		$	13,188,508		$	14,109,917		$	13,260,312

Home BancShares, Inc.

Non-GAAP Reconciliations

(Unaudited)

	Quarter Ended															Year Ended
(Dollars and shares in thousands,	Dec. 31,			Sep. 30,			Jun. 30,			Mar. 31,			Dec. 31			Dec. 31,			Dec. 31,
except per share data)	2020			2020			2020			2020			2019			2020			2019

Pre-tax net income	$	107,669		$	90,377		$	82,077		$	(2,420	)	$	96,470		$	277,703		$	385,621
Provision for credit losses		–			14,000			11,441			86,823			–			112,264			1,325
Unfunded commitment expense		–			–			9,214			7,775			–			16,989			–
Pre-tax net income, excluding provision for credit losses and unfunded commitment expense (PPNR) (A)	$	107,669		$	104,377		$	102,732		$	92,178		$	96,470		$	406,956		$	386,946

Total revenue (net) (B)		181,910			176,089			173,690			162,652			167,812			694,341			662,733

Pre-tax net income to total revenue (net)		59.19	%		51.32	%		47.25	%		-1.49	%		57.49	%		40.00	%		58.19	%
P5_NR (Pre-tax, pre-provision, profit percentage) (PPNR to total revenue (net))		59.19	%		59.28	%		59.15	%		56.67	%		57.49	%		58.61	%		58.39	%

	Quarter Ended

	Dec. 31,			Sep. 30,			Jun. 30,			Mar. 31,			Dec. 31,
(Dollars in thousands)	2020			2020			2020			2020			2019

TANGIBLE BOOK VALUE PER COMMON SHARE

Book value per common share: (A/B)	$	15.78		$	15.38		$	15.09		$	14.72		$	15.10
Tangible book value per common share: ((A-C-D)/B)		9.70			9.30			8.99			8.61			9.12

Total stockholders’ equity (A)	$	2,605,758		$	2,540,799		$	2,492,146		$	2,430,271		$	2,511,531
End of period common shares outstanding (B)		165,095			165,163			165,206			165,148			166,373
Goodwill (C)		973,025			973,025			973,025			973,025			958,408
Core deposit and other intangibles (D)		30,728			32,149			33,569			35,055			36,572


TANGIBLE COMMON EQUITY TO TANGIBLE ASSETS

Equity to assets: (B/A)		15.89	%		15.35	%		14.75	%		15.65	%		16.71	%
Tangible common equity to tangible assets: ((B-C-D)/(A-C-D))		10.41	%		9.88	%		9.35	%		9.79	%		10.80	%

Total assets (A)	$	16,398,804		$	16,549,758		$	16,895,406		$	15,531,732		$	15,032,047
Total stockholders’ equity (B)		2,605,758			2,540,799			2,492,146			2,430,271			2,511,531
Goodwill (C)		973,025			973,025			973,025			973,025			958,408
Core deposit and other intangibles (D)		30,728			32,149			33,569			35,055			36,572

January 21, 2021 8:17 am

Unifor and Aleafia Health enter exclusive agreement to support medical cannabis coverage for members

TORONTO, Jan. 21, 2021 (GLOBE NEWSWIRE) — Unifor and Aleafia Health Inc. (TSX: AH, OTC: ALEAF), have entered into an exclusive 10-year agreement to support union members, retirees and their eligible dependents who receive medical cannabis insurance coverage through Unifor’s collective bargaining agreements.

“Unifor members across the country deserve access to the benefits of medical cannabis coverage through their benefits. As a union we will support our local bargaining committees to add this coverage where possible,” said Jerry Dias, Unifor National President.

The agreement supports a historic breakthrough in access to legal cannabis in Canada.

Aleafia brings unique national scale, organization and expertise to provide union members, retirees and their eligible dependents with access to medical cannabis product insurance reimbursement and physician-led cannabinoid therapy.

“This agreement will provide thousands of union members and their families with improved and affordable access to medical cannabis care, and ultimately be one of the largest breakthroughs in patient access since the early days of legalization in Canada,” said Geoffrey Benic, Aleafia Health CEO. “Our dedicated team of medical professionals and program managers are excited to begin working directly with Unifor members and launching this program.”

Through its subsidiaries, Aleafia Health provides an enhanced level of service not available through any other Canadian cannabis company. Members will receive a customized wellness regime, including cannabis education, virtual physician consultation, medical authorization, when appropriate, product ordering and scheduled home delivery, all in one business day.

Physician Expertise: Aleafia Health is a pioneer in cannabinoid therapy in Canada, providing care to over 75,000 unique patients. This has also provided actionable data on best practices on dosing, modes of intake, strain selection and patient safety, resulting in peer reviewed research published in medical journals. Best in class electronic medical records systems also allow close collaboration between Canabo physicians and Unifor members’ family doctor.
Virtual Consultation: Canabo today serves patients in every province of Canada. Since the beginning of Covid-19, the Company has transitioned to completing 100 per cent of consultations online and over the phone, allowing patients to receive professional care from the safety and convenience of their homes.
Product Portfolio: Through its flagship medical cannabis brand Emblem, members will benefit from access to a diverse portfolio of high-quality cannabis formats, including oils, capsules, sprays, sublingual strips, vapes and exclusive dried flower cultivars. In addition, the Company looks forward to releasing a new line of CBD wellness products, which includes formats not yet available in Canada.
Scheduled Same Day Delivery: Through its AssureHome Delivery platform, Unifor members can order and will receive their medical cannabis order that evening, with best in class delivery times.

As Canada’s largest private sector union, Unifor represents over 315,000 members across every sector of the Canadian economy. Aleafia Health, a global cannabis health and wellness company, has provided over 75,000 individual patients with cannabinoid therapy through its national network of clinics, along with access to high-quality, federally regulated medical cannabis products.

About Unifor:

https://www.unifor.org/en/about-unifor

Unifor is Canada’s largest union in the private sector, representing 315,000 workers in every major area of the economy. The union advocates for all working people and their rights, fights for equality and social justice in Canada and abroad, and strives to create progressive change for a better future.

About Aleafia Health:

www.AleafiaHealth.com

For media inquiries or to arrange interviews via FaceTime, Zoom or Skype with Dias or Benic please contact:

Hamid Osman, Unifor Communications Representative
647-448-2823 (cell) [email protected]

Nicholas Bergamini, VP Investor Relations
1-833-879-2533 [email protected]

Aleafia Health is a vertically integrated and federally licensed Canadian cannabis company offering cannabis health and wellness services and products in Canada and in international markets. The Company operates medical clinics, education centres and production facilities for the production and sale of cannabis.

Aleafia Health owns three significant licensed cannabis production facilities, including the first large-scale, legal outdoor cultivation facility in Canadian history. The Company produces a diverse portfolio of commercially proven, high-margin derivative products including oils, capsules and sprays. Aleafia Health operates the largest national network of medical cannabis clinics and education centres staffed by MDs, nurse practitioners and educators and operates internationally in three continents.

Innovation, the heart of Aleafia Health’s competitive advantage, has led to the Company maintaining a medical cannabis dataset with over 10 million data points to inform proprietary illness-specific product development and its highly differentiated education platform FoliEdge Academy. The Company is committed to creating sustainable shareholder value; the TSX Venture Exchange named Aleafia the 2019 top performing company prior to its graduation to the TSX.

Forward Looking Information

This news release contains forward-looking information within the meaning of applicable Canadian and United States securities laws. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes” or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking information involves known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company or its subsidiaries to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information contained in this news release. Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information, including risks contained in the Company’s annual information form filed with Canadian securities regulators available on the Company’s SEDAR profile at www.sedar.com. Although the Company believes that the assumptions and factors used in preparing the forward-looking information in this news release are reasonable, undue reliance should not be placed on such information and no assurance can be given that such events will occur in the disclosed time frames or at all. The forward-looking information included in this news release are made as of the date of this news release and the Company does not undertake any obligation to publicly update such forward-looking information to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.

January 21, 2021 8:16 am

IIROC Trading Halt – CVI.P

Canada NewsWire

VANCOUVER, BC, Jan. 21, 2021 /CNW/ – The following issues have been halted by IIROC:

Company: COMPASS VENTURE INC.

TSX-Venture Symbol: CVI.P

Reason: Pending Closing

Halt Time (ET): 8:00 AM

IIROC can make a decision to impose a temporary suspension (halt) of trading in a security of a publicly-listed company. Trading halts are implemented to ensure a fair and orderly market. IIROC is the national self-regulatory organization which oversees all investment dealers and trading activity on debt and equity marketplaces in Canada.

SOURCE Investment Industry Regulatory Organization of Canada (IIROC) – Halts/Resumptions

January 21, 2021 8:11 am

Bio-Thera Solutions Announces Initiation of Phase I Clinical Trial for BAT1308, a Monoclonal Antibody Targeting PD-1

GUANGZHOU, China–(BUSINESS WIRE)–
Bio-Thera Solutions, Ltd. (SHA: 688177), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase I clinical study to compare the pharmacokinetics and safety of BAT1308, a monoclonal antibody targeting PD-1 in cancer patient volunteers.

“PD-1 is a validated drug target. BAT1308 has demonstrated a very attractive preclinical profile.” said Dr. Shengfeng Li, CEO, Bio-Thera Solutions. “We have multiple immune-oncology (IO) assets in our pipeline targeting tumor infiltrating regulatory T cells (Tregs). We plan to explore combinations of BAT1308 with those IO assets targeting tumor infiltrating Tregs and other IO assets in our innovative pipeline to treat a broad range of cancers.”

The Phase 1, multicenter, open-label, dose-escalation clinical trial of BAT1308 is designed to assess the safety and tolerability of BAT1308 as a single agent. The study is expected to enroll subjects with advanced solid tumor. Key objectives in the study include determining maximum tolerated dose, pharmacokinetics and preliminary anti-tumor activity. Disease-specific expansion cohorts will be enrolled at the maximally tolerated or biologically relevant dose.

Bio-Thera Solutions is developing several additional innovative oncology assets directed at important IO targets, including TIGIT, CTLA4, OX40, CD47 and TGFβ and IO bispecifics targeting synergistic targets like PD-L1/CD47.

About Bio-Thera Solutions

Bio-Thera Solutions, Ltd., a leading global biotechnology company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. A leader in next generation antibody discovery and engineering, the company has advanced five candidates into late stage clinical trials and has one approved product, QLETLI, in China. In addition, the company has multiple promising candidates in early clinical trials and IND-enabling studies, focusing on innovative targets in immuno-oncology and autoimmune diseases. For more information, please visit www.bio-thera.com/en/ or follow us on Twitter (@bio_thera_sol) and wechat (Bio-Thera).

Cautionary Note Regarding Forward-Looking Statements

This news release contains certain forward-looking statements relating to BAT1308 or the product pipelines in general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing “could,” “may,” “should,” “will,” “would,” “anticipate,” “believe,” “plan,” “promising,” “potentially,” or similar expressions. They reflect the company’s current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions, and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies, for example, the development processes could be lengthy and high in vitro affinity may not translate to desired results in vivo or successful clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company’s financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company’s views or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210121005310/en/

Bio-Thera Solutions, Ltd.:

Bert E. Thomas IV +1.410.627.1734

[email protected]

KEYWORDS: China Asia Pacific

INDUSTRY KEYWORDS: Biotechnology Health Pharmaceutical Clinical Trials Oncology

MEDIA:

Logo

January 21, 2021 8:08 am

Salarius Pharmaceuticals Regains Compliance with Nasdaq Minimum Bid Price Listing Requirement

HOUSTON, Jan. 21, 2021 (GLOBE NEWSWIRE) — Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for patients with pediatric cancers, solid tumors, and other cancers, announced today that it has received a letter from the Nasdaq Listing Qualifications staff notifying the Company that it has regained compliance with Nasdaq’s Listing Rule 5550(a)(2) pertaining to the minimum bid price requirement for continued listing on the Nasdaq Capital Market.

About Salarius Pharmaceuticals

Salarius Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing cancer therapies for patients in need of new treatment options. Salarius’ lead candidate, seclidemstat, is being studied as a potential treatment for pediatric cancers, solid tumors and other cancers with limited treatment options. Seclidemstat is currently in a Phase 1/2 clinical trial for relapsed/refractory Ewing sarcoma, for which it has received Fast Track Designation, Orphan Drug Designation and Rare Pediatric Disease Designation from the U.S. Food and Drug Administration. Salarius is also developing seclidemstat for several cancers with high unmet medical need, with a second Phase 1/2 clinical study in advanced solid tumors, including prostate, breast, and ovarian cancers. Salarius has received financial support from the National Pediatric Cancer Foundation to advance the Ewing sarcoma clinical program and was also the recipient of a Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT). For more information, please visit salariuspharma.com.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These forward-looking statements may be identified by terms such as “anticipate,” “potential,” “progress,” “design,” “estimate,” “continue,” “will,” “aim,” “can,” “believe,” “plan,” “allow,” “expect,” “intend,” “goal,” “provide,” “able to,” “position,” “project,” “developing,” and similar terms or expressions or the negative thereof. Examples of such statements include, but are not limited to, statements relating to the following: The status and anticipated progress and milestones of Salarius’ clinical trials in advanced solid tumors and Ewing sarcoma; statements related to Salarius’ developing cancer therapies for patients that need them the most, Salarius’ developing seclidemstat for several cancers with high unmet medical need; Salarius’ developing seclidemstat as a potential treatment for pediatric cancers, solid tumors and other cancers with limited treatment options. Salarius may not actually achieve the plans, carry out the intentions or meet the expectations or objectives disclosed in the forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements are subject to risks and uncertainties which could cause actual results and performance to differ materially from those discussed in the forward-looking statements. These risks and uncertainties include, but are not limited to, the following: the sufficiency of Salarius’ capital resources; the ability of, and need for, Salarius to raise additional capital to meet Salarius’ business operational needs and to achieve its business objectives and strategy; Salarius’ ability to project future capital needs and cash utilization and timing and accuracy thereof; the ability of Salarius to access the remaining funding available under the CPRIT grant; future clinical trial results and impact of results on Salarius; that the results of studies and clinical trials may not be predictive of future clinical trial results; the sufficiency of Salarius’ intellectual property protection; risks related to the drug development and the regulatory approval process; the competitive landscape and other industry-related risks; market conditions and regulatory or contractual restrictions which may impact the ability of Salarius to raise additional capital; the possibility of unexpected expenses or other uses of Salarius’ cash resources; risks related to the COVID-19 outbreak; and other risks described in Salarius’ filings with the Securities and Exchange Commission, including those discussed in Salarius’ quarterly report on Form 10-Q for the quarter ended September 30, 2020 and in Salarius’ annual report on Form 10-K for the year ended December 31, 2019. The forward-looking statements contained in this press release speak only as of the date of this press release and are based on management’s assumptions and estimates as of such date. Salarius disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made.

Contact

Tiberend Strategic Advisors, Inc.
Maureen McEnroe, CFA/Miriam Miller (Investors)
(212) 375-2664/ 2694
[email protected]/[email protected]

Johanna Bennett (Media)
(212) 375-2686
[email protected]

January 21, 2021 8:06 am

IIROC Trading Halt – RVV

Canada NewsWire

VANCOUVER, BC, Jan. 21, 2021 /CNW/ – The following issues have been halted by IIROC:

Company: Revive Therapeutics Ltd.

CSE Symbol: RVV

All Issues: Yes

Reason: At the request of the Company Pending News

Halt Time (ET): 7:47 AM

SOURCE Investment Industry Regulatory Organization of Canada (IIROC) – Halts/Resumptions

January 21, 2021 8:06 am

HanesBrands Names Joe Cavaliere Group President, Global Innerwear

HanesBrands Names Joe Cavaliere Group President, Global Innerwear

Howard Upchurch announces retirement

WINSTON-SALEM, N.C.–(BUSINESS WIRE)–
HanesBrands (NYSE: HBI), a leading global marketer of branded everyday basic apparel, today announced that Joe Cavaliere has been named to the newly created role of group president, global innerwear, effective Feb. 8, 2021.

Howard Upchurch, group president, innerwear Americas, has announced his retirement after 34 years with the company.

“I am pleased to name Joe group president of our global innerwear business,” said Steve Bratspies, CEO of HanesBrands. “He brings deep experience driving sales and transformation in retail and consumer goods, and has an impressive record of leading high-performing global teams. I look forward to working with him as he builds our great brands, drives innovation and delivers long-term growth in our global innerwear business.”

Upchurch joined the company as a marketing assistant in the hosiery business. He was a leader in creating the company’s integrated innerwear organization and led the expansion of the Hanes brand into new retail channels.

“I thank Howard for the many contributions he has made to HanesBrands during his 34 years with the company,” Bratspies said. “His leadership and vision have helped build our great brands and made the company an industry leader. I appreciate everything he has done to position us to realize the enormous opportunities ahead. On behalf of everyone at HanesBrands, I wish Howard all the best in the future.”

Cavaliere brings more than 30 years of leadership in major transformations, sales, marketing and operations to HanesBrands, where he will be responsible for some of the world’s most recognized and respected apparel brands, including Hanes, Bonds, Maidenform, Playtex, Bali and DIM.

He joins HanesBrands from C&S Wholesale Grocers, where he was president and general manager of the company’s retail chain division. Prior to joining C&S in 2018, he was president and global chief customer officer at Newell Brands with accountability for global customer development and geographic responsibility for Europe, Middle East, Africa, Canada, Australia and New Zealand. Before that, Cavaliere was executive vice president of customer development at Unilever with responsibility for $11 billion in revenue across 17 categories. He also served as executive vice president of sales at Kraft Foods, where he held a number of leadership positions in more than 20 years with the company.

Cavaliere holds a bachelor’s degree from Ursinus College in Collegeville, Pa.

HanesBrands

HanesBrands, based in Winston-Salem, N.C., is a socially responsible leading marketer of everyday basic innerwear and activewear apparel in the Americas, Europe, Australia and Asia-Pacific. The company sells its products under some of the world’s strongest apparel brands, including Hanes, Champion, Bonds, Maidenform, DIM, Bali, Playtex, Bras N Things, Nur Die/Nur Der,Alternative, L’eggs, JMS/Just My Size, Lovable, Wonderbra, Berlei and Gear for Sports. The company sells T-shirts, bras, panties, shapewear, underwear, socks, hosiery, and activewear produced in the company’s low-cost global supply chain. A Fortune 500 company and member of the S&P 500 stock index (NYSE: HBI), Hanes has approximately 63,000 employees in more than 40 countries. For more information, visit the company’s corporate website at www.Hanes.com/corporate and newsroom at https://newsroom.hanesbrands.com/. Connect with the company via social media: Twitter (@hanesbrands), Facebook (www.facebook.com/hanesbrandsinc), Instagram (@hanesbrands), and LinkedIn (@Hanesbrandsinc).

View source version on businesswire.com: https://www.businesswire.com/news/home/20210121005436/en/

News Media Contact: Kirk Saville (336) 519-6192

Analysts and Investors Contact: T.C. Robillard (336) 519-2115

KEYWORDS: North Carolina United States North America

INDUSTRY KEYWORDS: Retail Textiles Manufacturing Fashion

MEDIA:

Logo