Earnings – Business Times Oman http://www.businesstimesoman.com Fri, 08 Mar 2024 21:05:00 +0000 en-US hourly 1 https://wordpress.org/?v=5.3.2 Entera Bio Announces Full Year 2023 Financial Results and Provides Business Updates http://www.businesstimesoman.com/?p=310487/ http://www.businesstimesoman.com/?p=310487/#respond Fri, 08 Mar 2024 21:05:00 +0000 http://www.businesstimesoman.com/?p=310487 JERUSALEM, March 08, 2024 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides, today reported financial results and key business updates for the fourth quarter and year ended December 31, 2023.

“2023 was an inflection point for Entera, with consistent validation of our disruptive N–Tab™ oral peptide technology platform and the unveiling of our goal to advance five potential first–in–class oral peptide programs, Phase 1 through Phase 3, into the clinic by the end of 2025. Each of these programs has been carefully selected to align with our platform and our mission to develop treatments that stand to become the number one choice for patients requiring peptide therapies, in a simple and convenient tablet format. Each of these programs is expected to have important catalysts during 2024. Following our December 2023 financing, we expect to have sufficient cash to fund operations through the first half of 2025,” said Miranda Toledano, CEO of Entera.

EB613: First Oral PTH(1–34) Daily Osteoanabolic Tablets for Osteoporosis

  • In March 2023, a Type D meeting between Entera and the U.S. Food and Drug Administration (FDA) re–affirmed that a placebo–controlled phase 3 study design with Bone Mineral Density (BMD) and not fracture as primary endpoint could support a New Drug Application for EB613
  • In November 2023, Entera echoed the American Society for Bone and Mineral Research (ASBMR) announcement that the Strategy to Advance BMD as a Regulatory Endpoint (SABRE) team had submitted its final qualification plan to the FDA
  • At the Annual ASBMR Meeting in October 2023, Entera presented the differentiated pharmacokinetic profile of EB613, versus Forteo® PTH(1–34) 20 µg which requires a daily subcutaneous injection. EB613 consistently shows an increased Cmax and shorter duration of systemic exposure versus Forteo®. Furthermore, EB613’s brief “pulsatile” action appears to simultaneously stimulate both a dual bone formation and a mild anti–resorptive effect, as compared to Forteo®
  • During the fourth quarter of 2023, Entera submitted its Phase 2 manuscript for potential publication in a major medical journal related to its phase 2, 6–month, 161–patient, placebo–controlled study in post–menopausal women with low bone mass and osteoporosis which met primary and secondary endpoints

“We expect an update on the qualification process of SABRE and BMD as the surrogate endpoint for fracture in 2024. We view this as the final de–risking event from a regulatory standpoint to move EB613 to Phase 3. We believe EB613 stands as the first program to potentially avail itself of the landmark SABRE initiative which is also the first biomarker to potentially be approved as part of the 2016 21st Century Cures Act. As the first potential oral tablet osteoanabolic treatment, EB613 holds the potential to address the treatment chasm in this severe, potentially lethal disease which remains significantly undertreated despite efficacious injectable treatments. Fracture rates continue to rise globally, and we have not seen any new drugs approved for osteoporosis since 2019 due to the ethical concerns and the costs of fracture endpoint studies. Our discussions with key clinicians and patient advocacy groups and other key stakeholders in this ecosystem indicate that an oral anabolic treatment is absolutely warranted and a potential ‘game changer’ for the estimated 200 million women with osteoporosis globally. We continue to hold strategic discussions related to EB613 and look forward to initiating our pivotal phase 3 study once the final qualification of the SABRE endpoint is announced by FDA,” said Miranda Toledano, CEO of Entera.

EB612: First Oral PTH(1–34) Peptide Replacement Therapy Tablets for Hypoparathyroidism
EB612, is being developed as the first oral PTH(1–34) peptide replacement treatment for hypoparathyroidism. Entera is currently evaluating its hypoparathyroidism program with an improved formulation of EB612 using the naked PTH(1–34) peptide and new intellectual property, tailored to optimize its PK profile and the potential for reduced daily dosing. Entera is also combining its N–Tab™ platform with an alternative PTH receptor agonist in a third party collaboration. Entera expects to submit data from the Phase 1 of its next generation EB612 program using the naked PTH(1–34) peptide in the first half of 2024.

First GLP–2 Peptide Tablets for Short Bowel Syndrome
Under a collaboration agreement with OPKO Health (“OPKO”), Entera is combining its N–Tab™ technology with a proprietary long–acting GLP–2 peptide for the development of the first potential daily oral GLP–2 for the treatment of short bowel syndrome and other GI disorders such as Crohn’s and Celiac disease for which GLP–2 has relevance. Entera published pre–clinical data in May 2023 demonstrating that its oral peptide delivery platform enables gastric absorption of teduglutide (Gattex®), the only approved GLP–2 treatment, as a convenient potential tablet alternative to daily injections. Pre–IND in vivo PK data for oral GLP–2 using OPKO’s long–acting analogue is expected in the first half of 2024.

First GLP–1/Glucagon Agonist (Oxyntomodulin) Peptide Tablets for Obesity
Under a collaboration agreement with OPKO, Entera is combining its N–Tab™ technology with a proprietary long–acting Oxyntomodulin (OXM) peptide for the development of the first potential daily OXM treatment for obesity and other metabolic diseases. Previously, an injectable pegylated version of this OXM peptide demonstrated significant reductions in weight loss and decreased plasma triglyceride levels with cardioprotective benefits in over 420 patients in phase 2/2B studies. Pre–IND in vivo PK data for oral OXM using OPKO’s long acting, modified analogue is expected in mid–2024.

EB613: First Oral PTH(1–34) Osteoanabolic Tablets to Treat Intense Sport and Military Stress Injuries
Entera is collaborating with leading researchers in orthopedics and sports medicine to contribute its proprietary oral PTH(1–34) tablets for an investigator sponsored Phase 2 Study seeking to treat young women and men athletes that experience stress fractures as a result of intense sports training. More details on this study are expected in the second half of 2024.

Financial Results for the year Ended December 31, 2023

As of December 31, 2023, Entera had cash and cash equivalents of $11.0 million. The Company believes that its existing cash resources will be sufficient to meet its projected operating requirements through the second quarter of 2025, which includes the capital required to fund our ongoing operations, including R&D, the completion of the Phase 1 PK study related to our new generation platform and the GLP–2/OXM collaborative research we are conducting with OPKO.

Research and development expenses for the year ended December 31, 2023 were $4.5 million, as compared to $5.8 million for the year ended December 31, 2022. The decrease of $1.3 million was primarily due to a decrease of $1.5 million in pre–clinical activity and materials costs and a decrease of $0.6 million in employee compensation, including a one–time payment made to a former employee pursuant to the terms of his separation agreement. The decrease was partially offset by an increase of $0.8 million in clinical expenses for our Phase 1 PK study related to our new generation platform and new formulations for EB612.

General and administrative expenses for the year ended December 31, 2023 were $4.4 million, compared to $7.3 million for the year ended December 31, 2022. The decrease of $2.8 million was mainly attributable to a decrease of $1.1 million in employee compensation, including a one–time payment to our former employee pursuant to the terms of his separation agreement, a decrease of $0.8 million as part of a restructuring of professional fees and other advisor expenses, a decrease in Board fees of $0.2 million due to the Board’s forfeiture of their fees for the third and fourth quarters of 2023 and a decrease of $0.7 million in D&O insurance costs.

Operating expenses for year ended December 31, 2023 were $8.9 million, as compared to $13.0 million for the year ended December 31, 2022.

Net loss was $8.9 million, or $0.31 per ordinary share (basic and diluted), for the year ended December 31, 2023, as compared to $13.1 million, or $0.45 per ordinary share (basic and diluted), for the year ended December 31, 2022.

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform and its pipeline includes five differentiated, first–in–class oral peptide programs, expected to enter into the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (oral PTH(1–34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n=161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint which is expected to occur in 2024. The EB612 program is being developed as the first oral PTH(1–34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP–2 peptide tablet as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

Cautionary Statement Regarding Forward–Looking Statements

Various statements in this press release are “forward–looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera’s forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s expectations regarding licensing, business transactions and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statements Regarding Forward–Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10–K filed with the SEC, as well as the company’s subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

 

ENTERA BIO LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
 
       
  December 31   December 31
  2023   2022
  (Unaudited)   (Audited)
   
Cash and cash equivalents 11,019   12,309
Accounts receivable and other current assets 238   540
Property and equipment, net 100   139
Other assets, net 408   139
Total assets 11,765   13,127
     
     
Accounts payable and other current liabilities 1,091   1,341
Total non–current liabilities 288   32
Total liabilities 1,379   1,373
Total shareholders' equity 10,386   11,754
Total liabilities and shareholders' equity 11,765   13,127

ENTERA BIO LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
 
(Unaudited)
 
  Year Ended
December 31,
  2023   2022
       
REVENUES   134
COST OF REVENUES   101
GROSS PROFIT   33
OPERATING EXPENSES:      
Research and development 4,510   5,848
General and administrative 4,430   7,253
Other income (49)   (51)
TOTAL OPERATING EXPENSES 8,891   13,050
OPERATING LOSS 8,891   13,017
FINANCIAL INCOME, NET (31)   (83)
LOSS BEFORE INCOME TAX 8,860   12,934
INCOME TAX EXPENSES 29   137
NET LOSS 8,889   13,071
       
BASIC AND DILUTED LOSS PER SHARE 0.31   0.45
WEIGHTED AVERAGE NUMBER OF SHARES      
OUTSTANDING USED IN COMPUTATION OF 29,007,794   28,808,090
BASIC AND DILUTED LOSS PER SHARE      


GLOBENEWSWIRE (Distribution ID 9060543)

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Entera Bio Reports Q3 2023 Financial Results, Highlights Transformational Steps and Unveils Vision as Premier Oral Peptide Company with Five Potential Programs in Development http://www.businesstimesoman.com/entera-bio-reports-q3-2023-financial-results-highlights-transformational-steps-and-unveils-vision-as-premier-oral-peptide-company-with-five-potential-programs-in-development/ http://www.businesstimesoman.com/entera-bio-reports-q3-2023-financial-results-highlights-transformational-steps-and-unveils-vision-as-premier-oral-peptide-company-with-five-potential-programs-in-development/#respond Tue, 14 Nov 2023 12:30:00 +0000 http://www.businesstimesoman.com/?p=309649 JERUSALEM, Nov. 14, 2023 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company"), a leader in the development of orally delivered peptides and small therapeutic proteins, today reported corporate updates and financial results for the third quarter ended September 30th, 2023.

"Today, after over a year of steadfast transformation and execution, Entera stands as a premier oral peptide company. It is our goal to potentially move five high value, first–in–class programs, Phase 1 through Phase 3, into the clinic by the end of 2025."

"Our disruptive and proprietary technology simultaneously inhibits gastrointestinal enzymatic degradation and consistently produces bioavailability of peptides, via a simple tablet format (around 6mm in diameter). Each of our oral peptide programs has been carefully selected based on platform alignment and our mission to successfully develop treatments that stand to become the number one choice for patients. Importantly Entera has sufficient cash on hand to enable key read–outs from our significant pipeline expansion efforts over the coming year," said Miranda Toledano, Chief Executive Officer of Entera.

"With our Phase 3 ready EB613 (oral PTH (1–34) peptide), we aim to transform the lives of osteoporosis patients, starting with the estimated 200 million women globally at–risk of fracture. We are also exploring the potential use of EB613 to accelerate stress fracture healing due to high intensity athletic or military training. Our EB612 program aimed at the development of a once–a–day (oral PTH (1– 34) peptide) replacement therapy for patients suffering from hypoparathyroidism, a disease which also disproportionately afflicts women, is being tested using a new generation of our platform. In September 2023, we announced a transformative collaboration with OPKO Health, Inc. ("OPKO") that expands our oral delivery technology across two additional peptides: GLP–2 for the treatment of short bowel syndrome, and oxyntomodulin, a dual targeted GLP–1 / glucagon agonist, for the treatment of obesity," said Ms. Toledano

"On a separate note, we would like to thank our collaborators, partners, and shareholders around the world for reaching out during the last six weeks since the war in Israel erupted to ensure the safety of our team and loved ones. Entera houses R&D, some manufacturing and key personnel across Israel, alongside our clinical, supply chain, regulatory and other functions in the U.S., UK and the EU. While our entire team at Entera is "safe" and continues to meet goals; we are all deeply affected by the current situation. Entera stands with Israel and its right to protect its diverse population of Jewish, Muslim, Druze and Christian citizens and residents. All of us are united in the protection and preservation of our heterogeneous and democratic country," said Ms. Toledano.

Entera Q3 2023 Updates and Goals for 5 Oral Peptide Programs:

EB613: First Oral PTH (1–34) Daily Osteoanabolic Tablets for Osteoporosis
EB613 (oral PTH (1–34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for osteoporosis. Entera is prepared to initiate a pivotal phase 3 study in post–menopausal women with high–risk osteoporosis and no prior fracture. Entera successfully completed a phase 2, 6–month, 161–patient, placebo–controlled study. EB613 produced rapid dose–proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increased lumbar spine, total hip, and femoral neck BMD in postmenopausal women with low mass or osteoporosis and no prior fracture. In October 2022, following a Type C meeting and in March 2023 following a Type D meeting, Entera announced the U.S. Food and Drug Administration's (FDA) concurrence that a 2–year, placebo–controlled phase 3 (registrational) study with Total Hip Bone Mineral Density (BMD) as primary endpoint could support an NDA for EB613. On November 9th, 2023, Entera reported that the American Society for Bone and Mineral Research (ASBMR) announced that the SABRE (Strategy to Advance BMD as a Regulatory Endpoint) project team had submitted to its full qualification plan to FDA for the use of BMD as a surrogate endpoint for fractures in future trials of new anti–osteoporosis drugs. EB613 stands as the first program to potentially avail itself of the ASBMR–SABRE BMD endpoint.

EB613: First Oral PTH (1–34) Osteoanabolic Tablets to Treat Intense Sport and Military Stress Injuries
Entera's ability to consistently deliver its oral PTH (1–34) peptide in a simple mini tablet format with reproduceable, dose dependent pharmacokinetics and rapid biological responses across gender, age, and health status was highlighted as part of two poster sessions at the Annual Society of Bone and Mineral Research (ASBMR) 2023 Annual Meeting held on October 13–16, 2023. This work also builds the foundation for Entera's oral PTH (1–34) tablets to potentially treat diverse patient populations including younger men and women athletes at risk of stress fractures. The Company is working towards a potential Phase 2 study for EB613 in this important indication.

EB612: First Oral PTH (1–34) Peptide Replacement Therapy Tablets for Hypoparathyroidism
EB612, is the first oral formulation of PTH (1–34), as a hormone replacement treatment for hypoparathyroidism. An open–label Phase 2a multicenter Phase 2A study, evaluating the safety, tolerability and PK of EB612 in 19 patients with hypoparathyroidism, achieved its primary and secondary endpoints, including a significant reduction in calcium supplementation (42% reduction from baseline, (p=0.001), a decline of 23% (p=0.0003) in median serum phosphate levels two hours following the first dose that was maintained for the duration of the study, improvement in quality of life score and maintenance of median calcium levels above the lower target level for hypoparathyroidism patients (>7.5 mg/dL) throughout the study. There were no treatment emergent adverse events of hypercalcemia reported and no treatment–emergent serious adverse events. Entera is currently evaluating its hypoparathyroidism program with improved formulations of EB612 based on new intellectual property, tailored to optimize its PK profile and the potential for reduced daily dosing as well as by potentially combining Entera's platform with alternative PTH analogues. Updates from the ongoing PK/PD study are expected by the end of 2023.

First GLP–2 Peptide Tablets for Short Bowel Syndrome
Under our collaboration agreement with OPKO, OPKO will supply its proprietary long–acting GLP–2 peptide to combine with Entera's oral peptide platform for the development of the first potential daily oral GLP–2 for the treatment of short bowel syndrome. Treatment with Glucagon–Like Peptide–2 (GLP–2) analogs has been shown to improve the absorption of nutrients in patients with short bowel syndrome (SBS) and reduce parenteral support requirements. Teduglutide, the only approved GLP–2 analog, requires daily subcutaneous injections. In SBS patients, oral drug delivery is particularly challenging because the site of absorption, the intestine, is short and less functional. Entera published pre–clinical data in May 2023 demonstrating that its oral peptide delivery platform enables gastric absorption of teduglutide, as a convenient potential tablet alternative to daily injections. OPKO and Entera expect to update on the program in the first half of 2024.

First GLP–1/Glucagon Agonist (Oxyntomodulin) Peptide Tablets for Obesity
Oxyntomodulin is a naturally occurring peptide hormone found in the colon, with glucagon–like–peptide 1 (GLP–1) and glucagon dual agonist activity which suppresses appetite and induces weight loss. OPKO has developed several proprietary, modified OXM analogs as potential candidates for treating obesity, including an injectable pegylated peptide which demonstrated significant reductions in weight loss and decreased plasma triglyceride levels with cardioprotective benefits in a 420 patient phase 2 study. Under the collaboration agreement, OPKO will supply certain OXM analogs to combine with Entera's oral peptide platform. OPKO and Entera expect to update on the program in the first half of 2024.

Financial Results for the Three Months Ended September 30, 2023

As of September 30, 2023, Entera had cash and cash equivalents of $7.6 million. The Company expects that its existing cash resources are sufficient to meet its projected operating requirements into the third quarter of 2024, which includes the capital required to fund our ongoing operations, including the completion of the Phase 1 PK study related to our new generation platform and the GLP–2/OXM collaborative research we are conducting with OPKO.

Research and development expenses for the three months ended September 30, 2023 and 2022 were approximately $1.4 million. For the quarter ended September 30, 2023, there was an increase of $0.4 million in clinical expenses for our Phase 1 PK study related to our new generation platform and new formulations for EB612, which was offset by a decrease of $0.3 million materials and production costs and a decrease of $0.1 million in share–based compensation expense.

General and administrative expenses for the three months ended September 30, 2023 were $1.0 million, as compared to $1.5 million for the three months ended September 30, 2022. The decrease of $0.5 million was mainly attributable to a decrease of $0.3 million in professional fees and other consultants and a decrease of $0.2 million in D&O insurance costs.

Operating expenses for the three months ended September 30, 2023 were $2.4 million, as compared to $2.9 million for the three months ended September 30, 2022.

Net loss was $2.4 million, or $0.08 per ordinary share (basic and diluted), for the three months ended September 30, 2023, as compared to $3.1 million, or $0.11 per ordinary share (basic and diluted), for the three months ended September 30, 2022.

About Entera Bio

Entera focuses on significant unmet medical needs where an oral tablet form of a peptide treatment or protein replacement therapy holds the potential to transform the standard of care. The Company's oral PTH (1–34) teriparatide mini tablets have been administered to a total of 240 subjects (153 patients) across Phase 1 and Phase 2 studies, with demonstrated bioavailability and clinical benefit across two distinct diseases. The Company's most advanced product candidate, EB613 (oral PTH (1–34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613. EB612 is being developed as the first tablet peptide replacement therapy for the treatment of hypoparathyroidism. The Company is currently conducting a phase 1 PK study of novel PTH formulations using its proprietary, next generation oral delivery platform with data expected in the second half of 2023. Entera is also developing oral GLP–2 peptide as an injection–free alternative for patients suffering from short bowel syndrome and other severe intestinal and malabsorption metabolic conditions and oral Oxyntomodulin (GLP1/glucagon) peptide for obesity in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release are "forward–looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, "anticipate," "believe," "can," "could," "expect," "estimate," "design," "goal," "intend," "may," "might," "objective," "plan," "predict," "project," "target," "likely," "should," "will," and "would," or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera's forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA's interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera's product candidates; Entera's reliance on third parties to conduct its clinical trials; Entera's expectations regarding licensing, business transactions and strategic collaborations; Entera's operation as a development stage company with limited operating history; Entera's ability to continue as a going concern absent access to sources of liquidity; Entera's ability to obtain and maintain regulatory approval for any of its product candidates; Entera's ability to comply with Nasdaq's minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera's intellectual property position and its ability to protect its intellectual property; and other factors that are described in the "Cautionary Statements Regarding Forward–Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Entera's most recent Annual Report on Form 10–K filed with the SEC, as well as the company's subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

ENTERA BIO LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
September 30 December 31
2023 2022
(Unaudited) (Audited)
Cash and cash equivalents 7,585 12,309
Accounts receivable and other current assets 431 540
Property and equipment, net 108 139
Other assets, net 441 139
Total assets 8,565 13,127
Accounts payable and other current liabilities 2,027 1,341
Total non–current liabilities 302 32
Total liabilities 2,329 1,373
Total shareholders' equity 6,236 11,754
Total liabilities and shareholders' equity 8,565 13,127

ENTERA BIO LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)

(Unaudited)

Three Months Ended
September 30,
2023 2022
REVENUES 8
COST OF REVENUES 6
GROSS PROFIT 2
OPERATING EXPENSES:
Research and development 1,370 1,413
General and administrative 1,028 1,460
Other income (12) (6)
TOTAL OPERATING EXPENSES 2,386 2,867
OPERATING LOSS 2,386 2,865
FINANCIAL EXPENSES (INCOME), NET (36) 8
LOSS BEFORE INCOME TAX 2,350 2,873
INCOME TAX 29 194
NET LOSS 2,379 3,067
BASIC AND DILUTED LOSS PER SHARE 0.08 0.11
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE 28,813,952 28,809,922


GLOBENEWSWIRE (Distribution ID 8979236)

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Lifezone Metals Announces Publication of H1 2023 Financial Results and Shareholder Letter http://www.businesstimesoman.com/lifezone-metals-announces-publication-of-h1-2023-financial-results-and-shareholder-letter/ http://www.businesstimesoman.com/lifezone-metals-announces-publication-of-h1-2023-financial-results-and-shareholder-letter/#respond Wed, 20 Sep 2023 10:05:00 +0000 http://www.businesstimesoman.com/?p=309131 New York (United States), Sept. 20, 2023 (GLOBE NEWSWIRE) — Lifezone Metals Limited ("Lifezone Metals" or the "Company") (NYSE: LZM), a modern metals company creating value across the battery metals supply chain from mine to metals production and recycling, announced today that it has published the Company's first half 2023 financial results in a Form 6–K and an accompanying Shareholder Letter.

Highlights to–date in 2023, as expanded upon in detail in the Shareholder Letter, include:

  • Lifezone Metals' public listing on the New York Stock Exchange (NYSE) as LZM, creating the first pure–play NYSE publicly traded nickel resource and cleaner technology company
  • Completion of a second investment by BHP of $50 million, enabling continued progress at the Kabanga Nickel ("Kabanga") project site in North–west Tanzania and on key study areas
  • Progress on Kabanga DFS and resource definition activities, building on years of studies and 621 kilometres of historical resource drilling, and further defining the Kabanga resource as the Company works towards an updated S–K 1300
  • Updated Kabanga metallurgical test work results, which indicate Kabanga nickel concentrate is amenable to processing using Lifezone Metals' Hydromet Technology, and is integral to the Kabanga–Kahama nickel refinery flow sheet
  • Headway on Kabanga site operations, early works and site access, with simultaneous critical path activities including expanded camp and internal roads upgrades enabling drilling and land surveys
  • Key achievements in the areas of Kabanga external affairs, sustainability and permitting, with a comprehensive program in place comprised of an operating team of 100+ actively focused on community engagement, environment, Corporate Social Responsibility (CSR) and social performance
  • Acquisition of Simulus Laboratories, expanding capabilities for Lifezone Metals' growth strategy beyond Kabanga
  • Formal commencement of off–take marketing of Kabanga nickel cathode, creating an off–take monetization opportunity for the nickel, copper and cobalt production from Kabanga given the interest in these products from original equipment manufacturers
  • Evolved Hydromet opportunities beyond Kabanga, entering into a Memorandum of Understanding (MoU) with a global platinum group metals (PGM) customer for a commercial scale PGM recycling facility

Keith Liddell, Founder & Chair of Lifezone Metals, said: "We are excited to share our first ever Shareholder Letter. As we are new to the public market, our first instalment of this communication will both introduce Lifezone Metals to those who are new to our story and present a detailed overview on what we believe are the key accomplishments for our Company so far in 2023."

The documents can be accessed via the links below:

If you would like to sign up for Lifezone Metals news alerts, please register here.

About Lifezone Metals

Lifezone Metals (NYSE: LZM) is a modern metals company creating value across the battery metals supply chain from resource to metals production and recycling. Our mission is to provide commercial access to proprietary technology and cleaner metals production through a scalable platform underpinned by our tailored Hydromet Technology. This technology has the potential to be a cleaner and lower cost alternative to smelting, allowing us to responsibly and cost–effectively provide cleaner metals.

By pairing the Kabanga Nickel project in Tanzania, which we believe is one of the largest and highest–grade undeveloped nickel sulphide deposits in the world, with our proprietary Hydromet Technology, we will work to unlock the value of a key new source of supply to global battery metals markets. We have a long–standing partnership with BHP on the Kabanga Nickel project, with BHP having invested USD100 million, as we work to empower Tanzania to achieve full value creation in–country and become the next premier source of nickel.

www.lifezonemetals.com

Forward–Looking Statements

Certain statements made herein are not historical facts but may be considered "forward–looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), Section 21E of the Securities Exchange Act of 1934, as amended and the "safe harbor" provisions under the Private Securities Litigation Reform Act of 1995. Forward–looking statements generally are accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" or the negatives of these terms or variations of them or similar terminology or expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward–looking statements include, but are not limited to, statements regarding future events, the business combination between GoGreen Investments Corporation ("GoGreen") and Lifezone Holdings Limited ("LHL") that formed Lifezone Metals, the estimated or anticipated future results of Lifezone Metals, future opportunities for Lifezone Metals, including the efficacy of Lifezone Metals' hydromet technology ("Hydromet Technology") and the development of, and processing of mineral resources at, the Kabanga Project, and other statements that are not historical facts.

These statements are based on the current expectations of Lifezone Metals' management and are not predictions of actual performance. These forward–looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on, by any investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Lifezone Metals. These statements are subject to a number of risks and uncertainties regarding Lifezone Metals' business, and actual results may differ materially. These risks and uncertainties include, but are not limited to: general economic, political and business conditions, including but not limited to the economic and operational disruptions and other effects of the COVID–19 pandemic; the outcome of any legal proceedings that may be instituted against the Lifezone Metals in connection with the business combination; failure to realize the anticipated benefits of the business combination, including difficulty in integrating the businesses of LHL and GoGreen; the risks related to the rollout of Lifezone Metals' business, the efficacy of the Hydromet Technology, and the timing of expected business milestones; Lifezone Metals' development of, and processing of mineral resources at, the Kabanga Project; the effects of competition on Lifezone Metals' business; the ability of Lifezone Metals to execute its growth strategy, manage growth profitably and retain its key employees; the ability of Lifezone Metals to maintain the listing of its securities on a U.S. national securities exchange; costs related to the business combination; and other risks that will be detailed from time to time in filings with the U.S. Securities and Exchange Commission (the "SEC"). The foregoing list of risk factors is not exhaustive. There may be additional risks that Lifezone Metals presently does not know or that Lifezone Metals currently believes are immaterial that could also cause actual results to differ from those contained in forward–looking statements. In addition, forward–looking statements provide Lifezone Metals' expectations, plans or forecasts of future events and views as of the date of this communication. Lifezone Metals anticipates that subsequent events and developments will cause Lifezone Metals' assessments to change. However, while Lifezone Metals may elect to update these forward–looking statements in the future, Lifezone Metals specifically disclaims any obligation to do so. These forward–looking statements should not be relied upon as representing Lifezone Metals' assessments as of any date subsequent to the date of this communication. Accordingly, undue reliance should not be placed upon the forward–looking statements. Nothing herein should be regarded as a representation by any person that the forward–looking statements set forth herein will be achieved or that any of the contemplated results in such forward–looking statements will be achieved. You should not place undue reliance on forward–looking statements in this communication, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein.

Certain statements made herein include references to "clean" or "green" metals, methods of production of such metals, energy or the future in general. Such references relate to environmental benefits such as lower green–house gas ("GHG") emissions and energy consumption involved in the production of metals using the Hydromet Technology relative to the use of traditional methods of production and the use of metals such as nickel in the batteries used in electric vehicles. While studies by third parties (commissioned by Lifezone Metals) have shown that the Hydromet Technology, under certain conditions, results in lower GHG emissions and lower consumption of electricity compared to smelting with respect to refining platinum group metals, no active refinery currently licenses Lifezone Metals' Hydromet Technology. Accordingly, Lifezone Metals' Hydromet Technology and the resultant metals may not achieve the environmental benefits to the extent Lifezone Metals expects or at all. Any overstatement of the environmental benefits in this regard may have adverse implications for Lifezone Metals and its stakeholders.


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[INVNT GROUP]â„¢ achieves record global growth, accelerating history-making brand campaigns, strategic partnerships, and humanitarian work. http://www.businesstimesoman.com/invnt-group-achieves-record-global-growth-accelerating-history-making-brand-campaigns-strategic-partnerships-and-humanitarian-work/ http://www.businesstimesoman.com/invnt-group-achieves-record-global-growth-accelerating-history-making-brand-campaigns-strategic-partnerships-and-humanitarian-work/#respond Thu, 11 May 2023 14:25:55 +0000 http://www.businesstimesoman.com/?p=308160 New York, NY, May 11, 2023 (GLOBE NEWSWIRE) — [INVNT GROUP] THE GLOBAL BRANDSTORY PROJECT and leading agency portfolio of complementary brand storytelling disciplines, continues its explosive growth trajectory and worldwide expansion, reporting a top line revenue of $142 Million in 2022, up over 132% year–over–year (YOY).

Led by Scott Cullather, President & CEO of [INVNT GROUP] and CEO of INVNT.ATOM, the group represents a growing portfolio of innovative complementary disciplines designed to help forward–thinking brands everywhere, impact the audiences that matter, anywhere.

Operating across 9 offices in 6 countries and counting on over 270 employees globally, the full–service group leads clients including Lamborghini, AWS, PepsiCo, Samsung, General Motors, Spotify, Merck, Meta, Dick's Sporting Goods, Pfizer, SHRM and Netflix. Attributing its explosive growth to a unique formula of engagement–driven brand campaigns, production of disruptive events and experiences, launch of new vertical business units, strategic partnerships and acquisitions, and pro bono humanitarian initiatives.

Since 2008 [INVNT GROUP] has thoughtfully expanded its global service offerings through the launch of new divisions and initiatives: INVNT.ATOM the digital innovation and Web3 agency based in Singapore; Hypnogram the boutique OOH–focused creative multimedia studio; INVNT Higher Ed, events designed for colleges and universities; and BZAR the group's proprietary, self–funded, decentralized content led metaverse; established as a marketplace for physical and digital transactions, NFTs, entertainment, social and gaming experiences.

The GROUP also bet big on live, with the newly formed ITP LIVE, strategically acquiring full–service production companies including: InSync Production Services Inc., Thunder Audio, Morpheus Lights, and Any Venue Video. For over 25 years, these production companies have supported the design and execution of experiential and live entertainment programs for many of the largest corporations, trade associations, sports franchises, governmental agencies (including the White House), and musical artists: Bruce Springsteen, Snoop Dog, Lady Gaga, Lionel Richie, Billy Joel, Diana Ross, Metallica, Post Malone, Tyler Perry and more.

Prior to adding these offerings the group consisted of founding agencies including: modern brand strategy firm Folk Hero; creative–led culture consultancy, Meaning; production studio & digital creative agency, HEV'; and the original live brand storytelling agency, INVNT.

"Our growing global mission and our Group are powered by the future of BrandStory, engagement, and community. Working with many of the most dynamic brands and organizations across a multiverse of industries – each influencing their markets, audiences, the environment, and our collective society. We pride ourselves on being a big, small agency defined by a tapestry of creativity, innovation, diverse perspectives, and disciplines. Above all, we believe in doing great work, and work that does great things," Scott Cullather, President & CEO of [INVNT GROUP] and CEO of INVNT.ATOM.

Named best–in–class for Marketing on Inc.'s Best in Business list, [INVNT GROUP] has delivered award–winning campaigns for a diverse roster of global brand partners and pro bono humanitarian causes, leading across creative, strategy, design, production, content, and marketing communications, including:

  • Back–to–back Lamborghini Campaigns: Launched the world's first 1:1 NFT supercar auction attached to the last physical Lamborghini Aventador Ultimae Coup, in collaboration with Steve Aoki, Krista Kim, and RM Sotheby's. INVNT.ATOM led the campaign, and HEV' designed and produced digital content, along with Hypnogram. This collaboration generated 587 Million social media impressions, with the auction closing at $1.6 Million USD "" landing it in the top 10 brand new Lamborghinis ever sold at auction. On the heels of that campaign, INVNT.ATOM launched Lamborghini's 60th anniversary celebration with "The Epic Road Trip' an 8–month long NFT drop campaign. Collectively, the two campaigns garnered 1.8 Billion global media impressions.

  • Multiple Samsung Launches: In partnership with Cheil Worldwide, INVNT produced a takeover of Times Square (New York) and Piccadilly Square (London), featuring an exclusive world–premiere music video by K–pop group, BTS, followed by a 3–week local, interactive, and experiential popup in each city. The overall experience welcomed over 200,000 visitors across New York and London. Additionally, INVNT delivered Samsung's Developer Conference (SDC) in San Francisco, and produced the most recent marquee Samsung Galaxy Unpacked event, back as an in–person live event after a 3–year hiatus.

  • General Motors: After producing GM's CES 2022 Keynote, featuring Chair and CEO, Mary Barra, INVNT led the "Factory Zero' launch, GM's first all–electric vehicle facility in Detroit. U.S. President Joe Biden toured the facility and delivered a keynote to the press tied to his administration's sustainability and worker policy plans. GM commemorated the milestone by ringing the NYSE bell directly from the production floor within the facility, alongside local unions, and the GM community.

  • Launching A New Era for Vanderbilt University: INVNT Higher Ed partnered with Vanderbilt University to celebrate its past and share bold visions for its future with a series of strategic engagements throughout 2021, 2022, and 2023. Producing a weekend of ceremonies and celebrations to mark the Investiture of Vanderbilt's 9th Chancellor, Daniel Diermeier, in 2022, followed by kicking off the university's 150th anniversary in 2023 with live events and a signature interactive online experience for Vanderbilt's global community. INVNT produced The Clinton Global Initiative University, hosted by Vanderbilt in March of 2023, and then launched Vanderbilt's ambitious "Dare to Grow" campaign in April "" a $3.2 Billion effort to strengthen the university for the future.

  • Circles.Life "Be the Main Character' Campaign: INVNT broke ground introducing Australia's first–ever 3D, metaverse, out–of–home billboard merging technology and data; turning influencers and consumers into avatars to deliver messages of connection and humanity.

  • PepsiCo Expo 2020 Dubai: INVNT designed and built three one–of–a–kind, interactive, and educational pavilions at Expo 2020 Dubai. Each pavilion was designed around core Expo themes of Mobility (The Bolt: Gatorade), Sustainability (The Drop: Aquafina), and Opportunity (The Plus: Pepsi Black + Lays). Open for 6 months, welcoming over 24 Million people physically and 50 Million virtually, the brand experience generated 246 Million global media impressions.

  • Captain Morgan x NFL "Fan of Year' Campaign: HEV' partnered with Sports Illustrated to celebrate the 2023 Super Bowl LVII, putting Captain Morgan at the center of the NFL universe through a strategic digital content launch featuring former New York Giants wide receiver Victor Cruz. HEV' created talent–led hype videos, a web hub, and social content to incentive dedicated fans to submit their own content, which resulted in 32 Fan of the Year (FOTY) winners (one representing each team) – positioning Captain Morgan at the center of the NFL conversation and social matrix. The winners were featured on the Caption Morgan FOTY web hub on SI.com, as a faux SI print cover providing a few dynamic and fun facts on each of the 32 winners. The campaign garnered over 432K Owned Organic Social Impressions, 700 media placements, totaling 4.5 Billion in earned global media impressions.

  • Intimissimi: Folk Hero developed and reimagined the company's BrandStory, ultimately leading to the launch of INTIMISSIMI's new global platform and campaign 'The Art of Italian Lingerie', featuring Heidi Klum and Lena Klum.

  • One Plus: Hypnogram was commissioned by OnePlus to create anamorphic video illusions on 3 different 3D billboards to promote the latest OnePlus flagship mobile device, Ovaltine across Kuala Lumpur, Bangkok, and NYC. Hypnogram strategized to create a viral and shareable experience, something that had never done before with the "Naked Eye 3D' billboard format. The NYC (Times Square) OnePlus billboard garnered over 538K overall impressions.

  • AESPA X Blake Kathryn NFT Collection: Aespa, the globally acclaimed female K–Pop group (and the first group in the metaverse with matching avatars) joined forces with visual and digital artist Blake Kathryn and INVNT.ATOM, to launch an exclusive NFT collection via Sotheby's. The AEGirls collection marked the world's first collaboration between a K–pop group and a global NFT artist.

Some of [INVNT GROUP]'s mission–focused Pro Bono work:

  • Championing "Freedom for All' with Dr. Opal Lee the grandmother of Juneteenth "" campaigning and delivering over 2 Million signatures to the White House, resulting in the historic federal passing of Juneteenth as a national holiday in the U.S., as well as talent representation with Creative Artists Agency (CAA), a Nobel Peace Prize nomination, and strategic partnerships w/ Adidas, Smithsonian, NBC, Sephora, and more.

  • Alongside United Talent Agency (UTA), [INVNT GROUP] hosted the "Ukraine Solidarity to Action' fundraising event by BlueCheck Ukraine, a humanitarian aid initiative co–founded by actor/director Liev Schreiber and UTA co–founder and CEO of Doctors Without Borders – USA executive director and BlueCheck Ukraine co–founder, Jason Cone. The event raised more than $250,000, with funds going directly towards supporting local Ukrainian NGOs and grassroots organizations providing on–the–ground humanitarian assistance to civilians severely impacted by the war.

  • [INVNT GROUP] partnered with Sunflower Network, a non–profit organization focused on providing direct and essential aid to Ukrainians in need, to present the Sonya exhibition on an online New York City pop–up charity art gallery and fundraising space exhibiting the work of Ukrainian artists and fundraising towards direct aid to Ukraine. The exhibit brought in over $200,000 in fundraising aid.

  • In partnership with the Deep Creek Lions Club, who since 1973 has been providing visually impaired youth with the opportunity to learn to downhill ski through the Blind Skiers Program, [INVNT GROUP] powered a fundraising gala highlighting achievements of program volunteers and participants, recruiting new members, and raising funds to grow the program into the future.

  • The Drum and [INVNT GROUP] hosted the second annual fundraiser of the traditional Scottish celebration raising funds for Brixton Finishing School in support of expanding diversity in our experiential, creative, and events industry for marginalized communities across all identities – raising over 18,500 for the effort.

"[INVNT GROUP]'s growth is a testament to not only our spectacular global team, but also the impact of our clients, partners, and causes. Since founding the GROUP's original live brand storytelling business INVNT, we've helped industry leaders and organizations around the world activate at emerging frontiers of engagement – launching in new markets and connecting them to their most relevant audiences. Our geographic expansion around the world grants us unique operational opportunities to reach and build communities at scale, in more direct and creative ways," Kristina McCoobery, CEO of INVNT and COO of [INVNT GROUP].

[INVNT GROUP] announced strategic business partnerships with MSM, the global talent and motorsport agency, and Trident3, the Web3 platform onboarding brands into the world of Web3, the metaverse, and NFTs. The partnerships aim to offer best–in–class marketing and commercial solutions across respective industries. HEV', also announced a client partnership with SHRM (Society of Human Resource Management), the largest HR organization in the world, with HEV' as agency of record, leading SHRM's brand messaging, creative design, and digital marketing strategies globally as the Human Resources organization celebrates its 75th Anniversary.

"Our business model is rooted in investment–worthy experiential moments that create brand growth, build community, engagement, and drive revenue. We're thrilled with [INVNT GROUP]'s trajectory as we continue broadening our business and partnership plans, cultivating the future of the experiential industry globally. Through ongoing strategic organic growth and acquisitions, we continue to provide more juice from the squeeze for our clients, key stakeholders, team members, and shareholders," Wolf Karbe, CFO of [INVNT GROUP].

###

ABOUT [INVNT GROUP]

[INVNT GROUP] was established as an evolution of the founding global live brand storytelling agency INVNT in 2008, with a vision to provide consistent, meaningful, well–articulated BrandStory across all platforms. With offices in New York, Sydney, London, Singapore, Dubai, San Francisco, Stockholm, Detroit, and Washington D.C.; headed by President and CEO, Scott Cullather, [INVNT GROUP], THE GLOBAL BRANDSTORY PROJECT represents a growing portfolio of complementary disciplines designed to help forward–thinking organizations everywhere, impact the audiences that matter, anywhere. The GROUP consists of modern brand strategy firm, Folk Hero; creative–led culture consultancy, Meaning; production studio & creative agency, HEV'; events for colleges and universities, INVNT Higher Ed; digital innovation division, INVNT.ATOM; creative multimedia experience studio, Hypnogram; and the original live brand storytelling agency, INVNT. For more information visit www.invntgroup.com

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Cellebrite Announces First-Quarter 2023 Results http://www.businesstimesoman.com/cellebrite-announces-first-quarter-2023-results/ http://www.businesstimesoman.com/cellebrite-announces-first-quarter-2023-results/#respond Wed, 10 May 2023 11:30:00 +0000 http://www.businesstimesoman.com/?p=308142 Revenue of $71.2 million, 14% year–over–year increase due primarily to
27% growth in subscription revenue;

ARR of $261.3 million, up 30% year–over–year;

Adjusted EBITDA of $7.3 million, 10.3% adjusted EBITDA margin

PETAH TIKVA, Israel and TYSONS CORNER, Va., May 10, 2023 (GLOBE NEWSWIRE) — Cellebrite (NASDAQ: CLBT), a global leader in Digital Intelligence ("DI") solutions for the public and private sectors, today announced financial results for the three months ending March 31, 2023.

"Our first–quarter results demonstrate that we are off to a strong start in 2023 as we work closely with our customers to help them modernize their investigative workflows," said Yossi Carmil, Cellebrite's CEO. "During the quarter, we made tangible progress with key strategic initiatives aimed at advancing innovation by delivering important breakthroughs with our Collect and Review capabilities. It is gratifying to see customers increasingly turn to Cellebrite for our powerful digital intelligence software solutions, which is translating into higher usage of our Collect and Review solutions and increasing traction for additional growth engines such as our Investigative Analytics and our Case and Evidence Management offerings. As a result, we move forward with solid momentum in a healthy marketplace, which is reflected in our ARR and NRR metrics. With a strong first quarter behind us and attractive opportunities ahead, we believe that we are on track to achieve our original FY23 financial targets."

First–Quarter 2023 Financial Highlights

  • Revenue of $71.2 million, up 14% year–over–year
  • Subscription revenue of $61.3 million, up 27% year–over–year
  • Annual Recurring Revenue (ARR) of $261.3 million, up 30% year–over–year
  • Recurring revenue dollar–based net retention rate (NRR) of 128%
  • GAAP gross profit and gross margin of $58.8 million and 82.6%, respectively; Non–GAAP gross profit and gross profit margin of $59.2 million and 83.1%, respectively
  • GAAP net loss of $40.6 million; Non–GAAP net income of $6.9 million
  • GAAP diluted net loss per share of $(0.21); Non–GAAP diluted EPS of $0.03
  • Adjusted EBITDA and adjusted EBITDA margin of $7.3 million and 10.3%, respectively

First–Quarter 2023 and Recent Digital Intelligence Highlights

  • Closed 21 large deals in the first quarter, each valued at $500,000 or more. Notable deals included:
    • A large national agency in Latin America expanded its Premium licensing, added Guardian and Pathfinder, and became the first customer in this region to integrate cryptocurrency data and insights within its Cellebrite DI solutions. This customer's ARR increased by a factor of 13x to $1.6 million.
    • Two police departments serving mid–sized U.S. cities added Premium to support their digital forensic labs and began deploying Pathfinder to accelerate their investigations and Guardian to securely share digital evidence among examiners, investigators and prosecutors. ARR for one of these customers quadrupled to nearly $600,000 and ARR for the other customer increased by over 10x to just under $300,000.
    • A specialist intelligence agency in Western Europe upgraded its digital intelligence collection capabilities by expanding its use of Premium ES nationwide while also renewing the licenses for other Collect & Review offerings. As a result, this customer's ARR increased by over 60% to $1.2 million.
  • Launched Pathfinder X, an elevated suite of artificial intelligence (AI)–enabled investigative analytics for digital evidence that helps law enforcement agencies resolve cases faster and more efficiently. New Pathfinder X features include cloud deployment options on AWS and Azure virtual private cloud, a deployment format optimal for geographically dispersed teams and a new user management system.
  • Announced integration between Cellebrite's LegalView Physical Analyzer and Relativity's RelativityOne, bringing more ease and speed to corporate investigations in the private sector.
  • Received Frost & Sullivan's 2022 North American Customer Value Leadership Award for its digital intelligence solutions.

Supplemental financial information can be found on the Investor Relations section of our website at https://investors.cellebrite.com/financial–information/quarterly–results.

Financial Outlook

"Having largely completed our transition to subscription software, we are starting to see our subscription software and ARR growth rates converge, which is consistent with our prior expectations," said Dana Gerner, Chief Financial Officer of Cellebrite. "Looking ahead, we anticipate continued success in increasing wallet share from existing customers and further expanding our global customer base with new logo wins. Based on our results to date and the opportunities we see to drive top–line growth, in combination with our prudent spending plans, Cellebrite is well positioned to drive improved year–over–year profitability and strong free cash flow over the coming quarters. We reiterate our full–year 2023 guidance."

  • Full year 2023 revenue is expected to be between $305 and $315 million, representing 13–16% year–over–year growth.
  • December 2023 ARR is expected to be between $300 and $310 million, representing 21–25% year–over–year growth.
  • Full year 2023 adjusted EBITDA is expected to be between $35.0 and $40.0 million, representing 11–13% margin.

Conference Call Information

Cellebrite will host a live conference call and webcast later this morning to review the Company's financial results for the first quarter of 2023 and discuss its full–year 2023 outlook. Pertinent details include:

Date: Wednesday, May 10, 2023
Time: 8:30 a.m. ET
Call–In Number: 203–518–9814
Conference ID: CLBTQ123
Event URL: https://investors.cellebrite.com/events/event–details/cellebrite–q1–23–earnings
Webcast URL: https://edge.media–server.com/mmc/p/u58372yq

In conjunction with the conference call and webcast, historical financial tables and supplemental data will be available on the quarterly results section of Company's investor relations website at https://investors.cellebrite.com/financial–information/quarterly–results. A transcript of the call will be added to this page along with access to the replay of the call later in the day.

Non–GAAP Financial Information

This press release includes non–GAAP financial measures. Cellebrite believes that the use of non–GAAP net income, non–GAAP operating income and Adjusted EBITDA is helpful to investors. These measures, which the Company refers to as our non–GAAP financial measures, are not prepared in accordance with GAAP.

The Company believes that the non–GAAP financial measures provide a more meaningful comparison of its operational performance from period to period, and offer investors and management greater visibility to the underlying performance of its business. Mainly:

  • Share–based compensation expenses utilize varying available valuation methodologies, subjective assumptions and a variety of equity instruments that can impact a company's non–cash expenses;
  • Acquired intangible assets are valued at the time of acquisition and are amortized over an estimated useful life after the acquisition, and acquisition–related expenses are unrelated to current operations and neither are comparable to the prior period nor predictive of future results;
  • To the extent that the above adjustments have an effect on tax (income) expense, such an effect is excluded in the non–GAAP adjustment to net income;
  • Tax expense, depreciation and amortization expense vary for many reasons that are often unrelated to our underlying performance and make period–to–period comparisons more challenging; and
  • Financial instruments are remeasured according to GAAP and vary for many reasons that are often unrelated to the Company's current operations and affect financial income.

Each of our non–GAAP financial measures is an important tool for financial and operational decision making and for evaluating our own operating results over different periods of time. The non–GAAP financial measures do not represent our financial performance under U.S. GAAP and should not be considered as alternatives to operating income or net income or any other performance measures derived in accordance with GAAP. Non–GAAP measures should not be considered in isolated from, or as an alternative to, financial measures determined in accordance with GAAP. Non–GAAP financial measures may not provide information that is directly comparable to that provided by other companies in our industry, as other companies in our industry may calculate non–GAAP financial results differently, particularly related to non–recurring, unusual items. In addition, there are limitations in using non–GAAP financial measures because the non–GAAP financial measures are not prepared in accordance with GAAP, and exclude expenses that may have a material impact on our reported financial results. Further, share–based compensation expense has been, and will continue to be for the foreseeable future, significant recurring expenses in our business and an important part of the compensation provided to our employees. In addition, the amortization of intangible assets is expected recurring expense over the estimated useful life of the underlying intangible asset and acquisition–related expenses will be incurred to the extent acquisitions are made in the future. Furthermore, foreign exchange rates may fluctuate from one period to another, and the Company does not estimate movements in foreign currencies.

A reconciliation of each of these non–GAAP financial measures to their most comparable GAAP measure is set forth in a table included at the end of this press release, which is also available on our website at https://investors.cellebrite.com.

In regard to forward–looking non–GAAP guidance, we are not able to reconcile the forward–looking Adjusted EBITDA measure to the closest corresponding GAAP measure without unreasonable efforts because we are unable to predict the ultimate outcome of certain significant items including, but not limited to, fair value movements, share–based payments for future awards, tax expense, depreciation and amortization expense, and certain financing and tax items.

Key Performance Indicators

This press release also includes key performance indicators, including annual recurring revenue and dollar–based retention rate.

Annual recurring revenue ("ARR") is defined as the annualized value of active term–based subscription license contracts and maintenance contracts related to perpetual licenses in effect at the end of that period. Subscription license contracts and maintenance contracts for perpetual licenses are annualized by multiplying the revenue of the last month of the period by 12. The annualized value of contracts is a legal and contractual determination made by assessing the contractual terms with our customers. The annualized value of maintenance contracts is not determined by reference to historical revenue, deferred revenue or any other GAAP financial measure over any period. ARR is not a forecast of future revenues, which can be impacted by contract start and end dates and renewal rates.

Dollar–based net retention rate ("NRR") is calculated by dividing customer recurring revenue by base revenue. We define base revenue as recurring revenue we recognized from all customers with a valid license at the last quarter of the previous year period, during the four quarters ended one year prior to the date of measurement. We define our customer revenue as the recurring revenue we recognized during the four quarters ended on the date of measurement from the same customer base included in our measure of base revenue, including recurring revenue resulting from additional sales to those customers.

About Cellebrite

Cellebrite's (NASDAQ: CLBT) mission is to enable its customers to protect and save lives, accelerate justice, and preserve privacy in communities around the world. We are a global leader in Digital Intelligence solutions for the public and private sectors, empowering organizations in mastering the complexities of legally sanctioned digital investigations by streamlining intelligence processes. Trusted by thousands of leading agencies and companies worldwide, Cellebrite's Digital Intelligence platform and solutions transform how customers collect, review, analyze and manage data in legally sanctioned investigations. To learn more, visit us at www.cellebrite.com and https://investors.cellebrite.com.

Note: References to our website and the websites of third parties mentioned in this press release are inactive textual references only, and information contained therein or connected thereto is not incorporated into this press release.

Caution Regarding Forward–Looking Statements

This document includes "forward–looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. Forward looking statements may be identified by the use of words such as "forecast," "intend," "seek," "target," "anticipate," "will," "appear," "approximate," "foresee," "might," "possible," "potential," "believe," "could," "predict," "should," "could," "continue," "expect," "estimate," "may," "plan," "outlook," "future" and "project" and other similar expressions that predict, project or indicate future events or trends or that are not statements of historical matters. Such forward–looking statements include estimated financial information for fiscal year 2023 and certain statements related to being on track to achieve our original FY23 financial targets, being well positioned to drive improved year–over–year profitability and strong free cash flow over the coming quarters, and reiterating our full–year 2023 guidance. Such forward–looking statements including those with respect to 2023 revenue and annual recurring revenue, profitability and earnings as well as commentary associated with future performance, strategies, prospects, and other aspects of Cellebrite's business are based on current expectations that are subject to risks and uncertainties. A number of factors could cause actual results or outcomes to differ materially from those indicated by such forward–looking statements. These factors include, but are not limited to: Cellebrite's ability to keep pace with technological advances and evolving industry standards; Cellebrite's material dependence on the purchase, acceptance and use of its solutions by law enforcement and government agencies; real or perceived errors, failures, defects or bugs in Cellebrite's DI solutions; Cellebrite's failure to maintain the productivity of sales and marketing personnel, including relating to hiring, integrating and retaining personnel; intense competition in all of Cellebrite's markets; the inadvertent or deliberate misuse of Cellebrite's solutions; failure to manage its growth effectively; Cellebrite's ability to introduce new solutions and add–ons; its dependency on its customers renewing their subscriptions; the low volume of business Cellebrite conducts via e–commerce; risks associated with the use of artificial intelligence; the risk of requiring additional capital to support the growth of its business; risks associated with higher costs or unavailability of materials used to create its hardware product components; fluctuations in foreign currency exchange rates; lengthy sales cycle for some of Cellebrite's solutions; near term declines in new or renewed agreements; risks associated with inability to retain qualified personnel and senior management; the security of Cellebrite's operations and the integrity of its software solutions; risks associated with the negative publicity related to Cellebrite's business and use of its products; risks related to Cellebrite's intellectual property; the regulatory constraints to which Cellebrite is subject; risks associated with different corporate governance requirements applicable to Israeli companies and risks associated with being a foreign private issuer and an emerging growth company; market volatility in the price of Cellebrite's shares; changing tax laws and regulations; risks associated with joint, ventures, partnerships and strategic initiatives; risks associated with Cellebrite's significant international operations; risks associated with Cellebrite's failure to comply with anti–corruption, trade compliance, anti–money–laundering and economic sanctions laws and regulations; risks relating to the adequacy of Cellebrite's existing systems, processes, policies, procedures, internal controls and personnel for Cellebrite's current and future operations and reporting needs; and other factors, risks and uncertainties set forth in the section titled "Risk Factors" in Cellebrite's annual report on Form 20–F filed with the SEC on April 27, 2023 and in other documents filed by Cellebrite with the U.S. Securities and Exchange Commission ("SEC"), which are available free of charge at www.sec.gov. You are cautioned not to place undue reliance upon any forward–looking statements, which speak only as of the date made, in this communication or elsewhere. Cellebrite undertakes no obligation to update its forward–looking statements, whether as a result of new information, future developments or otherwise, should circumstances change, except as otherwise required by securities and other applicable laws.

Contacts:

Investor Relations
Andrew Kramer
Vice President, Investor Relations
investors@cellebrite.com
+1 973.206.7760

Media
Victor Cooper
Sr. Director of Corporate Communications + Content Operations
Victor.cooper@cellebrite.com
+1 404.804.5910

Cellebrite DI Ltd.
First–Quarter 2023 Results Summary
(U.S Dollars in thousands)
For the three months ended
March 31,
2023 2022
(Unaudited) (Unaudited)
Revenue 71,234 62,385
Gross profit 58,828 51,402
Gross margin 82.6 % 82.4 %
Operating income (loss) 136 (1,946 )
Operating margin 0.2 % (3.1 )%
Net (loss) income (40,605 ) 55,438
Cash flow from operating activities 12,476 (10,537 )
Non–GAAP Financial Data:
Operating income 5,653 2,634
Operating margin 7.9 % 4.2 %
Net income 6,899 1,420
Adjusted EBITDA 7,304 4,082
Adjusted EBITDA margin 10.3 % 6.5 %

Cellebrite DI Ltd.
Condensed Consolidated Balance Sheets
(U.S. Dollars in thousands)
March 31, December 31,
2023 2022
Unaudited Audited
Assets
Current assets
Cash and cash equivalents $ 98,972 $ 87,645
Short–term deposits 54,740 51,335
Marketable securities 48,938 44,643
Trade receivables (net of allowance for doubtful accounts of $1,264 and $1,904 as of March 31, 2023 and December 31, 2022, respectively) 69,594 78,761
Prepaid expenses and other current assets 20,259 17,085
Contract acquisition costs 6,377 6,286
Inventories 11,405 10,176
Total current assets 310,285 295,931
Non–current assets
Other non–current assets 2,657 1,731
Marketable securities 18,521 22,125
Deferred tax assets, net 11,894 12,511
Property and equipment, net 16,725 17,259
Intangible assets, net 10,458 11,254
Goodwill 26,829 26,829
Operating lease right–of–use assets, net 15,320 15,653
Total non–current assets 102,404 107,362
Total assets $ 412,689 $ 403,293
Liabilities and shareholders' equity
Current Liabilities
Trade payables $ 4,918 $ 4,612
Other accounts payable and accrued expenses 37,198 45,453
Deferred revenues 157,903 152,709
Operating lease liabilities 4,723 5,003
Total current liabilities 204,742 207,777
Long–term liabilities
Other long term liabilities 5,577 5,394
Deferred revenues 48,384 42,173
Restricted Sponsor Shares liability 28,574 17,532
Price Adjustment Shares liability 46,126 26,184
Warrant liability 29,824 20,015
Operating lease liabilities 10,105 10,353
Total long–term liabilities 168,590 121,651
Total liabilities $ 373,332 $ 329,428
Shareholders' equity
Share capital * ) * )
Additional paid–in capital (119,061 ) (125,624 )
Treasury share, NIS 0.00001 par value; 41,776 ordinary shares (85 ) (85 )
Accumulated other comprehensive (loss) income (135 ) 331
Retained earnings 158,638 199,243
Total shareholders' equity 39,357 73,865
Total liabilities and shareholders' equity $ 412,689 $ 403,293

*) Less than 1 USD

Cellebrite DI Ltd.
Condensed Consolidated Statements of Income
(U.S Dollars in thousands, except share and per share data)
For the three months ended
March 31,
2023 2022
(Unaudited) (Unaudited)
Revenue:
Subscription services $ 47,367 $ 36,361
Term–license 13,915 11,824
Total subscription 61,282 48,185
Other non–recurring* 2,918 5,972
Professional services 7,034 8,228
Total revenue 71,234 62,385
Cost of revenue:
Subscription services 4,492 3,768
Term–license 2 250
Total subscription 4,494 4,018
Other non–recurring* 2,981 2,207
Professional services 4,931 4,758
Total cost of revenue 12,406 10,983
Gross profit $ 58,828 $ 51,402
Operating expenses:
Research and development 21,131 19,576
Sales and marketing 27,601 23,259
General and administrative 9,960 10,513
Total operating expenses $ 58,692 $ 53,348
Operating income (loss) $ 136 $ (1,946 )
Financial (expense) income, net (38,775 ) 56,400
(Loss) Income before tax (38,639 ) 54,454
Tax expense (income) 1,966 (984 )
Net (Loss) income $ (40,605 ) $ 55,438
(Loss) earnings per share
Basic $ (0.21 ) $ 0.29
Diluted $ (0.21 ) $ 0.27
Weighted average shares outstanding
Basic 186,338,076 180,545,126
Diluted 198,184,236 196,142,739
Other comprehensive (loss) income:
Unrealized loss on hedging transactions (44 ) (1,150 )
Unrealized income (loss) on marketable securities 177 (49 )
Currency translation adjustments (598 ) 402
Total other comprehensive loss, net of tax (465 ) (797 )
Total other comprehensive (loss) income $ (41,070 ) $ 54,641

* Other non–recurring is composed of hardware sales, usage fees and perpetual licenses, and was previously referred to "Perpetual license and other." Changing the name for this type of revenue reflects that perpetual license revenue has declined to relatively insignificant levels with hardware sales now representing the majority of this type of revenue.

Cellebrite DI Ltd.
Condensed Consolidated Statements of Cash Flow
(U.S Dollars in thousands, except share and per share data)
For the three months ended
March 31,
2023 2022
(Unaudited) (Unaudited)
Cash flow from operating activities:
Net (loss) income $ (40,605 ) $ 55,438
Adjustments to reconcile net income to net cash provided by operating activities:
Share based compensation and RSUs 4,457 2,858
Amortization of premium, discount and accrued interest on marketable securities (171 ) 17
Depreciation and amortization 2,447 2,112
Interest income from short term deposits (684 ) (62 )
Deferred income taxes 560 (924 )
Remeasurement of warrant liability 9,809 (17,083 )
Remeasurement of Restricted Sponsor Shares 11,042 (13,506 )
Remeasurement of Price Adjustment Shares liabilities 19,942 (25,759 )
Decrease in trade receivables 9,627 7,015
Increase (decrease) in deferred revenue 10,468 (5,916 )
Increase in other non–current assets (927 ) (33 )
(Increase) decrease in in prepaid expenses and other current assets (3,637 ) 750
Changes in operating lease assets 1,367 ""
Changes in operating lease liability (1,562 ) ""
Increase in inventories (1,225 ) (1,347 )
Increase (decrease) in trade payables 264 (352 )
Decrease in other accounts payable and accrued expenses (8,879 ) (11,085 )
Increase (decrease) in other long–term liabilities 183 (2,660 )
Net cash provided by (used in) operating activities 12,476 (10,537 )
Cash flows from investing activities:
Purchases of property and equipment (1,064 ) (2,305 )
Investment in marketable securities (16,352 ) (29,276 )
Proceeds from maturity of marketable securities 16,073 ""
Investment in short term deposits (16,000 ) (7,000 )
Redemption of short term deposits 13,279 25,181
Net cash used in investing activities (4,064 ) (13,400 )
Cash flows from financing activities:
Exercise of options to shares 2,106 3,627
Proceeds from Employee Share Purchase Plan, net 624 ""
Net cash provided by financing activities 2,730 3,627
Net increase (decrease) in cash and cash equivalents 11,142 (20,310 )
Net effect of Currency Translation on cash and cash equivalents 185 56
Cash and cash equivalents at beginning of period 87,645 145,973
Cash and cash equivalents at end of period $ 98,972 $ 125,719
Supplemental cash flow information:
Income taxes paid $ 3,625 $ 1,287
Non–cash activities
Purchase of property and equipment $ "" $ 133

Cellebrite DI Ltd.
Reconciliation of GAAP to Non–GAAP Financial Information
(U.S Dollars in thousands, except share and per share data)
For the three months ended
March 31,
2023 2022
Unaudited Unaudited
Cost of revenue $ 12,406 $ 10,983
Less:
Share based compensation 386 246
Acquisition related costs 13 ""
Non–GAAP cost of revenue $ 12,007 $ 10,737

For the three months ended
March 31,
2023 2022
Unaudited Unaudited
Gross profit $ 58,828 $ 51,402
Share based compensation 386 246
Acquisition related costs 13
Non–GAAP gross profit $ 59,227 $ 51,648

For the three months ended
March 31,
2023 2022
Unaudited Unaudited
Operating expenses $ 58,692 $ 53,348
Less:
Share based compensation 4,071 2,612
Amortization of intangible assets 796 664
Acquisition related costs 251 1,058
Non–GAAP operating expenses $ 53,574 $ 49,014

For the three months ended
March 31,
2023 2022
Unaudited Unaudited
Operating income (loss) $ 136 $ (1,946 )
Share based compensation 4,457 2,858
Amortization of intangible assets 796 664
Acquisition related costs 264 1,058
Non–GAAP operating income $ 5,653 $ 2,634

Cellebrite DI Ltd.
Reconciliation of GAAP to Non–GAAP Financial Information
(U.S Dollars in thousands, except share and per share data)
For the three months ended
March 31,
2023 2022
Unaudited Unaudited
Net (loss) income $ (40,605 ) $ 55,438
One time tax income "" (1,825 )
Share based compensation 4,457 2,858
Amortization of intangible assets 796 664
Acquisition related costs 264 1,058
Tax expense (income) 1,194 (425 )
Finance expense (income) from financial derivatives 40,793 (56,348 )
Non–GAAP net income $ 6,899 $ 1,420
Non–GAAP Earnings per share:
Basic $ 0.04 $ 0.01
Diluted $ 0.03 $ 0.01
Weighted average shares outstanding:
Basic 186,338,076 180,545,126
Diluted 198,184,236 196,142,739

For the three months ended
March 31,
2023 2022
Unaudited Unaudited
Net (loss) income $ (40,605 ) $ 55,438
Financial expense (income), net 38,775 (56,400 )
Tax expense (income) 1,966 (984 )
Share based compensation 4,457 2,858
Amortization of intangible assets 796 664
Acquisition related costs 264 1,058
Depreciation expenses 1,651 1,448
Adjusted EBITDA $ 7,304 $ 4,082


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Entera Bio Announces Q1 2023 Financial Results and Corporate Updates http://www.businesstimesoman.com/entera-bio-announces-q1-2023-financial-results-and-corporate-updates/ http://www.businesstimesoman.com/entera-bio-announces-q1-2023-financial-results-and-corporate-updates/#respond Fri, 05 May 2023 20:05:00 +0000 http://www.businesstimesoman.com/?p=308110 JERUSALEM, May 05, 2023 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and therapeutic proteins, today reported corporate updates and financial results for the first quarter ended March 31, 2023.

"Our primary objectives for 2023 are to finalize our discussion with the FDA regarding our registrational phase 3 study for EB613 in post–menopausal women with low bone mineral density (BMD) and osteoporosis, and to update on our PK study which will assess the potential for a novel oral PTH(1–34) candidate for the treatment of hypoparathyroidism," said Miranda Toledano, the Company's Chief Executive Officer. "We also remain focused on our earlier stage R&D initiatives with peptides that best align to our technology, such as GLP–2."

Corporate Updates for First Quarter 2023:

  • Concluded Type D Meeting with the FDA Related to EB613. Entera previously reported that it will continue discussions with the agency until final guidance is received on the proposed statistical evaluation of its primary endpoint. This is likely to occur pursuant to the FDA's evaluation and qualification of the Foundation for the National Institutes of Health Bone Quality Project (FNIH BQP)1. Entera plans to provide an update on its discussions with the FDA as the year progresses. Meanwhile, the Company continues to strengthen its ecosystem of endocrinology and women's health advisory board for EB613 with the addition of Dr. Steve Goldstein, a global leader in menopause health and former President of the North American and International Menopause Society.
  • Institutional Review Board (IRB) Accepted and the Company Plans to Initiate Next Generation Platform PK Study in H1'2023. Topline results expected in H2'2023 including the potential for a novel candidate to treat hypoparathyroidism with once or twice a day oral PTH(1–34) tablets. This initiative builds on prior PK and Phase 2 results of an earlier generation of EB612 in hypoparathyroidism patients.
  • Entera Oral GLP–2 Pre–Clinical Manuscript Accepted for Publication by the International Journal of Peptide Research and Therapeutics. Based on this work, Entera believes GLP–2 represents a strong candidate for its oral delivery platform and warrants further development as an injection free alternative to patients suffering from short bowel syndrome and other disorders requiring parenteral nutrition.
  • Amgen Research Collaboration. After over four years of collaborative pre–clinical work evaluating the use of Entera's delivery technology with one molecule selected by Amgen, both collaborators have agreed to discontinue the Research Collaboration and License Agreement entered into in 2018 out of mutual convenience.

_______________
1 FNIH BQP is also knows as the ASBMR FNIH–SABRE, American Society for Bone and Mineral Research–Foundation for the National Institutes of Health (FNIH) Strategy to Advance BMD as a Regulatory Endpoint (SABRE)

Financial Results for the Three Months Ended March 31, 2023

As of March 31, 2023, Entera had cash and cash equivalents of $10.7 million. Entera expects that its existing cash resources are sufficient to meet its projected operating requirements into the third quarter of 2024, which includes the capital required to fund our ongoing operations, including R&D and the completion of the Phase 1 PK study related to the new formulation of EB612.

Research and development expenses for the three months ended March 31, 2023 were $0.9 million, as compared to $1.7 million for the three months ended March 31, 2022. The decrease of $0.8 million was primarily due to a decrease of $0.6 million in materials and production costs and a decrease of $0.2 million in employee compensation, including share–based compensation.

General and administrative expenses for the three months ended March 31, 2023 were $1.3 million, as compared to $2.2 million for the three months ended March 31, 2022. The decrease of $0.9 million was mainly attributable to a decrease of $0.6 million in employee compensation, including share–based compensation, a decrease of $0.2 million in professional fees and a decrease of $0.1 million in D&O insurance costs.

Operating expenses for the quarter ended March 31, 2023 were $2.2 million, as compared to $3.8 million for the quarter ended March 31, 2022. Entera's operating loss was $2.2 million for quarter ended March 31, 2023, as compared to $3.8 million for the quarter ended March 31, 2022.

Net loss was $2.2 million, or $0.08 per ordinary share (basic and diluted), for the quarter ended March 31, 2023, as compared to $3.8 million, or $0.13 per ordinary share (basic and diluted), for the quarter ended March 31, 2022.

About Entera Bio

Entera is a leader in the development of orally delivered macromolecules, including peptides and other therapeutic proteins. The Company focuses on significant unmet medical needs where a daily mini tablet form of a peptide treatment or replacement therapy holds the potential to transform the standard of care. The Company's most advanced product candidates, EB613 for the treatment of high risk, post–menopausal osteoporosis and EB612 for the treatment of hypoparathyroidism, are in clinical development. EB613 is the first oral, once daily mini tablet presentation of synthetic hPTH (1–34), (teriparatide), consisting of the exact same 34 amino acid sequence as daily subcutaneous teriparatide injection, Forteo , which requires daily SC injections. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/biomarker) and secondary endpoints (BMD) in a dose dependent manner and was presented at the ASBMR 2021 Annual Conference. A phase 1 PK study of novel PTH formulations is planned for H1 2023 to ascertain feasibility of a new hypo candidate (a prior formulation had positive Phase 2a data announced in 2015 and published in JBMR 2019) and for another potential indication. For more information on Entera Bio, visit www.enterabio.com.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release are "forward–looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, "anticipate," "believe," "can," "could," "expect," "estimate," "design," "goal," "intend," "may," "might," "objective," "plan," "predict," "project," "target," "likely," "should," "will," and "would," or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera's forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA's interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera is contractually obligated to provide, such as those pursuant to Entera's agreement with Amgen; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera's product candidates; Entera's reliance on third parties to conduct its clinical trials; Entera's expectations regarding licensing, business transactions and strategic collaborations; Entera's operation as a development stage company with limited operating history; Entera's ability to continue as a going concern absent access to sources of liquidity; Entera's ability to obtain and maintain regulatory approval for any of its product candidates; Entera's ability to comply with Nasdaq's minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera's intellectual property position and its ability to protect its intellectual property; and other factors that are described in the "Cautionary Statements Regarding Forward–Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Entera's most recent Annual Report on Form 10–K filed with the SEC, as well as the company's subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

ENTERA BIO LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share data)
(Unaudited)
March 31 December 31
2023 2022
Cash and cash equivalents 10,691 12,309
Accounts receivable and other current assets 682 540
Property and equipment, net 136 139
Other assets, net 97 139
Total assets 11,606 13,127
Accounts payable and other current liabilities 1,494 1,341
Total non–current liabilities 32 32
Total liabilities 1,526 1,373
Total shareholders' equity 10,080 11,754
Total liabilities and shareholders' equity 11,606 13,127

ENTERA BIO LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)

Three Months Ended
March 31,
2023 2022
REVENUES 68
COST OF REVENUES 54
GROSS PROFIT 14
OPERATING EXPENSES:
Research and development 931 1,690
General and administrative 1,294 2,171
Other income (13 ) (12 )
TOTAL OPERATING EXPENSES 2,212 3,849
OPERATING LOSS 2,212 3,835
FINANCIAL INCOME, NET (22 ) (44 )
LOSS BEFORE INCOME TAX 2,190 3,791
INCOME TAX BENEFIT (7 )
NET LOSS 2,190 3,784
LOSS PER SHARE BASIC AND DILUTED 0.08 0.13
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE 28,809,922 28,804,411


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Entera Bio Provides 2022 Corporate Milestones and Financial Results for the Year Ended December 31, 2022 http://www.businesstimesoman.com/entera-bio-provides-2022-corporate-milestones-and-financial-results-for-the-year-ended-december-31-2022/ http://www.businesstimesoman.com/entera-bio-provides-2022-corporate-milestones-and-financial-results-for-the-year-ended-december-31-2022/#respond Fri, 31 Mar 2023 20:00:00 +0000 http://www.businesstimesoman.com/?p=307825 JERUSALEM, March 31, 2023 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and therapeutic proteins, today announced a summary of 2022 corporate achievements and financial results for the year ended December 31, 2022.

"The year 2022 and 2023 year to date, has been a critical time for Entera, during which focus, optimization and execution across our organization has been paramount to adequately prepare our EB613 program to become phase 3 ready, from a clinical, regulatory, and manufacturing standpoint. EB613 (oral PTH(1–34), teriparatide) is positioned as the first potential daily tablet anabolic therapy for the treatment of post–menopausal women with low Bone Mineral Density (BMD) and osteoporosis. In addition, we have continued to harness our scientific capabilities and intellectual property to expand our proprietary platform with novel drug candidates, including a new generation for EB612, potentially the first PTH (1–34) peptide replacement therapy in tablet form for the treatment of hypoparathyroidism," stated Miranda Toledano, Chief Executive Officer of Entera.

A brief review of key EB613 related milestones:

  • In June 2021, Entera reported positive results from its double–blind, placebo–controlled Phase 2 study of EB613 in 161 post–menopausal women with low BMD and osteoporosis. The study met all PD/ biomarker, BMD endpoints, and demonstrated a generally well tolerated safety profile. It was also noted that EB613 had a differentiated biomarker and BMD profile versus historical 6–month data reported with daily subcutaneous injections of Forteo in a similar population.
  • In January 2022, Entera received FDA's End of Phase 2 meeting minutes which conveyed concern with the previously proposed Phase 3 study, based on a 12–month non–inferiority head–to–head design versus Forteo and whether such a trial would be successful.
  • In response to the FDA's End of Phase 2 minutes, Entera re–designed the proposed phase 3 to potentially align with FDA's suggestion to explore a placebo–controlled phase 3 design with a Total Hip BMD (TH BMD) endpoint, given emerging seminal publications from the FNIH BQP–ASBMR project.
  • On July 18th, 2022, Entera announced that the FDA had granted Entera's request for a Type C Meeting based on the revised phase 3 registrational protocol for EB613.
  • On October 6th 2022, Entera announced the conclusion of its Type C meeting and concurrence with the FDA that a single well designed Phase 3 placebo–controlled study with a proposed primary endpoint of TH BMD may support a New Drug Application (NDA) submission of EB613; and that a relative PK study comparing its oral tablet form of teriparatide, EB613 versus the subcutaneous injection of teriparatide, Forteo , may be utilized as a scientific bridge to support the 505(b)(2) NDA pathway.
  • On February 15th, 2023, Entera announced that a Type D meeting had been accepted by the FDA. As part of its briefing documents for the Type D process, Entera aimed to confirm that the protocol fully met FDA's expectations, including the analysis of the primary TH BMD endpoint and the population PK evaluations.

"We look forward to continuing our dialogue with the FDA and reaching consensus to de–risk our potential pivotal regulatory pathway for EB613. It is our belief that Entera stands as the first osteoporosis drug development company to potentially pursue a placebo–controlled registrational study with a BMD (rather than fracture) endpoint. We are cognizant that to be successful in pioneering a path takes time and the agency's partnership to move forward successfully. From a corporate finance perspective, Entera has sufficient cash on hand into Q3 2024 including the read–out from our planned next generation platform PK study, which may enable us to advance the EB612 program for the treatment of hypoparathyroidism into Phase 2 in 2024. From a strategic standpoint, we will continue to hold both strategic and other discussions to determine the best path forward to finance our pivotal program for EB613. This process is of course dependent on when we conclude our regulatory discussions with FDA. This has been a challenging year for the Company, and I am proud of our resilience and accomplishments," stated Miranda Toledano, Chief Executive Officer of Entera.

Financial Results for the year Ended December 31, 2022

Revenues for the year ended December 31, 2022 and 2021 were $134,000 and $571,000, respectively, mainly attributable to research and development, or R&D services provided to Amgen and other third parties under material transfer agreements. The cost of revenues for the year ended December 31, 2022 was $101,000 as compared to $373,000 for the year ended December 31, 2021 and primarily attributed to expenses in connection with R&D services provided and reimbursed by Amgen.

Research and development expenses for the year ended December 31, 2022, were $5.8 million, as compared to $6.8 million for the year ended December 31, 2021. The decrease was primarily attributed to completion of pre–clinical activities related to our Phase 3 clinical trial for EB613 which was offset by continued materials and production expenses related to clinical supply and a one–time payment to our former President. in 2021.

General and administrative expenses for the year ended December 31, 2022 were $7.3 million, compared to $5.7 million for the year ended December 31, 2021. The increase was mainly attributable to an increase in non–cash share–based compensation granted to directors and executive officers and a one–time payment to our former Chief Executive Officer.

Operating expenses for the year ended December 31, 2022 were $13 million compared to $12.4 million for the year ended December 31, 2021. Entera's operating loss was $13 million for the year ended December 31, 2022, compared to $12.2 million for the year ended December 31, 2021.

Net loss was $13.1 million or $0.45 per ordinary share (basic and diluted) for the year ended December 31, 2022, compared to $12.2 million, or $0.47 per ordinary share (basic and diluted) for the year ended December 31, 2021.

As of December 31, 2022, Entera had cash and cash equivalents of $12.3 million. Entera expects that its existing cash resources are sufficient to meet our projected operating requirements into the third quarter of 2024, which includes the capital required to fund our ongoing operations, including R&D and the completion of the Phase 1 PK study related to the new formulation EB612. This does not include the capital required to fund our proposed Phase 3 pivotal program for EB613 in osteoporosis.

About Entera Bio

Entera is a leader in the development of orally delivered macromolecules, including peptides and other therapeutic proteins. The Company focuses on significant unmet medical needs where a mini daily tablet form of a peptide treatment or replacement therapy holds the potential to transform the standard of care. The Company's most advanced product candidates, EB613 for the treatment of high risk, post–menopausal osteoporosis and EB612 for the treatment of hypoparathyroidism, are in clinical development. EB613 is the first oral, once daily mini tablet presentation of synthetic hPTH (1–34), (teriparatide), consisting of the exact same 34 amino acid sequence as daily subcutaneous teriparatide injection, Forteo , which requires daily SC injections. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/biomarker) and secondary endpoints (BMD) in a dose dependent manner and was presented at the ASBMR 2021 Annual Conference. A phase 1 PK study of novel PTH formulations is planned for H1 2023 to ascertain feasibility of a new hypo candidate (a prior formulation had positive Phase 2a data announced in 2015 and published in JBMR 2019) and for another potential indication. For more information on Entera Bio, visit www.enterabio.com.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release are "forward–looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, "anticipate," "believe," "can," "could," "expect," "estimate," "design," "goal," "intend," "may," "might," "objective," "plan," "predict," "project," "target," "likely," "should," "will," and "would," or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera's forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA's interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera is contractually obligated to provide, such as those pursuant to Entera's agreement with Amgen; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera's product candidates; Entera's reliance on third parties to conduct its clinical trials; Entera's expectations regarding licensing, business transactions and strategic collaborations; Entera's operation as a development stage company with limited operating history; Entera's ability to continue as a going concern absent access to sources of liquidity; Entera's ability to obtain and maintain regulatory approval for any of its product candidates; Entera's ability to comply with Nasdaq's minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera's intellectual property position and its ability to protect its intellectual property; and other factors that are described in the "Cautionary Statements Regarding Forward–Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Entera's most recent Annual Report on Form 10–K filed with the SEC, as well as the company's subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

ENTERA BIO LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share data)
(Unaudited)
December 31 December 31
2022 2021
Cash and cash equivalents 12,309 24,892
Accounts receivable and other current assets 540 437
Property and equipment, net 139 156
Other assets, net 139 502
Total assets 13,127 25,987
Accounts payable and other current liabilities 1,341 3,161
Total non–current liabilities 32 261
Total liabilities 1,373 3,422
Total shareholders' equity 11,754 22,565
Total liabilities and shareholders' equity 13,127 25,987

ENTERA BIO LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
Year ended
December 31,
2022 2021
REVENUES 134 571
COST OF REVENUES 101 373
GROSS PROFIT 33 198
OPERATING EXPENSES:
Research and development 5,848 6,771
General and administrative 7,253 5,690
Other income (51 ) (46 )
TOTAL OPERATING EXPENSES 13,050 12,415
OPERATING LOSS 13,017 12,217
FINANCIAL EXPENSES(INCOME), net (83 ) 29
LOSS BEFORE INCOME TAX 12,934 12,246
INCOME TAX EXPENSE(BENEFIT) 137 (59 )
NET LOSS 13,071 12,187
LOSS PER SHARE BASIC AND DILUTED 0.45 0.47
WEIGHTED–AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE 28,808,090 28,133,770


GLOBENEWSWIRE (Distribution ID 8799784)

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Cellebrite Announces Fourth Quarter 2022 Results http://www.businesstimesoman.com/cellebrite-announces-fourth-quarter-2022-results/ http://www.businesstimesoman.com/cellebrite-announces-fourth-quarter-2022-results/#respond Wed, 15 Feb 2023 12:00:00 +0000 http://www.businesstimesoman.com/?p=307422 ARR of $249 million, up 33% year–over–year

Fourth–quarter revenue of $74.0 million, Increase 9% year–over–year

Fourth–quarter adjusted EBITDA of $16.1 million, 21.8% adjusted EBITDA margin

PETAH TIKVA, Israel and TYSONS CORNER, Va., Feb. 15, 2023 (GLOBE NEWSWIRE) — Cellebrite (NASDAQ: CLBT), a global leader in Digital Intelligence ("DI") solutions for the public and private sectors, today announced financial results for the three and twelve months ending December 31, 2022.

"We ended 2022 with solid quarterly results fueled by our industry–leading technology in a healthy Digital Intelligence market. Our market leadership remains strong as a result of the tangible progress and investments we have made in innovating across our platforms and executing on our go–to–market strategy," said Yossi Carmil, Cellebrite's CEO. "As data volumes are surging, data complexity is increasing and scrutiny around ethics and accountability are mounting, we are committed to helping customers modernize their investigations by digitizing the evidence workflows end–to–end. We enter 2023 well positioned to accelerate our revenue growth rate and drive improved profitability as we continue to capitalize on the strong demand we see for our offerings."

Fourth Quarter Financial Highlights

  • Annual Recurring Revenue (ARR) of $249 million, up 33% year–over–year
  • Revenue of $74.0 million, up 9% year–over–year, of which subscription revenue was $62.3 million, up 24% year–over–year
  • Recurring revenue dollar–based net retention rate of 130%
  • GAAP gross profit and gross margin of $61.9 million and 83.6%, respectively
  • GAAP net income of $7.1 million; Non–GAAP net income of $15.3 million
  • GAAP diluted EPS of $0.04; Non–GAAP diluted EPS of $0.08
  • Adjusted EBITDA and adjusted EBITDA margin of $16.1 million and 21.8%, respectively

Full Year Financial Highlights

  • Revenue of $270.7 million, up 10% year–over–year, of which subscription revenue was $216.0 million, up 18% year–over–year
  • GAAP gross profit and gross margin of $219.9 million and 81.3%, respectively
  • GAAP net income of $120.8 million; Non–GAAP net income of $19.7 million
  • Adjusted EBITDA and Adjusted EBITDA margin of $25.9 million and 10%, respectively

Fourth Quarter and Recent Digital Intelligence Highlights

  • Closed 29 large deals in the fourth quarter, each valued at $500,000 or more.
  • Won a $14 million agreement with a leading law enforcement agency in Asia for the company's Advanced Extraction Solution.
  • Signed a $10+ million deal with a major West European national police force, marking one of the Company's largest digital intelligence deals, further validating digital intelligence as an essential accelerator for investigators.
  • Announced that its collaboration with the Vanderburgh Co. Cyber Crime Task Force to service 29 agencies across 11 U.S. states has helped accelerate justice by reducing the time it takes to investigate and successfully prosecute felonies.
  • Launched new cloud workplace app collection capability for Cellebrite Endpoint Inspectorthataims to improve organizations' investigation and eDiscovery capabilities. Thisnew functionalitywill enable customers to collect remote mobile and computer data as well as cloud workplace application data in one unified platform, reducing time and costs associated with the collection of data of these apps.
  • Published the Enterprise Solutions 2023 Industry Trends Report, which highlights major data collection headaches arising from a hybrid work environment that threaten to slow down corporate fraud, IP theft and sexual harassment investigations for eDiscovery professionals and corporate investigators.
  • Partnered with the Gangmasters and Labour Abuse Authority (GLAA), and The Exodus Road to help these organizations advance their efforts to advance their respective missions and eliminate forced labor and human trafficking.

Supplemental financial information can be found on the Investor Relations section of our website at https://investors.cellebrite.com/financial–information/quarterly–results.

Financial Outlook

"With a strong 33% annual growth in ARR during 2022 and 84% of our fourth–quarter 2022 revenue coming from subscription software licenses, Cellebrite has largely completed a successful, multi–year transition to subscription software," said Dana Gerner, Chief Financial Officer of Cellebrite. "Looking ahead, we are well positioned to increase our revenue growth rate and sustain solid ARR momentum in 2023 as we continue expanding wallet share with existing customers, complemented by winning new logos. We anticipate that the combination of our top–line growth and prudent investment in our operations will enable us to drive improvement in our profitability during 2023, and keep us on track to reach our original long–term EBITDA margin target of 20% or greater."

  • December 2023 ARR is expected to be between $300 and $310 million, representing 21–25% year on year growth.
  • Full year 2023 revenue is expected to be between $305 and $315 million, representing 13–16% year on year growth.
  • Full year 2023 Adjusted EBITDA is expected to be between $35.0 and $40.0 million, representing 11–13% margin.

Conference Call Information
Today, February 15, 2023, at 8:30 a.m. ET, Cellebrite will host a conference call and webcast to discuss the Company's financial results for the fourth quarter 2022. The call details are below:

Telephone participants are advised to register in advance at:
https://register.vevent.com/register/BIa98ecd8f02c04567a1515497e1f850c8.

Upon registration, participants will receive a confirmation email detailing how to join the conference call, including the dial–in number and a unique registrant ID.

The live conference call will be webcast in listen–only mode at: https://edge.media–server.com/mmc/p/6j7zngzy.

The webcast will remain available after the call at: https://investors.cellebrite.com/events–presentations

Non–GAAP Financial Information

This press release includes non–GAAP financial measures. Cellebrite believes that the use of non–GAAP net income, non–GAAP operating income and Adjusted EBITDA is helpful to investors. These measures, which the Company refers to as our non–GAAP financial measures, are not prepared in accordance with GAAP.

The Company believes that the non–GAAP financial measures provide a more meaningful comparison of its operational performance from period to period and offers investors and management greater visibility to the underlying performance of its business. Mainly:

  • Share–based compensation expenses utilize varying available valuation methodologies, subjective assumptions and a variety of equity instruments that can impact a company's non–cash expenses;
  • Acquired intangible assets are valued at the time of acquisition and are amortized over an estimated useful life after the acquisition, and acquisition–related expenses are unrelated to current operations and neither are comparable to the prior period nor predictive of future results;
  • To the extent that the above adjustments have an effect on tax (income) expense, such an effect is excluded in the non–GAAP adjustment to net income;
  • Tax expense, depreciation and amortization expense vary for many reasons that are often unrelated to our underlying performance and make period–to–period comparisons more challenging; and
  • Financial instruments are remeasured according to GAAP and vary for many reasons that are often unrelated to the Company's current operations and affect financial income.

Each of our non–GAAP financial measures is an important tool for financial and operational decision making and for evaluating our own operating results over different periods of time. The non–GAAP financial measures do not represent our financial performance under U.S. GAAP and should not be considered as alternatives to operating income or net income or any other performance measures derived in accordance with GAAP. Non–GAAP measures should not be considered in isolated from, or as an alternative to, financial measures determined in accordance with GAAP. Non–GAAP financial measures may not provide information that is directly comparable to that provided by other companies in our industry, as other companies in our industry may calculate non–GAAP financial results differently, particularly related to non–recurring, unusual items. In addition, there are limitations in using non–GAAP financial measures because the non–GAAP financial measures are not prepared in accordance with GAAP, and exclude expenses that may have a material impact on our reported financial results. Further, share–based compensation expense has been, and will continue to be for the foreseeable future, significant recurring expenses in our business and an important part of the compensation provided to our employees. In addition, the amortization of intangible assets is expected recurring expense over the estimated useful life of the underlying intangible asset and acquisition–related expenses will be incurred to the extent acquisitions are made in the future. Furthermore, foreign exchange rates may fluctuate from one period to another, and the Company does not estimate movements in foreign currencies.

A reconciliation of each of these non–GAAP financial measures to their most comparable GAAP measure is set forth in a table included at the end of this press release, which is also available on our website at https://investors.cellebrite.com.

Key Performance Indicators

This press release also includes key performance indicators, including annual recurring revenue and dollar–based retention rate.

Annual recurring revenue ("ARR") is defined as the annualized value of active term–based subscription license contracts and maintenance contracts related to perpetual licenses in effect at the end of that period. Term–based license contracts and maintenance contracts for perpetual licenses are annualized by multiplying the revenue of the last month of the period by 12. The annualized value of contracts is a legal and contractual determination made by assessing the contractual terms with our customers. The annualized value of maintenance contracts is not determined by reference to historical revenue, deferred revenue or any other GAAP financial measure over any period. ARR is not a forecast of future revenues, which can be impacted by contract start and end dates and renewal rates.

Dollar–based net retention rate ("NRR") is calculated by dividing customer recurring revenue by base revenue. We define base revenue as recurring revenue we recognized from all customers with a valid license at the last quarter of the previous year period, during the four quarters ended one year prior to the date of measurement. We define our customer revenue as the recurring revenue we recognized during the four quarters ended on the date of measurement from the same customer base included in our measure of base revenue, including recurring revenue resulting from additional sales to those customers.

About Cellebrite

Cellebrite's (NASDAQ: CLBT) mission is to enable its customers to protect and save lives, accelerate justice, and preserve privacy in communities around the world. We are a global leader in Digital Intelligence solutions for the public and private sectors, empowering organizations in mastering the complexities of legally sanctioned digital investigations by streamlining intelligence processes. Trusted by thousands of leading agencies and companies worldwide, Cellebrite's Digital Intelligence platform and solutions transform how customers collect, review, analyze and manage data in legally sanctioned investigations. To learn more, visit us at www.cellebrite.com and https://investors.cellebrite.com.

Caution Regarding Forward Looking Statements

This document includes "forward looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. Forward looking statements may be identified by the use of words such as "forecast," "intend," "seek," "target," "anticipate," "will," "appear," "approximate," "foresee," "might," "possible," "potential," "believe," "could," "predict," "should," "could," "continue," "expect," "estimate," "may," "plan," "outlook," "future" and "project" and other similar expressions that predict, project or indicate future events or trends or that are not statements of historical matters. Such forward looking statements include estimated financial information. Such forward looking statements with respect to revenues, earnings, performance, strategies, prospects, and other aspects of Cellebrite's business are based on current expectations that are subject to risks and uncertainties. A number of factors could cause actual results or outcomes to differ materially from those indicated by such forward looking statements. These factors include, but are not limited to: Cellebrite's ability to keep pace with technological advances and evolving industry standards; Cellebrite's material dependence on the acceptance of its solutions by law enforcement and government agencies; real or perceived errors, failures, defects or bugs in Cellebrite's DI solutions; Cellebrite's failure to maintain the productivity of sales and marketing personnel, including relating to hiring, integrating and retaining personnel; uncertainties regarding the impact of macroeconomic and/or global conditions, including COVID–19 and military actions involving Russia and Ukraine; intense competition in all of Cellebrite's markets; the inadvertent or deliberate misuse of Cellebrite's solutions; political and reputational factors related to Cellebrite's business or operations; risks relating to estimates of market opportunity and forecasts of market growth; Cellebrite's ability to properly manage its growth; risks associated with Cellebrite's credit facilities and liquidity; Cellebrite's reliance on third–party suppliers for certain components, products, or services; challenges associated with large transactions and long sales cycle; risks that Cellebrite's customers may fail to honor contractual or payment obligations; risks associated with a significant amount of Cellebrite's business coming from government customers around the world; risks related to Cellebrite's intellectual property; security vulnerabilities or defects, including cyber–attacks, information technology system breaches, failures or disruptions; the mishandling or perceived mishandling of sensitive or confidential information; the complex and changing regulatory environments relating to Cellebrite's operations and solutions; the regulatory constraints to which we are subject; risks associated with different corporate governance requirements applicable to Israeli companies and risks associated with being a foreign private issuer and an emerging growth company; market volatility in the price of Cellebrite's shares; changing tax laws and regulations; risks associated with joint, ventures, partnerships and strategic initiatives; risks associated with Cellebrite's significant international operations; risks associated with Cellebrite's failure to comply with anti–corruption, trade compliance, anti–money–laundering and economic sanctions laws and regulations; risks relating to the adequacy of Cellebrite's existing systems, processes, policies, procedures, internal controls and personnel for Cellebrite's current and future operations and reporting needs; and other factors, risks and uncertainties set forth in the section titled "Risk Factors" in Cellebrite's annual report on Form 20–F filed with the SEC on March 29, 2022,as amended on April 14, 2022 and in other documents filed by Cellebrite with the U.S. Securities and Exchange Commission ("SEC"), which are available free of charge at www.sec.gov. You are cautioned not to place undue reliance upon any forward looking statements, which speak only as of the date made, in this communication or elsewhere. Cellebrite undertakes no obligation to update its forward looking statements, whether as a result of new information, future developments or otherwise, should circumstances change, except as otherwise required by securities and other applicable laws.

Contacts:

Investors
Investor Relations
investors@cellebrite.com

Media
Victor Cooper
Public Relations and Corporate Communications Director
+1 404 804 5910
Victor.cooper@cellebrite.com

Cellebrite DI Ltd.
Fourth Quarter 2022 Results Summary
(U.S Dollars in thousands)

For the three months ended For the Year ended
December 31, December 31,
2022 2021 2022 2021
Revenue 74,018 67,908 270,651 246,246
Gross profit 61,887 55,572 219,905 203,689
Gross margin 83.6 % 81.8 % 81.3 % 82.7 %
Operating income 9,674 4,306 1,044 13,822
Operating margin 13.1 % 6.3 % 0.4 % 5.6 %
Cash flow from operating activities 35,743 29,792 20,577 36,052
Non–GAAP Financial Data:
Operating income 14,428 7,751 19,538 42,869
Operating margin 19.5 % 11.4 % 7.2 % 17.4 %
Adjusted EBITDA 16,114 8,874 25,906 47,905
Adjusted EBITDA margin 21.8 % 13.1 % 9.6 % 19.5 %


Cellebrite DI Ltd.
Condensed Consolidated Balance Sheets
(U.S. Dollars in thousands)

December 31, December 31,
2022 2021
Assets
Current assets
Cash and cash equivalents $ 87,645 $ 145,973
Short–term deposits 51,335 35,592
Marketable securities 44,643 ""
Trade receivables (net of allowance for doubtful accounts of $1,904 and $1,040 as of December 31, 2022 and 2021, respectively) 78,761 67,505
Prepaid expenses and other current assets 17,085 12,818
Contract acquisition costs 6,286 4,813
Inventories 10,176 6,511
Total current assets 295,931 273,212
Non–current assets
Other non–current assets 1,731 1,958
Marketable securities 22,125 ""
Deferred tax assets, net 12,511 9,800
Property and equipment, net 17,259 16,756
Intangible assets, net 11,254 11,228
Goodwill 26,829 26,829
Operating lease right–of–use assets, net 15,653 ""
Total non–current assets 107,362 66,571
Total assets $ 403,293 $ 339,783
Liabilities and shareholders' equity (deficiency)
Current Liabilities
Trade payables $ 4,612 $ 9,546
Other accounts payable and accrued expenses 45,453 54,044
Deferred revenues 152,709 122,983
Operating lease liabilities 5,003 ""
Total current liabilities 207,777 186,573
Long–term liabilities
Other long term liabilities 5,394 9,537
Deferred revenues 42,173 36,426
Restricted Sponsor Shares liability 17,532 44,712
Price Adjustment Shares liability 26,184 79,404
Warrant liability 20,015 56,478
Operating lease liabilities 10,353 ""
Total long–term liabilities 121,651 226,557
Total liabilities $ 329,428 $ 413,130
Shareholders' equity (deficiency)
Share capital *) *)
Additional paid–in capital (125,624 ) (153,072 )
Treasury share, NIS 0.00001 par value; 41,776 ordinary shares (85 ) (85 )
Accumulated other comprehensive income 331 1,372
Retained earnings 199,243 78,438
Total shareholders' equity (deficiency) 73,865 (73,347 )
Total liabilities and shareholders' equity (deficiency) $ 403,293 $ 339,783

*) Less than 1 USD



Cellebrite DI Ltd.
Condensed Consolidated Statements of Income
(U.S Dollars in thousands, except share and per share data)

For the three months ended For the Year ended
December 31, December 31,
2022 2021 2022 2021
Revenue:
Subscription services $ 43,698 $ 31,999 $ 153,470 $ 120,889
Term–license 18,625 18,088 62,487 62,428
Total subscription 62,323 50,087 215,957 183,317
Perpetual license and related 3,666 9,387 21,373 34,169
Professional services 8,029 8,434 33,321 28,760
Total revenue 74,018 67,908 270,651 246,246
Cost of revenue:
Subscription services 3,681 2,045 16,875 9,369
Term–license 50 753 425 2,299
Total subscription 3,731 2,798 17,300 11,668
Perpetual license and related 3,381 4,659 12,987 9,817
Professional services 5,019 4,879 20,459 21,072
Total cost of revenue 12,131 12,336 50,746 42,557
Gross profit $ 61,887 $ 55,572 $ 219,905 $ 203,689
Operating expenses:
Research and development 19,734 18,833 80,620 65,541
Sales and marketing 23,669 21,239 97,387 76,389
General and administrative 8,810 11,194 40,854 47,937
Total operating expenses $ 52,213 $ 51,266 $ 218,861 $ 189,867
Operating income $ 9,674 $ 4,306 $ 1,044 $ 13,822
Financial (expense) income, net (572 ) 49,809 119,716 68,483
Income before tax 9,102 54,115 120,760 82,305
Tax expense (income) 2,024 2,244 (45 ) 10,909
Net income $ 7,078 $ 51,871 $ 120,805 $ 71,396
Earnings per share
Basic $ 0.04 $ 0.28 $ 0.64 $ 0.49
Diluted $ 0.04 $ 0.25 $ 0.59 $ 0.44
Weighted average shares outstanding
Basic 184,952,107 180,170,342 182,693,375 144,002,394
Diluted 192,786,615 199,082,479 195,393,558 161,538,579
Other comprehensive income:
Unrealized income (loss) on hedging transactions 1,194 495 (953 ) (944 )
Unrealized income (loss) on marketable securities 44 "" (502 ) ""
Currency translation adjustments (133 ) 955 414 995
Total other comprehensive income (loss) net of tax 1,105 1,450 (1,041 ) 51
Total other comprehensive income $ 8,183 $ 53,321 $ 119,764 $ 71,447


Cellebrite DI Ltd.
Condensed Consolidated Statements of Cash Flow
(U.S Dollars in thousands, except share and per share data)

For the three months ended For the Year ended
December 31, December 31,
2022 2021 2022 2021
Cash flow from operating activities:
Net income $ 7,078 $ 51,871 $ 120,805 $ 71,396
Adjustments to reconcile net income to net cash provided by operating activities:
Share based compensation and RSU's 3,787 1,661 13,708 6,480
Amortization of premium, discount and accrued interest on marketable securities (225 ) "" (372 )
Depreciation and amortization 2,520 1,814 9,194 7,007
Interest income from short term deposits (318 ) "" (684 ) ""
Deferred income taxes (61 ) 269 (2,392 ) (1,638 )
Remeasurement of warrant liability 375 (15,506 ) (36,463 ) (11,967 )
Remeasurement of Restricted Sponsor Shares 1,381 (11,181 ) (27,180 ) (17,635 )
Remeasurement of Price Adjustment Shares liabilities 1,211 (23,934 ) (53,220 ) (38,271 )
Decrease (increase) in trade receivables 11,242 8,690 (12,885 ) (1,958 )
Increase in deferred revenue 18,953 9,152 38,966 21,804
Decrease (increase) in other non–current assets 94 (1,779 ) 227 (1,394 )
(Increase) decrease in prepaid expenses and other current assets (4,431 ) 2,541 (5,692 ) (8,304 )
Changes in operating lease assets 4,667 "" 4,667 ""
Changes in operating lease liability (5,955 ) "" (5,955 ) ""
Increase in inventories (812 ) (1,711 ) (3,680 ) (1,798 )
(Decrease) increase in trade payables (895 ) 2,955 (5,471 ) 4,239
(Decrease) increase in other accounts payable and accrued expenses (2,060 ) 2,428 (8,853 ) 5,107
(Decrease) increase in other long–term liabilities (808 ) 2,522 (4,143 ) 2,984
Net cash provided by operating activities 35,743 29,792 20,577 36,052
Cash flows from investing activities:
Purchases of property and equipment (1,391 ) (778 ) (6,897 ) (5,111 )
Cash paid in conjunction with acquisitions, net of acquired cash "" (20,000 ) "" (20,000 )
Purchase of Intangible assets (1,788 ) "" (2,188 ) ""
Investment in marketable securities (9,253 ) "" (89,364 ) ""
Proceeds from maturity of marketable securities 7,445 "" 22,277 ""
Assets acquisition "" "" "" (3,000 )
Investment in short term deposits (51,000 ) (21,000 ) (76,000 ) (21,000 )
Redemption of short term deposits 18,544 47,210 60,941 94,337
Net cash (used in) provided by investing activities (37,443 ) 5,432 (91,231 ) 45,226
Cash flows from financing activities:
Payment of dividend "" "" "" (100,000 )
Exercise of options to shares 1,327 944 12,628 2,305
Proceeds from Employee Share Purchase Plan, net 657 "" 1,337 ""
Exercise of public warrants "" "" 5 ""
Proceeds from Recapitalization transaction, net "" "" "" 29,298
Net cash provided by (used in) financing activities 1,984 944 13,970 (68,397 )
Net increase (decrease) in cash and cash equivalents 284 36,168 (56,684 ) 12,881
Net effect of Currency Translation on cash and cash equivalents 2,795 (81 ) (1,644 ) (754 )
Cash and cash equivalents at beginning of period 84,566 109,886 145,973 133,846
Cash and cash equivalents at end of period $ 87,645 $ 145,973 $ 87,645 $ 145,973
Supplemental cash flow information:
Income taxes paid $ 3,727 $ 1,758 $ 9,053 $ 8,157
Non–cash activities
Purchase of property and equipment $ "" $ 749 $ "" $ 814
Purchase of Intangible assets $ 493 $ "" $ 664 $ ""


Cellebrite DI Ltd.

Reconciliation of GAAP to Non–GAAP Financial Information
(U.S Dollars in thousands, except share and per share data)

For the three months ended For the year ended
December 31, December 31,
2022 2021 2022 2021
Unaudited Unaudited Unaudited Unaudited
Operating income $ 9,674 $ 4,306 $ 1,044 $ 13,822
Issuance expenses "" "" "" 11,835
Dividend participation compensation "" "" "" 966
Share based compensation 3,787 1,661 13,708 6,480
Amortization of intangible assets 834 607 2,826 1,971
Acquisition related costs 133 1,177 1,960 7,795
Non–GAAP operating income $ 14,428 $ 7,751 $ 19,538 $ 42,869
For the three months ended For the year ended
December 31, December 31,
2022 2021 2022 2021
Unaudited Unaudited Unaudited Unaudited
Net income $ 7,078 $ 51,871 $ 120,805 $ 71,396
One time tax (income) expense "" "" (2,368 ) 7,067
Issuance expenses "" "" "" 11,835
Dividend participation compensation "" "" "" 966
Share based compensation 3,787 1,661 13,708 6,480
Amortization of intangible assets 834 607 2,826 1,971
Acquisition related costs 133 1,177 1,960 7,795
Tax expense (income) 516 498 (384 ) (1,670 )
Finance expense (income) from financial derivatives 2,967 (50,621 ) (116,863 ) (67,873 )
Non–GAAP net income $ 15,315 $ 5,193 $ 19,684 $ 37,967
Non–GAAP Earnings per share:
Basic 0.08 $ 0.03 0.10 $ 0.26
Diluted 0.08 $ 0.03 0.10 $ 0.24
Weighted average shares outstanding:
Basic 184,952,107 180,170,342 182,693,375 144,002,394
Diluted 192,786,615 199,082,479 195,393,558 161,538,579

For the three months ended For the year ended
December 31, December 31,
2022 2021 2022 2021
Unaudited Unaudited Unaudited Unaudited
Net income $ 7,078 $ 51,871 $ 120,805 $ 71,396
Financial expense (income), net 572 (49,809 ) (119,716 ) (68,483 )
Tax expense (income) 2,024 2,244 (45 ) 10,909
Issuance expenses "" "" "" 11,835
Dividend participation compensation "" "" "" 966
Share based compensation 3,787 1,661 13,708 6,480
Amortization of intangible assets 834 607 2,826 1,971
Acquisition related costs 133 1,177 1,960 7,795
Depreciation expenses 1,686 1,123 6,368 5,036
Adjusted EBITDA $ 16,114 $ 8,874 $ 25,906 $ 47,905


GLOBENEWSWIRE (Distribution ID 8749609)

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Entera Bio Provides Corporate Updates and Financial Results for the Third Quarter of 2022 http://www.businesstimesoman.com/entera-bio-provides-corporate-updates-and-financial-results-for-the-third-quarter-of-2022/ http://www.businesstimesoman.com/entera-bio-provides-corporate-updates-and-financial-results-for-the-third-quarter-of-2022/#respond Thu, 10 Nov 2022 21:15:00 +0000 http://www.businesstimesoman.com/?p=305835 JERUSALEM, Nov. 10, 2022 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and therapeutic proteins, today announced its financial results for the third quarter of 2022 and provided the following corporate updates.

Corporate Updates:

Achieved FDA Agreement for Pivotal Study of EB613, the World's First Daily Bone Forming Oral PTH Tablet

  • On October 6th, 2022, Entera announced that it had successfully completed its Type C meeting and reached a record agreement with the U.S. Food and Drug Administration (FDA) that a single pivotal Phase 3 placebo–controlled study could support a New Drug Application (NDA) submission for its lead clinical candidate, EB613 under the 505(b)(2) regulatory pathway.
  • Importantly, the FDA also agreed that total hip bone mineral density (BMD), not fracture, could serve as the primary endpoint for the registrational study of EB613; and that Entera could enroll the same post–menopausal osteoporosis patient population that significantly benefited from EB613 treatment during Entera's Phase 2 clinical study which was reported in 2021.
  • EB613 is the first oral, daily tablet formulation of synthetic hPTH (1–34), (teriparatide), consisting of the exact same 34 amino acid sequence as daily subcutaneous teriparatide injection, Forteo which has been the leading anabolic treatment of osteoporosis since 2002 with peak sales of $1.7 billion in 2018 prior to patent expiration. EB613 tablets are simple, small (~ 6 mm wide) and administered once daily.
  • Low BMD osteoporotic patients at high risk of fracture are often reluctant to initiate injectable anabolic (bone forming) therapy and represent an estimated 40% of the 3 million currently treated patients across the United States, while current bone forming injections treat less than 10% of these patients1. As the first daily tablet PTH osteoanabolic treatment, EB613 could significantly impact the osteoporosis treatment paradigm. Patient enrollment in the pivotal phase 3 study is expected to commence in 2023.

New Phase 2 Data Presented at the ASBMR Annual Meeting Demonstrate Statistically Significant Correlation of EB613's Dose Proportional Oral Absorption and Clinical Benefit

  • New findings on EB613 were presented in a poster titled "A Six–month Phase 2 Study of Oral PTH (EBP05) in Postmenopausal Women with Low Bone Mass "" Dose Proportional Absorption and Effect on Lumbar Spine BMD (SUN–591)" at the American Society for Bone and Mineral Research (ASBMR) 2022 Annual Meeting in September.
  • New analyses of hPTH concentration in blood shortly after a dose of EB613 tablets confirmed a strong, statistically significant correlation between mean blood level and the dose of EB613 taken.
  • These findings are consistent with the positive correlation between the change in lumbar spine BMD and EB613 dose after six months of treatment.

"Following a full redesign of our proposed Phase 3 study, timely submission, and successful conclusion of our Type C meeting, our third quarter culminated with the FDA's concurrence with our proposed registrational path for EB613. This was an historic moment for Entera. We believe this is the first osteoporosis program that has reached agreement on both a placebo–controlled design and a BMD endpoint, which we believe speaks to the urgent need for highly effective and more patient friendly treatments to help rebuild bone. EB613 leverages the validated and safe mechanism of action of PTH which has been at the forefront of osteoporosis therapy for the last 20 years, and addresses patients' unease with injections via our simple daily tablet form. We continue to strengthen all functional areas at Entera to remain on track for patient enrollment to commence in 2023, while continuing our strategic discussions and preparing our new formulation of EB612 PTH tablets for hypoparathyroidism to re–enter the clinic in 2023," stated Miranda Toledano, Chief Executive Officer of Entera.

Results for Third Quarter Ended September 30, 2022

Revenues for the three months ended September 30, 2022 were $8,000 compared to $140,000 for the three months ended September 30, 2021. For both the three months ended September 30, 2022 and 2021, the majority of our revenues were attributable to pre–clinical R&D services provided to Amgen as part of our ongoing license agreement. The decrease in revenue for the quarter ended September 30, 2022 as compared to the prior year period was primarily due to finalization of third year pre–clinical R&D services to Amgen. The cost of revenues for the three months ended September 30, 2022 was $6,000 compared to $65,000 for the three months ended September 30, 2021 and were primarily attributed to expenses in connection with R&D services provided to Amgen.

Research and development expenses for the three months ended September 30, 2022 were $1.4 million compared to $1.8 million for the three months ended September 30, 2021. The decrease of $0.4 million was primarily due to a decrease of $0.7 million in pre–clinical activities related to our Phase 3 clinical trial for EB613 and a decrease of $0.1 million related to the completion of our Phase 2 trial for EB613 in September 2021. This decrease was partially offset by an increase of $0.1 million in connection with a one–time employee compensation payment as part of a separation agreement and an increase of $0.3 million attributed to ongoing materials and production costs to supply our Phase 3 clinical trial for EB613.

General and administrative expenses for both the three months ended September 30, 2022 and 2021 were $1.5 million. For the quarter ended September 30, 2022, there was an increase of $0.2 million in professional fees and an increase of $0.1 million in D&O insurance costs, as compared to the 2021 period, which was offset by a decrease of $0.3 million in share–based compensation mainly due to a reversal of share–based compensation expense related to the separation agreement of our former Chief Executive Officer.

Operating expenses for the three months ended September 30, 2022 were $2.9 million compared to $3.3 million for the three months ended September 30, 2021. Entera's operating loss was $2.9 million for the three months ended September 30, 2022, compared to $3.2 million for the three months ended September 30, 2021.

The net comprehensive loss was $3.1 million or $0.11 per ordinary share (basic and diluted) for the three months ended September 30, 2022, compared to $3.2 million, or $0.11 per ordinary share (basic and diluted) for the three months ended September 31, 2021.

As of September 30, 2022, Entera had cash and cash equivalents of $14.3 million, compared to $17.3 million as of June 30, 2022. Entera expects that its existing cash resources are sufficient to fund operations through the second quarter of 2023. This assumes ongoing R&D, the Hypo PK study and continued investments in production, analytics, and clinical research operations to enable initiation of EB613 phase 3 during the second half of 2023.

About EB613 (a.k.a. EBP05)

EB613 is the first oral, daily tablet formulation of synthetic hPTH (1–34), (teriparatide), consisting of the exact same 34 amino acid sequence as daily subcutaneous teriparatide injection, Forteo which has been the leading anabolic treatment of osteoporosis since 2002 with peak sales of $1.7 billion in 2018 prior to patent expiration. Entera's Oral PTH formulations have been administered collectively to a total of 225 subjects in two Phase 1 studies and 3 phase 2 studies (including 35 in 2 phase 2 hypoparathyroidism studies). The most recent study was a dose ranging Phase 2 study in postmenopausal women with low bone mass. This study met primary and key secondary endpoints and was presented in a late–breaker oral presentation at the ASBMR 2021 conference. For the primary efficacy endpoint: a statistically significant increase in P1NP (a bone formation marker) at 3 months was achieved. A significant dose response was observed for 0.5, 1.0, 1.5 and 2.5 mg oral PTH doses on P1NP, Osteocalcin and bone mineral density (BMD). Subjects receiving the 2.5 mg dose of EB613 showed significant increases in dose–related BMD at the Lumbar Spine, Total Hip, and Femoral Neck at 6 months. Subjects receiving the 2.5 mg dose of EB613 daily for 6 months had a significant placebo adjusted increase of 3.78% in Lumbar Spine BMD (p<0.008) which is similar to the 3.9% increase in Lumbar Spine BMD seen with Forteo in clinical studies reported in the literature. Increases in Total Hip and Femoral Neck BMD were greater than those previously reported with Forteo at 6 months. EB613 exhibited an excellent safety profile, with no drug related serious adverse events. The most common adverse events included mild nausea, moderate back pain, moderate headache, and moderate upper abdominal pain.

About Entera Bio

Entera is a leader in the development of orally delivered macromolecules therapeutics including peptides and other therapeutic proteins, for use in areas with significant unmet medical need where adoption of injectable therapies is limited due to cost, convenience and compliance challenges for patients. The Company's proprietary, oral drug delivery technology is designed to address the technical challenges of poor absorption, high variability, and the inability to deliver large molecules to the targeted location in the body through the use of a synthetic absorption enhancer to facilitate the absorption of large molecules, and protease inhibitors to prevent enzymatic degradation and support delivery to targeted tissues. The Company's most advanced product candidates, EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism are in clinical development. Entera also licenses its technology to biopharmaceutical companies for use with their proprietary compounds and, to date, has established a collaboration with Amgen Inc. For more information on Entera Bio, visit www.enterabio.com.

Contact:

Entera Bio:
Ms. Miranda Toledano
Chief Executive Officer
Entera Bio
Email: miranda@enterabio.com

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release are "forward–looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, "anticipate," "believe," "can," "could," "expect," "estimate," "design," "goal," "intend," "may," "might," "objective," "plan," "predict," "project," "target," "likely," "should," "will," and "would," or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera's forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA's interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera is contractually obligated to provide, such as those pursuant to Entera's agreement with Amgen; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera's product candidates; Entera's reliance on third parties to conduct its clinical trials; Entera's expectations regarding licensing, business transactions and strategic collaborations; Entera's operation as a development stage company with limited operating history; Entera's ability to continue as a going concern absent access to sources of liquidity; Entera's ability to obtain and maintain regulatory approval for any of its product candidates; Entera's ability to comply with Nasdaq's minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera's intellectual property position and its ability to protect its intellectual property; and other factors that are described in the "Cautionary Statements Regarding Forward–Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Entera's most recent Annual Report on Form 10–K filed with the SEC, as well as the company's subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

ENTERA BIO LTD.

CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share data)
(Unaudited)
September 30 December 31
2022 2021
Cash and cash equivalents 14,323 24,892
Accounts receivable and other current assets 867 437
Property and equipment, net 152 156
Other assets, net 198 502
Total assets 15,540 25,987
Accounts payable and other current liabilities 1,193 3,161
Total non current liabilities 35 261
Total liabilities 1,228 3,422
Total shareholders' equity 14,312 22,565
Total liabilities and shareholders' equity 15,540 25,987


ENTERA BIO LTD.

CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)

Three Months ended September 30,
2022 2021
REVENUES 8 140
COST OF REVENUES 6 65
GROSS PROFIT 2 75
OPERATING EXPENSES:
Research and development 1,413 1,771
General and administrative 1,460 1,535
Other income (6 ) (11 )
TOTAL OPERATING EXPENSES 2,867 3,295
OPERATING LOSS 2,865 3,220
FINANCIAL EXPENSES, net 8 7
LOSS BEFORE INCOME TAX 2,873 3,227
INCOME TAX (BENEFIT) EXPENSE 194 (13 )
NET LOSS 3,067 3,214
LOSS PER SHARE BASIC AND DILUTED 0.11 0.11
WEIGHTED–AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE 28,809,922 28,680,833

___________________________
1
Triangle Insights Group June 2022 Analysis, EB613 Osteoporosis Opportunity


GLOBENEWSWIRE (Distribution ID 8694353)

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Entera Bio Provides Business Highlights and Financial Results for the Second Quarter 2022 http://www.businesstimesoman.com/entera-bio-provides-business-highlights-and-financial-results-for-the-second-quarter-2022/ http://www.businesstimesoman.com/entera-bio-provides-business-highlights-and-financial-results-for-the-second-quarter-2022/#respond Thu, 11 Aug 2022 10:30:00 +0000 http://www.businesstimesoman.com/?p=305266 JERUSALEM, Aug. 11, 2022 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and therapeutic proteins, today announced its financial and operating results for the quarter ended June 30, 2022.

"We have reset our thesis and executed on several critical milestones in the first half of 2022. On July 18th, we announced the submission of our proposed registrational protocol for EB613 to the U.S. Food and Drug Administration (FDA). We are simultaneously finalizing the validation of an optimized formulation of EB612, while expanding our pre–clinical pipeline with additional anti–inflammatory and metabolic protein candidates. Lastly, we finished the quarter with $17.3 million in cash which, given our revised Phase 3 schedule, is projected to fund our current operations through the first half of 2023," commented Ms. Miranda Toledano, Chief Executive Officer of the Company. "I am incredibly energized by the opportunities ahead. By continuing to carry forward our internal clinical programs and strategic dialogues, we are poised to deliver tremendous value to patients and our shareholders as we reshape the future of Entera. We look forward to providing a comprehensive update to the investment community later this year."

Business Highlights:

Entera expects to hold a Type C Meeting with the FDA to discuss the potential registrational study for its lead clinical asset, EB613 in the second half of 2022. The Phase 3 is designed as an 18 month double blind placebo–controlled study using FNIH–BQP1 total hip Bone Mineral Density (BMD) thresholds as the primary endpoint to evaluate fracture risk, followed by a 6–month open label transition to alendronate. EB613 is the first oral formulation of PTH (1–34), teriparatide, and the first proposed oral anabolic (bone forming) drug candidate to treat post–menopausal women with osteoporosis. EB613 has the same amino acid sequence as Forteo which requires daily subcutaneous injections and reported peak sales surpassing $1.7 billion in 2017, prior to patent expiry. According to early commercial assessments and clinician surveys, it is estimated that less than 10% of osteoporosis patients use current anabolic drugs (including PTH receptor activators currently available such as Forteo and Tymlos ). Despite the validated mechanism of action of these treatments, patients are deterred by their high cost and injectable mode of administration. As the first oral PTH receptor activator EB613 is expected to address this significant unmet clinical need.

Additionally, Entera is finalizing the development of an optimized formulation for EB612 which may enable twice a day administration (versus the previous 4 times a day) to patients with hypoparathyroidism. The Company anticipates conducting a first–in–human PK study of the new formulation in the first half of 2023. Entera previously conducted a pilot 4–month Phase 2 study, results of which were presented (ASBMR 2015) and published in a peer–reviewed journal (JBMR 2021), as well as a Phase 2 PK–PD study versus Natpara, whose findings have also been publicly presented (ASBMR 2019). These studies demonstrated that EB612 induced a rapid decline in median serum phosphate levels and maintenance of target calcium levels throughout the study, even as patients were able to meaningfully reduce their calcium and active vitamin D supplementation which is key to reducing common comorbidities of this disease.

Finally, Entera announced the formation of its Clinical and Scientific Advisory Board (CSAB), comprising world class experts in bone diseases, endocrinology, and metabolic disorders and will be presenting incremental data from its 6–month Oral PTH (EB613) Phase 2 Study in postmenopausal women with low bone mass, at the 2022 Annual Meeting of the American Society for Bone and Mineral Research (ASBMR), which will take place in Austin, Texas from September 9–12, 2022.

Financial Results for the Six–Month Period Ended June 30, 2022

Revenues for the six months ended June 30, 2022 were $112,000 compared to $226,000 for the six months ended June 30, 2021. In this period, the majority of our revenues were attributable to research and development, or R&D services provided to Amgen under our 2018 collaboration agreement. The cost of revenues for the six months ended June 30, 2022 were $87,000 compared to $172,000 for the six months ended June 30, 2021 and were primarily attributed to salaries and related expenses in connection with the R&D services provided to Amgen.

Operating expenses for the six months ended June 30, 2022 were $7.1 million compared to $5.0 million for the six months ended June 30, 2021. Entera's operating loss was $7.1 million for the six months ended June 30, 2022, compared to $4.9 million for the six months ended June 30, 2021.

Research and development expenses for the six months ended June 30, 2022 were $3.1 million, compared to $2.4 million for the six months ended June 30, 2021, an increase of $0.7 million. The increase was primarily due to an increase of $0.7 in materials and production costs and pre–clinical activity as part of the preparation for our Phase 3 clinical trial for EB613 and an increase of $0.4 million in employee's compensation. The increase was partially offset by a decrease of $0.4 million in other clinical trial expenses related to our Phase 2 trial for EB613 that was completed in June 2021.

General and administrative expenses for the six months ended June 30, 2022 were $4.1 million, compared to $2.7 million for the six months ended June 30, 2021, an increase of $1.4 million. The increase of $1.4 million was mainly attributable to an increase of $0.8 million in share–based compensation granted to non–executive directors and employees, an increase of $0.4 million in legal, accounting fees and others consultants and an increase of $0.2 million in D&O insurance costs.

The net comprehensive loss was $7.0 million or $0.24 per ordinary share (basic and diluted) for the six months ended June 30, 2022, compared to $4.9 million, or $0.21 per ordinary share (basic and diluted) for the six months ended June 31, 2021.

As of June 30, 2022, Entera had cash and cash equivalents of $17.3 million, compared to $20.1 million as of March 31, 2021.

Entera expects that the current cash is sufficient to fund the operations through the second quarter of 2023.

About EB613 (a.k.a. EBP05)

Parathyroid hormone (PTH) is an 84–amino acid hormone and the primary regulator of calcium and phosphate metabolism in bone and kidney. EB613 is an oral formulation of synthetic hPTH (1–34), (teriparatide), a peptide consisting of the first 34 amino acids of PTH which represent the functional region. Subcutaneous Forteo (teriparatide injection) has been the leading anabolic treatment of osteoporosis since 2002. EB613 utilizes Entera's oral drug delivery platform which promotes enteric absorption and stabilizes teriparatide in the gastrointestinal tract. Entera's Oral PTH formulations have been administered collectively to a total of 225 subjects in two Phase 1 studies and 3 phase 2 studies (including 35 in 2 phase 2 hypoparathyroidism studies). The most recent study was a dose ranging Phase 2 study in postmenopausal women with low bone mass. This study met primary and key secondary endpoints and was presented in a late–breaker oral presentation at the ASBMR 2021 conference. For the primary efficacy endpoint: a statistically significant increase in P1NP (a bone formation marker) at 3 months was achieved. A significant dose response was observed for 0.5, 1.0, 1.5 and 2.5 mg oral PTH doses on P1NP, Osteocalcin and bone mineral density (BMD). Subjects receiving the 2.5 mg dose of EB613 showed significant increases in dose–related BMD at the lumbar spine, total hip, and femoral neck at 6 months. Subjects receiving the 2.5 mg dose of EB613 daily for 6 months had a significant placebo adjusted increase of 3.78% in lumbar spine BMD (p<0.008) which is similar to the 3.9% increase in lumbar spine BMD seen with Forteo in clinical studies reported in the literature. Increases in total hip and femoral neck BMD were greater than those previously reported with Forteo . EB613 exhibited an excellent safety profile, with no drug related serious adverse events. The most common adverse events included mild nausea, moderate back pain, moderate headache, and moderate upper abdominal pain.

About Entera Bio

Entera is a leader in the development of orally delivered macromolecules therapeutics including peptides and other therapeutic proteins, for use in areas with significant unmet medical need where adoption of injectable therapies is limited due to cost, convenience and compliance challenges for patients. The Company's proprietary, oral drug delivery technology is designed to address the technical challenges of poor absorption, high variability, and the inability to deliver large molecules to the targeted location in the body through the use of a synthetic absorption enhancer to facilitate the absorption of large molecules, and protease inhibitors to prevent enzymatic degradation and support delivery to targeted tissues. The Company's most advanced product candidates, EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism are in clinical development. The Company recently completed the phase 2 study for EB613 and has a Type C meeting scheduled with FDA with respect to its Phase 3 program in H2 2022. Entera also licenses its technology to biopharmaceutical companies for use with their proprietary compounds and, to date, has established a collaboration with Amgen Inc. For more information on Entera Bio, visit www.enterabio.com.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release are "forward–looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, "anticipate," "believe," "can," "could," "expect," "estimate," "design," "goal," "intend," "may," "might," "objective," "plan," "predict," "project," "target," "likely," "should," "will," and "would," or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera's forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA's interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera is contractually obligated to provide, such as those pursuant to Entera's agreement with Amgen; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera's product candidates; Entera's reliance on third parties to conduct its clinical trials; Entera's expectations regarding licensing, business transactions and strategic collaborations; Entera's operation as a development stage company with limited operating history; Entera's ability to continue as a going concern absent access to sources of liquidity; Entera's ability to obtain and maintain regulatory approval for any of its product candidates; Entera's ability to comply with Nasdaq's minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera's intellectual property position and its ability to protect its intellectual property; and other factors that are described in the "Cautionary Statements Regarding Forward–Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Entera's most recent Annual Report on Form 10–K filed with the SEC, as well as the company's subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

ENTERA BIO LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share data)
(Unaudited)
June 30
December 31
2022
2021
Cash and cash equivalents 17,279 24,892
Accounts receivable and other current assets 1,147 437
Property and equipment, net 166 156
Other assets, net 496 502
Total assets 19,088 25,987
Accounts payable and other current liabilities 1,692 3,161
Total non current liabilities 127 261
Total liabilities 1,819 3,422
Total shareholders' equity 17,269 22,565
Total liabilities and shareholders' equity 19,088 25,987

ENTERA BIO LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
SIX Months ended June 30,
2022 2021
REVENUES 112 266
COST OF REVENUES 87 172
GROSS PROFIT 25 94
OPERATING EXPENSES:
Research and development 3,084 2,351
General and administrative 4,052 2,674
Other income (27 ) (22 )
TOTAL OPERATING EXPENSES 7,109 5,003
OPERATING LOSS 7,084 4,909
FINANCIAL EXPENSES (INCOME), net (104 ) (5 )
LOSS BEFORE INCOME TAX 6,980 4,904
INCOME TAX(BENEFIT) EXPENSE (11 ) (31 )
NET LOSS 6,969 4,873
LOSS PER SHARE BASIC AND DILUTED 0.24 0.21
WEIGHTED–AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE 28,806,217 23,377,668

_____________________________
1 Foundation for the National Institutes of Health Bone Quality Program (FNIH BQP)


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