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JERUSALEM, Nov. 08, 2024 (GLOBE NEWSWIRE) — Entera Bio Ltd. ENTX, (“Entera” or the “Company”) a leader in the development of oral peptides and small therapeutic proteins, today reported financial results and key business updates for the quarter ended September 30, 2024.

“The third quarter of 2024 drew consistent attention to our pivotal-staged clinical asset, EB613, the first oral PTH(1-34) tablet treatment dedicated to post-menopausal women with high risk osteoporosis. Entera’s proprietary N-Tab™ platform consistently delivered across our oral GLP-2 tablet, oral GLP-1/Glucagon tablet and confidential hypoparathyroidism tablet program. Finally, we are humbled by key additions from around the world to our clinical and scientific advisory board which we view as testament to what we are aspiring to build at Entera,” said Miranda Toledano, Chief Executive Officer of Entera.

Ms. Toledano continued, “We are headed into a busy year end across all programs and keenly anticipating FDA’s potential landmark ruling on the ASBMR-FNIH SABRE regulatory endpoint for osteoporosis drugs, expected in January 2025. Current regulatory guidelines requiring fracture outcomes have curtailed innovation in the treatment of this significant disease due to ethical, time and sizing of studies required to evaluate new treatments. The SABRE work is based on a statistical meta-analysis of over 170,000 patients across 53 randomized clinical studies and 7 osteoporosis drug classes correlating total hip Bone Mineral Density (BMD) to fracture outcomes. We believe that our pivotal program for EB613 is first in line to leverage this pathway. Our recent discussions with patients, regulatory agencies, clinicians and fellow industry colleagues acknowledge the need for new treatments for osteoporosis and, especially, oral anabolic therapy. Osteoporosis is one of the foremost underserved women’s health issues globally, where fracture rates continue to rise and where, despite medical guidelines, efficacious injectable anabolics are used in a minority of patients worldwide. We are developing EB613 to help close this treatment gap.”

Q3 2024 Updates:

EB613: First Oral PTH(1-34) Anabolic Tablet Treatment for Women with Osteoporosis

• In September 2024, new comparative pharmacological data for EB613 was presented at the American Society for Bone Mineral Research September 2024 (ASBMR 2024) Annual Meeting in Toronto. The abstract was previewed by Dr. Serge Ferrari of Geneva University Hospital in Switzerland in his sneak-peak highlights of cutting-edge clinical abstracts on osteoporosis therapy at ASBMR2024.

First GLP-1/Glucagon Agonist (Oxyntomodulin) Peptide Tablets for Obesity

• In September 2024, Entera and OPKO Health, Inc. ((“OPKO”, NASDAQ:OPK), jointly announced topline pharmacokinetic/ pharmacodynamic (PK/PD) results for the oral oxyntomodulin (OXM) tablet program. The program is focused on developing the first oral dual agonist GLP-1/glucagon peptide as a potential once-daily treatment for patients with obesity and metabolic disorders using Entera’s proprietary N-Tab™ platform. Oral OXM exhibited significant systemic exposure across two in vivo models, a favorable PK profile and bioavailability. The high plasma concentrations with prolonged systemic exposure were consistent with the reported half-life for semaglutide (Rybelsus®), the only approved oral GLP-1 analog. Oral OXM showed a statistically significant reduction in plasma glucose levels compared with placebo. Entera plans to present this data together with OPKO at an upcoming clinical conference.

First GLP-2 Peptide Tablets for Short Bowel Syndrome

• Entera continues pre-IND validation of its oral GLP-2 tablet in partnership with OPKO. Final in vivo PK/PD data is expected in the second half of 2024. This program is being developed as the first potential tablet GLP-2 replacement therapy for patients suffering with Short Bowel Syndrome, a rare and devastating intestinal failure condition. The program may also provide value to other critical conditions of GI inflammation, which is being explored with external parties. 

EB612: First Oral PTH(1-34) Peptide Replacement Therapy Tablets for Hypoparathyroidism

• Entera continues to collaborate productively with a third party on the oral tablet development of another PTH replacement treatment for hypoparathyroidism.

Financial Results for the Quarter Ended September 30, 2024

As of September 30,2024, Entera had cash and cash equivalents of $6.9 million. The Company expects that its existing cash resources are sufficient to meet its projected operating requirements into the third quarter of 2025.

Research and development expenses for the three months ended September 30, 2024 were $1.5 million, as compared to $1.4 million for the three months ended September 30, 2023. The increase of $0.1 million was primarily due to an increase of $0.5 million in materials required in connection with the optimization processes related to the preparation of the EB613 phase 3 study. The increase was partially offset by a decrease of $0.4 million related to a completed Phase 1 PK, which occurred in 2023.

General and administrative expenses for the three months ended September 30, 2024 were $1.5 million, as compared to $1.0 million for the three months ended September 30, 2023. The increase of $0.5 million was mainly attributable to increases in intellectual property expenses, consultancy fees and share-based compensation.

Operating expenses for the period ended September 30, 2024 were $3.0 million, as compared to $2.4 million for the quarter ended September 30, 2023.

Net loss was $3.0 million, or $0.08 per ordinary share (basic and diluted), for the quarter ended September 30, 2024, as compared to $2.4 million, or $0.08 per ordinary share (basic and diluted), for the quarter ended September 30, 2023.

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 a disruptive and proprietary technology platform (N-Tab™) and its pipeline includes five differentiated, first-in-class oral peptide programs, expected to enter the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (oral PTH (1-34)), 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. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n=161) met primary (PD/bone turnover biomarker) and secondary (BMD) endpoints. 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 by January 2025. The EB612 program is being developed as the first oral PTH (1-34) tablet peptide replacement therapy for hypoparathyroidism. In collaboration with OPKO Health, Entera is also developing the first oral oxyntomodulin, a dual targeted GLP-1/glucagon peptide, in tablet form for the treatment of obesity; and the first oral GLP-2 peptide tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome. For more information, visit www.enterabio.com or follow us on LinkedIn, X (formerly Twitter), Facebook and 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.

Contact:

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

CLAYTON, Mo., Nov. 08, 2024 (GLOBE NEWSWIRE) — FutureFuel Corp. FF (“FutureFuel”), a manufacturer of custom and performance chemicals and biofuels, today announced financial results for the third quarter ended September 30, 2024.

Third quarter 2024 Financial Highlights (all comparisons are with the third quarter of 2023)

• Revenues were $51.1 million, a decrease of 56% or $65.6 million compared to $116.8 million.
• Net loss was $1.2 million, or $0.03 per diluted share, down from a net income of $2.8 million, or $0.06 per diluted share.
• Adjusted EBITDA⁽¹⁾ was $(1.0) million, down from $9.7 million.

Nine months 2024 Financial Highlights (all comparisons are with the first nine months of 2023)

• Revenues were $181.8 million, a decrease of 34% or $94.4 million compared to $276.2 million.
• Net income was $12.7 million, or $0.29 per diluted share, down from $14.0 million, or $0.32 per diluted share.
• Adjusted EBITDA⁽¹⁾ was $13.0 million, down from $18.2 million.

⁽¹⁾  A non-GAAP financial measure.  See “Non-GAAP Financial Measures” for a description of the measure and a reconciliation to the applicable GAAP measure.

“In the third quarter we continued to see a market-driven slowdown in our chemical segment with increased margin pressure driven by sluggish demand in our end-use markets.  Our biodiesel segment has also experienced increased margin pressure, leading to margin and RIN pricing contraction.  We anticipate that some of this pressure and market uncertainty will turn once there is more clarity around the IRA 45Z or Clean Fuel Production Credit, which takes effect January 1, 2025.  (See Note 2 to our consolidated financial statements for more detail.) 

“Also impacting the latter half of the quarter was an unplanned outage of the infrastructure supporting our biodiesel plant which reduced production.  This issue was resolved before the close of the quarter and production has returned to normal rates. 

“It is encouraging within the chemical segment, to see robust activities continuing with key customers on future business development programs as we invest to support future growth,” said Roeland Polet, Chief Executive Officer for FutureFuel Corp.

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2024 Cash Dividends

FutureFuel paid a regular quarterly cash dividend in the third quarter in the amount of $0.06 per share on our common stock. The remaining 2024 quarterly dividend of $0.06 per share will be paid in December.  

Financial Overview and Key Operating Metrics

Financial and operating metrics, which include non-GAAP financial measures (see “Non-GAAP Financial Measures” for additional information), include all dollar amounts in thousands, except per share amounts:

Financial and Business Summary

Consolidated revenue in the three months ended September 30, 2024 decreased $65,612 compared to the three months ended September 30, 2023. This decline was driven mostly by lower sales volumes in the biofuel segment of $41,015. Production issues, primarily stemming from delays by equipment suppliers that created an extended service utility downtime, prevented us from building the biodiesel inventories we would typically have available to sell in the three months ended September 30, 2024. Also reducing sales revenue in the three-month period, were lower prices in the biofuel segment of $24,678 due to a decline in renewable fuel and RIN prices with market supply in excess of the Environmental Protection Agency (“EPA”) Renewable Identification Number (“RIN”) mandate. In our chemical segment, sales revenue increased $81 for the three months ended September 30, 2024, compared to the prior-year period, due primarily to stronger sales volumes in the coatings market $1,457, but was mostly offset by reduced chemical sales prices, $1,376, from chemicals sold into the agricultural and energy markets.

Consolidated revenue in the nine months ended September 30, 2024 decreased $94,411 compared to the nine months ended September 30, 2023. As noted above, this decline was driven mostly by lower sales volumes in the biofuel segment of $48,590 as production issues in the first three months of the year related to harsh winter weather and the production issues noted above in the three months ended September 30, 2024, prevented us from building the biodiesel inventories we would typically have available to sell during the current period.  Also reducing sales revenue in the nine-month period were lower prices in the biofuel segment of $42,560 due to a decline in renewable fuel and RIN prices with market supply in excess of the EPA RIN mandate. In our chemical segment, sales revenue declined a net $3,261 ($5,382 on reduced prices on chemicals sold into the agricultural and energy markets partially offset by increased volumes in the energy market, $2,121), compared to the prior-year period.

Income from operations in the three months ended September 30, 2024 decreased $3,185 as compared to the same period of 2023, due primarily to lower sales prices in the chemical agricultural and energy markets and reduced throughput of biofuel segment volumes primarily due to the issues noted above.

Income from operations in the nine months ended September 30, 2024 decreased $2,204 as compared to the same period of 2023, primarily due to: (i) a reduction of RIN sales in the current nine-month period and (ii) the change in the adjustment in the carrying value of our inventory as determined utilizing the LIFO method of inventory accounting.  This adjustment increased gross profit by $2,885 in the nine months ended September 30, 2024, as compared to an increase of $6,023 in the same period of 2023.  Income from operations was negatively impacted by the change in the activity of derivative instruments with a realized loss of $354 and unrealized loss of $1,696 in the nine months ended September 30, 2024, as compared to a realized gain of $9,437 and unrealized gain of $3,259 in the same period of 2023.  Gross profit was also negatively impacted in the nine-month period ended September 30, 2024, by higher costs resulting from the impact of extreme winter weather and the production issues noted above. 

Capital Expenditures

Capital expenditures were $10,605 in the first nine months of 2024, compared with $4,994 in the same period in 2023.

Cash and Cash Equivalents

Cash and cash equivalents totaled $133,398 as of September 30, 2024, compared with $219,444 as of December 31, 2023. A special cash dividend of $2.50 per common share was paid April 9, 2024 which totaled $109,408.  

About FutureFuel

FutureFuel is a leading manufacturer of diversified chemical products and biofuels. FutureFuel’s chemicals segment manufactures specialty chemicals for specific customers (“custom chemicals”) as well as multi-customer specialty chemicals (“performance chemicals”). FutureFuel’s custom manufacturing product portfolio includes proprietary agrochemicals, adhesion promoters, a biocide intermediate, and an antioxidant precursor. FutureFuel’s performance chemicals products include a portfolio of proprietary nylon and polyester polymer modifiers and several small-volume specialty chemicals and solvents for diverse applications. FutureFuel’s biofuels segment primarily produces and sells biodiesel to its customers. Please visit www.futurefuelcorporation.com for more information.

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Forward-Looking Statements

This document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements deal with FutureFuel’s current plans, intentions, beliefs, and expectations, and statements of future economic performance. Statements containing such terms as “believe,” “do not believe,” “plan,” “expect,” “intend,” “estimate,” “anticipate,” and other phrases of similar meaning are considered to contain uncertainty and are forward-looking statements. In addition, from time-to-time FutureFuel or its representatives have made or will make forward-looking statements orally or in writing. Furthermore, such forward-looking statements may be included in various filings that the company makes with United States Securities and Exchange Commission (the “SEC”), in press releases, or in oral statements made by or with the approval of one of FutureFuel’s authorized executive officers.

These forward-looking statements are subject to certain known and unknown risks and uncertainties, as well as assumptions that could cause actual results to differ materially from those reflected in these forward-looking statements. Factors that might cause actual results to differ include, but are not limited to, those set forth under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in FutureFuel’s Form 10-K Annual Report, as amended for the year ended December 31, 2023 and in its future filings made with the SEC. An investor should not place undue reliance on any forward-looking statements contained in this document, which reflect FutureFuel management’s opinions only as of their respective dates. Except as required by law, the company undertakes no obligation to revise or publicly release the results of any revisions to forward-looking statements. The risks and uncertainties described in this document and in current and future filings with the SEC are not the only ones faced by FutureFuel. New factors emerge from time to time, and it is not possible for the company to predict which will arise. There may be additional risks not presently known to the company or that the company currently believes are immaterial to its business. In addition, FutureFuel cannot assess the impact of each factor on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. If any such risks occur, FutureFuel’s business, operating results, liquidity, and financial condition could be materially affected in an adverse manner. An investor should consult any additional disclosures FutureFuel has made or will make in its reports to the SEC on Forms 10-K, 10-Q, and 8-K, and any amendments thereto. All subsequent written and oral forward-looking statements attributable to FutureFuel or persons acting on its behalf are expressly qualified in their entirety by the cautionary statements contained in this document.

Non-GAAP Financial Measures

In this press release, FutureFuel used adjusted EBITDA as a key operating metric to measure both performance and liquidity. Adjusted EBITDA is a non-GAAP financial measure. Adjusted EBITDA is not a substitute for operating income, net income, or cash flow from operating activities (each as determined in accordance with GAAP), as a measure of performance or liquidity. Adjusted EBITDA has limitations as an analytical tool, and should not be considered in isolation or as a substitute for analysis of results as reported under GAAP. FutureFuel defines adjusted EBITDA as net income before interest, income taxes, depreciation, and amortization expenses, excluding, when applicable, non-cash share-based compensation expense, public offering expenses, acquisition-related transaction costs, purchase accounting adjustments, loss on disposal of property and equipment, non-cash gains or losses on derivative instruments, and other non-operating income or expense. Information relating to adjusted EBITDA is provided so that investors have the same data that management employs in assessing the overall operation and liquidity of FutureFuel’s business. FutureFuel’s calculation of adjusted EBITDA may be different from similarly titled measures used by other companies; therefore, the results of its calculation are not necessarily comparable to the results of other companies.

Adjusted EBITDA allows FutureFuel’s chief operating decision makers to assess the performance and liquidity of FutureFuel’s business on a consolidated basis to assess the ability of its operating segments to produce operating cash flow to fund working capital needs, to fund capital expenditures, and to pay dividends. In particular, FutureFuel management believes that adjusted EBITDA permits a comparative assessment of FutureFuel’s operating performance and liquidity, relative to a performance and liquidity based on GAAP results, while isolating the effects of depreciation and amortization, which may vary among its operating segments without any correlation to their underlying operating performance, and of non-cash stock-based compensation expense, which is a non-cash expense that varies widely among similar companies, and non-cash gains and losses on derivative instruments, whose immediate recognition can cause net income to be volatile from quarter to quarter due to the timing of the valuation change in the derivative instruments relative to the sale of biofuel.

A table included in this earnings release reconciles adjusted EBITDA with net income, the most directly comparable GAAP performance financial measure, and a table reconciles adjusted EBITDA with cash flows from operations, the most directly comparable GAAP liquidity financial measure.

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As of September 30, 2024, FutureFuel held 5.0 million RINs with a fair market value of $2,556 and no cost. Comparatively, at September 30, 2023, FutureFuel held 4.2 million RINs with a fair market value of $6,971 and no cost.

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COMPANY CONTACT
FutureFuel Corp.
Roeland Polet
(314) 854-8352
www.futurefuelcorporation.com

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