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Can-Fite to Treat Decompensated Liver Cirrhosis Patients with Namodenoson Under Compassionate Use Setting

• Liver organ shortage puts patients at risk of death from decompensated cirrhosis with no treatment options available
• Liver cirrhosis treatment market is estimated to reach approximately $15 billion in the U.S. by 2030

PETACH TIKVA, Israel–(BUSINESS WIRE)–Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, announced today that patients with decompensated cirrhosis, an advanced form of cirrhosis associated with liver failure for which there are no therapeutic options other than liver transplantation, will be treated with Namodenoson at the Soroka Medical Center in Israel under compassionate use. This drug is currently used in a pivotal Phase III study for patients with advanced liver cancer and a Phase IIb study for NASH.

Decompensated cirrhosis is defined as an acute deterioration in liver function in a patient with cirrhosis and is characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage. While some drugs can treat symptoms, there is no therapeutic approach that has shown efficacy in slowing disease progression.

An estimated 10.6 million people globally had decompensated cirrhosis in 2017, with few treatment options available aside from liver transplants if the decompensated cirrhosis has reached an advanced stage. Underscoring the need for an effective treatment, the American Liver Foundation states there are more people who need a liver than supply available, and some people can be on the wait list for a liver transplant for more than 5 years. The treatment of liver cirrhosis in the U.S. is estimated to become an approximately $15 billion market by 2030.

Ohad Etzion, MD, Head, Hepatology Department at the Soroka Medical Center, Beer Sheva, Israel, the Investigator and Initiator of this study commented, “Given the evidence of Namodenoson’s clinical benefit in patients with decompensated cirrhosis for whom there is no accepted well established treatment, Namodenoson may give hope to this patient population in the compassionate use setting.”

Compassionate use allows doctors and their patients the option of early access to investigational new drugs, under closely controlled and monitored circumstances, when a patient who is facing serious illness has exhausted all available treatment options.

Namodenoson’s unique characteristics of inducing hepato-protective effects make it suitable to treat patients with decompensated cirrhosis. In a Phase II study, Namodenoson was found to increase overall survival in advanced liver cancer patients defined as Child Pugh B7, known to suffer from cirrhosis. In a Phase IIa NASH study, Namodenoson met its primary efficacy endpoint showing positive activity manifested in anti-inflammatory, anti-steatotic, and antifibrotic effects with a very favorable safety profile.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company’s lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis. Can-Fite’s liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.com.

Forward-Looking Statements

This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those relating to historical facts, are “forward looking statements”. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to the COVID-19 pandemic and the Russian invasion of Ukraine; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 24, 2022 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.

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Can-Fite BioPharma

Motti Farbstein

[email protected]

+972-3-9241114

KEYWORDS: Israel Middle East

INDUSTRY KEYWORDS: Oncology Health Clinical Trials General Health Pharmaceutical Biotechnology

MEDIA:

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Kezar Life Sciences to Change Virtual R&D Day Date to March 15, 2023

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–
Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today announced that the Company will pull forward its virtual Research and Development (R&D) Day to Wednesday, March 15, 2023 at 4:30 pm ET/1:30 pm PT.

“The goal of Kezar’s R&D Day is to set expectations for 2023, provide updates on our two clinical assets, and highlight the productivity from our Discovery team. We are progressing more quickly than planned with initiating PALIZADE, our next study of zetomipzomib for the treatment of lupus nephritis, and look forward to sharing the details,” said John Fowler, Kezar’s Co-founder and Chief Executive Officer.

In addition, Craig S. Lammert, M.D., Assistant Professor of Medicine at Indiana University School of Medicine and Executive Director of the Autoimmune Hepatitis Association, will present on autoimmune hepatitis (AIH), the unmet need, and the treatment landscape. PORTOLA, a signal seeking study of zetomipzomib in AIH, initiated in the first quarter 2023.

The presentation will be followed by a Q&A session.

Presenters:

• John Fowler, Chief Executive Officer, Co-Founder
• Noreen Roth Henig, M.D., Chief Medical Officer
• Craig S. Lammert, M.D., Assistant Professor of Medicine at Indiana University School of Medicine, and Executive Director of the Autoimmune Hepatitis Association
• Neel Anand, D. Phil. (Ph.D.), Senior Vice President, Research and Drug Discovery

To register for this event, please visit the Events & Presentations page of Kezar’s website. On the day of the event, a live webcast and conference call will be accessible from the Events & Presentations page of Kezar’s website. Additionally, a replay of the event will be available for 90 days following the presentation.

About Zetomipzomib

Zetomipzomib (KZR-616) is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Data generated from Phase 1 and Phase 2 clinical trials provide evidence that zetomipzomib exhibits a favorable safety and tolerability profile for development in severe, chronic autoimmune diseases.

About Lupus Nephritis

Lupus nephritis (LN) is one of the most serious complications of systemic lupus erythematosus (SLE). LN is a disease comprising a spectrum of vascular, glomerular and tubulointerstitial lesions and develops in approximately 50% of SLE patients within 10 years of their initial diagnosis. LN is associated with considerable morbidity, including an increased risk of end-stage renal disease requiring dialysis or renal transplantation and an increased risk of death. There are limited approved therapies for the treatment of LN. Management typically consists of induction therapy to achieve remission and long-term maintenance therapy to prevent relapse.

About Autoimmune Hepatitis

Autoimmune hepatitis (AIH) is a rare chronic disease in which the immune system attacks the liver and causes inflammation and tissue damage, severely impacting patients’ physical health and quality of life. Lifelong maintenance therapy is required to avoid relapse and burdensome adverse effects. If left untreated, AIH can lead to cirrhosis, liver failure and hepatocellular carcinoma. In the United States, AIH affects approximately 140,000 individuals, with incidence rates increasing. The cause of this condition remains unclear, with females affected four times as often as males. Currently, standard of care treatment for AIH is chronic, immunosuppressive treatment with corticosteroids that frequently cause life-altering side effects, including diabetes, osteoporotic fractures and cataracts. There is a significant need for treatment regimens that reduce or remove the need for chronic immunosuppression from using corticosteroids.

About KZR-261 and the Inhibition of Protein Secretion

KZR-261 is a first-in-class small molecule compound, derived from Kezar’s research and discovery platform of protein secretion pathway inhibitors. This broad-spectrum anti-tumor agent directly targets the Sec61 translocon and inhibits multiple cancer drivers both within tumor cells and the tumor microenvironment. A Phase 1 clinical trial is underway for the treatment of solid tumor malignancies.

Kezar’s drug discovery platform of protein secretion pathway inhibitors is a novel approach with broad application. The protein secretion pathway is a highly conserved and ubiquitously functioning pathway in all cells in the body and involves a conserved protein complex called the Sec61 translocon, the target of Kezar’s compounds. In preclinical models, Kezar’s library of protein secretion inhibitors have demonstrated broad activity with far-reaching potential in oncology, immune-oncology, and autoimmunity.

About Kezar Life Sciences

Kezar Life Sciences is a clinical-stage biopharmaceutical company discovering and developing novel treatments for immune-mediated and oncologic disorders. The company is pioneering first-in-class, small-molecule therapies that harness master regulators of cellular function to inhibit multiple drivers of disease via single, powerful targets. Zetomipzomib, its lead development asset, is a selective immunoproteasome inhibitor that has completed a Phase 2 clinical trial in lupus nephritis. This product candidate also has the potential to address multiple chronic immune-mediated diseases. KZR-261 is the first anti-cancer clinical candidate from the company’s platform targeting the Sec61 translocon and the protein secretion pathway. An open-label dose-escalation Phase 1 clinical trial of KZR-261 to assess safety, tolerability and preliminary tumor activity in solid tumors is underway. For more information, visit www.kezarlifesciences.com.

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Investor Contact:

Gitanjali Jain

Vice President, Investor Relations and External Affairs

[email protected]

Media Contact:

Julia Deutsch

Solebury Strategic Communications

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Biotechnology Pharmaceutical Health Oncology

MEDIA:

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Benson Hill Announces Full Year 2022 Financial Results and Expectations for Strong Proprietary Product Growth in 2023

• Revenues increased 319 percent to $381 million, including a near doubling of proprietary revenues to $73 million.
• Gross profit was $3.5 million ($8.5 million when excluding an approximate $4.9 million loss from open mark-to-market timing differences).
• 2023 proprietary revenues are expected to grow to an estimated range of $100 million to $110 million and help drive a more than doubling of gross profit in the range of $20 million to $30 million.
• 2023 Adjusted EBITDA loss is expected to narrow and use of free cash is expected to increase due primarily to planned investments to enable additional, higher margin food-grade manufacturing capabilities.
• In 2025, management remains committed to the target of positive Adjusted EBITDA and free cash flow as it focuses on the highest-margin proprietary products in response to persistent high costs across the supply chain.
• The Company expects to execute a plan to optimize its capital structure and actions to increase return on capital.

ST. LOUIS–(BUSINESS WIRE)–Benson Hill, Inc. (NYSE: BHIL, the “Company” or “Benson Hill”), a food tech company unlocking the natural genetic diversity of plants, today announced operating and financial results for the year ended December 31, 2022.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230313005303/en/

“2022 was an exceptional year for Benson Hill, and we expect 2023 to bring continued proprietary revenue growth and gross margin expansion led by our soy ingredient products,” said Matt Crisp, Chief Executive Officer of Benson Hill. “Demand for our innovations remains strong, although persistent high supply chain costs are impacting our profitability in certain food ingredient categories, which we believe will continue for the foreseeable future. To meet the needs of our customers, we will execute a more targeted growth strategy focused on the highest-margin proprietary products and one that de-emphasizes lower margin products. In addition, we are finalizing and expect to implement capital management changes designed to reduce debt, interest and operating expenses, and increase return on capital, while maintaining our commitment to fully fund the business. Our team demonstrated its ability to meet our strategic objectives, and we remain steadfast in our commitment to shareholders to achieve significant yet disciplined growth, as well as our target of profitability in 2025.”

Full Year 2022 Results as Compared to The Same Period of 2021

The financial results discussed in this press release exclude the Fresh business, which was divested in a two-part transaction announced on January 3, 2023, the initial portion of which was consummated on December 29, 2022, and the second portion of which is expected to close in the second quarter of 2023. The Company recorded the Fresh business as discontinued operations as of December 31, 2022. The impact of open mark-to-market timing differences on the profit and loss statement and reconciliation of non-GAAP financial measures can be found on pages 6 and 12, respectively.

• Revenues were $381.2 million, an increase of $290.3 million, or 319 percent. Strong demand from customers and greater availability of proprietary soy ingredients, meal and edible oil products resulted in a near doubling of proprietary revenues to $72.6 million. Non-proprietary revenues increased significantly due to favorable soy and yellow pea commodity prices and operational excellence associated with the startup of two soy production facilities.
• Gross profit was $3.5 million, an increase of $9.4 million. Excluding approximately $4.9 million in losses due to open mark-to-market timing differences, gross profit was $8.5 million and gross margins were 2.2 percent. Favorable top line growth, proprietary revenue mix, and contributions from partnership and licensing agreements were partially offset by cost pressures in the supply chain as well as the impact from adverse weather in the month of December.
• Operating expenses were $128.5 million, a $16.0 million increase, which includes $34.0 million for non-cash items primarily related to stock compensation and depreciation.
  • Selling, general and administrative expenses were $81.0 million, an increase of $9.1 million or 13 percent.
  • R&D expenses were $47.5 million, an increase of $6.9 million or 17 percent.
  • All year-over-year operating expense increases were related to non-cash items.
• Inclusive of open mark-to-market timing differences, net loss from continuing operations was $99.7 million, a decrease in loss of $22.5 million or 18 percent. Adjusted EBITDA was a loss of $81.6 million, or a loss of $76.7 million, excluding the impact from open mark-to-market timing differences, which was in line with the prior year.
• Cash, restricted cash, and marketable securities of $175.0 million were on hand as of December 31, 2022.

Fourth Quarter 2022 Results as Compared to The Same Period of 2021

• Revenues were $99.2 million, an increase of $68.4 million, or 223 percent. The performance was driven by sales for both proprietary and non-proprietary soy and yellow pea products.
• Gross profit was $0.8 million, an increase in profitability of $4.0 million, and includes an approximately $3.3 million loss due to open mark-to-market timing difference. Gross margins were approximately 4 percent when excluding open mark-to-market timing differences.
• Inclusive of mark-to-market timing differences, net loss from continuing operations was $30.8 million, a decrease in loss of $10.4 million or 25.3 percent. Adjusted EBITDA was a loss of $21.4 million compared to a loss of $29.1 million.

Outlook

Excludes the Fresh segment which is now classified as discontinued operations.

Management expects continued strong demand for its proprietary products in 2023 resulting in a 40 percent to 50 percent increase in proprietary revenues to a range of $100 million to $110 million. Non-proprietary revenues are expected to decline moderately in favor of proprietary products, which sets the expectation for consolidated revenues to be in the range of $390 million to $430 million.

Consolidated gross profit is expected to be in the range of $20 million to $30 million driven by anticipated increases in proprietary sales, increased revenues from partnership and licensing agreements, which is expected to have higher margins, and favorable soy commodity markets for non-proprietary product sales. This outlook includes assumptions for persistent inflationary and supply chain logistics.

The Company expects a net loss of $125 million to $135 million and Adjusted EBITDA loss in the range of $63 million to $68 million.

Capital expenditures are expected to be in the range of $20 million to $25 million due to a two-year capital project to add the capability for soy flour texturization at the Creston, Iowa facility.

Management is in the advanced stages of finalizing a plan designed to lower the cost of capital, increase return on capital, and reduce costs. During the back half of this year, the Company expects to retire the existing $100 million high-cost debt two years early and replace it with a conventional, lower cost lending facility. The Company intends to utilize its current shelf registration statement, including its ATM facility, or alternative equity financing, for up to $100 million to supplement the cash needed to fully fund the business to profitability in 2025. The anticipated retirement of the existing debt will incur pre-payment penalties and other costs that, along with the planned capital expenditures, is expected to result in a free cash flow loss in 2023 of $120 million to $128 million. Management is also exploring strategic options for its Seymour, Indiana, soy crush facility to deploy capital more effectively within the closed-loop operations, reduce costs, and increase return on capital.

Management remains committed to its objective of achieving positive Adjusted EBITDA and positive free cash flow in 2025. The adoption of the targeted growth strategy is expected to result in proprietary revenues in 2025 of at least $300 million compared to the prior target of over $350 million. Consolidated revenues are forecasted to be $400 million or greater. The target for gross margins remains at 25 percent.

Webcast

A webcast of the conference call will begin at 8:30 a.m. ET today. The link to participate is available on the Investor Relations page of the Company’s website.

About Benson Hill

Benson Hill moves food forward with the CropOS^® platform, a cutting-edge food innovation engine that combines data science and machine learning with biology and genetics. Benson Hill empowers innovators to unlock nature’s genetic diversity from plant to plate, with the purpose of creating nutritious, great-tasting food and ingredient options that are both widely accessible and sustainable. More information can be found at bensonhill.com or on Twitter at @bensonhillinc.

Use of Non-GAAP Financial Measures

In this press release, the Company includes references to non-GAAP performance measures. The Company uses these non-GAAP financial measures to facilitate management’s financial and operational decision-making, including evaluation of the Company’s historical operating results. The Company’s management believes these non-GAAP measures are useful in evaluating the Company’s operating performance and are similar measures reported by publicly listed U.S. competitors, and regularly used by securities analysts, institutional investors, and other interested parties in analyzing operating performance and prospects. These non-GAAP financial measures reflect an additional way of viewing aspects of the Company’s operations that, when viewed with GAAP results and the reconciliations to corresponding GAAP financial measures, may provide a more complete understanding of factors and trends affecting the Company’s business. By referencing these non-GAAP measures, the Company’s management intends to provide investors with a meaningful, consistent comparison of the Company’s performance for the periods presented. These non-GAAP financial measures should be considered supplemental to, and not a substitute for, financial information prepared in accordance with GAAP. The Company’s definition of these non-GAAP measures may differ from similarly titled measures of performance used by other companies in other industries or within the same industry. Because non-GAAP financial measures exclude the effect of items that will increase or decrease the Company’s reported results of operations, management strongly encourages investors to review the Company’s consolidated financial statements and publicly filed reports in their entirety.

Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the tables accompanying this press release.

Cautionary Note Regarding Forward-Looking Statements

Certain statements in this press release may be considered “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements generally relate to future events or the Company’s future financial or operating performance and may be identified by words such as “may,” “should,” “expect,” “intend,” “will,” “estimate,” “anticipate,” “believe,” “predict,” or similar words. These forward-looking statements are based upon assumptions made by the Company as of the date hereof and are subject to risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements include, among other things, statements regarding the Company’s plans to improve its capital structure; the Company’s current guidance regarding certain expected 2023 financial and operating results, including guidance regarding consolidated, proprietary and non-proprietary revenues and revenues from partnership and licensing agreements, margins, consolidated gross profit, net loss, Adjusted EBITDA, capital expenditures and use of free cash flow; expectations regarding actions intended to lower the cost of capital, increase return on capital, and reduce costs, including plans to retire its existing debt early and replace it with a conventional lending facility, including expectations regarding pre-payment penalties and other costs in connection therewith, plans regarding equity financing to supplement the cash needed to fully fund the business to profitability in 2025, and statements regarding the Company’s plans to explore strategic options for its Seymour, Indiana, soy crush facility; any statements regarding the Company’s plans to fully fund the business to profitability in 2025; expectations regarding macro-economic trends; expectations regarding the sources of expected consolidated revenue and gross profit growth, including improved commodity market conditions for non-proprietary product sales, and enhanced focus on higher margin product categories; expectations regarding revenue and gross profit mix; expectations regarding future costs and uses of free cash flow; expectations regarding the unwinding of mark-to-market timing differences and the Company’s assessment of its futures contracts; the expected timing and anticipated benefits of the divestiture of the Fresh business, including the consummation of the pending transaction pertaining to the Fresh assets remaining to be sold; any financial or other information based upon or otherwise incorporating judgments or estimates relating to future performance, events or expectations; expectations regarding the Company’s hedging and other risk management strategies, including expectations about future sales and purchases that relate to the Company’s mark-to-market adjustments and the fair valuation of futures contracts; the Company’s strategies, positioning, resources, capabilities, and expectations for future performance; estimates and forecasts of financial and other performance metrics; projections of market opportunity and supply chain constraints; the Company’s outlook and financial and other guidance; management’s strategy and plans for growth, including those intended to lower the cost of capital, increase return on capital and reduce costs. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: risks associated with the Company’s inability to execute on its plans to lower the cost of capital, increase return on capital and reduce costs; the risk that the Company’s actions intended to fully fund the business to profitability in 2025 will be insufficient to achieve such objective; risks associated with the Company’s ability to grow and achieve growth profitably, including continued access to the capital resources necessary for growth; the risk that the Company will be unable to renegotiate or retire any of its existing debt by entering into an amended or new facility in a timely manner, on favorable terms, or at all; risks relating to the failure to realize the anticipated benefits of the Company’s shelf registration statement, including its at-the-market facility, or otherwise fail to raise equity capital to supplement its cash needs; risks relating to potential dilution; risks relating to the Company’s hedging and other risk management strategies, including expectations about future sales and purchases that relate to the Company’s mark-to-market adjustments and the fair valuation of futures contracts; the risk that the Company will not realize the anticipated benefits of the divestiture of the Fresh business, including risks relating to the failure to satisfy the conditions to the consummation of the pending transaction to sell the remaining assets of the Fresh business, and the risk that such transaction may not be completed in a timely manner or at all; risks associated with managing capital resources; risks associated with maintaining relationships with customers and suppliers and developing and maintaining partnering and licensing relationships; risks associated with changing industry conditions and consumer preferences; risks associated with the Company’s ability to generally execute on its business strategy; risks associated with the effects of global and regional economic, agricultural, financial and commodities market, political, social and health conditions; risks associated with the Company’s transition to becoming a public company; the effectiveness of the Company’s risk management strategies; and other risks and uncertainties set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in our filings with the SEC, which are available on the SEC’s website at www.sec.gov. The Company can make no assurances that it will be able to retire its existing debt early on the anticipated timeframe, or at all, or that it will be able to replace such debt with a conventional, lower cost, lending facility, or any facility, on favorable terms, in a timely manner, or at all. Similarly, the Company can make no assurances that it will be able to raise up to $100 million, or any amount, of equity financing, whether under the Company’s shelf registration statement, including its ATM facility, or otherwise. Forward-looking statements are also subject to the risks and other issues described above under “Use of Non-GAAP Financial Measures,” which could cause actual results to differ materially from current expectations included in the Company’s forward-looking statements included in this press release. Nothing in this press release 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 of such forward looking statements will be achieved, including without limitation, any expectations about our operational and financial performance or achievements through and including 2025. There may be additional risks about which the Company is presently unaware or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. The reader should not place undue reliance on forward-looking statements, which speak only as of the date they are made. The Company expressly disclaim any duty to update these forward-looking statements, except as otherwise required by law.

Benson Hill, Inc.

Material Items Included in Consolidated Revenues and Cost of Sales

(In Thousands)

Currently, the Company does not seek cash flow hedge accounting treatment for its derivative financial instruments and thus changes in fair value are reflected in current earnings.

Mark-to-market timing difference comprises the estimated net temporary impact resulting from unrealized period-end gains/losses associated with the fair valuation of futures contracts associated with the Company’s committed future operating capacity. These mark-to-market timing differences are not indicative of the Company’s operating performance.

The Company recorded the fair value of acquired sales and purchase contracts in the acquisition of the Company’s Creston, Iowa location, which are amortized, not marked-to-market, to revenues and cost of sales to the physical contracts.

The table below summarizes the pre-tax gains and losses related to derivatives and contract assets and liabilities:

	Fiscal Year 2022
					Open Mark-to-Market Timing Differences
​	2022 Reported (unaudited)				Q1 Impact				Q2 Impact			Q3 Impact			Q4 Impact				2022 Excluding Impact
Revenues	$	381,233			$	(5,002	)		$	3,885		$	3,267		$	(4,534	)		$	383,617
Gross profit	$	3,527			$	(8,181	)		$	5,227		$	1,381		$	(3,353	)		$	8,453
Total operating expenses	$	128,534			$	—			$	—		$	—		$	—			$	128,534
Net loss from continuing operations	$	(99,700	)		$	(8,181	)		$	5,227		$	1,381		$	(3,353	)		$	(94,774	)
Adjusted EBITDA	$	(81,645	)		$	(8,181	)		$	5,227		$	1,381		$	(3,353	)		$	(76,719	)

• 2022: The net temporary unrealized period-end loss on revenues and cost of sales was $2.4 million and $4.9 million, respectively. Management expects the open mark-to-market timing differences to unwind in the coming months.
• See Adjusted EBITDA reconciliation on page 12.

Benson Hill, Inc. Consolidated Balance Sheets (Unaudited) (In Thousands)
​	December 31,
​	2022				2021
Assets	​			​	​
Current assets:	​				​
Cash and cash equivalents	$	25,053			$	78,940
Marketable securities		132,121				103,689
Accounts receivable, net		28,591				22,128
Inventories, net		62,110				37,004
Prepaid expenses and other current assets		29,346				16,806
Current assets held for sale		23,507				24,791
Total current assets		300,728				283,358
Property and equipment, net		99,759				98,076
Right of use asset, net		68,193				73,712
Goodwill and intangible assets, net		27,377				35,397
Other assets		4,863				4,538
Noncurrent assets held for sale		—				39,816
Total assets	$	500,920			$	534,897

Liabilities and stockholders’ equity	​			​	​
Current liabilities:	​			​	​
Accounts payable	$	36,717			$	20,288
Current lease liability		3,682				1,831
Current maturities of long-term debt		2,242				6,901
Accrued expenses and other liabilities		33,435				25,608
Current liabilities held for sale		16,441				17,054
Total current liabilities		92,517				71,682
Long-term debt		103,991				77,035
Long-term lease liability		77,722				77,152
Warrant liabilities		24,285				46,051
Conversion option liability		8,091				8,783
Deferred tax liabilities		283				294
Other non-current liabilities		129				316
Noncurrent liabilities held for sale		—				2,137
Total liabilities		307,018				283,450
Stockholders’ equity:
Redeemable convertible preferred stock, $0.0001 par value; 1,000 authorized, no shares issued and outstanding as of December 31, 2022 and 2021, respectively		—				—
Common stock, $0.0001 par value, 440,000 and 440,000 shares authorized; 206,668 and 178,089 shares issued and outstanding as of December 31, 2022 and 2021, respectively		21				18
Additional paid-in capital		609,450				533,101
Accumulated deficit		(408,474	)			(280,569	)
Accumulated other comprehensive loss		(7,095	)			(1,103	)
Total stockholders’ equity		193,902				251,447
Total liabilities and stockholders’ equity	$	500,920			$	534,897

Benson Hill, Inc. Consolidated Statements of Operations (Unaudited) (In Thousands, Except Per Share Information)
​	Three Months Ended December 31,								Year Ended December 31,
​		2022				2021				2022				2021
Revenues	$	99,180			$	30,732			$	381,233			$	90,945
Cost of sales		98,391				33,972				377,706				96,846
Gross profit (loss)		789				(3,240	)			3,527				(5,901	)
Operating expenses:
Research and development		11,761				14,171				47,500				40,574
Selling, general and administrative expenses		21,586				21,534				81,034				71,947
Total operating expenses		33,347				35,705				128,534				112,521
Loss from operations		(32,558	)			(38,945	)			(125,007	)			(118,422	)
Other (income) expense:
Interest expense, net		5,414				611				21,444				4,481
Loss on extinguishment of debt		—				—				—				11,742
Change in fair value of warrants and conversion		(7,387	)			398				(49,063	)			(12,127	)
Other (income) expense, net		149				1,226				2,253				(549	)
Total other (income) expense, net		(1,824	)			2,235				(25,366	)			3,547
Net loss from continuing operations before income tax		(30,734	)			(41,180	)			(99,641	)			(121,969	)
Income tax expense		29				13				59				231
Net loss from continuing operations, net of tax		(30,763	)			(41,193	)			(99,700	)			(122,200	)
Net loss from discontinued operations, net of tax		(22,843	)			(1,014	)			(28,205	)			(4,047	)
Net loss	$	(53,606	)		$	(42,207	)		$	(127,905	)		$	(126,247	)
Net loss per common share:
Basic and diluted net loss per common share from continuing operations	$	(0.17	)		$	(0.26	)		$	(0.55	)		$	(1.00	)
Basic and diluted net loss from discontinued operations, net of tax	$	(0.12	)		$	(0.01	)		$	(0.16	)		$	(0.04	)
Basic and diluted net loss per common share	$	(0.29	)		$	(0.27	)		$	(0.71	)		$	(1.04	)
Weighted average shares outstanding:
Basic and diluted weighted average shares outstanding		186,787				158,323				179,867				121,838

Benson Hill, Inc. Consolidated Statements of Comprehensive Loss (Unaudited) (In Thousands)
​	Three Months Ended December 31,								Year Ended December 31,
​		2022				2021				2022				2021
Net loss	$	(53,606	)		$	(42,207	)		$	(127,905	)		$	(126,247	)
Foreign currency:
Comprehensive (loss) income		37				(26	)			(9	)			4
​		37				(26	)			(9	)			4
Marketable securities:
Comprehensive loss		6,240				(1,963	)			(3,678	)			(1,813	)
Adjustments for net (losses) income realized in net loss		(4,437	)			1,234				(2,305	)			1,031
​		1,803				(729	)			(5,983	)			(782	)
Total other comprehensive (loss) income		1,840				(755	)			(5,992	)			(778	)
Total comprehensive loss	$	(51,766	)		$	(42,962	)		$	(133,897	)		$	(127,025	)

Benson Hill, Inc. Consolidated Statements of Cash Flows (Unaudited) (In Thousands)
​	Year Ended December 31,
​		2022				2021
Operating activities	​				​
Net loss	$	(127,905	)		$	(126,247	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		22,836				12,817
Stock-based compensation expense		19,520				7,183
Bad debt expense		863				309
Change in fair value of warrants and conversion options		(49,063	)			(12,127	)
Amortization related to financing activities		9,279				1,389
Loss on extinguishment of debt		—				11,742
Loss on divestiture of discontinued operations		10,246				—
Impairment		11,579				—
Loss on investments and amortization on premiums		4,755				—
Other		4,579				(65	)
Changes in operating assets and liabilities:
Accounts receivable		(3,070	)			(7,038	)
Inventories		(4,663	)			(11,690	)
Other assets		6,542				(13,149	)
Accounts payable		(5,313	)			11,293
Accrued expenses		6,419				7,539
Other liabilities		—				294
Net cash used in operating activities		(93,396	)			(117,750	)
Investing activities
Purchases of marketable securities		(372,170	)			(648,923	)
Proceeds from maturities of marketable securities		139,063				2,499
Proceeds from sales of marketable securities		193,250				639,612
Payments for acquisitions of property and equipment		(16,486	)			(31,490	)
Payments made in connection with business acquisitions		(1,034	)			(116,287	)
Proceeds from divestitures of discontinued operations		17,131				—
Net cash used in investing activities		(40,246	)			(154,589	)
Financing activities
Net contributions from Merger, at-the-market offering and PIPE financing, net of transaction costs of $4,087 and $34,940 for 2022 and 2021, respectively		81,109				285,378
Payments for extinguishment of debt		—				(43,082	)
Principal payments on debt		(7,288	)			(4,400	)
Proceeds from issuance of debt		23,540				103,634
Borrowing under revolving line of credit		19,774				20,954
Repayments under revolving line of credit		(19,821	)			(20,907	)
Proceeds from issuance of redeemable convertible preferred stock, net of costs		—				—
Retirement of redeemable convertible preferred stock		—				—
Repayments of financing lease obligations		(1,630	)			(703	)
Proceeds from the exercise of stock options and warrants		2,325				681
Net cash provided by financing activities		98,009				341,555
Effect of exchange rate changes on cash		(9	)			4
Net increase (decrease) in cash, cash equivalents and restricted cash		(35,642	)			69,220
Cash, cash equivalents and restricted cash, beginning of year		78,963				9,743
Cash, cash equivalents and restricted cash, end of year	$	43,321			$	78,963

Supplemental disclosure of cash flow information
Cash paid for taxes	$	57			$	53
Cash paid for interest	$	14,398			$	6,591
Supplemental disclosure of non-cash activities
Issuance of Notes Payable Warrants and Convertible Notes Payable Warrants	$	—			$	6,663
Conversion of Notes Payable Warrants upon Merger	$	—			$	4,576
Public Warrants and Private Placement Warrants acquired in Merger	$	—			$	50,850
Issuance of conversion option	$	—			$	8,783
Purchases of property and equipment included in accounts payable and accrued expenses and other current liabilities	$	3,058			$	3,578
Purchases of inventory included in accounts payable and accrued expenses and other current liabilities	$	1,553			$	1,854
Financing leases	$	806			$	46,021

Benson Hill, Inc.

Non-GAAP Reconciliation

(Dollar Amounts in Thousands)

This press release contains financial measures not derived in accordance with generally accepted accounting principles (“GAAP”). Reconciliations to the most comparable GAAP measures are provided below. The Company defines Adjusted EBITDA as net loss from continuing operations excluding income taxes, interest, depreciation, amortization, stock-based compensation, and the impact of significant non-recurring items.

Adjustments to reconcile net loss from our continuing operations to Adjusted EBITDA for the years ended December 31, 2022 and 2021 are as follows:

		Three Months Ended December 31,								Year Ended December 31,
(in thousands)		2022 (unaudited)				2021 (unaudited)				2022 (unaudited)				2021 (unaudited)
Adjustments to reconcile net loss from continuing operations to Adjusted EBITDA
Net loss from continuing operations		$	(30,763	)		$	(41,193	)		$	(99,700	)		$	(122,200	)
Interest expense, net			5,414				611				21,444				4,481
Income tax expense (benefit)			29				13				59				231
Depreciation and amortization			5,909				3,444				20,513				10,478
Stock-based compensation			3,749				4,414				19,520				7,183
Change in fair value of warrants			(7,389	)			398				(49,063	)			(12,127	)
Other non-recurring costs, including acquisitions			1,619				3,193				5,582				4,688
Employee retention credit			—				—				—				(1,550	)
Merger transaction costs			—				—				—				11,693
Non-recurring public company readiness costs			—				—				—				5,265
Loss on extinguishment of debt			—				—				—				11,742
South America seed production costs			—				—				—				2,805
Adjusted EBITDA		$	(21,432	)		$	(29,120	)		$	(81,645	)		$	(77,311	)

Adjustments to reconcile estimated 2023 net loss from continuing operations to estimated Adjusted EBITDA are as follows:

	2023 Estimate
Net loss from continuing operations	$	(125,000	)	–	(135,000	)
Interest expense, net		27,000		–	29,000
Depreciation and amortization		21,000		–	23,000
Stock-based compensation		14,000		–	15,000
Total Adjusted EBITDA	$	(63,000	)	–	(68,000	)

Benson Hill, Inc. Supplemental Schedules – 2023 Free Cash Flow Non-GAAP Reconciliation (Dollar Amounts in Thousands)
Adjustments to reconcile estimated free cash flow:
	2023 Estimate
Net loss from continuing operations	$ (125,000) – (135,000)
Depreciation and amortization	21,000 – 23,000
Stock-based compensation	14,000 – 15,000
Changes in working capital	(12,000) – (14,000)
Other	2,000 – 8,000
Net Cash Used on Operating Activities	$ (100,000) – (103,000)
Payments for acquisition of property and equipment	(20,000) – (25,000)
Free Cash Flow	$ (120,000) – (128,000)

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20230313005303/en/

Investors: Ruben Mella: (314) 714-6313 / [email protected]

Media: Christi Dixon: (636) 359-0797 / [email protected]

KEYWORDS: Missouri United States North America

INDUSTRY KEYWORDS: Food Tech Retail Technology Agriculture Natural Resources Food/Beverage

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Benson Hill, Inc., a food tech company unlocking the natural genetic diversity of plants, today announced operating and financial results for the year ended December 31, 2022. (Graphic: Business Wire)

Cleveland-Cliffs Raises Price for Hot Rolled Steel to $1,200 per net ton

CLEVELAND–(BUSINESS WIRE)–
Cleveland-Cliffs Inc. (NYSE: CLF) today announced that it is increasing current spot market base prices for all carbon hot rolled, cold rolled and coated steel products by a minimum of $100 per net ton, effective immediately with all new orders. Cliffs’ minimum base price for hot rolled steel is now $1,200 per net ton.

About Cleveland-Cliffs Inc.

Cleveland-Cliffs is the largest flat-rolled steel producer in North America. Founded in 1847 as a mine operator, Cliffs also is the largest manufacturer of iron ore pellets in North America. The Company is vertically integrated from mined raw materials, direct reduced iron, and ferrous scrap to primary steelmaking and downstream finishing, stamping, tooling, and tubing. Cleveland-Cliffs is the largest supplier of steel to the automotive industry in North America and serves a diverse range of other markets due to its comprehensive offering of flat-rolled steel products. Headquartered in Cleveland, Ohio, Cleveland-Cliffs employs approximately 27,000 people across its operations in the United States and Canada.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230313005231/en/

MEDIA CONTACT:

Patricia Persico

Senior Director, Corporate Communications

(216) 694-5316

INVESTOR CONTACT:

James Kerr

Manager, Investor Relations

(216) 694-7719

KEYWORDS: United States North America Ohio

INDUSTRY KEYWORDS: Machine Tools, Metalworking & Metallurgy Manufacturing Steel

MEDIA:

Posted on March 13, 2023 7:09 am

EVgo Inc. to Report Fourth Quarter and Full Year 2022 Results on March 30, 2023

EVgo Inc. to Report Fourth Quarter and Full Year 2022 Results on March 30, 2023

LOS ANGELES–(BUSINESS WIRE)–
EVgo Inc. (Nasdaq: EVGO), (“EVgo” or the “Company”), one of the nation’s largest public fast charging networks for electric vehicles (EVs), announced today that it will report results for its fourth quarter and full year 2022 on March 30, 2023 and will host a conference call to discuss those results at 8:00 a.m. PT/11:00 a.m. ET on March 30, 2023.

EVgo also disclosed, in response to investor inquiries, that it has no cash deposits or equivalents in Silicon Valley Bank.

EVgo confirms that it expects to report 2022 financial and operational results within the guidance ranges previously provided by the Company on November 2, 2022 and as reconfirmed by the Company on February 23, 2023.

Conference Call Information

Interested investors and other parties may access a live webcast of the conference call on the Events & Presentations page in the Investor Relations section of EVgo’s website at https://investors.evgo.com/events-and-presentations.

The call can also be accessed live over the telephone by dialing:

Toll Free: (888) 340-5044 (for U.S. callers)

Toll/International: (646) 960-0363 (for callers outside the U.S.)

Conference ID: 6304708

Please log into the webcast or dial in to the call at least 10 minutes before the start of the event. An archive of the webcast will be available for a period of time shortly after the call on the Events & Presentations page in the Investor Relations section of EVgo’s website.

About EVgo

EVgo (Nasdaq: EVGO) is a leader in charging solutions, building and operating the infrastructure and tools needed to expedite the mass adoption of electric vehicles for individual drivers, rideshare and commercial fleets, and businesses. Since its founding in 2010, EVgo has led the way to a cleaner transportation future, and its network has been powered by 100% renewable energy since 2019 through the purchase of renewable energy certificates. As one of the nation’s largest public fast charging networks, EVgo’s owned and operated charging network includes around 900 fast charging locations, 60 metropolitan areas and 30 states. EVgo continues to add more DC fast charging locations through EVgo eXtend™, its white label service offering. EVgo is accelerating transportation electrification through partnerships with automakers, fleet and rideshare operators, retail hosts such as grocery stores, shopping centers, and gas stations, policy leaders, and other organizations. With a rapidly growing network, robust software products and unique service offerings for drivers and partners including EVgo Optima^™, EVgo Inside^™, EVgo Rewards^™, and Autocharge+, EVgo enables a world-class charging experience where drivers live, work, travel and play.

Cautionary Statement Regarding Preliminary Financial Results

The Company has not yet completed its financial close processes for fiscal year 2022. Therefore, the Company’s statements regarding its expectations for its financial results for the year ended December 31, 2022 included in this press release are based on preliminary unaudited estimates only and should not be viewed as a substitute for full audited financial statements prepared in accordance with GAAP. They reflect management’s estimates based solely upon information available to management as of the date of this press release. Further information learned during the financial close processes and audit may alter the final results. The Company cautions you that actual results which are prepared in accordance with GAAP and are subject to a full-year audit may differ materially from such expectations. Accordingly, you should not place undue reliance upon this preliminary financial information.

Forward-Looking Statements

This press release contains “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 “estimate,” “plan,” “project,” “forecast,” “intend,” “will,” “expect,” “anticipate,” “believe,” “seek,” “target” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements are based on management’s current expectations or beliefs and are subject to numerous assumptions, risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These forward-looking statements include, but are not limited to, our preliminary results for revenue and Adjusted EBITDA (Non-GAAP), network throughput, stalls in operation or under construction or other operational measures, including any guidance issued in respect thereof; express or implied statements regarding EVgo’s future financial performance, revenues, capital expenditures, stalls in operation or under construction and network throughput; EVgo’s expectation of market position and acceleration in its business due to factors including increased EV adoption and demand for EV charging; and the Company’s collaboration with partners enabling transportation electrification and effective deployment of chargers. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of EVgo’s management and are not predictions of actual performance. There are a significant number of factors that could cause actual results to differ materially from the statements made in this press release, including information learned during the completion of financial close or audit processes; changes or developments in the broader general market; ongoing impacts from COVID-19 on EVgo’s business, customers, and suppliers; macro political, economic, and business conditions, including inflation and geopolitical conflicts that could impact our supply chains; increased competition, including from new and existing entrants in the EV charging market; unfavorable conditions or further disruptions in the capital and credit markets and EVgo’s ability to obtain additional capital on commercially reasonable terms; EVgo’s limited operating history as a public company; EVgo’s dependence on widespread adoption of EVs and increased installation of charging stations; mechanisms surrounding energy and non-energy costs for EVgo’s charging stations; the impact of governmental support and mandates that could reduce, modify, or eliminate financial incentives, rebates, and tax credits; supply chain disruptions; EVgo’s ability to expand into new service markets, grow its customer base, and manage its operations; impediments to EVgo’s expansion plans, including permitting delays; the need to attract additional fleet operators as customers; potential adverse effects on EVgo’s revenue and gross margins if customers increasingly claim clean energy credits and, as a result, they are no longer available to be claimed by us; risks related to EVgo’s dependence on its intellectual property; and risks that EVgo’s technology could have undetected defects or errors. Additional risks and uncertainties that could affect the Company’s financial results are included under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations of EVgo” in EVgo’s Annual Report on Form 10-K for the year ended December 31, 2021, and the caption “Risk Factors” in its Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2022, June 30, 2022 and September 30, 2022, in each case filed with the Securities and Exchange Commission (the “SEC”), as well as its other filings with the SEC, copies of which are available on EVgo’s website at investors.evgo.com, and on the SEC’s website at www.sec.gov. All forward-looking statements in this press release are based on information available to us as of the date hereof, and EVgo does not assume any obligation to update the forward-looking statements provided to reflect events that occur or circumstances that exist after the date on which they were made, except as required by applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230313005274/en/

For Investors:

[email protected]

For Media:

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Alternative Vehicles/Fuels EV/Electric Vehicles Vehicle Technology Automotive General Automotive Utilities Automotive Manufacturing Alternative Energy Manufacturing Energy

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Posted on March 13, 2023 7:08 am

Harrow Announces Transitional Pass-Through Reimbursement Status for IHEEZO™ (Chloroprocaine Hydrochloride Ophthalmic Gel) 3%

Harrow Announces Transitional Pass-Through Reimbursement Status for IHEEZO™ (Chloroprocaine Hydrochloride Ophthalmic Gel) 3%

NASHVILLE, Tenn.–(BUSINESS WIRE)–
Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, today announced that the Centers for Medicare & Medicaid Services (CMS) has approved transitional pass-through reimbursement status for IHEEZO™ (chloroprocaine hydrochloride ophthalmic gel) 3%, which is indicated for ocular surface anesthesia.

Beginning April 1, 2023, and for the three years thereafter, IHEEZO will be eligible for separate reimbursement outside of the surgical bundled payment in both the Ambulatory Surgery Center (ASC) and Hospital Outpatient Department (HOPD) settings of care. CMS previously approved the issuance of a permanent, product-specific J‑Code (J2403), enabling access to IHEEZO for ophthalmologists, optometrists, and retina specialists for the in‑office setting of care. This new CMS pass-through approval makes IHEEZO the only ocular anesthetic with separate reimbursement in all traditional settings of care – the eyecare professional’s office, the ASC, and the HOPD.

CMS grants pass-through status to certain new and innovative medical devices, drugs, and biological products. Drugs that are administered in the ASC and HOPD settings can have pass‑through status and be reimbursed accordingly by Medicare. By having pass-through status, IHEEZO will be separately reimbursed by Medicare at Average Sales Price (ASP) +6% in both the ASC and HOPD settings of care. Until an ASP is established, IHEEZO will be reimbursed accordingly at Wholesale Acquisition Cost (WAC) +3%.

“We are grateful to CMS for their approval of transitional pass-through reimbursement status for IHEEZO and for their support of our mission to make innovative ophthalmic prescription medications accessible and affordable,” said Mark L. Baum, Chairman and Chief Executive Officer of Harrow. “With approximately 5 million cataract surgeries and more than 8 million intravitreal injections performed each year in the U.S., we believe that IHEEZO’s receipt of both a permanent J‑Code, which we announced on February 2, 2023, and now, pass‑through reimbursement status, will contribute to greater patient access to this important new treatment to anesthetize the eye. We remain on track for the commercial launch of IHEEZO at the May 2023 American Society of Cataract and Refractive Surgery (ASCRS) meeting in San Diego.”

About IHEEZO™ (chloroprocaine hydrochloride ophthalmic gel) 3%

• IHEEZO is a sterile, single-patient‑use, physician‑administered, ophthalmic gel preparation, containing no preservatives, for ocular surface anesthesia.
• IHEEZO was approved by the FDA on September 26, 2022.
• In a clinical trial of IHEEZO in patients undergoing routine cataract surgery, patients treated with IHEEZO did not require any supplemental treatment to complete the intended surgical procedure.
• IHEEZO represents the first branded ocular surface anesthetic approved for the U.S. market in nearly 14 years.
• IHEEZO is protected by an Orange Book-listed patent that is valid until 2038. 

INDICATIONS AND USAGE

IHEEZO™ is indicated for ocular surface anesthesia.

CONTRAINDICATIONS

IHEEZO™ is contraindicated in patients with a history of hypersensitivity to any component of this preparation.

WARNINGS AND PRECAUTIONS

IHEEZO™ should not be injected or intraocularly administered. Patients should not touch the eye for at least 10 to 20 minutes after using an anesthetic as accidental injuries can occur due to insensitivity of the eye. Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss. Do not touch the dropper tip to any surface as this may contaminate the gel. IHEEZO™ is indicated for administration under the direct supervision of a healthcare provider. IHEEZO™ is not intended for patient self‑administration.

ADVERSE REACTIONS

The most common adverse reaction is mydriasis (approximately 25%).

For additional information about IHEEZO™, including important safety information, please see the Full Prescribing Information on the www.IHEEZO.com website.

About Harrow

Harrow (Nasdaq: HROW) is a leading U.S. eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic prescription therapies that are accessible and affordable. Harrow owns U.S. commercial rights to ten FDA-approved ophthalmic pharmaceutical products. Harrow also owns and operates ImprimisRx, the leading U.S. ophthalmic‑focused pharmaceutical compounding business, which also serves as a mail‑order pharmacy licensed to ship prescription medications in all 50 states. Harrow has non‑controlling equity positions in Surface Ophthalmics, Inc. and Melt Pharmaceuticals, Inc., companies that began as subsidiaries of Harrow. Harrow also owns royalty rights in four late‑stage drug candidates being developed by Surface and Melt.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include the continued impact of the COVID-19 pandemic and any future health epidemics on our financial condition, liquidity and results of operations; our ability to make commercially available our FDA-approved products and compounded formulations and technologies in a timely manner or at all; market acceptance of the Company’s products and challenges related to the marketing of the Company’s products; risks related to our pharmacy operations; our ability to enter into other strategic alliances, including arrangements with pharmacies, physicians and healthcare organizations for the development and distribution of our products; our ability to obtain intellectual property protection for our assets; our ability to accurately estimate our expenses and cash burn, and raise additional funds when necessary; risks related to research and development activities; the projected size of the potential market for our technologies and products; unexpected new data, safety and technical issues; regulatory and market developments impacting compounding pharmacies, outsourcing facilities and the pharmaceutical industry; competition; and market conditions. These and additional risks and uncertainties are more fully described in Harrow’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Such documents may be read free of charge on the SEC’s website at www.sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230313005255/en/

Investors

Jamie Webb

Director of Communications and Investor Relations

[email protected]

615-733-4737

Media

Deb Holliday

Holliday Communications, Inc.

[email protected]

412-877-4519

KEYWORDS: United States North America Tennessee

INDUSTRY KEYWORDS: Biotechnology Pharmaceutical Optical Health

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Electra Produces Lithium from Battery Recycling Trial, Significantly Improving its Project Economics

TORONTO–(BUSINESS WIRE)–Electra Battery Materials Corporation (NASDAQ: ELBM; TSX-V: ELBM) (“Electra”, or the “Company”) announced today that it has successfully recovered lithium, a critical mineral needed for the electric vehicle (EV) battery supply chain, in its black mass recycling trial being conducted at its refinery north of Toronto. The recovery and subsequent production of a technical-grade lithium carbonate product in a plant-scale setting validates Electra’s proprietary hydrometallurgical process and efforts to date in commissioning its larger refinery complex.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230313005237/en/

“Recovering lithium from black mass represents a potential game changer for Electra and the North American EV supply chain,” said Trent Mell, CEO of Electra Battery Materials. “Recycling lithium from expired batteries through hydrometallurgy lowers the carbon footprint of manufacturing electric vehicles and represents an important source of future supply for a commodity whose demand is expected to grow significantly in the coming years. From Electra’s perspective, it considerably strengthens the economics of our battery recycling strategy by providing another high-value product we can sell.”

Mr. Mell added, “Successfully demonstrating our lithium recovery process in a plant-scale environment supports our plans to commercialize our process with our industry partners and is a testament to efforts of Electra’s technical team.”

“Our refinery team, combined with our consulting engineering partners, achieved a significant milestone in proving up our hydrometallurgical process for treating black mass,” said Mark Trevisiol, Electra’s Vice President of Project Development. “We achieved these outstanding results in less than two years, going from bench-scale laboratory testing to plant scale production.”

Black mass is the industry term used to describe the material remaining once expired lithium-ion batteries are shredded and all casings removed. Black mass contains high-value elements, including lithium, nickel, cobalt, manganese, copper, and graphite, that once recovered, can be recycled to produce new lithium-ion batteries.

Established North American battery recyclers have focused on collecting and shredding of batteries with the resulting black mass material primarily treated by a pyrometallurgical smelting process that has a higher carbon footprint and lower metal recoveries than hydrometallurgical processes.

Recycling black mass will increasingly become a key feature of the EV battery supply chain given the strong demand for critical minerals and the looming supply deficit of metals such as nickel and cobalt. According to data from McKinsey & Company, available battery material for recycling is expected to grow by 20% per year through 2040.

Electra launched its black mass demonstration plant at the end of December 2022, and has processed material in a batch mode, successfully extracting lithium, nickel, cobalt, manganese, copper, and graphite.

As disclosed previously, Electra has decided to extend its black mass processing and recovery activities through June 2023, beyond the Company’s initial target of 75 tonnes, as a result of preliminary results achieved to date and interest expressed by potential commercial partners.