Market Newsdesk

BOCA RATON, Fla., Oct. 09, 2023 (GLOBE NEWSWIRE) — Sensus Healthcare, Inc. (Nasdaq: SRTS), a medical device company specializing in highly effective, non-invasive, minimally-invasive and cost-effective treatments for oncological and non-oncological conditions, announces that management will deliver a company presentation and hold investor meetings at the Roth MKM 2023 Healthcare Opportunities Conference being held October 12, 2023 in New York City. Sensus management will also participate in the 43^rd Annual Fall Clinical Dermatology Conference being held October 19-22, 2023 at the Wynn Hotel in Las Vegas.

Joe Sardano, chairman and chief executive officer of Sensus Healthcare, will deliver a 10-minute presentation at 11:15 a.m. Eastern time at the Yale Club. The presentation will not be webcast. Management will also be available for one-on-one meetings at the conference. To request a meeting with Sensus Healthcare management, please contact your Roth MKM representative or Kim Golodetz at LHA Investor Relations at [email protected].

Sensus will showcase its advancements in superficial radiotherapy at the 43^rd Annual Fall Clinical Dermatology Conference, while demonstrating its SRT-100™, SRT-100+™, SRT-100 Vision™ with IG-SRT, using the latest ultrasound technology for accurate visualization of the dermis, and Sentinel™, its proprietary IT Solutions product.

Sensus Healthcare’s devices utilize the Multi-Dimensional Superficial Radiotherapy platform, which provides an alternative low-energy X-ray treatment for various types of non-melanoma skin cancer and keloids. Designed to deliver effective and safe radiotherapy, SRT offers patients a non-surgical, painless and cosmetically appealing treatment option. By enabling seamless integration with existing healthcare systems, Sensus Healthcare’s solutions ensure enhanced flexibility and convenience for healthcare providers.

Fall Clinical participants are invited to visit Sensus Healthcare at the Wynn Hotel to witness live product demonstrations and interact with the company’s knowledgeable representatives. To schedule an appointment or for more information about Sensus Healthcare’s participation, please contact Sensus Healthcare by visiting www.sensushealthcare.com.

About Sensus Healthcare

Sensus Healthcare, Inc. is a global pioneer in the development and delivery of non-invasive treatments for skin cancer and keloids. Leveraging its cutting-edge superficial radiotherapy (SRT) technology, the company provides healthcare providers with a highly effective, patient-centric treatment platform. With a dedication to driving innovation in radiation oncology, Sensus Healthcare offers solutions that are safe, precise, and adaptable to a variety of clinical settings. For more information, please visit www.sensushealthcare.com.

Forward-Looking Statements

This press release includes statements that are, or may be deemed, ”forward-looking statements.” In some cases, these statements can be identified by the use of forward-looking terminology such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately,” “potential” or negative or other variations of those terms or comparable terminology, although not all forward-looking statements contain these words.

Forward-looking statements involve risks and uncertainties because they relate to events, developments, and circumstances relating to Sensus, our industry, and/or general economic or other conditions that may or may not occur in the future or may occur on longer or shorter timelines or to a greater or lesser degree than anticipated. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward looking statements contained in this press release, as a result of the following factors, among others: our ability to return to profitability; our ability to sell the number of SRT units we anticipate for the balance of 2023; the possibility that inflationary pressures continue to impact our sales; our ability to obtain and maintain the intellectual property needed to adequately protect our products, and our ability to avoid infringing or otherwise violating the intellectual property rights of third parties; the level and availability of government and/or third party payor reimbursement for clinical procedures using our products, and the willingness of healthcare providers to purchase our products if the level of reimbursement declines; the regulatory requirements applicable to us and our competitors; our ability to efficiently manage our manufacturing processes and costs; the risks arising from doing business in China and other foreign countries; legislation, regulation, or other governmental action that affects our products, taxes, international trade regulation, or other aspects of our business; concentration of our customers in the U.S. and China, including the concentration of sales to one particular customer in the U.S.; and other risks described from time to time in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.

To date, we do not expect that the Russian invasion of Ukraine and global geopolitical uncertainty have not had any particular impact on our business, but we continue to monitor developments and will address them in future disclosures, if applicable.

In addition, even if future events, developments, and circumstances are consistent with the forward-looking statements contained in this press release, they may not be predictive of results or developments in future periods. Any forward-looking statements that we make in this press release speak only as of the date of such statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of this press release, except as may be required by applicable law. You should read carefully our “Introductory Note Regarding Forward-Looking Information” and the factors described in the “Risk Factors” section of our periodic reports filed with the Securities and Exchange Commission to better understand the risks and uncertainties inherent in our business.

Contact:

LHA Investor Relations
Kim Sutton Golodetz
212-838-3777
[email protected]

# # #

Company nets $53 million from tax credits generated by negative carbon intensity renewable natural gas investment; additional $800 million of IRA investment and production tax credits expected in the next four years from Aemetis renewable fuel projects

CUPERTINO, Calif., Oct. 09, 2023 (GLOBE NEWSWIRE) — viaNewMediaWire — Aemetis, Inc. (NASDAQ: AMTX), a renewable natural gas and renewable fuels company focused on negative carbon intensity products, announced today the receipt of $53 million of cash, after transaction costs and buyer discount, from the sale of $63 million of Inflation Reduction Act (IRA) investment tax credits generated by its subsidiary, Aemetis Biogas LLC. The tax credits were sold to a corporate purchaser on September 29, 2023, and the payment was received by Aemetis on October 6, 2023.

The IRA was signed into law in August 2022, and provides transferable federal income tax credits for investments in certain renewable fuel projects and products. The IRA Section 48 investment tax credits were generated from biogas projects constructed and brought in service by Aemetis prior to the date of the tax credit sale agreement.

“The $53 million of cash proceeds received by Aemetis achieves the goals of the Inflation Reduction Act by funding methane capture using passive anaerobic biogas digesters at dairies for conversion into RNG transportation fuel as a replacement for petroleum diesel in trucks and other vehicles,” stated Eric McAfee, Chairman and CEO of Aemetis. “In addition, the repayment of high interest rate debt using these funds expands our access to lower cost debt funding. The Aemetis Five Year Plan is expected to qualify for more than $800 million of IRA investment and production tax credits during the next four years to support our biogas projects, CO2 re-use by our ethanol plant, the construction of our sustainable aviation fuel plant and CO2 sequestration.”

The Aemetis ethanol production facility supplies about two million pounds per day of animal feed to more than 80 dairies to feed more than 100,000 dairy cows in the local area. To capture methane at dairies and produce RNG, Aemetis has completed and is operating seven dairy biogas digesters, 33 miles of biogas pipeline, a central biogas to RNG production facility, and a PG&E utility gas pipeline interconnection unit. An additional five digesters are under construction and a total of 37 dairies are under contract.

In addition to the $53 million received from this sale of IRA tax credits, Aemetis invested $30 million of equity and has been awarded $23 million of grants for the Aemetis Biogas Central Dairy Project. The total combined equity, grants and IRA tax credit sales related to the Aemetis Biogas project exceeds $100 million.

In October 2022 and July 2023, Aemetis Biogas closed a total of $50 million of construction and long-term debt financing for dairy digester construction based upon USDA Renewable Energy for America Program (REAP) loan guarantee commitments. An additional $150 million of 20-year, USDA-guaranteed, REAP loan financing is in process, with planned closings during 2023 and 2024.

Aemetis is also building its own RNG fueling station at the Keyes ethanol plant to fuel trucks with locally produced renewable natural gas that provides a 90% reduction in emissions compared to petroleum diesel fuel.

Approximately 25% of methane emissions in California are emitted from dairy waste lagoons. When fully built, the Aemetis Biogas project plans to capture methane from the waste produced by more than 150,000 cows at dairy farms in California and produce 1,650,000 MMBtu of renewable natural gas from captured dairy methane each year. The project is designed to reduce greenhouse gas emissions equivalent to an estimated 6.8 million metric tons of carbon dioxide over ten years, equal to removing the emissions from approximately 150,000 cars per year.

About Aemetis

Headquartered in Cupertino, California, Aemetis is a renewable natural gas, renewable fuel and biochemicals company focused on the acquisition, development and commercialization of innovative technologies that replace petroleum-based products and reduce greenhouse gas emissions. Founded in 2006, Aemetis is expanding a California biogas digester network and pipeline system to convert dairy waste gas into Renewable Natural Gas. Aemetis owns and operates a 65 million gallon per year ethanol production facility in California’s Central Valley near Modesto that supplies about 80 dairies with animal feed. Aemetis also owns and operates a 60 million gallon per year production facility on the East Coast of India producing high quality distilled biodiesel and refined glycerin for customers in India and Europe. Aemetis is developing the Carbon Zero sustainable aviation fuel (SAF) and renewable diesel fuel biorefineries in California to utilize renewable hydrogen, hydroelectric power, and renewable oils to produce low carbon intensity renewable jet and diesel fuel. For additional information about Aemetis, please visit www.aemetis.com.

Safe Harbor Statement

This news release contains forward-looking statements, including statements regarding assumptions, projections, expectations, targets, intentions or beliefs about future events or other statements that are not historical facts. Forward-looking statements in this news release include, without limitation, statements relating to the development, construction and operation of the Aemetis Biogas RNG project, the SAF and renewable diesel plant, and the carbon capture and sequestration wells, as well as our ability to qualify for the receipt and transferability of tax credits under the Inflation Reduction Act, expected greenhouse gas emission reductions from the completed Aemetis Biogas RNG project, the development of biogas upgrading facilities, and our ability to promote, develop and deploy technologies to produce renewable fuels and biochemicals.  Words or phrases such as “anticipates,” “may,” “will,” “should,” “believes,” “estimates,” “expects,” “intends,” “plans,” “predicts,” “projects,” “showing signs,” “targets,” “view,” “will likely result,” “will continue” or similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on current assumptions and predictions and are subject to numerous risks and uncertainties.  Actual results or events could differ materially from those set forth or implied by such forward-looking statements and related assumptions due to certain factors, including, without limitation, competition in the ethanol, biodiesel and other industries in which we operate, commodity market risks including those that may result from current weather conditions, financial market risks, customer adoption, counter-party risks, risks associated with changes to federal policy or regulation, and other risks detailed in our reports filed with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2022, and in our subsequent filings with the SEC. We are not obligated, and do not intend, to update any of these forward-looking statements at any time unless an update is required by applicable securities laws.

External Investor Relations

Contact:

Kirin Smith
PCG Advisory Group
(646) 863-6519
[email protected]

Company Investor Relations/

Media Contact:

Todd Waltz
(408) 213-0940
[email protected]

NOVATO, Calif., Oct. 09, 2023 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that data from its ongoing late-stage program evaluating setrusumab (UX143) in osteogenesis imperfecta (OI) will be presented at the American Society for Bone and Mineral Research 2023 Annual Meeting (ASBMR) October 13-16, 2023, in Vancouver, British Columbia.

Ultragenyx and its collaborators will present late-breaking presentations on new, updated data from the Phase 2 portion of the Phase 2/3 Orbit study evaluating setrusumab on annualized clinical fracture rate in patients aged 5 to <26 years, and data on the burden of fractures for individuals living with OI. The company will also present information on the Phase 3 Cosmic study design comparing setrusumab to intravenous bisphosphonate (IV-BP) in patients aged 2 to <5 years.

Details of the setrusumab presentations are as follows:

Abstract Title: Evaluating Setrusumab for the Treatment of Osteogenesis Imperfecta: Phase 2 Data from the Phase 2/3 ORBIT Study (Lewiecki, E.M. et al.)
Session: Late-breaking poster session I
Session Date and Time: Saturday, Oct 14, 2023, 13:30–15:00 PDT
Presentation Number: LB SAT-650

Abstract Title: Burden of Fractures for Individuals Living with Osteogenesis Imperfecta: Integrating Real-world Claims Data in the United States and Caregiver Panel Interviews (Byers, H. et al.)
Session: Late-breaking poster session I
Session Date and Time: Saturday, Oct 14, 2023, 13:30–15:00 PDT
Presentation Number: LB SAT-648

Abstract Title:
Cosmic: An open-label, randomized, active-controlled, phase 3 study of setrusumab compared with bisphosphonates in pediatric subjects with osteogenesis imperfecta (Krolczyk, S. et al.)
Session: Poster session I
Session Date and Time: Saturday, Oct 14, 2023, 13:30–15:00 PDT
Presentation Number: SAT-500

Ultragenyx is leading the clinical development of setrusumab as part of a collaboration and license agreement with Mereo BioPharma Group plc (NASDAQ: MREO), a clinical-stage biopharmaceutical company focused on rare diseases. The companies previously announced positive data from the dose-selection Phase 2 portion of the Orbit study showing that setrusumab rapidly induced bone production in OI-affected patients.

U.S. residents can learn more by visiting ultraclinicaltrials.com.

About Osteogenesis Imperfecta (OI)

Osteogenesis Imperfecta (OI) includes a group of genetic disorders impacting bone metabolism. Approximately 85% to 90% of OI cases are caused by mutations in the COL1A1 or COL1A2 genes, leading to either reduced or abnormal collagen and changes in bone metabolism. The collagen mutations in OI can result in increased bone brittleness, which contributes to a high rate of fractures, including at atypical sites. Patients with OI also exhibit increased bone resorption (breakdown of old bone) and inadequate production of new bone, which leads to decreased bone mass, bone fragility and weakness. OI can also lead to bone deformities, abnormal spine curvature, pain, decreased mobility, and short stature. No treatments are approved for OI, which affects approximately 60,000 people in the developed world.

About Setrusumab (UX143)

Setrusumab is a fully human monoclonal antibody that inhibits sclerostin, a protein that acts on a key bone-signaling pathway that inhibits the maturation and activity of bone-forming cells. The goal of blocking inhibitory effects of sclerostin is to increase new bone formation, bone mineral density and bone strength. Sclerostin inhibition also reduces excessive bone resorption, further enhancing its impact on bone density. In mouse models of OI, the use of anti-sclerostin antibodies was shown to stimulate bone formation, improve bone mass and density, and increase bone strength against fracture force testing.

Mereo BioPharma’s Phase 2b study (ASTEROID) treatment phase of the dose-finding study of setrusumab for the treatment of OI in 112 adults was concluded in 2019. The ASTEROID study demonstrated treatment with setrusumab resulted in a clear, dose-dependent and statistically significant effect on bone formation and bone density at multiple anatomical sites among adult participants with OI.

Ultragenyx and Mereo BioPharma are collaborating on the development of setrusumab globally. The companies have developed a comprehensive late-stage program to continue development of setrusumab in pediatric and young adult patients across OI sub-types I, III and IV.

About Ultragenyx

Ultragenyx is a biopharmaceutical company committed to bringing novel products to patients for the treatment of serious rare and ultrarare genetic diseases. The company has built a diverse portfolio of approved therapies and product candidates aimed at addressing diseases with high unmet medical need and clear biology for treatment, for which there are typically no approved therapies treating the underlying disease.

The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. Ultragenyx’s strategy is predicated upon time- and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency. For more information on Ultragenyx, please visit ultragenyx.com.

Ultragenyx Forward-Looking Statements and Use of Digital Media

Except for the historical information contained herein, the matters set forth in this press release, including statements related to Ultragenyx’s expectations and projections regarding its future operating results and financial performance, business plans and objectives for UX143, expectations regarding the tolerability and safety of UX143, and future clinical and regulatory developments for UX143 are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, collaboration with third parties, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainty of clinical drug development and unpredictability and lengthy process for obtaining regulatory approvals, the ability of the company and Mereo BioPharma to successfully develop UX143, the company’s ability to achieve its projected development goals in its expected timeframes, risks related to adverse side effects, risks related to reliance on third party partners to conduct certain activities on the company’s behalf, the potential for any license or collaboration agreement, including the company’s collaboration agreement with Mereo to be terminated, smaller than anticipated market opportunities for the company’s products and product candidates, manufacturing risks, competition from other therapies or products, and other matters that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations, the company’s future operating results and financial performance, the timing of clinical trial activities and reporting results from same, and the availability or commercial potential of Ultragenyx’s products and drug candidates. Ultragenyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Ultragenyx in general, see Ultragenyx’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 3, 2023, and its subsequent periodic reports filed with the SEC.

In addition to its SEC filings, press releases and public conference calls, Ultragenyx uses its investor relations website and social media outlets to publish important information about the company, including information that may be deemed material to investors, and to comply with its disclosure obligations under Regulation FD. Financial and other information about Ultragenyx is routinely posted and is accessible on Ultragenyx’s Investor Relations website (

https://ir.ultragenyx.com/

) and LinkedIn website (

https://www.linkedin.com/company/ultragenyx-pharmaceutical-inc-/

).

Contacts

Investors
Josh Higa
[email protected]

Media
Jeff Blake
+1-415-612-7784
[email protected]

First Patient Expected to be Dosed by Year-end 2023; Early Data Expected by Mid-2024

Clinical Study in Chronic Inducible Urticaria Planned to Commence in Early 2024

REDWOOD CITY, Calif., Oct. 09, 2023 (GLOBE NEWSWIRE) — Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a biotechnology company focused on the development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) to address mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), as well as lower to intermediate risk myelodysplastic syndromes (LR-MDS) and novel stem cell transplant conditioning regimens, today announced that its investigational new drug (IND) application for a Phase 1b/2a repeat dose clinical study of subcutaneous briquilimab in the treatment of CSU has been cleared by the U.S. Food and Drug Administration (FDA).

“We’re very excited to be advancing briquilimab into clinical studies for chronic urticaria patients,” said Edwin Tucker, Chief Medical Officer of Jasper. “The clearance to proceed by the FDA for our IND allows us to move quickly to commence our CSU study in patients who are ineligible for, or refractory to, omalizumab, which is a patient population of high unmet need. We expect this dose escalation study to provide proof of concept for the depletion of mast cells by briquilimab as a differentiated mechanism of action in CSU and to help identify optimal doses and dosing regimens for future registrational studies in the broader CSU patient population.”

The Phase 1b/2a study in CSU is a dose escalation study evaluating repeat doses of subcutaneous briquilimab in adult CSU patients who remain symptomatic after treatment with, or who cannot tolerate omalizumab. The study is expected to enroll approximately 40 patients across 6 cohorts and the primary endpoints will be safety and tolerability of briquilimab with secondary endpoints focused on efficacy measures and pharmacokinetics. The study will be conducted at sites in the US and EU and Jasper is expecting to enroll the first patient by the end of 2023 and to be able to report data from early cohorts by mid-2024.

“Clearance of the IND for the CSU study is a critical milestone for Jasper, which represents the first step in building out our pipeline with a focus on treating mast cell diseases with briquilimab,” said Ronald Martell, President and Chief Executive Officer of Jasper. “In parallel with our preparations for the CSU study, the team was also developing a proof of concept study in CIndU to further expand our mast cell franchise. A clinical trial application for the CIndU study has now been filed with the European Medicines Agency and we expect to commence the study in the first quarter of 2024, with an initial data read out targeted as early as year-end 2024.”

About Briquilimab

Briquilimab (formerly JSP191) is a targeted aglycosylated monoclonal antibody that blocks stem cell factor from binding to the cell-surface receptor c-Kit, also known as CD117, thereby inhibiting signaling through the receptor. This inhibition disrupts the critical survival signal, leading to the depletion of the mast cells via apoptosis which removes the underlying source of the inflammatory response in mast cell driven disease such as chronic urticaria. Jasper intends to start clinical studies of briquilimab as a primary treatment in Chronic Spontaneous Urticaria as well as in Chronic Inducible Urticaria. Briquilimab is also currently in clinical studies as a treatment for patients with Low to Intermediate Risk myelodysplastic syndromes (MDS) and as a conditioning agent for cell and gene therapies for rare diseases. To date, briquilimab has a demonstrated efficacy and safety profile in more than 145 dosed participants and healthy volunteers, with clinical outcomes as a conditioning agent in severe combined immunodeficiency (SCID), acute myeloid leukemia (AML), MDS, Fanconi anemia (FA), and sickle cell disease (SCD).

About Jasper

Jasper is a clinical-stage biotechnology company developing briquilimab, a monoclonal antibody targeting c-Kit (CD117) as a therapeutic for chronic mast and stem cell diseases such as chronic urticaria and lower to intermediate risk myelodysplastic syndromes (MDS) and as a conditioning agent for stem cell transplants for rare diseases such as sickle cell disease (SCD), Fanconi anemia (FA) and severe combined immunodeficiency (SCID). To date, briquilimab has a demonstrated efficacy and safety profile in more than 145 dosed participants and healthy volunteers, with clinical outcomes as a conditioning agent in SCID, acute myeloid leukemia (AML), MDS, FA, and SCD. For more information, please visit us at www.jaspertherapeutics.com.

Forward-Looking Statements

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding briquilimab’s potential, the development of briquilimab for CSU, LR-MDS and stem cell transplant conditioning; the Phase 1b/2a repeat dose clinical study of subcutaneous briquilimab in the treatment of CSU, including the expected number of patients to be dosed, the cohorts, the site locations and the primary and secondary endpoints; Jasper’s expectations regarding the results of the study, including the potential to provide proof of concept and help identify optimal doses and dosing regimens for future registrational studies; Jasper’s plans to commence a proof of concept study in CIndU, including the expected timing for commencing the study and the expected timing for the initial data read out; briquilimab’s further development and the strategic direction for briquilimab. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of Jasper and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Many actual events and circumstances are beyond the control of Jasper. These forward-looking statements are subject to a number of risks and uncertainties, including general economic, political and business conditions; the risk that the potential product candidates that Jasper develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; the risk that clinical studies or trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; the risk that Jasper will be unable to successfully market or gain market acceptance of its product candidates; the risk that prior study results may not be replicated; the risk that Jasper’s product candidates may not be beneficial to patients or successfully commercialized; patients’ willingness to try new therapies and the willingness of physicians to prescribe these therapies; the effects of competition on Jasper’s business; the risk that third parties on which Jasper depends for laboratory, clinical development, manufacturing and other critical services will fail to perform satisfactorily; the risk that Jasper’s business, operations, clinical development plans and timelines, and supply chain could be adversely affected by the effects of health epidemics; the risk that Jasper will be unable to obtain and maintain sufficient intellectual property protection for its investigational products or will infringe the intellectual property protection of others; and other risks and uncertainties indicated from time to time in Jasper’s filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2022 and any subsequent Quarterly Reports on Form 10-Q. If any of these risks materialize or Jasper’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While Jasper may elect to update these forward-looking statements at some point in the future, Jasper specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Jasper’s assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Contacts:

John Mullaly (investors)
LifeSci Advisors
617-429-3548
[email protected]

Herb Cross (investors)
Jasper Therapeutics
408-621-5925
[email protected]

Lauren Barbiero (media)
Real Chemistry
646-564-2156
[email protected]

THE WOODLANDS, Texas, Oct. 09, 2023 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that Tom Garner is joining the company as senior vice president and chief commercial officer, effective October 9, 2023.

Mr. Garner has over 25 years of pharmaceutical industry experience, having started his career in the United Kingdom with roles of increasing seniority at Boehringer Ingelheim and Eli Lilly before joining Bristol Myers Squibb (BMS) in 2002. During his time at BMS, Mr. Garner held a broad array of roles throughout BMS’ commercial organization including positions at local, country, and global levels, and across a diverse range of brands and therapeutic areas. In his most recent role, Mr. Garner was the senior vice president and head of the U.S. Cardiovascular and Established Brands business unit, the single largest business unit across the BMS enterprise with reported total revenues in excess of $10 billion. In this role, he had overarching responsibility for several key brands including ELIQUIS^® (apixaban), the most prescribed oral, branded medicine in the United States, and CAMZYOS^® (mavacamten), BMS’ first-in-class treatment for obstructive hypertrophic cardiomyopathy. In addition, he also held responsibility for BMS’ established brands portfolio, which includes medicines such as ABRAXANE^® (paclitaxel) and NULOJIX^® (belatacept). Prior to this role, Mr. Garner was the global commercial lead for BMS’ lung and head and neck cancer programs, where he led the successful 1L NSCLC global launches of OPDIVO^® (nivolumab) and YERVOY^® (ipilimumab). Before moving to the United States in 2015, Mr. Garner was the General Manager for BMS Denmark, having spent the first 10 years of his career working in different sales, management and marketing positions across the United Kingdom and Ireland.

“We are very excited that Mr. Garner is joining Lexicon as our chief commercial officer,” said Lonnel Coats, Lexicon’s chief executive officer. “His overall breadth and depth of commercial and general management experience, with notable success in the cardiovascular space and leading launches, makes him a particularly valuable addition to our management team as we continue to drive the launch of INPEFA^® (sotagliflozin) for the treatment of heart failure. As the leader of our commercial organization, Mr. Garner will have a critical role in ensuring we are effectively executing on our launch strategy for INPEFA and delivering against the promise we believe this differentiated brand can have for patients.”

“I am very enthusiastic about joining the Lexicon leadership team and leading the commercial organization. I’m particularly excited to leverage my expertise for the ongoing launch of INPEFA,” said Mr. Garner. “My vision for the brand and the clear commercial potential for INPEFA, coupled with the potential opportunity to bring LX9211 to market for diabetic peripheral neuropathic pain following late-stage clinical development, is what attracted me to Lexicon, and I cannot wait to step into this role and get started.”

Mr. Garner holds a BSc (Hons) degree in International Business Management from the Royal Agricultural University (UK) and a certification in General Management from INSEAD (France).

About Lexicon Pharmaceuticals

Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through its Genome5000™ program, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat diseases safely and effectively. Lexicon has advanced multiple medicines to market and has a pipeline of promising drug candidates in heart failure, neuropathic pain, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com.

About INPEFA

^®

(sotagliflozin)

Discovered using Lexicon’s unique approach to gene science, INPEFA^® (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose reabsorption by the kidney and SGLT1 is responsible for glucose absorption in the gastrointestinal tract. INPEFA has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients.

INDICATION

INPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with:

• heart failure or
• type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors

IMPORTANT SAFETY INFORMATION

Dosing: Assess renal function and volume status and, if necessary, correct volume depletion prior to initiation of INPEFA. INPEFA dosing for patients with decompensated heart failure may begin when patients are hemodynamically stable, including when hospitalized or immediately upon discharge.

Contraindications: INPEFA is contraindicated in patients with hypersensitivity to any component.

Warnings and Precautions:

Ketoacidosis: INPEFA increases the risk of ketoacidosis in patients with type 1 diabetes mellitus (T1DM). Type 2 diabetes mellitus (T2DM) and pancreatic disorders are also risk factors. The risk of ketoacidosis may be greater with higher doses. There have been postmarketing reports of fatal events of ketoacidosis in patients with type 2 diabetes using sodium glucose transporter 2 (SGLT2) inhibitors. Before initiating INPEFA, assess risk factors for ketoacidosis. Consider ketone monitoring in patients with T1DM and consider ketone monitoring in others at risk for ketoacidosis, and educate patients on the signs/symptoms of ketoacidosis. Patients receiving INPEFA may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis.

Assess patients who present with signs and symptoms of metabolic acidosis or ketoacidosis, regardless of blood glucose level. If suspected, discontinue INPEFA, evaluate, and treat promptly. Monitor patients for resolution of ketoacidosis before restarting INPEFA.

Volume Depletion: INPEFA can cause intravascular volume depletion which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine. There have been post-marketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients with type 2 diabetes mellitus receiving SGLT2 inhibitors. Patients with impaired renal function (eGFR < 60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics may be at increased risk for volume depletion or hypotension. Before initiating INPEFA in patients with one or more of these characteristics, assess volume status and renal function, and monitor for signs and symptoms of hypotension during therapy.

Urosepsis and Pyelonephritis: Treatment with SGLT2 inhibitors, including INPEFA, increases the risk for urinary tract infections. Serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization have been reported. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly.

Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues: Insulin and insulin secretagogues are known to cause hypoglycemia. INPEFA may increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue. Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used with INPEFA.

Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Reports of Fournier’s Gangrene, a rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention, have been identified in post-marketing surveillance in patients with diabetes mellitus receiving SGLT2 inhibitors. Assess patients who present with pain, tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, start treatment immediately with broad-spectrum antibiotics and, if necessary, surgical debridement. Discontinue INPEFA, closely monitor patient signs and symptoms, and provide appropriate alternative therapy for heart failure.

Genital Mycotic Infections: INPEFA increases the risk of genital mycotic infections. Monitor and treat as appropriate.

Urinary Glucose Test and 1,5-anhydroglucitol (1,5-AG) Assay: these are not reliable for patients taking SGLT2 inhibitors. Use alternative testing methods to monitor glucose levels.

Common Adverse Reactions: the most commonly reported adverse reactions (incidence ≥ 5%) were urinary tract infection, volume depletion, diarrhea, and hypoglycemia.

Drug Interactions:

• Digoxin: Monitor patients appropriately as there is an increase in the exposure of digoxin when coadministered with INPEFA 400 mg.
• Uridine 5′-diphospho-glucuronosyltransferase (UGT) Inducer: The coadministration of rifampicin, an inducer of UGTs, with sotagliflozin resulted in a decrease in the exposure of sotagliflozin.
• Lithium: Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Monitor serum lithium concentration more frequently during INPEFA initiation and with dosage changes.

Use in Specific Populations:

• Pregnancy and Lactation: INPEFA is not recommended during the second and third trimesters of pregnancy, nor while breastfeeding.
• Geriatric Use: No INPEFA dosage change is recommended based on age. No overall differences in efficacy were detected between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be at increased risk for volume depletion adverse reactions, including hypotension.
• Renal Impairment: INPEFA was evaluated in patients with chronic kidney disease (eGFR 25 to 60 mL/min/1.73 m²) and in patients with heart failure with eGFR <60 mL/min/1.73 m². The safety profile of INPEFA across eGFR subgroups in these studies was consistent with the known safety profile. There was an increase in volume-related adverse events (e.g., hypotension, dizziness) in patients with eGFR <30 mL/min/1.73m² relative to the overall safety population. Efficacy and safety studies with INPEFA did not enroll patients with an eGFR less than 25 mL/min/1.73 m2 or on dialysis. After starting therapy in the studies, patients were discontinued if eGFR fell below 15 mL/min/1.73 m2 or were initiated on chronic dialysis.
• Hepatic Impairment: INPEFA is not recommended in patients with moderate or severe hepatic impairment.

Click here for full Prescribing Information.

About LX9211

Discovered using Lexicon’s unique approach to gene science, LX9211 is a potent, orally delivered, selective, investigational small molecule inhibitor of adaptor-associated kinase 1 (AAK1). Lexicon identified AAK1 in its target discovery efforts as a promising approach for the treatment of neuropathic pain and identified LX9211 and another development candidate in a neuroscience drug discovery alliance with Bristol-Myers Squibb from which Lexicon holds exclusive development and commercialization rights. Preclinical studies of LX9211 demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways. LX9211 has received Fast Track designation from the U.S. Food and Drug Administration for development in diabetic peripheral neuropathic pain.

Safe Harbor Statement

This press release contains “forward-looking statements,” including statements relating to the therapeutic and commercial potential, research and clinical development and regulatory status of INPEFA

^®

(sotagliflozin). In addition, this press release also contains forward looking statements relating to Lexicon’s financial position and long-term outlook on its business, growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize INPEFA in heart failure on the timeline and/or at the prices currently contemplated or at all, conduct preclinical and clinical development and obtain necessary regulatory approvals of INPEFA (in other indications), LX9211 and its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2022 and other subsequent disclosure documents filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

CAMZYOS^®, ABRAXANE^®, NULOJIX^®, OPDIVO^® and YERVOY^® are registered trademarks of Bristol-Myers Squibb.

For Investor Inquiries:
Investor Relations
Lexicon Pharmaceuticals, Inc.
[email protected]

For Media Inquiries:
Alina Cocuzza
Lexicon Pharmaceuticals, Inc.
[email protected]

NEW YORK, Oct. 09, 2023 (GLOBE NEWSWIRE) — Inspired Entertainment, Inc. (“Inspired” or the “Company”) (NASDAQ: INSE), a leading B2B provider of gaming content, technology, hardware and services, is excited to showcase its robust portfolio of sporting licenses and differentiated cross-platform content at this year’s Global Gaming Expo (“G2E”) at the Venetian in Las Vegas, Nevada from October 10-13. The Company will be featuring its suite of entertaining content at Booth #4216. This year we are proud to unveil our first-ever NFL-themed Virtual Sports offering, V-Play NFL. With Inspired sublicensed through Aristocrat Gaming, V-Play NFL is an officially licensed product of the National Football League (NFL), giving football enthusiasts an exciting and unique way to interact with their favorite NFL teams.

In addition to our Virtual Sports offerings, Inspired is proud to unveil a revolutionary new product category at G2E, Hybrid Dealer^®. This unique product offers players branded table and gameshow content for online play, eliminating the challenges of live-dealer products. Hybrid Dealer game outcomes require no physical studios; instead, they are RNG-generated. It seamlessly blends physical and digital elements in a way that offers operators unlimited branding and customizable possibilities that are unique from game to game. The scheduled action continues 24/7, with hosts rotating regularly to keep players engaged. Hybrid Dealer’s technology allows us to develop and customize games quickly and cost-effectively for individual clients. It is a game-changing solution for operators seeking unprecedented flexibility.

Inspired is also excited to offer a new product feature that will bring winning benefits to players, operators and venues in the Illinois VGT market: a promotional leaderboard, tied to the much-anticipated launch of our Space Invaders game. Inspired’s leaderboard is designed to enhance players’ gaming experience by making it more interactive. Route venues can use leaderboards to introduce competitive and promotional elements to gameplay, adding a new dimension that evokes the familiarity and nostalgia of traditional leaderboard tables.

Inspired’s latest must-have mechanics for its Gaming and iGaming games will be on display at G2E as well, including:

• Fortune Spins, which lets players replace standard base game spins with a selection of new game modes, featuring such enhancements as removing symbols for increased bonus chances or playing a subset of the standard base game, paying only a single symbol, mini or full bonus round
• Fortune Bet, which features a variety of game enhancements for a premium cost, including improving players’ chances of triggering a bonus
• Bonus Buy, which lets players purchase direct entry into the bonus by wagering a specific stake multiplier to guarantee bonus entry on their next spin.
• Gamble to Bonus, which allows players to risk their base game wins to win more cash or risk to trigger a bonus round.
• Win & Spin Bonus, which awards players with three lives that recharge every time the Win Symbol lands, and rewards a big win once a full screen of Win & Spin symbols is achieved

Inspired is constantly pushing the bounds of creativity and innovation in the gaming industry, and its latest offerings are sure to impress players and operators alike. Please visit Inspired’s G2E booth to experience the strength and breadth of the product offerings that make Inspired “Winning Entertainment.”

About Inspired Entertainment, Inc.

Inspired offers an expanding portfolio of content, technology, hardware and services for regulated gaming, betting, lottery, social and leisure operators across land-based and mobile channels around the world. Inspired’s gaming, Virtual Sports, interactive and leisure products appeal to a wide variety of players, creating new opportunities for operators to grow their revenue. Inspired operates in approximately 35 jurisdictions worldwide, supplying gaming systems with associated terminals and content for approximately 50,000 gaming machines located in betting shops, pubs, gaming halls and other route operations; virtual sports products through more than 32,000 retail venues and various online websites; digital games for 170+ websites; and a variety of amusement entertainment solutions with a total installed base of more than 16,000 terminals.

Additional information can be found at www.inseinc.com.

Forward-Looking Statements

This news release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “expect,” “estimate,” “plan,” “will,” “would” and “project” and other similar expressions that indicate future events or trends or are not statements of historical matters. These statements are based on Inspired’s management’s current expectations and beliefs, as well as a number of assumptions concerning future events.

Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside of Inspired’s control and all of which could cause actual results to differ materially from the results discussed in the forward-looking statements. Accordingly, forward-looking statements should not be relied upon as representing Inspired’s views as of any subsequent date and Inspired does not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as required by law. You are advised to review carefully the “Risk Factors” section of Inspired’s annual report on Form 10-K for the fiscal year ended December 31, 2022, and in subsequent quarterly reports on Form 10-Q, which are available, free of charge, on the U.S. Securities and Exchange Commission’s website at www.sec.gov and on Inspired’s website at www.inseinc.com.

Contacts:

Investor Relations

[email protected]

+1 646 277 1285

For Press and Sales

[email protected]

www.inseinc.com

@Inspired_News

• 53.3% of patients who received a single dose of 750mg IV imsidolimab achieved GPPPGA 0/1 (clear or almost clear) at Week 4 (primary endpoint), compared to 13.3% of patients on placebo (p=0.0131)
• Demonstrated favorable safety and tolerability with no SAEs, low incidence and no increase of infections vs. placebo and no cases of DRESS or Guillain-Barre in imsidolimab-treated patients
• Only one of 30 (3.3%) imsidolimab-treated patients had detectable ADA, which were non-neutralizing
• Plan to present comprehensive data from GEMINI-1 and top-line GEMINI-2 results at a medical meeting in H2 2024
• Intend to out-license imsidolimab in 2024

SAN DIEGO, Oct. 09, 2023 (GLOBE NEWSWIRE) — AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today announced positive top-line results from its global Phase 3 GEMINI-1 trial evaluating the safety and efficacy of imsidolimab (IL-36R mAb) in patients with generalized pustular psoriasis (GPP) flares. Investigational imsidolimab met its primary endpoint in the study population achieving rapid clearance of pustulation, erythema and scaling through Week 4 after a single dose of 750mg IV imsidolimab. Top-line data also demonstrate a favorable safety and tolerability profile.

“The success of the GEMINI-1 trial highlights Anaptys’ commitment to patients and our ability to internally discover and develop differentiated antibodies,” said Daniel Faga, president and chief executive officer of Anaptys. “Moving forward, we intend to out-license imsidolimab with this compelling and competitive dataset to bring this therapy to patients living with this highly morbid condition and reallocate the potential proceeds of a transaction to further invest in the broad development of our best-in-class immune cell modulators, including our checkpoint agonists, in autoimmune and inflammatory diseases.”

Imsidolimab is an IgG4 antibody that inhibits the function of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system shown to be involved in the pathogenesis of inflammatory diseases, including GPP. The registration-enabling GEMINI-1 trial in GPP, which recruited 45 patients, is the first randomized, double-blind, placebo-controlled trial to use the composite endpoint of Generalized Pustular Psoriasis Physician Global Assessment (GPPPGA) at Week 4 as its primary assessment. The GPPPGA assessment, representing a stringent and comprehensive characterization of disease severity, required satisfying an overall clinical response score of 0/1 (clear or almost clear) collectively across each GPP disease attribute, including pustulation, erythema and scaling.

“GPP is an unpredictable and potentially life-threatening skin disease with systemic symptoms,” said Professor Hervé Bachelez, M.D., Ph.D., Hôpital Saint-Louis, Paris, one of the world’s leading experts on GPP. “Achieving positive top-line results utilizing the GPPPGA composite endpoint in this well conducted, randomized controlled, global trial, along with a compelling safety profile, represents the potential for a single dose of imsidolimab to predictably provide relief for patients living with this burdensome disease.”

Imsidolimab Met Primary Endpoint Achieving Rapid Clearance of GPP Through Week 4 After a Single Dose

53.3% of patients who received a single dose of 750mg IV imsidolimab achieved GPPPGA 0/1 (clear or almost clear) at Week 4 (primary endpoint), compared to 13.3% of patients on placebo (p=0.0131).

Additionally, 66.7% (10/15) of placebo patients exited GEMINI-1 early, crossed-over to GEMINI-2 and were eligible to receive rescue therapy with a single dose of 750mg IV imsidolimab.

Imsidolimab Was Well Tolerated Through End of Study

• All AEs reported in imsidolimab-treated patients were mild or moderate and balanced across imsidolimab-treated vs. placebo patients
• No SAEs or severe AEs reported in imsidolimab-treated patients
• No cases reported of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) or Guillain-Barre syndrome (GBS)
• Low incidence and no elevation of infections vs. placebo
• No infusion reactions reported
• One of 30 (3.3%) imsidolimab-treated patients had detectable anti-drug antibodies, which were non-neutralizing

Anaptys plans to present comprehensive data from GEMINI-1 and top-line GEMINI-2 results at a medical meeting in H2 2024. Furthermore, the company anticipates filing a biologics license application (BLA) with the U.S. Food and Drug Administration (FDA) by Q3 2024.

“We are excited that these top-line results from the Phase 3 GEMINI-1 trial support that a single infusion of imsidolimab is efficacious and well tolerated,” said Paul Lizzul, M.D., Ph.D., chief medical officer of Anaptys. “We would like to thank the patients, investigators and study personnel for their participation in this trial. We look forward to engaging with FDA and plan to submit a BLA by Q3 2024.”

GEMINI-1 Trial Design and Patient Demographics

Anaptys’ Phase 3 registration-enabling GEMINI-1 clinical trial was a four week, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of imsidolimab (IL-36R) in patients with GPP, irrespective of mutational status.

A total of 45 patients, 15 patients per arm, were enrolled across diverse global regions ranging from the U.S., EU, MENA, and Asia. Patients were randomized 1:1:1 to receive a single infusion of 750mg IV imsidolimab, 300mg IV imsidolimab or placebo at Day 0. Placebo patients who were worsening or not improved after Day 8 were eligible for rescue therapy and crossover into the GEMINI-2 Phase 3 trial where they received a single infusion of 750mg IV imsidolimab.

GEMINI-2 Trial Design

Patients who were rescued or completed the GEMINI-1 trial are subsequently being enrolled in GEMINI-2, the second Phase 3 trial for imsidolimab in GPP, where they are receiving monthly doses of 200mg subcutaneous imsidolimab or placebo depending upon whether they are responders, partial responders or non-responders to treatment under GEMINI-1.

The objective of the ongoing GEMINI-2 trial is to assess the efficacy and safety of imsidolimab for the prevention and/or reduction in severity of recurrent GPP flares when dosed chronically as a monthly subcutaneous dosing over a three-year period.

About imsidolimab (IL-36R) and GPP

Imsidolimab is a fully humanized IgG4 antibody that inhibits the function of the interleukin-36-receptor, or IL-36R, that is being developed for the treatment of GPP.

GPP is a rare, chronic, systemic autoinflammatory disease that is potentially life-threatening, if left untreated.

During a GPP flare, individuals experience the sudden eruption of painful pustules. These pustules appear over large areas of the skin, accompanied by redness, severe itchiness, and dry, cracked, or scaly skin. People with GPP may also experience more general symptoms such as fever, headache, extreme tiredness, or a burning sensation on the skin.

About Anaptys

Anaptys is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics. It is developing immune cell modulators, including two checkpoint agonists in clinical-stage development, for autoimmune and inflammatory disease: rosnilimab, its PD-1 agonist, in a Phase 2b trial for the treatment of moderate-to-severe rheumatoid arthritis; and ANB032, its BTLA agonist, in a Phase 2b trial for the treatment of moderate-to-severe atopic dermatitis. Its preclinical immune cell modulator portfolio includes ANB033, an anti-CD122 antagonist antibody for the treatment of autoimmune and inflammatory diseases. In addition, Anaptys has developed two cytokine antagonists available for out-licensing: imsidolimab, an anti-IL-36R antagonist, in Phase 3 for the treatment of generalized pustular psoriasis, or GPP, and etokimab, an anti-IL-33 antagonist for the treatment of respiratory disorders that is Phase 2/3 ready. Anaptys has also discovered multiple therapeutic antibodies licensed to GSK in a financial collaboration for immune-oncology, including an anti-PD-1 antagonist antibody (Jemperli (dostarlimab-gxly)), an anti-TIM-3 antagonist antibody (cobolimab, GSK4069889) and an anti-LAG-3 antagonist antibody (GSK4074386).

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of the release of data from the Company’s clinical trials, including imsidolimab’s Phase 3 GEMINI-2 clinical trial in GPP; the timing of GEMINI-1 and GEMINI-2 clinical trial data to be presented at a medical meeting; the timing of a BLA filing for imsidolimab; whether any of the Company’s product candidates will be best in class; the company’s ability to find a licensing partner for imsidolimab or etokimab and the timing of any such transaction. Statements including words such as “plan,” “intend,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

Contact:

Nick Montemarano
Senior Director, Investor Relations and Strategic Communications
858.732.0178
[email protected]

 

Nanjing, China, Oct. 09, 2023 (GLOBE NEWSWIRE) — Ostin Technology Group Co., Ltd. (the “Company”) (Nasdaq: OST), a supplier of display modules and polarizers in China, today announced it has secured new purchase orders of nearly 5,000 “21.5-inch module” treadmill screen products from a leading fitness equipment manufacturer in China. The Company also unveiled the grand opening of its flagship Douyin store. This exciting launch unveils the M4 and GT8-PRO smartwatches, now available for purchase online.

Recognizing the extraordinary influence and widespread appeal of Chinese short-video platforms, the Company is harnessing the power of live streaming, dedicated fan communities, and compelling social media advertising to amplify sales. In addition to Douyin, the Company expects to captivate audiences and drive sales momentum by showcasing its remarkable smartwatches on other prominent platforms like Kuaishou (Kwai) and WeChat Channel within the year.

The M4 and GT8-PRO smartwatches unleash a plethora of advanced health and fitness tracking features, empowering users to elevate their well-being to new heights. With exercise reminders, sleep tracking tools, built-in GPS, voice assistants, and seamless integration with popular mobile applications like Alipay, these smartwatches offer a comprehensive and intuitive user experience.

Mr. Tao Ling, Chairman and CEO of the Company, commented: “We are so excited to open our first flagship store on short-video live streaming platform and unveil our smartwatch products. Our new smartwatch products signify our milestone in wearable technology. With their exceptional features, sleek design, and user-friendly interface, we are confident that customers will embrace these products, propelling our market share to new heights.”

Mr. Ling further emphasized the significance of short video live streaming platforms such as Douyin, WeChat Channel, and Kuaishou (Kwai) in revolutionizing product promotion and sales in China. “We will harness the power of these platforms to engage specific audiences with tailor-made content, immersive interactive features, and establish unwavering trust and influence for the Ostin brand through live streaming, thus bolstering sales and profitability,” added Mr. Ling.

About Ostin Technology Group Co., Ltd.

Founded in 2010, the Company is a supplier of display modules and polarizers in China. The Company designs, develops, and manufactures TFT-LCD display modules in a wide range of sizes and customized sizes which are mainly used in consumer electronics, outdoor LCD displays, and automotive displays. The Company also manufactures polarizers used in the TFT-LCD display modules.

For more information, please visit http://www.austinelec.com/

Forward-Looking Statement

This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, underlying assumptions, and other statements that are other than statements of historical facts. When the Company uses words such as “may, “will, “intend,” “should,” “believe,” “expect,” “anticipate,” “project,” “estimate” or similar expressions that do not relate solely to historical matters, it is making forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties that may cause the actual results to differ materially from the Company’s expectations discussed in the forward-looking statements. These statements are subject to uncertainties and risks including, but not limited to, the following: the Company’s goals and strategies; the Company’s forecast on market trends; the Company’s future business development; the demand for and market acceptance for new smartwatch products; expectation to receive customer orders for new smartwatch products; the anticipated timing for the marketing and sales of new smartwatch products; changes in technology; the Company’s ability to attract and retain skilled professionals; client concentration; and general economic conditions affecting the Company’s industry and assumptions underlying or related to any of the foregoing and other risks contained in reports filed by the Company with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company’s filings with the SEC, which are available for review at www.sec.gov. The Company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof.

For more information, please contact:

Ostin Technology Group Co., Ltd.
[email protected]

Investor Relations:

Janice Wang
Wealth Financial Services LLC
Phone: +86 13811768599 +1 628 283 9214
Email: [email protected]

– Generated Sequential Revenue Growth of
65%
–

– Reaffirms Fiscal
2024
Full-Year Guidance –

– Applied Digital to Host Investor Day on October 12, 2023 –

DALLAS, Oct. 09, 2023 (GLOBE NEWSWIRE) — Applied Digital Corporation (Nasdaq: APLD)(“Applied Digital” or the “Company”), a designer, builder, and operator of next-generation digital infrastructure designed for High-Performance Computing (“HPC”) applications, artificial intelligence cloud services (“Cloud services”), and datacenter hosting (“Hosting”), reported financial results for the fiscal first quarter ended August 31, 2023. The Company also provided forward guidance and an operational update.

Fiscal
First
quarter
2024
Financial and Operational Highlights

• Total revenue of $36.3 million
• Net loss of $9.6 million
• Adjusted EBITDA of $10.0 million
• Adjusted net income from operations of $0.1 million, or adjusted earnings per share of less than $0.01
• Fully energized 180 megawatt (“MW”) hosting facility in Ellendale, ND

Adjusted EBITDA, adjusted net income, and adjusted earnings per share are non-GAAP measures. Reconciliations of adjusted EBITDA, adjusted net income, and adjusted earnings per share to the most directly comparable financial measure presented in accordance with accounting principles generally accepted in the United States (“GAAP”) are set forth in the schedule accompanying this release. See “Reconciliation of GAAP to Non-GAAP Measures.”

Management Commentary

“The first quarter represented a strong start to the fiscal year and continued momentum for Applied Digital as we made meaningful progress across our business,” said Applied Digital Chairman and CEO Wes Cummins. “We are finalizing details for our Garden City facility and have a clear path now to reaching 500 MW across our three hosting facilities. The pipeline of Cloud customer opportunities remains strong and we began deploying GPUs for our first customer in that line of business during the quarter. We remain on schedule with developing additional HPC data center capacity and look forward to signing our first anchor tenant soon.”

“Looking ahead, we remain confident about our growth prospects as a differentiated provider of HPC data center infrastructure. Demand for our services from both traditional customers and emerging HPC applications remains robust, and we remain excited about the year ahead.”

Cloud Service Update

Applied Digital’s Cloud Service, offered through its wholly owned subsidiary Sai Computing, provides high-performance computing power for artificial intelligence and machine learning applications.

The Company has ordered 34,000 GPUs for the Company’s Cloud services business. During the three months ended August 31, 2023, the Company received and deployed an initial production cluster of 1,024 GPUs, and began recognizing revenue on our first cloud services contract.

High-Performance Computing (HPC) Datacenter Hosting Update

Applied Digital’s HPC datacenter business designs, builds and operates next-generation datacenters designed to provide high computing power and support high-compute applications within a cost-effective model. The Company has over 300 MW of capacity in development, including 200 MW in North Dakota and 100 MW in Utah.

Datacenter Hosting Update

The Company’s Ellendale, North Dakota facility was fully energized during the quarter and the Jamestown, North Dakota facility operated at full capacity. The Company’s 200 MW facility in Garden City, Texas is expected to energize during the fourth quarter of calendar year 2023. On September 8, 2023, the Company entered into a facility extension agreement with Oncor Electricity Delivery Company LLC (“Oncor”) for the transmission and metering of power. With this in place, metering and telemetry equipment will be installed onsite by Oncor and once installed, the site will be energized. The installation is expected to be completed by October 23rd.

Financial Results for Fiscal
First
Quarter
2024
Ended
August 31, 2023

Balance Sheet

Applied Digital ended the fiscal quarter with cash, cash equivalents, and restricted cash of $31.2 million and $44.0 million in debt outstanding.

Operating Results

Total revenues in the fiscal first quarter 2024 were $36.3 million, up 425% from the fiscal first quarter 2023. Revenues were attributable to the Company’s operations in Jamestown, North Dakota along with the increase in energized MW capacity at the Ellendale, North Dakota facility, and revenue from the Company’s first Cloud Services contract.

Cost of revenues in the fiscal first quarter 2024 was $24.4 million compared to $6.1 million in the fiscal first quarter 2023. The increase in cost was attributable to higher energy costs used to generate hosting revenues, depreciation, amortization expense, and personnel expenses for employees working on our Jamestown and Ellendale hosting facilities.

Operating expenses for the fiscal first quarter 2024 were $17.1 million. For the fiscal first quarter 2023, operating expenses were $5.0 million, almost all of which were attributable to general and administrative costs.

Net loss for the fiscal first quarter 2024 was $9.6 million, or $(0.10) per basic and diluted share, based on a weighted average share count during the quarter of 100.5 million. This compares to a net loss of $4.7 million, or $(0.05) per basic and diluted share, based on a weighted average share count of 93.1 million for the fiscal first quarter 2023.

Adjusted EBITDA, a non-GAAP measure, for the fiscal first quarter 2024 was $10.0 million compared to an Adjusted EBITDA loss of $1.7 million for the fiscal first quarter 2023.

Adjusted net income attribute to Applied Digital, a non-GAAP measure, for the fiscal first quarter of 2024, was $0.1 million or adjusted net income per basic and diluted share of less than $0.01, based on a weighted average share count during the quarter of approximately 100.5 million. This compares to an adjusted net loss, a non-GAAP measure, attributable to Applied Digital of $3.3 million, or $(0.03) per basic and diluted share, for the fiscal first quarter of 2023 based on a weighted average share count during the quarter of approximately 93.1 million.

Cash Flows

The Company experienced a net decrease in cash, cash equivalents, and restricted cash during the fiscal first quarter 2024 of $12.4 million. The primary drivers of the change were as follows:

• Purchase of property, equipment, and other assets of $32.6 million, driven by construction of the Company’s and HPC hosting datacenters.
• Investments of $0.4 million.
• Finance lease prepayments of $7.6 million and repayment of finance leases of $4.8 million, primarily driven by the Company’s leases of hosting equipment for Cloud services.
• Debt repayments of approximately $42.8 million.

These were partially offset by the following:

• Net cash received from operating activities of $4.5 million, driven by the recurring operations of the business.
• Borrowings of $6.8 million driven by draws on the Company’s 9% loan from B. Riley and funding received from the 6.15% Vantage Garden City Loan
• Net cash received from the issuance of common stock of $64.5 million under the Company’s at-the-market sales agreement.

Guidance

For full-year fiscal 2024, Applied Digital reaffirms its previously announced guidance of total revenue in the range of $385 million – $405 million, and Adjusted EBITDA in the range of $195 million – $205 million.

Investor Day

Applied Digital will host an Investor Day on Thursday, October 12, 2023, in New York, NY. Presentations will be made by Chairman and CEO Wes Cummins, CFO David Rench, and other senior leaders of the Company. The presentations will provide an in-depth overview of Applied Digital’s business, growth strategy, and financial outlook. In-person attendance is by invitation only to institutional investors and analysts. Presentations are expected to begin at 8:30 a.m. ET, and the event is expected to conclude at 12:00 p.m. ET.

Conference Call

Applied Digital will host a conference call today, October 9, 2023, at 9:00 a.m. Eastern Time (6:00 a.m. Pacific Time) to discuss these results. A question-and-answer session will follow the management’s presentation.

To participate, please dial the appropriate number at least ten minutes prior to the start time and ask for the Applied Digital conference call.

U.S. dial-in number: 1-877-407-0792

International number: 1-201-689-8263

Conference ID: 13741431

The conference call will broadcast live and be available for replay here.

Please call the conference telephone number approximately 10 minutes before the start time. An operator will register your name and organization. If you have any difficulty connecting with the conference call, please contact Applied Digital’s investor relations team at 1-949-574-3860.

A replay of the call will be available after 1:00 p.m. Eastern Time October 9, 2023, through October 23, 2023.

Toll-free replay number: 1-844-512-2921

International replay number: 1-412-317-6671

Conference ID: 13741431

About Applied Digital

Applied Digital Corporation (Nasdaq: APLD) designs, develops, and operates next-generation data centers across North America to provide digital infrastructure solutions to the rapidly growing high-performance computing (HPC) industry. Find more information at www.applieddigital.com. Follow us on Twitter at @APLDdigital.

Forward-Looking Statements

This release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, future operating and financial performance, product development, market position, business strategy and objectives. These statements use words, and variations of words, such as “continue,” “build,” “future,” “increase,” “drive,” “believe,” “look,” “ahead,” “confident,” “deliver,” “outlook,” “expect,” and “predict.” Other examples of forward-looking statements may include, but are not limited to, (i) statements of Company plans and objectives, including our evolving business model, or estimates or predictions of actions by suppliers, (ii) statements of future economic performance, and (iii) statements of assumptions underlying other statements and statements about the Company or its business. You are cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events and thus are inherently subject to uncertainty. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the Company’s expectations and projections. These risks, uncertainties, and other factors include: decline in demand for our products and services; the volatility of the crypto asset industry; the inability to comply with developments and changes in regulation; cash flow and access to capital; and maintenance of third party relationships. Information in this release is as of the dates and time periods indicated herein, and the Company does not undertake to update any of the information contained in these materials, except as required by law.

Use and Reconciliation of Non-GAAP Financial Measures

This press release and our related earnings call contain certain non-GAAP financial measures. See below for discussion on each non-GAAP metric.

Adjusted Operating Loss and Adjusted Net Loss

“Adjusted Operating Loss” and “Adjusted Net Loss” are non-GAAP measures that represents operating loss and net loss, respectively, excluding stock-based compensation and nonrecurring expenses. We believe these are useful metrics as they provide additional information regarding factors and trends affecting our business and provide perspective on results absent one-time or significant non-cash items. However, Applied Digital’s presentation of these measures should not be construed as an inference that its future results will be unaffected by unusual or non-recurring items. Applied Digital’s computation of Adjusted Operating Loss and Adjusted Net Loss may not be comparable to other similarly titled measures computed by other companies, because all companies may not calculate Adjusted Operating Loss and Adjusted Net Loss in the same fashion.

Because of these limitations, Adjusted Operating Loss and Adjusted Net Loss should not be considered in isolation or as a substitute for performance measures calculated in accordance with GAAP. Applied Digital compensates for these limitations by relying primarily on its GAAP results and using Adjusted Operating Loss and Adjusted Net Loss on a supplemental basis. You should review the reconciliation of operating loss to Adjusted Operating Loss and net loss to Adjusted Net Loss above and not rely on any single financial measure to evaluate Applied Digital’s business.

EBITDA and Adjusted EBITDA

“EBITDA” is defined as earnings before interest, taxes, and depreciation and amortization. “Adjusted EBITDA” is defined as EBITDA adjusted for stock-based compensation, loss on extinguishment of debt, one-time professional service costs, and other nonrecurring costs. These costs have been adjusted as they are not indicative of business operations. Adjusted EBITDA is intended as a supplemental measure of Applied Digital’s performance that is neither required by, nor presented in accordance with, GAAP. Applied Digital believes that the use of EBITDA and Adjusted EBITDA provides an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing its financial measures with those of comparable companies, which may present similar non-GAAP financial measures to investors. We also believe EBITDA and Adjusted EBITDA are useful metrics to investors because they provide additional information regarding factors and trends affecting our business, which are used in the business planning process to understand expected operating performance, to evaluate results against those expectations, and because of their importance as measures of underlying operating performance, as the primary compensation performance measure under certain programs and plans. However, you should be aware that when evaluating EBITDA and Adjusted EBITDA, Applied Digital may incur future expenses similar to those excluded when calculating these measures. In addition, Applied Digital’s presentation of these measures should not be construed as an inference that its future results will be unaffected by unusual or non-recurring items. Applied Digital’s computation of Adjusted EBITDA may not be comparable to other similarly titled measures computed by other companies, because all companies may not calculate Adjusted EBITDA in the same fashion.

Because of these limitations, EBITDA and Adjusted EBITDA should not be considered in isolation or as a substitute for performance measures calculated in accordance with GAAP. Applied Digital compensates for these limitations by relying primarily on its GAAP results and using EBITDA and Adjusted EBITDA on a supplemental basis. You should review the reconciliation of net loss to EBITDA and Adjusted EBITDA above and not rely on any single financial measure to evaluate Applied Digital’s business.

Investor Relations Contacts

Matt Glover or Alex Kovtun
Gateway Group, Inc.
(949) 574-3860
[email protected]

Media Contact

Brenlyn Motlagh or Diana Jarrah
Gateway Group, Inc.
(949) 899-3135
[email protected]

APPLIED DIGITAL CORPORATION AND SUBSIDIARIES

Condensed Consolidated Balance Sheets (Unaudited)

(In thousands, except share and par value data)

		August 31, 2023				May 31, 2023
ASSETS
Current assets:
Cash and cash equivalents		$	5,942			$	28,999
Restricted cash			25,271				14,575
Accounts receivable			27				82
Prepaid expenses and other current assets			2,308				2,103
Total current assets			33,548				45,759
Property and equipment, net			222,666				195,593
Operating lease right of use assets, net			11,183				1,290
Finance lease right of use assets, net			55,691				14,303
Other assets			26,065				7,012
TOTAL ASSETS		$	349,153			$	263,957
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	16,229			$	6,446
Accrued liabilities			10,443				8,330
Current portion of operating lease liability			1,807				320
Current portion of finance lease liability			23,471				5,722
Current portion of debt			9,163				7,950
Customer deposits			32,559				32,559
Related party customer deposits			3,811				3,811
Deferred revenue			50,863				47,168
Related party deferred revenue			971				1,524
Sales and use tax payable			62				1,630
Total current liabilities			149,379				115,460
Long-term portion of operating lease liability			9,573				1,005
Long-term portion of finance lease liability			25,071				8,334
Long-term debt			34,882				33,222
Long-term related party loan			—				35,257
Other long-term related party liabilities			—				1,000
Total liabilities			218,905				194,278
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.001 par value, 166,666,667 shares authorized, 110,850,885 shares issued and 105,849,157 shares outstanding at August 31, 2023, and 100,927,358 shares issued and 95,925,630 shares outstanding at May 31, 2023			110				101
Treasury stock, 5,001,728 shares at August 31, 2023 and 5,001,728 shares at May 31, 2023, at cost			(62	)			(62	)
Additional paid in capital			240,073				160,194
Accumulated deficit			(109,873	)			(100,716	)
Total stockholders’ equity attributable to Applied Digital Corporation			130,248				59,517
Noncontrolling interest			—				10,162
Total stockholders’ equity including noncontrolling interest			130,248				69,679
TOTAL LIABILITIES AND SHAREHOLDERS’ DEFICIT		$	349,153			$	263,957

APPLIED DIGITAL CORPORATION AND SUBSIDIARIES

Condensed Consolidated Statements of Operations (Unaudited)

(In thousands, except per share data)

	Three Months Ended
	August 31, 2023				August 31, 2022
Revenue:
Hosting revenue	$	29,987			$	4,338
Cloud services revenue		2,152				—
Related party hosting revenue		4,184				2,586
Total revenue		36,323				6,924
Costs and expenses:
Cost of revenues		24,398				6,093
Selling, general and administrative		17,052				5,008
Total costs and expenses		41,450				11,101
Operating loss		(5,127	)			(4,177	)
Interest Expense		2,074				356
Loss on extinguishment of debt		2,353				94
Net loss before income tax expenses		(9,554	)			(4,627	)
Income tax expense		—				32
Net loss		(9,554	)			(4,659	)
Net loss attributable to noncontrolling interest		(397	)			(128	)
Net loss attributable to Applied Digital Corporation	$	(9,157	)		$	(4,531	)
Basic and diluted net (loss) gain per share:
Basic and diluted net loss per share	$	(0.10	)		$	(0.05	)
Basic and diluted weighted average number of shares outstanding		100,521,673				93,105,835

APPLIED DIGITAL CORPORATION AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows (Unaudited)(In thousands)

	Three Months Ended
	August 31, 2023				August 31, 2022
CASH FLOW FROM OPERATING ACTIVITIES
Net loss	$	(9,554	)		$	(4,659	)
Adjustments to reconcile net loss to net cash provided by operating activities:
Depreciation and amortization		7,860				1,136
Stock-based compensation		5,641				579
Deferred income taxes		—				32
Loss on extinguishment of debt		2,353				94
Amortization of debt issuance costs		235				—
Loss on abandonment of assets		173				—
Changes in operating assets and liabilities:
Accounts receivable		55				177
Prepaid expenses and other current assets		(205	)			(164	)
Customer deposits		—				4,042
Related party customer deposits		—				545
Current deferred revenue		3,695				15,316
Current related party deferred revenue		(553	)			—
Accounts payable		205				196
Accrued liabilities		2,113				—
Lease assets and liabilities		39				—
Sales and use tax payable		(1,568	)			—
Other assets		(5,972	)			—
CASH FLOW PROVIDED BY OPERATING ACTIVITIES		4,517				17,294
CASH FLOW FROM INVESTING ACTIVITIES
Purchases of property and equipment and other assets		(32,591	)			(31,673	)
Finance lease prepayments		(7,560	)			—
Purchases of investments		(390	)			—
CASH USED IN INVESTING ACTIVITIES		(40,541	)			(31,673	)
CASH FLOW FROM FINANCING ACTIVITIES
Repayment of finance leases		(4,849	)			(209	)
Borrowings of long-term debt		3,750				15,000
Borrowings of related party debt		3,000				—
Repayments of long-term debt		(3,463	)			(7,488	)
Repayment of related party debt		(39,257	)			—
Payment of deferred financing costs		—				(140	)
Noncontrolling interest contributions		—				1,747
Proceeds from issuance of common stock		64,482				—
CASH FLOW PROVIDED BY FINANCING ACTIVITIES		23,663				8,910
NET DECREASE IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH		(12,361	)			(5,469	)
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH, BEGINNING OF PERIOD		43,574				46,299
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH, END OF PERIOD	$	31,213			$	40,830
						—
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
Interest paid	$	1,839			$	356
SUPPLEMENTAL DISCLOSURE OF NON-CASH ACTIVITIES
Operating right-of-use assets obtained by lease obligation	$	10,272			$	—
Finance right-of-use assets obtained by lease obligation	$	46,952			$	922
Property and equipment in accounts payable	$	6,729			$	8,352
Conversion of non-controlling interest	$	9,765			$	—

APPLIED DIGITAL CORPORATION AND SUBSIDIARIES

Reconciliation of GAAP to Non-GAAP Measures (Unaudited)

(In thousands, except percentage data)

	Three Months Ended
	August 31, 2023				August 31, 2022
Adjusted operating income (loss)
Operating loss (GAAP)	$	(5,127	)		$	(4,177	)
Stock-based compensation		5,641				579
Non-recurring professional service costs		592				408
Other non-recurring expenses		653				200
Adjusted operating income (loss) (Non-GAAP)	$	1,759			$	(2,990	)
Adjusted operating margin		4.8	%		(43.2)%
Adjusted net income (loss)
Net loss attributable to Applied Digital (GAAP)	$	(9,157	)		$	(4,531	)
Stock-based compensation		5,641				579
Loss on extinguishment of debt		2,353				94
Non-recurring professional service costs		592				408
Other non-recurring expenses		653				200
Adjusted net income (loss) attributable to Applied Digital (Non-GAAP)	$	82			$	(3,250	)
Adjusted earnings per share (Non-GAAP)	$	—			$	(0.03	)
EBITDA and Adjusted EBITDA
Net loss attributable to Applied Digital (GAAP)	$	(9,157	)		$	(4,531	)
Interest expense		2,074				356
Income tax benefit (expense)		—				32
Depreciation and amortization		7,860				1,136
EBITDA (Non-GAAP)	$	777			$	(3,007	)
Stock-based compensation		5,641				579
Loss on extinguishment of debt		2,353				94
Non-recurring professional service costs		592				408
Other non-recurring expenses		653				200
Adjusted EBITDA (Non-GAAP)	$	10,016			$	(1,726	)

ELX-02 treatment improved podocyte foot process effacement in all three patients by an average of 60% based on a blinded kidney biopsy analysis by NIPOKA GmbH

Biopsy results support clinical benefit in all three patients as improvement of kidney morphology is consistent with reduction or stabilization of proteinuria during or up to 2 months post completion of dosing

Renowned key opinion leaders recommend continued development following review of clinical and biopsy results

WATERTOWN, Mass., Oct. 09, 2023 (GLOBE NEWSWIRE) — Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX), a leader in ribosomal RNA-targeted genetic therapies for rare diseases, today reported results from an assessment of patient biopsies by NIPOKA GmbH (Nipoka). They have developed a highly accurate method for the quantification of podocyte foot process morphology. These results confirm previously reported positive biopsy results from the proof-of-concept Phase 2 open-label clinical trial (NCT05448755) of ELX-02 for the treatment of Nonsense Mutation Alport syndrome patients. Analysis of formalin-fixed paraffin-embedded (FFPE) biopsy samples by Nipoka show ELX-02 treatment improved podocyte foot process morphology with lower effacement in all three patients at the end of the 8-week study period.

“With this accurate analysis of the patient biopsies and quantification of changes, we now have unequivocal evidence of morphology and clinical improvement in all three Nonsense Mutation Alport patients treated with ELX-02. Improvement in kidney morphology drives clinical benefit in this devastating rare disease,” said Sumit Aggarwal, President and Chief Executive Officer of Eloxx. “We believe that our proteinuria data, during and after treatment, in the context of this improvement in kidney morphology, confirms clinical benefit in all three patients.”

NIPOKA GmbH have developed a Podocyte Exact Morphology Procedure (PEMP) to quantify podocyte foot process morphology accurately and precisely in an unbiased and reproducible manner. PEMP utilizes immunostaining for foot-process specific protein markers followed by 3D-SIM imaging to quantify Filtration Slit Density (FSD) for 15 to 20 glomeruli per sample. FSD is a quantitative measure of the degree of podocyte foot process effacement. Higher FSD correlates with better podocyte health and lower podocyte foot process effacement. Healthy patients have an FSD of approximately 3.0 to 4.0. This analysis has been validated in multiple glomerular diseases.

PEMP analysis confirmed that ELX-02 treatment improved podocyte foot process effacement in all three patients with an average post-treatment increase in FSD of 60% as compared to baseline levels. These findings are also consistent with previous Transmission Electron Micrograph (TEM) image assessments.

Differences in Urine Protein-Creatinine ratio (UPCR) changes across patients during treatment were correlated to severity of disease (lower vs. higher FSD) at baseline. Therefore, improvement in UPCR was assessed both during and 2 months after treatment to evaluate clinical benefit and capture the full effect of the 45-day protein half-life.

Patient	FSD at end of treatment (% change vs. baseline)	Average change in UPCR during treatment vs. baseline	Average change in UPCR 2 months after end of treatment vs baseline	UPCR variability change vs baseline (Standard deviation 2 months after end of treatment vs baseline)
4401 – 01	1.50 (50%)	No change	No Change	-32%
4401 – 02	1.75 (13%)	-49%;	No Change	-46%
4402 – 01	1.73 (118%)	No change	-25%	-68%

As shown in the table above, all patients had proteinuria stabilization (lower variability vs. baseline) or improvement (reduction during or 2-months after treatment). This is consistent with clinical benefit and with the improvement in kidney morphology.

Renowned key opinion leaders have reviewed these data and overwhelmingly believe that they provide strong evidence of the potential of the disease modifying effect of ELX-02 and warrant advancement into a pivotal trial.   

About Nonsense Mutation Alport Syndrome

Nonsense Mutation Alport syndrome is a rare Type IV Collagenopathy characterized by mutations in the genes (COL4A3, COL4A4, and COL4A5) that result in a less than full length (truncated) Type 4 Collagen. This disorder mostly affects children with a median age at diagnosis of 9 to 20 years. It is characterized by rapid and progressive damage to the kidneys, ear and eyes, starting with worsening of kidney morphology to proteinuria and finally kidney failure, hearing loss and eye abnormalities. It is estimated that there are approximately 7,500 patients in the US and 20,000 patients in US, Europe, Japan and China with Nonsense Mutation Alport Syndrome. These patients have no approved treatment options.

About Eloxx Pharmaceuticals

Eloxx Pharmaceuticals, Inc. is engaged in the science of ribosome modulation, leveraging its innovative TURBO-ZM™ chemistry technology platform in an effort to develop novel Ribosome Modulating Agents (RMAs) and its library of Eukaryotic Ribosome Selective Glycosides (ERSGs). Eloxx’s lead investigational product candidate, ELX-02, is a small molecule drug candidate designed to restore production of full-length functional proteins. ELX-02 is in Phase 2 clinical development for the treatment of Alport syndrome in patients with nonsense mutations. For more information, please visit www.eloxxpharma.com.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release, including without limitation, statements regarding the potential of our product candidate to treat Alport syndrome, the Company’s intentions to advance ELX-02 into a global pivotal confirmatory trial for the potential treatment of patients with Alport Syndrome, to advance its clinical study of ZKN-013 and the exploration of strategic alternatives with potential development partners are forward-looking statements. Forward-looking statements can be identified by the words “aim,” “may,” “will,” “would,” “should,” “expect,” “explore,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” “seeks,” or “continue” or the negative of these terms similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections based on information currently available to us. Forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and actual results or outcomes may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to: our ability to progress any product candidates in preclinical or clinical trials; the uncertainty of clinical trial results and the fact that positive results from preclinical studies are not always indicative of positive clinical results; the scope, rate and progress of our preclinical studies and clinical trials and other research and development activities; the competition for patient enrollment from drug candidates in development; the impact of the global COVID-19 pandemic on our clinical trials, operations, vendors, suppliers, and employees; our ability to obtain the capital necessary to fund our operations; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; our ability to obtain financial in the future through product licensing, public or private equity or debt financing or otherwise; our ability to meet the continued listing requirements of, and remain listed on, the Nasdaq Capital Market; general business conditions, regulatory environment, competition and market for our products; and business ability and judgment of personnel, and the availability of qualified personnel and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2023, as any such factors may be updated from time to time in our other filings with the SEC, accessible on the SEC’s website at www.sec.gov and the “Financials & Filings” page of our website at https://investors.eloxxpharma.com/financials-filings.

All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Contact

Investors
John Woolford
[email protected]
443.213.0506

Media
Laureen Cassidy
[email protected]

SOURCE: Eloxx Pharmaceuticals, Inc.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5e112bd4-b39a-4356-8e29-2ceb97ffbac4