American Shared Hospital Services Announces Official Notice of Certificate of Need Approval to Acquire the Technology to Construct and Operate a Proton Beam Radiation Therapy Facility in the State of Rhode Island

SAN FRANCISCO, Dec. 17, 2024 (GLOBE NEWSWIRE) — American Shared Hospital Services (NYSE American: AMS) (the “Company” or “AMS”), a leading provider of turnkey technology solutions for stereotactic radiosurgery and advanced radiation therapy cancer treatment systems and services, today announced that its wholly owned subsidiary, ASHS – Rhode Island Proton Beam Radiation Therapy, LLC, has officially obtained a Certificate of Need (CON) to acquire the technology necessary to construct and operate a freestanding Proton Beam Radiation Treatment (PBRT) system in Johnston, Rhode Island.

Following the unanimous positive recommendation by the Health Service Council, the Director of the Rhode Island Department of Health accepted the recommendation of the Health Service Council to grant the CON.

Ray Stachowiak, Executive Chairman and CEO of the Company, commented,

“We are honored to have received this CON, as it gives us the opportunity to provide the physicians who comprise the Rhode Island cancer care community with the most highly sophisticated radiation therapy technology that exists, enabling Rhode Island cancer care providers to provide a continuum of coordinated comprehensive cancer care to their patients. We anticipate this facility being built and treating its first patients in 36 – 39 months. Once this occurs, Rhode Island residents whose physicians determine that their cancer can best be treated with proton therapy will no longer have to travel to Boston or New York to seek their care.

This facility would be our latest addition to the three Rhode Island photon radiation therapy facilities, in which AMS is the 60% majority owner in conjunction with the second and third largest health systems in RI. In addition, in April of 2024 a CON was granted to ASHS – Bristol Radiation Therapy, LLC a wholly owned subsidiary of AMS, that brings much needed radiation therapy to the underserved East Bay of Rhode Island augmenting our integrated network of strategic and conveniently located radiation therapy facilities in Rhode Island.”

Greg Mercurio, Sr Vice President of Radiation Oncology for AMS, a resident of RI, and a proven leader in advancing access to cancer care in Rhode Island, commented that “bringing proton therapy to Rhode Island will be a significant investment and great technological advancement in cancer care in Rhode Island.

The achievement of this CON is one of the three unique and local business opportunities we focused on and have successfully achieved and represents a potential growth driver for AMS locally and nationally. Currently, there are only two Proton Beam Radiation Therapy Systems in operation in the Northeast, and this facility, being conveniently located between the New York City and Boston Proton facilities, would create greater access to this cutting-edge, cancer-fighting technology in the Northeast.”

Ray Stachowiak concluded by noting that “to assist with these initiatives, the Company has recently added executives to its senior management team with many years of expertise and success in the development, acquisition, and operation of free-standing radiation therapy facilities, as well as partnering with health systems to grow their oncology service lines.”

About American Shared Hospital Services (NYSE American: AMS)

AMS has been in operation for 40 years, has been a publicly traded company since 1984 and is a leading provider of creative financial and turnkey solutions to cancer treatment centers, hospitals, and large cancer networks worldwide. The company works closely with all major global Original Equipment Manufacturers (OEMs) that provide leading edge clinical treatment systems and software to treat cancer using radiation therapy and radiosurgery. The Company is vendor agnostic and provides financial support for a wide range of radiation therapy technology including linear accelerators, Proton Beam Radiation Therapy Systems, Brachytherapy systems and suites, and through the Company’s subsidiary, GK Financing LLC., the Leksell Gamma Knife product and services. As a result of a strategic initiative to acquire the majority equity interest in the RI radiation therapy facilities in May 2024, AMS has expanded its US business model from that of a supplier of technology to health care systems to that of a direct provider of cancer care to patients utilizing the latest radiation therapy technology.

Safe Harbor Statement

This press release may be deemed to contain certain forward-looking statements with respect to the financial condition, results of operations and future plans of American Shared Hospital Services including statements regarding the expected continued growth of the Company and the expansion of the Company’s Gamma Knife, proton therapy and MR/LINAC business, which involve risks and uncertainties including, but not limited to, the risks of economic and market conditions, the risks of variability of financial results between quarters, the risks of the Gamma Knife and proton therapy businesses, the risks of changes to CMS reimbursement rates or reimbursement methodology, the risks of the timing, financing, and operations of the Company’s Gamma Knife, proton therapy, and MR/LINAC businesses, the risk of expanding within or into new markets, the risk that the integration or continued operation of acquired businesses could adversely affect financial results and the risk that current and future acquisitions may negatively affect the Company’s financial position. Further information on potential factors that could affect the financial condition, results of operations and future plans of American Shared Hospital Services is included in the filings of the Company with the Securities and Exchange Commission, including the Company’s Quarterly Reports on Form 10-Q for the three month periods ended March 31, 2024, June 30, 2024 and September 30, 2024, the Annual Report on Form 10-K for the year ended December 31, 2023, and the definitive Proxy Statement for the Annual Meeting of Shareholders that was held on June 25, 2024.

Contacts:

American Shared Hospital Services
Ray Stachowiak, Executive Chairman and CEO
[email protected]   

Investor Relations:

Kirin Smith
PCG Advisory, Inc.
[email protected]



Gaming and Leisure Properties Completes Previously Announced $395 Million Sale Leaseback Transaction with Bally’s for Kansas City and Shreveport Properties

WYOMISSING, Pa., Dec. 17, 2024 (GLOBE NEWSWIRE) — Gaming and Leisure Properties, Inc. (NASDAQ:GLPI) (“GLPI” or “the Company”), announced that it has completed the previously announced $395 million acquisition of the land and real estate assets of Bally’s Kansas City Casino and Bally’s Shreveport Casino & Hotel from Bally’s Corporation (NYSE: BALY) (“Bally’s”). The two properties have been put into a new Bally’s Master Lease that is cross-defaulted with the Company’s existing Bally’s Master Lease, with initial annual cash rent of $32.2 million representing an 8.2% initial cash capitalization rate. Total rent coverage on the Kansas City and Shreveport assets is expected to be 2.2x in the first year of ownership.

Peter Carlino, Chairman and CEO of GLPI commented, “We are pleased to announce the completion of our sale-leaseback transactions for Bally’s properties in Kansas City and Shreveport, which we expect will be accretive to our financial results. This transaction was executed at an attractive cap rate and expands our partnership with Bally’s, while strengthening our portfolio which has now grown to include 67 high-quality regional gaming assets.”

Bally’s Kansas City Casino is located on the Missouri River in Kansas City, Missouri and recently completed a $70 million renovation and expansion. The property features a 42,000 square foot casino with over 900 slot machines, 24 table games and more than 50 video poker and keno terminals. It also offers three restaurants, including a location of the award-winning Chickie’s & Pete’s sports bar, a full-service bar, nearly 3,000 square feet of event space and several entertainment lounges.

Bally’s Shreveport Casino & Hotel is located along the Red River in downtown Shreveport, Louisiana. The property features a 30,000 square foot casino with more than 950 slot machines, over 50 table games, a poker room, and a Bally Bet Sportsbook. It has a 400-room hotel with full-service spa, three on-site restaurants including an award-winning fine dining steakhouse and noodle bar, event spaces, live entertainment and two on-site nightclubs.

About Gaming and Leisure Properties, Inc.

GLPI is engaged in the business of acquiring, financing, and owning real estate property to be leased to gaming operators in triple-net lease arrangements, pursuant to which the tenant is responsible for all facility maintenance, insurance required in connection with the leased properties and the business conducted on the leased properties, taxes levied on or with respect to the leased properties and all utilities and other services necessary or appropriate for the leased properties and the business conducted on the leased properties.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including our expectations regarding the benefits of the transaction to our shareholders. Forward-looking statements can be identified by the use of forward-looking terminology such as “expects,” “believes,” “estimates,” “intends,” “may,” “will,” “should” or “anticipates” or the negative or other variation of these or similar words, or by discussions of future events, strategies or risks and uncertainties. Such forward-looking statements are inherently subject to risks, uncertainties and assumptions about GLPI and its subsidiaries, including risks related to the following: GLPI’s ability to successfully consummate the announced transactions with Bally’s, including the ability of the parties to satisfy the various conditions to advancing loan proceeds, including receipt of all required regulatory approvals and other approvals and consents, or other delays or impediments to completing the proposed transactions; the potential negative impact of recent high levels of inflation (which have been exacerbated by the armed conflict between Russia and Ukraine) on our tenants’ operations; GLPI’s ability to maintain its status as a REIT; our ability to access capital through debt and equity markets in amounts and at rates and costs acceptable to GLPI; the impact of our substantial indebtedness on our future operations; changes in the U.S. tax law and other state, federal or local laws, whether or not specific to REITs or to the gaming or lodging industries; and other factors described in GLPI’s Annual Report on Form 10-K for the year ended December 31, 2023, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, each as filed with the Securities and Exchange Commission. All subsequent written and oral forward-looking statements attributable to GLPI or persons acting on GLPI’s behalf are expressly qualified in their entirety by the cautionary statements included in this press release. GLPI undertakes no obligation to publicly update or revise any forward-looking statements contained or incorporated by reference herein, whether as a result of new information, future events or otherwise, except as required by law. In light of these risks, uncertainties and assumptions, the forward-looking events discussed in this press release may not occur as presented or at all.

Contact:

Gaming and Leisure Properties, Inc.   Investor Relations
Matthew Demchyk, Chief Investment Officer   Joseph Jaffoni, Richard Land, James Leahy at JCIR
610/401-2900   212/835-8500
[email protected]   [email protected]



Brazil Potash to Ring the Opening Bell® at New York Stock Exchange

Commemorates Recent NYSE American Listing and Progress Toward Construction of Autazes Potash Project

MANAUS, Brazil, Dec. 17, 2024 (GLOBE NEWSWIRE) — Brazil Potash Corp. (“Brazil Potash” or the “Company”) (NYSE-American: GRO), an exploration and development company with a potash mining project located in the state of Amazonas, Brazil, today announced that it will ring the Opening Bell at the New York Stock Exchange (“NYSE”) on December 18, 2024, to celebrate its recent listing on the NYSE American exchange.

“Ringing the Opening Bell at the NYSE marks a significant milestone in Brazil Potash’s journey as we address a critical component of global food security,” said Matt Simpson, Chief Executive Officer of Brazil Potash. “Our strategic position—with our construction-ready status and strong stakeholder support—creates a compelling platform to develop a crucial domestic supply of potash for Brazil’s agricultural sector. We look forward to advancing the Autazes Project and delivering value for our shareholders while supporting Brazil’s agricultural self-sufficiency.”

About Brazil
Potash

Brazil Potash is an exploration and development company with a potash mining project (the “Autazes Project”) located in the state of Amazonas, Brazil. The Company’s technical operations are based in Autazes, Amazonas, Brazil and Belo Horizonte, Minas Gerais, Brazil, and its corporate office is in Toronto, Ontario, Canada. The Company is in the pre-revenue development stage and has not yet commenced any mining operations. The Company’s plan of operations for the next few years includes securing all required environmental licenses for the Autazes Project, and, subject to securing sufficient funds, commencing all phases of the construction of the Autazes Project.

Cautionary Note Regarding Forward-Looking
Statements

This press release includes forward-looking statements, which are statements that are not historical facts. Words such as “expects”, “anticipates” and “intends” or similar expressions are intended to identify forward-looking statements. Such forward-looking statements, including statements regarding Ringing the Opening Bell on the NYSE, the future and prospects of the Company and the Autazes Project, are subject to risks and uncertainties, many of which are beyond the control of the Company, including those described in the “Risk Factors” section of the Company’s registration statement on Form F-1, as amended, for the IPO filed with the SEC and the supplemented PREP prospectus filed in each of the provinces and territories of Canada, other than Québec. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based, unless required by law.

C
ontact:

Brazil Potash Investor Relations
[email protected]



EYLEA HD® (aflibercept) Injection 8 mg Phase 3 Trial Meets Primary Endpoint Showing Improved Vision with Extended Dosing Intervals in Patients with Macular Edema following Retinal Vein Occlusion

EYLEA HD demonstrated non-inferior vision gains with an every 8-week dosing regimen compared to EYLEA

®

(aflibercept) Injection 2 mg dosed every 4 weeks

Safety data remains consistent with the known EYLEA HD and EYLEA safety profiles

Supplementary biologics license application planned for submission to the U.S. Food and Drug Administration in the first quarter of 2025

TARRYTOWN, N.Y., Dec. 17, 2024 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the primary endpoint was met in the Phase 3 QUASAR trial investigating EYLEA HD® (aflibercept) Injection 8 mg for the treatment of patients with macular edema following retinal vein occlusion (RVO), including those with central, branch and hemiretinal vein occlusions. In the trial, patients treated with EYLEA HD every 8 weeks (after initial monthly doses) experienced non-inferior vision gains compared to those treated with the approved monthly dosing regimen of EYLEA® (aflibercept) Injection 2 mg, the current standard of care. These data will be submitted to regulatory authorities around the world, with a submission to the U.S. Food and Drug Administration (FDA) planned for the first quarter of 2025, and are planned for presentation at an upcoming medical meeting.

“All currently FDA-approved anti-VEGF therapies for retinal vein occlusion require monthly dosing, which can be burdensome for a patient. These impressive data from QUASAR demonstrated that EYLEA HD patients with retinal vein occlusion experienced improved vision with fewer injections than EYLEA – which could offer a significant advancement in this treatment setting,” said Seenu M. Hariprasad, M.D., Chair of the Department of Ophthalmology and Visual Science, The University of Chicago. “Furthermore, about 90% of EYLEA HD patients were able to maintain 8-week dosing intervals through 36 weeks.”

QUASAR is a global, double-masked, active-controlled Phase 3 trial evaluating the efficacy and safety of EYLEA HD, compared to EYLEA, in patients with RVO. EYLEA HD patients were treated with an 8-week dosing regimen (after 3 or 5 initial monthly doses), and EYLEA patients were treated every 4 weeks. The primary endpoint was met at 36 weeks, with both groups of EYLEA HD patients achieving non-inferior visual acuity gains compared to those receiving EYLEA. EYLEA HD results were consistent across patients with branch retinal vein occlusions, and those with central retinal or hemiretinal vein occlusions.

Outcomes at 36 weeks were as follows:

  EYLEA

4-week
regimen


(n=301)
EYLEA HD

8-week regimen after

3 initial monthly doses

(n=293)
EYLEA HD

8-week regimen after

5 initial monthly doses

(n=298)
Mean observed BCVA improvement 17.8 letters 17.0 letters 19.1 letters
Least squares mean difference in BCVA improvement, primary endpoint (non-inferiority p-value)*   -0.1
(p<0.0001)
0.8
(p<0.0001)
Mean observed BCVA 72.0 letters 72.8 letters 74.6 letters
Patients maintained on every 8-week dosing interval   88% 93%

BCVA: best corrected visual acuity
*Non-inferiority (1-sided) p-values are for the difference in least squares mean compared to EYLEA with margin of 4 letters. EYLEA HD groups met non-inferiority.

The safety profile of EYLEA HD (n=591) was similar to EYLEA (n=301) in QUASAR and remained generally consistent with the known safety profile of EYLEA HD in its pivotal trials. Ocular treatment emergent adverse events (TEAEs) occurring in ≥5% of all EYLEA HD patients included increased ocular pressure (5%), and there was one case each of endophthalmitis and retinal vasculitis. The rate of intraocular inflammation was 0.5% for EYLEA HD and 1.3% for EYLEA. Hypertension at baseline was present in 66% of EYLEA HD patients and 62% of EYLEA patients. Hypertension during the trial was reported in 8.1% of EYLEA HD patients and 4.7% of EYLEA patients. Thromboembolic events (APTC) occurred in 0.5% of EYLEA HD patients and 1.7% of EYLEA patients. 

“With these pivotal results in retinal vein occlusion, EYLEA HD with extended dosing has again met the high bar of vision gains and safety seen with standard-of-care EYLEA,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron, and a principal inventor of EYLEA. “EYLEA HD has already made a significant impact on the treatment of its three approved indications – wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy – and now has the potential to substantially reduce the treatment burden for patients with retinal vein occlusion. We look forward to sharing these results with regulatory authorities around the world as soon as possible.”

EYLEA HD (known as Eylea™ 8 mg in the European Union and Japan) is being jointly developed by Regeneron and Bayer AG. In the U.S., Regeneron maintains exclusive rights to EYLEA and EYLEA HD. Bayer has licensed the exclusive marketing rights outside of the U.S., where the companies share equally the profits from sales of EYLEA and EYLEA HD.

The safety and efficacy of EYLEA HD for the treatment of RVO has not been evaluated by any regulatory authority.

About the QUASAR Trial

QUASAR is a global double-masked, active-controlled Phase 3 trial evaluating the efficacy and safety of EYLEA HD in patients with macular edema secondary to RVO, including those with central retinal vein occlusion, branch retinal vein occlusion, or hemiretinal vein occlusion.

In the trial, patients were randomized into three groups to receive either: EYLEA HD every 8 weeks following 3 initial monthly doses; EYLEA HD every 8 weeks following 5 initial monthly doses; or EYLEA every 4 weeks. The primary endpoint was mean change in BCVA from randomization through week 36, as measured by the Early Treatment Diabetic Retinopathy Study letter score.

Patients in the EYLEA HD groups can have their dosing intervals shortened to a minimum of every 4 weeks throughout the trial if protocol-defined criteria for disease progression are met. Dosing intervals may be extended based on protocol-defined criteria starting at week 32 for patients who receive EYLEA or EYLEA HD after 3 initial monthly doses or at week 40 for patients who receive EYLEA HD after 5 initial monthly doses, with follow-up planned through week 64.

QUASAR is being operationalized by Bayer under a collaboration agreement with Regeneron.

About Retinal Vein Occlusion

RVO is a common cause of vision loss in adults and the second most common retinal vascular disease. RVO occurs when there is a blockage in a vein in the retina, which leads to a buildup of blood, restricted blood flow, increased pressure and sometimes pain in the eye. RVO may cause sudden blurry vision or vision loss and can ultimately result in serious complications like swelling in the eye called macular edema.

A protein called vascular endothelial growth factor (VEGF) is instrumental in causing the vascular leakage that leads to macular edema. When a vein in the retina is blocked, the levels of VEGF increase, which spurs new blood vessel growth. Too much VEGF can lead to the formation of abnormal blood vessels and may cause vision to become blurry. Anti-VEGF injections are commonly used to treat macular edema due to RVO.

There are two main types of RVO: central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO). In CRVO, the buildup occurs in the eye’s central retinal vein and in BRVO, the buildup occurs in one of the smaller branch veins. Globally, RVO affects over 28 million people.

About Ophthalmology at Regeneron

At Regeneron, we relentlessly pursue groundbreaking innovations in eye care science to help maintain the eye health of the millions of Americans impacted by vision-threatening conditions. Over a decade ago, our breakthrough scientific research resulted in the development of EYLEA, a vascular endothelial growth factor (VEGF) inhibitor designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels in the eye. EYLEA has since brought fundamental change to the retinal disease treatment landscape and is supported by a robust body of research.

Regeneron continues to advance our anti-angiogenesis expertise with new solutions with the aim of offering optimal flexibility for a broad group of patients and eye care professionals. This includes EYLEA HD, which has been developed with the aim of extending the time between injections, while maintaining the vision gains, anatomic benefits and safety previously observed with EYLEA.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

INDICATIONS

EYLEA HD® (aflibercept) Injection 8 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).

EYLEA® (aflibercept) Injection 2 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and Retinopathy of Prematurity (ROP) (0.4 mg).

IMPORTANT SAFETY INFORMATION

  • EYLEA HD and EYLEA are administered by injection into the eye. You should not use EYLEA HD or EYLEA if you have an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients in EYLEA HD or EYLEA, including aflibercept.
  • Injections into the eye with EYLEA HD or EYLEA can result in an infection in the eye, retinal detachment (separation of retina from back of the eye) and, more rarely, serious inflammation of blood vessels in the retina that may include blockage. Call your doctor right away if you or your baby (if being treated with EYLEA for Retinopathy of Prematurity) experience eye pain or redness, light sensitivity, or a change in vision after an injection.
  • In some patients, injections with EYLEA HD or EYLEA may cause a temporary increase in eye pressure within 1 hour of the injection. Sustained increases in eye pressure have been reported with repeated injections, and your doctor may monitor this after each injection.
  • In infants with Retinopathy of Prematurity (ROP), treatment with EYLEA will need extended periods of ROP monitoring.
  • There is a potential but rare risk of serious and sometimes fatal side effects, related to blood clots, leading to heart attack or stroke in patients receiving EYLEA HD or EYLEA.
  • The most common side effects reported in patients receiving EYLEA HD were cataract, increased redness in the eye, increased pressure in the eye, eye discomfort, pain, or irritation, blurred vision, vitreous (gel-like substance) floaters, vitreous detachment, injury to the outer layer of the eye, and bleeding in the back of the eye.
  • The most common side effects reported in patients receiving EYLEA were increased redness in the eye, eye pain, cataract, vitreous detachment, vitreous floaters, moving spots in the field of vision, and increased pressure in the eye.
  • The most common side effects reported in pre-term infants with ROP receiving EYLEA were separation of the retina from the back of the eye, increased redness in the eye, and increased pressure in the eye. Side effects that occurred in adults are considered applicable to pre-term infants with ROP, though not all were seen in clinical studies.
  • You may experience temporary visual changes after an EYLEA HD or EYLEA injection and associated eye exams; do not drive or use machinery until your vision recovers sufficiently.
  • For additional safety information, please talk to your doctor and see the full Prescribing Information for EYLEA HD and EYLEA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit

www.fda.gov/medwatch

or call 1-800-FDA-1088.

Please click here for full Prescribing Information for

EYLEA HD

and

EYLEA

.

About Regeneron

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.

Forward-Looking Statements and Use of Digital Media

This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation EYLEA HD® (aflibercept) Injection 8 mg; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, such as EYLEA HD for the treatment of patients with macular edema following retinal vein occlusion (“RVO”); uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron’s Products (such as EYLEA HD for the treatment of patients with RVO) and Regeneron’s Product Candidates; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron’s Products (such as EYLEA HD) and Regeneron’s Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates (including biosimilar versions of Regeneron’s Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on Regeneron’s business; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection 2 mg), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney’s Office for the District of Massachusetts), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2023 and its Form 10-Q for the quarterly period ended September 30, 2024. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron’s media and investor relations website (
https://investor.regeneron.com
) and its LinkedIn page (
https://www.linkedin.com/company/regeneron-pharmaceuticals
).

Contacts:

Media Relations

Mary Heather
Tel: +1 914-847-8650
[email protected]

Investor Relations

Mark Hudson
Tel: +1 914-847-3482
[email protected]



Better Choice Company Provides Shareholder Update Regarding its Authorized Stock Repurchase Program

As of December 16, 2024, the Company has repurchased a total of 102,405 shares at an average price of $1.9869 per share under its authorized up to $5 million program

TAMPA, Fla., Dec. 17, 2024 (GLOBE NEWSWIRE) — Better Choice Company, Inc. (NYSE American: BTTR) (“Better Choice” or the “Company”), a pet health and wellness company, today announced repurchasing 102,405 shares at an average price of $1.9869 per share under its previously announced authorized stock repurchase program under which the Company can repurchase up to $5 million of the currently outstanding shares of the Company’s common stock, until December 31, 2024.

Michael Young, Chairman of Better Choice, commented, “We continue to see value in our equity as the Company’s shares are currently trading significantly below Net Tangible Book Value. Beyond valuation, we are confident in the strength of our business and growth prospects. We will continue to be opportunistic with our share repurchases.”

Shares may be repurchased in open market or private transactions or pursuant to any trading plan that may be adopted in accordance with Rule 10b5-1 of the Securities and Exchange Commission (“SEC”). The timing and amount of any repurchases will depend on a number of factors, including the availability of stock, general market conditions, the trading price of the stock, alternative uses for capital, and the Company’s financial performance. Open market purchases will be made in accordance with Rule 10b-18 of the SEC and other applicable legal requirements. The Company is not obligated to repurchase any particular number of shares or any shares in any specific time period and the program may be modified, suspended, or discontinued at any time. Payment for shares repurchased under the program will be funded using the Company’s cash on hand.

About Better Choice Company Inc.

Better Choice Company Inc. is a rapidly growing pet health and wellness company committed to leading the industry shift toward pet products and services that help dogs and cats live healthier, happier, and longer lives. We take an alternative, nutrition-based approach to pet health relative to conventional dog and cat food offerings and position our portfolio of brands to benefit from the mainstream trends of growing pet humanization and consumer focus on health and wellness. We have a demonstrated, multi-decade track record of success selling trusted pet health and wellness products and leverage our established digital footprint to provide pet parents with the knowledge to make informed decisions about their pet’s health. We sell the majority of our dog food, cat food and treats under the Halo brand, which is focused, respectively, on providing sustainably sourced kibble and canned food derived from real whole meat, and minimally processed raw-diet dog food and treats. For more information, please visit https://www.betterchoicecompany.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. The Company has based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Some or all of the results anticipated by these forward-looking statements may not be achieved. Further information on the Company’s risk factors is contained in our filings with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Company Contact:

Better Choice Company, Inc.
Kent Cunningham, CEO

Investor Contact:

KCSA Strategic Communications
Valter Pinto, Managing Director
T: 212-896-1254
[email protected]



Tavia Acquisition Corp. Announces the Separate Trading of its Ordinary Shares and Rights Commencing December 20, 2024

London, United Kingdom, Dec. 17, 2024 (GLOBE NEWSWIRE) — Tavia Acquisition Corp. (the “Company”) announced that, commencing December 20, 2024, holders of the 11,500,000 units sold in the Company’s initial public offering may elect to separately trade the ordinary shares and rights included in the units. Any units not separated will continue to trade on The Nasdaq Global Market (the “Nasdaq”) under the symbol “TAVIU,” and the separated ordinary shares and rights are expected to trade on the Nasdaq under the symbols “TAVI” and “TAVIR,” respectively. Unitholders will need to have their brokers contact Continental Stock Transfer & Trust Company, the Company’s transfer agent, in order to separate the units into ordinary shares and rights.

The units were initially offered by the Company in an underwritten offering. EarlyBirdCapital, Inc. acted as the sole book-running manager of the offering. A registration statement relating to the units and the underlying securities was declared effective by the Securities and Exchange Commission (the “SEC”) on December 3, 2024.

The offering was made only by means of a prospectus. Copies of the prospectus related to this offering may be obtained from EarlyBirdCapital, Inc. at 366 Madison Avenue, 8th Floor, New York, New York 10017, Attention: Syndicate Department, by telephone at 212-661-0200.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Tavia Acquisition Corp.

Tavia Acquisition Corp. is a blank check company organized for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, or reorganization or engaging in any other similar business combination with one or more businesses or entities. The Company is led by Chief Executive Officer Kanat Mynzhanov and Chief Financial Officer Askar Mametov, along with independent directors, Christophe Charlier, Darrell Mays, and Marsha Kutkevitch. The Company may pursue a business combination with a target in any industry or geographic location it chooses, although it intends to primarily direct its attention on target businesses in North America and Europe focused on energy transition, the circular economy, and food technologies. The Company believes these areas are critical to addressing environmental challenges, demographic shifts, and the transition towards sustainable practices.

Forward-Looking Statements 

This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, including with respect to the anticipated separation of the units into ordinary shares and rights, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements, including those set forth in the risk factors section of the prospectus for the Company’s initial public offering. Copies of the prospectus can be accessed through the SEC’s website at www.sec.gov. No assurance can be given that the units will be separated on the date indicated. The Company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based, except as required by law.

Media Contact:

Tavia Acquisition Corp.
[email protected]



EyePoint to Present at the 43rd Annual J.P. Morgan Healthcare Conference

WATERTOWN, Mass., Dec. 17, 2024 (GLOBE NEWSWIRE) — EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced that Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint Pharmaceuticals will present at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 14, 2025 at 2:15 p.m. PT/5:15 p.m. ET.

A webcast and subsequent archived replay of the presentation may be accessed via the Investors section of the Company website at www.eyepointpharma.com.

About EyePoint Pharmaceuticals

EyePoint (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious retinal diseases. The Company’s pipeline leverages its proprietary bioerodible Durasert E technology for sustained intraocular drug delivery. The Company’s lead product candidate, DURAVYU (f/k/a EYP-1901), is an investigational sustained delivery treatment for VEGF-mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with bioerodible Durasert E. DURAVYU is presently in Phase 3 global, pivotal clinical trials as a sustained delivery treatment for wet age-related macular degeneration (wet AMD), the leading cause of vision loss among people 50 years of age and older in the United States, and in a Phase 2 clinical trial in diabetic macular edema (DME). EyePoint expects full topline data from the Phase 2 clinical trial in DME in Q1 2025 and topline data from both Phase 3 pivotal trials in wet AMD in 2026.

Pipeline programs include EYP-2301, a TIE-2 agonist, razuprotafib, formulated in Durasert E to potentially improve outcomes in serious retinal diseases. The proven Durasert® drug delivery technology has been safely administered to thousands of patient eyes across four U.S. FDA approved products. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts.

Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan.

DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain.

Investors:

Christina Tartaglia
Precision AQ
Direct: 212-698-8700
[email protected]

Media Contact:

Amy Phillips
Green Room Communications
Direct: 412-327-9499
[email protected]



Americold Realty Trust, Inc. Declares Fourth Quarter 2024 Dividend

ATLANTA, GA., Dec. 17, 2024 (GLOBE NEWSWIRE) — Americold Realty Trust (NYSE: COLD), a global leader in temperature-controlled logistics, real estate, and value-added services focused on the ownership, operation, acquisition and development of temperature-controlled warehouses, today announced that its Board of Directors has declared a dividend of $0.22 per share for the fourth quarter of 2024, payable to holders of the Company’s common stock. The dividend will be payable in cash on January 15, 2025 to stockholders of record at the close of business on December 31, 2024.

About Americold Realty Trust, Inc.

Americold is a global leader in temperature-controlled logistics real estate and value-added services. Focused on the ownership, operation, acquisition, and development of temperature-controlled warehouses, Americold owns and/or operates 239 temperature-controlled warehouses, with approximately 1.5 billion refrigerated cubic feet of storage, in North America, Europe, Asia-Pacific, and South America. Americold’s facilities are an integral component of the supply chain connecting food producers, processors, distributors, and retailers to consumers.

Contacts:

Americold Realty Trust, Inc.
Investor Relations
Telephone: 678-459-1959
Email: [email protected]



BioCardia Announces Commercial Availability of Morph® DNA™ Steerable Introducer Product Family

SUNNYVALE, Calif., Dec. 17, 2024 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today the commercial availability of its Morph DNA steerable introducer product family, currently utilized in the Company’s ongoing cell-therapy clinical trials.

“Our team is exploring an initial sales pipeline organically, without expending the operating costs associated with engaging a direct sales force or third-party medical device commercial partners.” said BioCardia CEO, Peter Altman, PhD. “We look forward to demonstrating the value of the Morph DNA product family to physicians for procedures throughout the vascular system.”

Dr. Altman added, “BioCardia remains focused on our CardiAMP Heart Failure I and II clinical trials, studying our investigational FDA designated breakthrough cell therapy product candidate to treat ischemic heart failure. We anticipate final results in the CardiAMP Heart Failure I Trial and five actively enrolling world class centers in the CardiAMP Heart Failure II Trial by the end of the first quarter of 2025.”

About Morph DNA Steerable Introducers

Developed initially to provide enhanced control for biotherapeutic delivery procedures within the heart, the Morph DNA steerable introducer family has bidirectional steering, a proprietary layup for torque response, ergonomic actuation, an adjustable brake for fine control, and a swiveling side port in its hemostasis valve to solve tangling issues and enhance procedures.

Morph DNA designs contain tensioning elements in the catheter that rotate around the catheter shaft, allowing consistent catheter performance in any direction. The DNA name reflects this design, as these tensioning elements resemble the double helix in a strand of DNA. This design is intended to enable smooth navigation and prevent “whip,” when the build-up of mechanical forces in the device causes a catheter to suddenly jump from one orientation to another.

A product brochure detailing available model numbers and sizes is available on the Company’s website at brochure link.

About BioCardia

BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms.

Forward Looking Statements:

This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the Company’s investigational product candidates, the advantages of the Morph DNA design and expectations for data availability and enrollment in the Company’s clinical trials. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.

We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release as a result of one or more risk factors. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 27, 2024, under the caption titled “Risk Factors” and in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.



Media Contact:
Miranda Peto, Investor Relations
Email: [email protected]
Phone: 650-226-0120

Investor Contact:
David McClung, Chief Financial Officer
Email: [email protected]
Phone: 650-226-0120

Unicycive Therapeutics Announces Publication of Oxylanthanum Carbonate (OLC) Positive Bioequivalence Data in Clinical Therapeutics

LOS ALTOS, Calif., Dec. 17, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced that data from the Company’s oxylanthanum carbonate (OLC) bioequivalence study in healthy volunteers was published in the peer-reviewed journal, Clinical Therapeutics.

The publication, entitled, “Two-Way Randomized Crossover Study to Establish Pharmacodynamic Bioequivalence Between Oxylanthanum Carbonate and Lanthanum Carbonate” described the study that established pharmacodynamic (PD) bioequivalence of OLC to Fosrenol®. In the study, OLC was well tolerated and demonstrated bioequivalence to lanthanum carbonate (LC).

“Demonstrating bioequivalence was a key component of our OLC New Drug Application, and we are pleased that these positive data have been published in the peer-reviewed journal, Clinical Therapeutics,” said, Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “With our NDA now under review, we are preparing for commercial launch of OLC in 2025.”

Phosphate binders are integral to hyperphosphatemia management in patients with end-stage kidney disease. This objective of the Unicycive study was to demonstrate the pharmacodynamic equivalence of orally administered OLC to LC in healthy participants. A total of 80 participants were randomized and 75 received all doses. Participants were treated with OLC swallowable 1000 mg tablets three times/day and LC chewable 1000 mg tablets three times/day in a two-way crossover design. The primary pharmacodynamic variable was the least squares mean (LSM) change in urinary phosphate excretion from baseline to the evaluation period (Days 1–4 of treatment). The LSM change in urinary phosphate excretion from Baseline to the Evaluation (Treatment) Period was similar for both OLC (–320.4 mg/day [90% CI: –349.7, –291.0]) and LC (–324.0 mg/day [90% CI: –353.3, –294.7]); the between-group LSM difference was 3.6 [90% CI: –37.8, 45.1] mg/day. Both drugs were well tolerated with an equal incidence of adverse events.

The full publication can be accessed here.

About Oxylanthanum Carbonate (OLC)

Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). OLC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1 The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.28 billion, with the North America accounting for more than $1 billion of that total.2 Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.3

Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.

About Hyperphosphatemia

Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.4

Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. Positive pivotal trial results were reported in June 2024 for OLC, and a New Drug Application (NDA) is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025. OLC is protected by a strong global patent portfolio including an issued patent on composition of matter with exclusivity until 2031, and with the potential patent term extension until 2035 after OLC approval. Unicycive’s second asset, UNI-494, is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. UNI-494 has successfully completed a Phase 1 trial. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.

Forward-looking statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Fosrenol® is a registered trademark of Shire International Licensing BV.
1Reason Research, LLC 2022 survey. Results here.
2 Fortune Business InsightsTM, Hyperphosphatemia Treatment Market, 2023-2030
3 US-DOPPS Practice Monitor, May 2021; http://www.dopps.org/DPM
4 Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004 Aug;15(8):2208-18. doi: 10.1097/01.ASN.0000133041.27682.A2. PMID: 15284307.

Investor Contacts:

Kevin Gardner

LifeSci Advisors
[email protected]

Chris Calabrese

LifeSci Advisors
[email protected]

SOURCE: Unicycive Therapeutics, Inc.