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ANI Pharmaceuticals Announces FDA Approval and Commercial Availability of New 1-mL Vial Size of Purified Cortrophin® Gel, Appropriate for Adjunctive Treatment of Certain Patients with Acute Gouty Arthritis Flares

Cortrophin Gel is the only FDA-approved purified corticotropin (ACTH) indicated for the treatment of appropriate patients with acute gouty arthritis flares

New 1-mL size furthers ANI’s commitment to providing ACTH options for appropriate acute gouty arthritis flare patients and their healthcare providers; available through distributors to help enable in-office administration and through specialty pharmacies

Cortrophin Gel will now be available in two sizes, including the 5-mL vial size launched in January 2022



BAUDETTE, Minn., Oct. 02, 2023 (GLOBE NEWSWIRE) — ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced U.S. Food and Drug Administration (FDA) approval and commercial availability of a 1-mL vial (80 USP units/1 mL) of Purified Cortrophin® Gel (repository corticotropin injection USP) (Cortrophin Gel). The 1-mL vial is now available via Cortrophin Gel’s existing specialty pharmacy network and will also be available for ordering via national specialty distributors. Cortrophin Gel is already available in a 5-mL vial. Cortrophin Gel is indicated for short-term administration as an adjunctive therapy during an acute episode or exacerbation in acute gouty arthritis. Cortrophin Gel is contraindicated for intravenous administration. For additional important safety information, please see below.

ANI reintroduced Cortrophin Gel to the market in January 2022. At that time, Cortrophin Gel became the first newly commercialized drug indicated for appropriate patients with acute gouty arthritis flares in 12 years. This smaller 1-mL product configuration was developed with the goal of helping enable rapid time to therapy, at point-of-care, for appropriate patients with acute gouty arthritis flares.

“More than 9 million people in the US are affected by gout, and each year a portion of these patients experience acute gouty arthritis flares as a symptom of their underlying disease. For some of these patients, Cortrophin Gel may be an appropriate additional treatment option for their flares. The approval of the 1-mL vial for Cortrophin Gel is another step forward in our mission to increase access for appropriate acute gouty arthritis flare patients in need. Scaling up our Rare Disease business is ANI’s largest growth driver and key to achieving our goal of building a high-growth biopharma company,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

“With this approval, we look forward to continuing the Cortrophin Gel launch momentum we have seen to date,” Lalwani continued. “The commercial launch of the 1-mL vial will be supported by ANI’s existing Cortrophin Gel field sales force, which is already engaging rheumatologists and nephrologists who treat patients with acute gouty arthritis flares. Importantly, we are enhancing Cortrophin in Your Corner™, our reimbursement and access hub, to include support for this new 1-mL configuration of Cortrophin Gel.”

“Gout is the most common type of inflammatory arthritis,” said Mary Pao, MD, PhD, Chief Medical Officer of ANI. “Acute gouty arthritis flare patients who are in need of an additional flare treatment options, beyond currently recommended first line therapies, have a need for alternatives. The development of the 1-mL vial represents ANI’s commitment to this patient population.”

Cortrophin Gel is an adrenocorticotropic hormone (ACTH), also known as purified corticotropin, and it is approved for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (MS) and rheumatoid arthritis (RA), in addition to excess urinary protein due to nephrotic syndrome. Cortrophin Gel is the only FDA-approved ACTH therapy indicated for the treatment of appropriate patients with acute gouty arthritis flares. For a full list of indications, please see below.

Indications

Cortrophin Gel is a prescription medicine that is injected subcutaneously or intramuscularly. It is indicated for:

  • Short-term administration as an adjunctive therapy during an acute episode or exacerbation in:
    • acute gouty arthritis
    • rheumatoid arthritis, including juvenile rheumatoid arthritis; psoriatic arthritis; and ankylosing spondylitis.
  • Exacerbations or as maintenance therapy in select cases of systemic lupus erythematosus and systemic dermatomyositis (polymyositis).
  • Severe erythema multiforme (Stevens-Johnson syndrome) and severe psoriasis.
  • Atopic dermatitis and serum sickness.
  • Severe acute and chronic allergic and inflammatory conditions affecting the eye and its adnexa, such as allergic conjunctivitis, keratitis, iritis and iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, and anterior segment inflammation.
  • Symptomatic sarcoidosis.
  • Inducing a diuresis or remission of proteinuria due to nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.
  • Acute exacerbations of multiple sclerosis.

Important Safety Information

Contraindications

  • Cortrophin Gel is contraindicated for intravenous administration.
  • Cortrophin Gel is contraindicated in patients who have any of the following conditions: scleroderma; osteoporosis; systemic fungal infections; ocular herpes simplex; recent surgery; history of or the presence of a peptic ulcer; congestive heart failure; hypertension; primary adrenocortical insufficiency; adrenocortical hyperfunction; or sensitivity to proteins derived from porcine sources.

Warnings and Precautions

  • Infections: Corticotropin therapy may increase susceptibility to infections and may mask the symptoms of infections.
  • Adrenal insufficiency: Prolonged corticotropin therapy can increase the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by gradually reducing the corticotropin dosage. Hormone therapy should be reinstituted if stressful situations arise during discontinuation.
  • Elevated blood pressure, salt and water retention, and hypokalemia: Corticotropin can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium or calcium.
  • Masking symptoms of other diseases: Corticotropin may only suppress signs and symptoms of chronic disease without altering the natural course of disease.
  • Psychiatric reactions: Psychic derangements may appear when corticotropin is used, ranging from euphoria, insomnia, mood swings, personality changes, and depression to psychosis. Existing conditions may be aggravated.
  • Ophthalmic reactions: Prolonged use of corticotropin may produce posterior subcapsular cataracts and glaucoma with possible damage to the optic nerves.
  • Immunogenicity potential: Prolonged administration of Cortrophin Gel may increase the risk of hypersensitivity reactions. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH and Cortrophin Gel activity.
  • Vaccination: Patients should not be vaccinated against smallpox while on corticotropin therapy. Other immunizations should be undertaken with caution due to possible neurologic complications and lack of antibody response.
  • Use in patients with hypothyroidism and cirrhosis: There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis.
  • Use in patients with latent tuberculosis or tuberculin reactivity: Closely observe for reactivation of the disease.
  • Comorbid diseases: Corticotropin should be used with caution in patients with diabetes, abscess, pyogenic infections, diverticulitis, renal insufficiency, and myasthenia gravis.
  • Growth and development: Carefully observe growth and development of infants and children on prolonged corticotropin therapy.
  • Acute gouty arthritis: Treatment of acute gouty arthritis should be limited to a few days. Conventional concomitant therapy should be administered during corticotropin treatment and for several days after it is stopped.
  • Drug interactions: Aspirin should be used cautiously with corticotropin in hypoprothrombinemia.
  • Pregnancy: Since fetal abnormalities have been observed in animals, Cortrophin Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Adverse Reactions

Adverse reactions for Cortrophin Gel include fluid or sodium retention; muscle weakness; osteoporosis; peptic ulcer with possible perforation and hemorrhage; injection site reactions; impaired wound healing; hypertension; convulsions; headache; development of Cushingoid state; suppression of growth in children; and weight gain. These are not all the adverse reactions reported with Cortrophin Gel.

Please click here for full prescribing information for Cortrophin Gel.

About ANI

ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. Our team is focused on delivering sustainable growth by scaling up our Rare Disease business through successful launch of our lead asset, Purified Cortrophin® Gel, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities. For more information, please visit our website www.anipharmaceuticals.com.

Forward-Looking Statements

To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, those relating to the commercialization and potential sales of the product and any additional product launches from the Company’s generic pipeline, other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” other words of similar meaning, derivations of such words and the use of future dates.

These forward-looking statements include statements regarding the commercial launch of Cortrophin Gel and the potential benefit of Cortrophin Gel to patients as a treatment option. Risks and uncertainties that may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements include, but are not limited to, the costs involved in commercializing Cortrophin Gel, the ability to maintain regulatory approval of the product and maintain sufficiency of the product, the ability to obtain reimbursement from third-party payors for this product, evolving government legislation, the opinions and views of key opinion leaders and physicians who treat patients with chronic diseases and who may prescribe Cortrophin Gel, manufacturing difficulties or delays, ANI’s ability to generate projected net product revenue and gain market share on the timeline expected, actions taken by competitors in response to a new market entrant, ANI’s reliance on third parties over which it may not always have full control, costs and regulatory requirements relating to contract manufacturing arrangements, increased competition and strategies employed by competitors, uncertainties regarding the COVID-19 pandemic, market trends for our products, regulatory environment and changes, and other risks and uncertainties. More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the Securities and Exchange Commission (“SEC”), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company’s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts:

Investor:

Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: [email protected]

Media:

Faith Pomeroy-Ward
T: 817-807-8044
E: [email protected]

Source: ANI Pharmaceuticals, Inc.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2efb6d4a-2b60-468e-93f0-ab6ceeb02958



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NovaBay Pharmaceuticals to Present at the Dawson James Small Cap Growth Conference

NovaBay Pharmaceuticals to Present at the Dawson James Small Cap Growth Conference

EMERYVILLE, Calif.–(BUSINESS WIRE)–NovaBay Pharmaceuticals, Inc. (NYSE American: NBY), a company developing and commercializing high-quality eyecare, skincare and wound care products, announces that Justin Hall, CEO and General Counsel, will present a company overview and hold investor meetings at the 8th Annual Dawson James Small Cap Growth Conference being held Thursday, October 12, 2023 at the Wyndham Grand Harborside Hotel in Jupiter, Fla.

“We are excited to showcase the innovative products in our eyecare, skincare, and wound care business segments at this upcoming conference,” said Mr. Hall. “I’ll be presenting our future strategies to address the large market opportunities for the Avenova®, DERMAdoctor® and PhaseOne® brands.”

Investors interested in arranging a meeting with NovaBay management should contact Jody Cain at LHA Investor Relations. The NovaBay corporate presentation can be access from the Presentation page of the Investor Relations section of the Company’s website.

About NovaBay Pharmaceuticals, Inc.:

NovaBay Pharmaceuticals, Inc. develops and sells scientifically created and clinically proven eyecare, skincare and wound care products. NovaBay’s leading product Avenova® Antimicrobial Lid & Lash Solution is often prescribed by eyecare professionals for blepharitis and dry-eye disease and is also available directly to consumers through online distribution channels such as Amazon. DERMAdoctor® offers more than 30 dermatologist-developed skincare products through the DERMAdoctor website, well-known traditional and digital beauty retailers, and international distributors. NovaBay also manufactures and sells effective, yet gentle and non-irritating wound care products. The PhaseOne® brand is distributed through commercial partners in the U.S. for professional use only, and the NeutroPhase® brand is distributed in China by China Pioneer Pharma Holdings, Limited. More information about NovaBay is available here.

NovaBay Pharmaceuticals Forward-Looking Statements

]Except for historical information herein, matters set forth in this press release may be forward looking within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including statements about the commercial progress and future financial performance of NovaBay Pharmaceuticals, Inc. This release contains forward-looking statements that are based upon management’s current expectations, assumptions, estimates, projections and beliefs. These statements include, but are not limited to, statements regarding our business strategies, current partnerships, marketing efforts, and any future revenue that may result from such partnerships and related marketing initiatives, as well as generally the Company’s expected future financial results. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results or achievements to be materially different and adverse from those expressed in or implied by the forward-looking statements. Factors that might cause or contribute to such differences include, but are not limited to, risks and uncertainties relating to the size of the potential market for our products, the possibility that the available market for the Company’s products will not be as large as expected, the Company’s products will not be able to penetrate one or more targeted markets, and revenues will not be sufficient to meet the Company’s cash needs. Other risks relating to NovaBay’s business, including risks that could cause results to differ materially from those projected in the forward-looking statements in this press release, are detailed in NovaBay’s latest Form 10-Q/K filings and Registration Statement on Form S-1 filing with the Securities and Exchange Commission, especially under the heading “Risk Factors.” The forward-looking statements in this release speak only as of this date, and NovaBay disclaims any intent or obligation to revise or update publicly any forward-looking statement except as required by law.

Socialize and Stay Informed on NovaBay’s Progress

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Visit NovaBay’s Website

Avenova Purchasing Information

For NovaBay Avenova purchasing information:

Please call 800-890-0329 or email [email protected]

Avenova.com

DERMAdoctor Purchasing Information

For DERMAdoctor purchasing information:

Please call 877-337-6237 or email [email protected]

DERMAdoctor.com

NovaBay Contact

Justin Hall

Chief Executive Officer and General Counsel

510-899-8800

[email protected]

Investor Contact

LHA Investor Relations

Jody Cain

310-691-7100

[email protected]

KEYWORDS: United States North America California Florida

INDUSTRY KEYWORDS: Research Other Health General Health Family Pharmaceutical Optical Consumer Science Biotechnology Women Medical Supplies Health Other Science

MEDIA:

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Brown & Brown, Inc. announces 2023 third-quarter earnings release and conference call dates

DAYTONA BEACH, Fla., Oct. 02, 2023 (GLOBE NEWSWIRE) —  Brown & Brown, Inc. (NYSE: BRO) announces it will release its 2023 third-quarter earnings on Monday, October 23, 2023, after the close of the market. On Tuesday, October 24, 2023, J. Powell Brown, Brown & Brown’s president and chief executive officer, and R. Andrew Watts, Brown & Brown’s executive vice president and chief financial officer, will host an investor update conference call concerning Brown & Brown’s third-quarter 2023 financial results. You are invited to listen to the call, which will be broadcast live on Brown & Brown’s website at 8:00 a.m. EDT. Simply log on to www.bbinsurance.com and click on “Investor Relations” and then “Calendar of Events.”

If you are unable to listen during the live webcast, audio from the conference call will be archived on Brown & Brown’s website, www.bbinsurance.com, for 14 days after the live broadcast. To access the website replay, go to “Investor Relations” and click on “Calendar of Events.”

About Brown & Brown, Inc.

Brown & Brown, Inc. (NYSE: BRO) is a leading insurance brokerage firm, delivering risk management solutions to individuals and businesses since 1939. With 15,000+ teammates in approximately 500 locations worldwide, we are committed to providing innovative strategies to help protect what our customers value most. For more information or to find an office near you, please visit bbinsurance.com.

This press release may contain certain statements relating to future results, which are forward-looking statements, including those associated with the timing of the release of our third-quarter results. These statements are not historical facts but instead represent only the current belief of Brown & Brown, Inc. and its subsidiaries (collectively the “Company”) regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company’s control. It is possible that actual events may differ from anticipated events contemplated by these forward-looking statements and that we may release our third-quarter results at a later date as a result. Further information concerning the Company and its business, including factors that potentially could materially affect the Company’s release of its financial results, is contained in the Company’s filings with the Securities and Exchange Commission. All forward-looking statements made herein are made only as of the date of this release, and the Company does not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which the Company hereafter becomes aware.

For more information:

R. Andrew Watts
Chief Financial Officer
(386) 239-5770



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iBio Explains Recent Filing of Registration Statement

– No new securities are being registered under the Post-Effective Amendment –

BRYAN, Texas and SAN DIEGO, Oct. 02, 2023 (GLOBE NEWSWIRE) — In response to investor inquiries received about the post-effective amendment to its Form S-3 on Form S-1 (the “Post-Effective Amendment”) filed on Friday, September 29, 2023 with the United States Securities and Exchange Commission (“SEC”), iBio Inc. (NYSEA:IBIO) (“iBio” or the “Company”), an AI-driven innovator of precision antibody immunotherapies, today provided the following clarification.

The Company filed a registration statement on Form S-3 (Registration No. 333-250973) (the “Original Registration Statement”) declared effective by the SEC on December 7, 2020, which registered up to $200,000,000 of any combination of iBio’s common stock, preferred stock, debt securities, warrants or units comprised of any of the foregoing securities of the Registrant. This Post-Effective Amendment was filed to convert the Original Registration Statement into a registration statement on Form S-1 in order to maintain the registration of certain common stock warrants issued and outstanding in connection with the Company’s December 2022 underwritten public offering, previously registered on the Original Registration Statement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 iBio, Inc.

iBio develops next-generation biopharmaceuticals using computational biology and 3D-modeling of subdominant and conformational epitopes, prospectively enabling the discovery of new antibody treatments for hard-to-target cancers and other diseases. iBio’s mission is to decrease drug failures, shorten drug development timelines, and open up new frontiers against the most promising targets. For more information, visit www.ibioinc.com.

FORWARD-LOOKING STATEMENTS

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are based upon current estimates and assumptions and include statements regarding filing the registration statement on Form S-1 to maintain the registration of certain common stock warrants issued and outstanding in connection with the Company’s December 2022 underwritten public offering previously registered on the Original Registration Statement. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the registration statement becoming effective; competition; the Company’s ability to retain its key employees or maintain its NYSE American listing; and the other factors discussed in the Company’s filings with the SEC including the Company’s Annual Report on Form 10-K for the year ended June 30, 2023, and the Company’s subsequent filings with the SEC on Forms 10-Q and 8-K. The information in this release is provided only as of the date of this release, and the Company undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

Contact:

Stephen Kilmer
iBio, Inc.
Investor Relations
(646) 274-3580
[email protected]



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Fisker Announces Successful Closing of $170 Million Additional Convertible Notes Offering; Now Able to Offer Up to $623.3 Million Additional 0% Convertible Notes For Up to $550 Million in Gross Proceeds As a Result of Purchase Agreement Amendment

Fisker Announces Successful Closing of $170 Million Additional Convertible Notes Offering; Now Able to Offer Up to $623.3 Million Additional 0% Convertible Notes For Up to $550 Million in Gross Proceeds As a Result of Purchase Agreement Amendment

LOS ANGELES–(BUSINESS WIRE)–
Fisker Inc. (NYSE: FSR) (“Fisker”), driven by a mission to create the world’s most emotional and sustainable electric vehicles, today announced the successful closing of its previously announced offering of $170,000,000 in aggregate principal amount of 0% senior unsecured convertible notes due 2025 (the “Notes”) to an institutional investor (the “Investor”), with such Notes having an original issue discount of approximately 12%, resulting in gross proceeds of $150,000,000 to Fisker. The sale of the Notes to the Investor was completed, and the funds were received by Fisker, on Friday, September 29, 2023.

The Notes were sold pursuant to a previously announced Securities Purchase Agreement, dated July 10, 2023 (the “Original Purchase Agreement”), by and between the Company and the Investor, as amended by Amendment No. 1 to the Securities Purchase Agreement, dated September 29, 2023 (the “Purchase Agreement Amendment” and, together with the Original Purchase Agreement, the “Securities Purchase Agreement”).

As a result of the Purchase Agreement Amendment, Fisker may now offer up to an additional $623,333,334 in aggregate principal amount of 0% senior unsecured convertible notes under the Securities Purchase Agreement, with such notes having an original issue discount of approximately 12%, resulting in additional gross proceeds of up to $550,000,000 to Fisker.

About Fisker Inc.

California-based Fisker Inc. is revolutionizing the automotive industry by designing and developing individual mobility in alignment with nature. Passionately driven by a vision of a clean future for all, the company is on a mission to create the world’s most sustainable and emotional electric vehicle.

Forward-Looking Statements

This press release includes forward-looking statements, which are subject to the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “feel,” “believes,” expects,” “estimates,” “projects,” “intends,” “should,” “is to be,” or the negative of such terms, or other comparable terminology and include, among other things, the closing and issuance of additional notes pursuant to the Securities Purchase Agreement, and other future events that involve risks and uncertainties. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, which could cause actual results to differ materially from the forward-looking statements contained herein due to many factors, including, but not limited to: Fisker’s limited operating history; Fisker’s ability to enter into additional manufacturing and other contracts with Magna or tier-one suppliers in order to execute on its business plan; the risk that OEM and supply partners do not meet agreed-upon timelines or experience capacity constraints; Fisker may experience significant delays in the design, manufacture, regulatory approval, launch and financing of its vehicles; Fisker’s ability to execute its business model, including market acceptance of its planned products and services; Fisker’s inability to retain key personnel and to hire additional personnel; competition in the electric vehicle market; Fisker’s inability to develop a sales distribution network; and the ability to protect its intellectual property rights; and those factors discussed in Fisker’s Annual Report on Form 10-K, under the heading “Risk Factors”, filed with the Securities and Exchange Commission (the “SEC”), as supplemented by Quarterly Reports on Form 10-Q, and other reports and documents Fisker files from time to time with the SEC. Any forward-looking statements speak only as of the date on which they are made, and Fisker undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date of this press release.

European Media:

[email protected]

US Media:

[email protected]

Customer service:

[email protected]

Fisker Inc. Communications:

Matthew DeBord

Sr Director, Communications Strategy & Storytelling

[email protected]

Franziska Queling

Regional Head of Public Relations Europe

[email protected]

Investor Relations:

Frank Boroch, VP of Investor Relations

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Automotive General Automotive Automotive Manufacturing EV/Electric Vehicles Manufacturing Alternative Vehicles/Fuels

MEDIA:

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Ferguson plc (“Company”): Total Voting Rights

Ferguson plc (“Company”): Total Voting Rights

WOKINGHAM, England–(BUSINESS WIRE)–NOTIFICATION OF TOTAL VOTING RIGHTS AND CAPITAL IN THE COMPANY

In accordance with DTR 5.6.1, the Company hereby notifies the following:

The Company’s issued share capital as at September 30, 2023 consisted of 232,171,182 ordinary shares of 10 pence each (“Ordinary Shares”), of which 28,307,378 Ordinary Shares were held in treasury as at the date of this disclosure. The voting rights of treasury shares are automatically suspended.

Therefore, the total voting rights in the Company is 203,863,804. This figure may be used by shareholders as the denominator for the calculations by which to determine if they are required to notify their interest in, or a change to their interest in, the Company under the FCA’s Disclosure Guidance and Transparency Rules and the Company’s Articles of Association.

Enquiries:


Kate McCormick, Company Secretary

(0118 927 3827)

KEYWORDS: United Kingdom Europe

INDUSTRY KEYWORDS: HVAC Manufacturing

MEDIA:

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Cellectar Biosciences Expands Global Intellectual Property Portfolio with Four Patent Grants

FLORHAM PARK, N.J., Oct. 02, 2023 (GLOBE NEWSWIRE) — Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, today announced significant advancements to its global intellectual property (IP) portfolio.

Cellectar has secured four patents across the key global regions Europe, Australia and Canada, covering the company’s proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform and lead drug in development, iopofosine I 131, including the following:

The European Patent Office (EPO) has granted patent application number 20172745.0, titled “Ether Phospholipid Compounds for Treating Cancer and Imaging Detection of Cancer Stem Cells”. This patent significantly enhances the use of iopofosine I 131 for treating various cancers, including gliomas, lung cancer, melanoma, and more, with a focus on cancer stem cells. It also extends coverage for iopofosine I 131’s application in underserved pediatric diseases, supporting upcoming clinical advancements.

The Canadian Intellectual Property Office (CIPO), the Australian Patent Office (IP Australia) and the EPO have granted patent number 17814042.2 for “Phospholipid Ether Analogs for the Identification and Isolation of Circulating Tumor Cells”. This patent encompasses a method using cancer-targeted alkylphosphocholine analogs to effectively identify and isolate circulating tumor cells (CTCs) from various cancer types, providing a valuable diagnostic and research tool in the field of oncology. It underscores Cellectar’s ability to target not only primary tumors but also elusive tumor cells in challenging locations, such as the bloodstream, and metastatic tissue which are often seeded by circulating tumor cells marking a significant advancement in developing targeted cancer treatments.

The IP Australia and the EPO have granted patent application number WO 2019199998 A1, titled “Fractionated Dosing Of A Phospholipid Ether Analog For The Treatment Of Cancer”. This patent represents a significant milestone for Cellectar, extending comprehensive protection to the company’s innovative fractionated dosing regimen of iopofosine I 131 for the targeted treatment of cancer.

The EPO has granted patent number EP3229810 (B1) titled “Phospholipid Ether Analogs as Cancer-Targeting Drug Vehicles”, which extends protection to Cellectar Biosciences’ phospholipid ether (PLE) analogs for precisely and selectively delivering radiation to tumors and cancer stem cells, thus minimizing radiation exposure to normal tissues. This patent encompasses both the composition of matter and the method of use for the company’s PDC™ products, including iopofosine I 131, and enables the development of targeted anticancer agents for various hematologic and solid tumors.

“The issuance of these important patents underscores our platform and thereby our compounds’ unique ability to target not only the primary tumor but also sites of metastases and distinct small tumor cell populations in protected or difficult to access locations. They also provide important additional protection for our lead compound, iopofosine I 131 as well as for our other PDCs,” said James Caruso, president and CEO of Cellectar. “The expanded protection in these key global regions supplements our existing patent portfolio and the coverage with these patents we have already obtained in the US and other territories. We believe that safeguarding our intellectual assets is pivotal to drive our mission to transform cancer care, and we look forward to harnessing the full potential of our portfolio for the benefit of patients worldwide.”

About Cellectar Biosciences, Inc.

Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects.

The company’s product pipeline includes lead asset iopofosine I 131, a small-molecule PDC designed to provide targeted delivery of iodine-131 (radioisotope), proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.

For more information, please visit www.cellectar.com and www.wmclinicaltrial.com or join the conversation by liking and following us on the company’s social media channels: Twitter, LinkedIn, and Facebook.

Forward-Looking Statement Disclaimer

This news release contains forward-looking statements. You can identify these statements by our use of words such as “may,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” “continue,” “plans,” or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes including our expectations regarding the WM CLOVER-WaM pivotal trial. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the disruptions at our sole source supplier of iopofosine, the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, patient enrollment and the completion of clinical studies, the FDA review process and other government regulation, our ability to maintain orphan drug designation in the United States for iopofosine, the volatile market for priority review vouchers, our pharmaceutical collaborators’ ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2022, and our Form 10-Q for the quarter ended June 30, 2023. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.

Contacts

INVESTORS:
Monique Kosse
LifeSci Advisors
212-915-3820
[email protected]

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Bliss Bio Health
315-765-1462
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Ault Alliance Signs Listing Agreement to Sell St. Petersburg High-rise Multifamily Project for $20 Million Asking Price

Ault Alliance Signs Listing Agreement to Sell St. Petersburg High-rise Multifamily Project for $20 Million Asking Price

LAS VEGAS–(BUSINESS WIRE)–Ault Alliance, Inc. (NYSE American: AULT), a diversified holding company (“Ault Alliance,” or the “Company”) announced today its wholly owned subsidiary, Third Avenue Apartments LLC (“Third Avenue”), itself a wholly owned subsidiary of Ault Global Real Estate Equities, Inc. (“AGREE”), has listed for sale its multifamily development site in St. Petersburg, Florida. Third Avenue has signed a listing agreement with international brokerage firm CBRE Inc.

The decision to sell the approximately one-acre property follows the decision to also list the four hotels also owned by AGREE and is driven by the Company’s desire to focus on its core businesses, including the crane rental business, the California licensed lender, and data center operations, which includes Bitcoin mining. Another driving force for selling the property is the current macroeconomic climate and the high-interest rate environment the financial markets are experiencing. Overall, the development of a high-rise multifamily project does not fit the Company’s current focus or capital allocation strategy. However, the Company is extremely proud of the redeveloped project and is confident that potential developers will benefit from the time and effort expended by the Company and all parties involved in the process. The Company plans to use the proceeds from the sale of the St. Petersburg property to pay off debt and commit more capital to its core businesses.

The project was redeveloped to permit a 23-story, 285-unit, mixed use multifamily property with luxury amenities throughout. While maintaining city standards for integrating the development into the local St. Petersburg community, the project was meant to bring a youthfully expressive property to celebrate the lifestyle of all current and future residents. The redevelopment designed proposed by Third Avenue and approved by the local zoning board planned resort-style amenities, including a fitness center, bowling alley, golf simulator, pool and amenity deck, and a dedicated pet grooming space. The ground floor anticipated multiple retail spaces for potential tenants providing residents and locals dining, retail, and fitness options to complement the projects amenities.

Milton “Todd” Ault III, Executive Chairman of Ault Alliance, shared his insight on the decision to sell the project, “We are proud of the time and effort expended to bring this project to this point and are excited to deliver a shovel-ready development to potential purchasers and the St. Petersburg area. The Company believes this project, in hands of the right development group, will succeed in bringing a unique and lively development to a historic St. Petersburg downtown location.”

Ault concluded, “There can be no assurance that the project will be sold or that our asking price will be met. With that being said, the Company believes the project is well-situated to capitalize on the fast-growing St. Petersburg market. The Company is optimistic that the project will garner significant interest on the open market and is excited to work with any potential purchaser throughout the transition.” Interested parties are encouraged to contact Ault Alliance for further details.

For more information on Ault Alliance and its subsidiaries, Ault Alliance recommends that stockholders, investors, and any other interested parties read Ault Alliance’s public filings and press releases available under the Investor Relations section at www.Ault.com or at www.sec.gov.

About Ault Alliance, Inc.

Ault Alliance, Inc. is a diversified holding company pursuing growth by acquiring undervalued businesses and disruptive technologies with a global impact. Through its wholly and majority-owned subsidiaries and strategic investments, Ault Alliance owns and operates a data center at which it mines Bitcoin and offers colocation and hosting services for the emerging artificial intelligence ecosystems and other industries, and provides mission-critical products that support a diverse range of industries, including metaverse platform, oil exploration, crane services, defense/aerospace, industrial, automotive, medical/biopharma, consumer electronics, hotel operations and textiles. In addition, Ault Alliance extends credit to select entrepreneurial businesses through a licensed lending subsidiary. Ault Alliance’s headquarters are located at 11411 Southern Highlands Parkway, Suite 240, Las Vegas, NV 89141; www.Ault.com.

Forward-Looking Statements

This press release contains “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. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “believes,” “plans,” “anticipates,” “projects,” “estimates,” “expects,” “intends,” “strategy,” “future,” “opportunity,” “may,” “will,” “should,” “could,” “potential,” or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties.

Forward-looking statements speak only as of the date they are made, and the Company undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect the Company’s business and financial results are included in the Company’s filings with the U.S. Securities and Exchange Commission, including, but not limited to, the Company’s Forms 10-K, 10-Q and 8- K. All filings are available at www.sec.gov and on the Company’s website at www.Ault.com.

Ault Alliance Investor Contact:

[email protected] or 1-888-753-2235

KEYWORDS: United States North America Florida Nevada

INDUSTRY KEYWORDS: Other Construction & Property Residential Building & Real Estate Construction & Property

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Rithm Capital to Acquire Specialized Loan Servicing LLC

Rithm Capital to Acquire Specialized Loan Servicing LLC

Transaction Grows Newrez’s Third-Party Servicing Business to $180 Billion

NEW YORK–(BUSINESS WIRE)–
Rithm Capital Corp. (NYSE: RITM) (“Rithm Capital”), an asset manager focused on the real estate and financial services industries, today announced it has entered into a definitive agreement with Computershare Limited (ASX: CPU) (“Computershare”) to acquire Computershare Mortgage Services Inc. and certain affiliated companies, including Specialized Loan Servicing LLC (“SLS”), for a purchase price of approximately $720 million.

The acquisition includes approximately $136 billion in unpaid principal balance (UPB) of mortgage servicing rights, of which $85 billion is third-party servicing, along with SLS’s origination services business. Following the close of the transaction, SLS’s portfolio and operations will be transitioned to and managed by Newrez LLC (“Newrez”), a Rithm portfolio company.

“We are thrilled to welcome SLS to the Newrez family. Our track record of acquisitions in the mortgage servicing space continues to deliver value not only for our shareholders, but also for the millions of consumers we serve,” said Michael Nierenberg, Chairman, Chief Executive Officer and President of Rithm Capital.

“The addition of SLS continues to grow our best-in-class special servicing business and adds more clients and homeowners to the Newrez platform,” said Baron Silverstein, President of Newrez. “It further strengthens our origination and servicing channels, both of which are designed to deliver a customer experience that prioritizes a successful homeownership journey.”

“Rithm has strong mortgage industry credentials and the ability to bring capital to scale the business further. With its track record of successful M&A execution and integration, we expect a smooth transition for the business and our customers,” said Stuart Irving, CEO and President of Computershare.

Financing and Transaction Details

Rithm intends to finance the transaction through a mix of existing cash and available liquidity on the balance sheet, as well as additional MSR financing.

The transaction remains subject to customary closing conditions, including regulatory approvals. Completion is expected to take place in the first half of 2024.

For more information visit https://www.rithmcap.com/.

About Rithm Capital

Rithm Capital is an asset manager focused on the real estate and financial services industries. Rithm Capital’s investments in operating entities include leading origination and servicing platforms held through its wholly-owned subsidiaries, Newrez LLC, Caliber Home Loans Inc. and Genesis Capital LLC, as well as investments in affiliated businesses that provide residential and commercial real estate related services. The Company seeks to provide attractive risk-adjusted returns across interest rate environments. Since inception in 2013, Rithm Capital has delivered approximately $4.7 billion in dividends to shareholders. Rithm Capital is organized and conducts its operations to qualify as a real estate investment trust (REIT) for federal income tax purposes and is headquartered in New York City.

About Newrez

Newrez is a leading mortgage company that combines mortgage origination and servicing to provide a customer-first journey and helps our customers make smart moves throughout the lifetime of their mortgage loans. Differentiated by its origination platform, the Company provides customers with unparalleled lending options to purchase and refinance. Its servicing business services loans on behalf of Newrez customers and includes third-party servicing brand, Shellpoint Mortgage Servicing. Founded in 2008, Newrez is headquartered in Fort Washington, Pennsylvania and is a member of the Rithm Capital Family of Companies. Caliber Home Loans, part of the Newrez Family of Companies, is also a proven leader in the U.S. mortgage market with a diversified, customer-centric, purchase-focused platform with headquarters in Coppell, Texas.

About Computershare Limited (CPU)

Computershare (ASX: CPU) is a global market leader in transfer agency and share registration, employee equity plans, mortgage servicing, proxy solicitation and stakeholder communications. We also specialize in corporate trust and a range of other diversified financial and governance services.

Founded in 1978, Computershare is renowned for its expertise in high integrity data management, high volume transaction processing and reconciliations, payments and stakeholder engagement. Many of the world’s leading organizations use us to streamline and maximize the value of relationships with their investors, employees, creditors and customers.

Computershare is represented in all major financial markets and has over 14,000 employees worldwide.

For more information, visit www.computershare.com

Cautionary Note Regarding Forward-Looking Statements

Certain information in this press release may constitute “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are not historical facts. They represent management’s current expectations regarding future events and are subject to a number of trends and uncertainties, many of which are beyond Rithm Capital’s control, which could cause actual results to differ materially from those described in the forward-looking statements. Accordingly, you should not place undue reliance on any forward-looking statements contained herein. These risks and factors include, but are not limited to, the risks relating to the transaction, including in respect of the satisfaction of closing conditions and the timing thereof; unanticipated difficulties financing the transaction; unexpected challenges related to the integration of SLS’s businesses and operations; changes in general economic and/or industry specific conditions; difficulties in obtaining governmental and other third party consents in connection with the transaction; unanticipated expenditures relating to or liabilities arising from the transaction or the acquired businesses; uncertainties as to the timing of the transaction; litigation or regulatory issues relating to the transaction or the acquired business; the impact of the transaction on relationships with, and potential difficulties retaining, employees, customers and other third parties; and the inability to obtain, or delays in obtaining, expected benefits from the transaction.

For a discussion of some of the risks and important factors that could affect such forward-looking statements, see the sections entitled “Cautionary Statements Regarding Forward Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Rithm Capital’s most recent annual and quarterly reports and other filings filed with the U.S. Securities and Exchange Commission, which are available on Rithm Capital’s website (www.rithmcap.com). New risks and uncertainties emerge from time to time, and it is not possible for Rithm Capital to predict or assess the impact of every factor that may cause its actual results to differ from those contained in any forward-looking statements. Forward-looking statements contained herein speak only as of the date of this press release, and Rithm Capital expressly disclaims any obligation to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Rithm Capital’s expectations with regard thereto or change in events, conditions or circumstances on which any statement is based.

Rithm

Investor Relations

212-850-7770

[email protected]

Media

Jon Keehner / Sarah Salky

Joele Frank, Wilkinson Brimmer Katcher

(212) 355-4449

[email protected]

Newrez

Media

Zach Pardes

Chief Marketing Officer

212-850-5083

[email protected]

Computershare

Michael Brown

Investor Relations

Ph +61 (0) 400 24 8080

[email protected]

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Finance Professional Services Residential Building & Real Estate Asset Management Construction & Property

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Adtran brings advanced integration to OIF 400ZR+ demo at ECOC 2023

Adtran brings advanced integration to OIF 400ZR+ demo at ECOC 2023

News summary:

  • Showcase of open network architecture features enhanced flexibility and 400ZR+ performance

  • Adtran continues to champion multi-vendor collaboration and forge a wide range of partnerships

  • Adtran’s advanced system integration facilitates automated setup and seamless interoperability

GLASGOW, Scotland–(BUSINESS WIRE)–
Adtran today announced its key role in the Optical Internetworking Forum (OIF)’s multi-vendor 400ZR+ Optics Demo at ECOC 2023. Illustrating its longstanding commitment to advancing open network architectures, Adtran is showcasing the benefits of its collaborative ecosystem approach, emphasizing enhanced flexibility, optimized optical performance and integrated end-to-end operation. Central to the joint trial is Adtran’s FSP 3000 open line system (OLS), which brings new levels of flexibility to optical networks and facilitates an automated setup of 400ZR+ connections. Involving 12 companies specializing in pluggable modules plus routers and test equipment vendors, the demo showcases 400ZR+ transmission over metro-regional distances, unlocking new opportunities for data center and telecom operators.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231002385604/en/

Adtran’s open optical solution is playing a key role in the OIF’s 400ZR+ multi-vendor demo. (Photo: Business Wire)

Adtran’s open optical solution is playing a key role in the OIF’s 400ZR+ multi-vendor demo. (Photo: Business Wire)

“At Adtran, interoperability isn’t just a buzzword; it’s the foundation of our whole vision for optical networking. By seamlessly integrating 400ZR+ modules hosted in routers with our FSP 3000 open line system, we’re optimizing end-to-end network performance,” said Jörg-Peter Elbers, head of advanced technology at Adtran. “Alongside other industry pioneers, we’re highlighting the advancements we can achieve when we champion intelligent open architectures. It’s about delivering customized multi-vendor solutions that offer customers the utmost flexibility and best overall network performance at the same time.”

The showcased joint solution demonstrates not only superior optical performance but also streamlined setup and operation. Central to its efficiency, the Adtran FSP 3000 OLS ensures fine-tuning across all system aspects, especially in controlling and setting up the pluggable modules. This precision reflects Adtran’s commitment to collaboration with other vendors, fostering an environment where the line system, routers and pluggable modules from industry leaders like Acacia integrate seamlessly. Adtran balances industry standards with a flexible platform tailored to clients, highlighting the strength of its ecosystem relationships.

“This ECOC 2023 demo exemplifies what can be achieved with strategic collaboration and integration. Through our close work with partners, including leading component vendors, we’re helping enable the flexibility and optical performance our customers will need to navigate the evolving networking landscape of tomorrow,” commented Steve Penticost, VP of global business development at Adtran. “This event is a platform for unveiling technologies that epitomize synergy and partnership-driven innovation. By placing a clear emphasis on tailored solutions and adopting a holistic ecosystem approach, we’re not just addressing today’s challenges but also anticipating the future, ensuring our customers remain at the forefront of optical networking.”

Additional notes

OIF Achieves Milestone with Largest Ever Multi-Vendor Interoperability Demo at ECOC 2023, Featuring Nearly 40 Companies Accelerating Implementation of Next-Generation Capabilities

OIF will showcase its largest-ever multi-vendor interoperability demonstration at ECOC 2023, highlighting advancements in four key technology areas: 400ZR(+) optics, Co-Packaging solutions, Common Electrical I/O (CEI) channels and Common Management Interface Specification (CMIS) implementations. The collaborative efforts of OIF’s network operator, system vendor, component vendor and test equipment vendor members play a vital role in driving the adoption of technologies for both present and future networks. The live and static interoperability demos featuring 39 companies will be held at OIF’s booth, #304.

About Adtran

ADTRAN Holdings, Inc. (NASDAQ: ADTN and FSE: QH9) is the parent company of Adtran, Inc., a leading global provider of open, disaggregated networking and communications solutions that enable voice, data, video and internet communications across any network infrastructure. From the cloud edge to the subscriber edge, Adtran empowers communications service providers around the world to manage and scale services that connect people, places and things. Adtran solutions are used by service providers, private enterprises, government organizations and millions of individual users worldwide. ADTRAN Holdings, Inc. is also the largest shareholder of Adtran Networks SE, formerly ADVA Optical Networking SE. Find more at Adtran, LinkedIn and Twitter.

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ADTRAN Holdings, Inc.

www.adtran.com

For media

Gareth Spence

+44 1904 699 358

[email protected]

For investors

Steven Williams

+49 89 890 665 918

[email protected]

KEYWORDS: United Kingdom Europe

INDUSTRY KEYWORDS: Technology Professional Services Security Telecommunications Software Networks Internet Mobile/Wireless Hardware Finance Electronic Design Automation

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Adtran’s open optical solution is playing a key role in the OIF’s 400ZR+ multi-vendor demo. (Photo: Business Wire)