On August 30, 2022 CLINUVEL reported its sixth consecutive annual net profit, driven by revenues of $66.987 million, a 38% increase. For the year ending 30 June 2022 (FY2022), the Group has reported profit after income tax expense (NPAT) of $20.876 million and profit before income tax expense (PBIT) of $34.321 million, as disclosed in its Appendix 4E and Annual Report (Press release, Clinuvel, AUG 30, 2022, View Source;mc_eid=a3338e0afe [SID1234618781]). The Group also reported a non-IFRS measure of adjusted net profit before tax of $39.837 million, which adjusts for certain material non-cash items that do not impact the Group’s cash position.

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"CLINUVEL’s commercial operations are scaling up to meet treatment demand worldwide, while the Group is pursuing R&D projects which aim to add value over the long-term," CLINUVEL’s Chief Financial Officer, Mr Darren Keamy said. "Our FY2022 results show a fundamentally strong business to date, allowing us to invest for future growth.

"Improved cash inflows this year have further bolstered the Company’s cash reserves enabling us to continue the implementation of a growth strategy in the face of difficult economic headwinds. The strong cash position has also allowed the Board to declare an increase in dividend this year, most of all recognising the loyalty and patience of long-term shareholders. We remain focused to translate our technology to the benefit of patients and specialised populations, particularly those at highest risk of light-induced damage and skin cancer," Mr Keamy said.

SIX YEARS OF REVENUE GROWTH AND PROFIT
CLINUVEL remains one of the few ASX-listed bio-pharmaceutical sciences companies to generate a profit. In FY2022 the Company delivered its sixth consecutive year of positive cashflow, revenues and profit, while maintaining control of operating expenses to facilitate growth and expansion.

The Group has outlined a clear long-term growth strategy reinvesting a large percentage of proceeds into new development. The expansion strategy is enabled by the ongoing increase of cash inflows from commercial operations. The accumulated cash reserves increased by $38.818 million (47%) during FY2022 to stand at $121.509 million as of 30 June 2022. CLINUVEL has committed to expenditures of $175 million over the five years to 30 June 2025 to achieve its growth and expansion objectives and, based on expenses in FY2021 and FY2022, is on track to achieve this projection.

INCREASE IN ANNUAL DIVIDEND
Following the financial results for the year ending 30 June 2022, the CLINUVEL Board has declared an increase to its full-year dividend distribution to $0.04 per ordinary share fully franked, up from 2.5 cents per share unfranked for the full year to 30 June 2021. This is the fifth consecutive dividend declared by the Group. Subject to sufficient cash reserves, the key dates for the dividend are:

Ex-dividend date: 06 September 2022;
Record date: 07 September 2022; and
Payment date: 21 September 2022.

Dividends are available to Australian and overseas registered shareholders, including holders of CLINUVEL’s Level 1, American Depository Receipts. Prior to the record date, shareholders are encouraged to confirm their personal shareholder information, including payment election information, with the share registrar.

On August 30, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer and Takeda Israel, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502/NSY:TAK) ("Takeda"), reported that the Israeli Ministry of Health has approved DANYELZA in Israel for the treatment, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy (Filing, 8-K, Y-mAbs Therapeutics, AUG 30, 2022, View Source [SID1234618780]).

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In Israel, DANYELZA is expected to be commercialized by Takeda Israel, under the exclusive license and distribution agreement entered in 2020 between Takeda Israel and the Company.

"The regulatory approval of DANYELZA in Israel represents our first marketing authorization outside of the U.S. and is a milestone for our collaboration with Takeda and more importantly for the pediatric patients we are dedicated to serving," said Thomas Gad, President, and Interim Chief Executive Officer. "The approval in Israel further demonstrates our commitment to expanding the reach of our commercial stage products internationally to patients with unmet medical needs."

"We are extremely excited by the approval of DANYELZA in Israel," said Arie Kramer, General Manager of Takeda Israel. "This registration, following the expedited reimbursement of the product last December by the Israeli Ministry of Health, allowing Takeda and Y-mAbs to offer a new innovative treatment for pediatric neuroblastoma patients in Israel, is in alignment with Takeda’s vision of Better Health and Brighter Future to every patient in the world."

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compound.

About DANYELZA (naxitamab-gqgk)

DANYELZA (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for complete Boxed Warning and other important safety information.

On August 30, 2022 Onxeo S.A. (Euronext Growth: ALONX, Nasdaq First North: ONXEO), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR) in particular against rare or resistant forms of cancer, reported that Nasdaq approved the removal of shares from First North Growth trading (Press release, Onxeo, AUG 30, 2022, View Source [SID1234618779]).

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Delisting/removal of shares

As announced on August 17, 2022, the Combined General Meeting of Onxeo SA has approved that the Company’s shares are to be delisted and removed from trading on Nasdaq’s First North Growth market.

Onxeo has subsequently applied for and received, by letter dated August 29, approval by Nasdaq Copenhagen that Onxeo shares are removed from trading on First North Growth. Shareholders holding Onxeo shares denominated in DKK and currently tradable on First North Growth (the "Danish Onxeo shares") are referred to as "Danish shareholders". These shares are issued via Euronext Securities (formerly VP Securities) in Denmark.

As a primary listing, Onxeo shares are listed for trading on Euronext Growth Paris, a multilateral trading facility. These shares denominated in euros (the "French Onxeo shares") are issued via Euroclear Bank N.V.

Both the French Onxeo shares and the Danish Onxeo shares are registered with the same security identification number ISIN FR0010095596. The rights attached to the Danish Onxeo shares and the French Onxeo shares are the same.

In accordance with Nasdaq Rulebook, Danish Onxeo shares will remain tradable on First North Growth, subject to availability of counterparties, for a period until November 8, 2022. After this period, they will be removed from trading and Onxeo will provide that these shares, issued via Euronext Securities, are exchanged for French Onxeo shares, issued via Euroclear and freely tradable on Euronext Growth, Paris.

Exchange of shares

Following the last day of trading on and removal from First North Growth, which will happen November 8, 2022, the Company is expecting to instruct Nordea Danmark, subsidiary of Nordea Bank Abp, Finland ("Nordea"), to exchange the Company’s Danish Onxeo shares with the Company’s French Onxeo shares, as Nordea holds such number of French Onxeo shares equal to and as basis for the issued Danish Onxeo shares.

Danish shareholders will receive one French Onxeo Share in exchange of each Danish Onxeo Share they hold. These shares, issued via Euroclear, will be deposited (by book entry) in a custody account that can contain Euroclear issued securities. For most, if not all, Danish shareholders this will constitute a foreign security and be placed in a foreign custody account. Danish shareholders’ banks holding the current custody account for shares in Euronext Securities are expected to have custody accounts for foreign securities with correspondent banks in which to hold the French Onxeo shares.

The exchange will be made with Onxeo discharging the cost and fees of Nordea that would normally be the cost of a Danish Shareholder requesting to convert/exchange a Danish Onxeo Share with a French Onxeo Share.

The expected timetable after the removal from trading for the expected exchange of shares will be announced as soon as the detailed timetable has been agreed with Nordea, acting as the share issuing agent of Onxeo.

Tax

The Danish Onxeo shareholders are advised to seek independent tax advise based on the individual shareholders circumstances. However, based on existing case law an exchange of shares with identical shareholder rights (economical rights and voting rights) should as a main rule be tax-exempt. Against this background, it is Onxeo’s view that the proposed expected exchange of the Danish Onxeo shares with French Onxeo shares should be tax-exempt as the shares have identical rights for the shareholders towards the company, same ISIN and only differ by way of denomination (EUR/DKK) and the marketplace where the shares are admitted for trading (Euronext Growth/First North Growth).

Investors objecting to the share exchange

Onxeo is not seeking shareholders’ consent for the exchange of Danish Onxeo shares with French Onxeo share, because this operation is expected to be executed to provide Danish shareholders with the best possible and cheapest solution to maintain a share that can be traded on a trading platform.

In case Danish Onxeo Shareholders do not accept a share exchange, they will need to give their custody bank written notice hereof no later than November 8, 2022, 5 pm CET. As a result, they will remain holders of Danish Onxeo shares and Onxeo will seek to have such remaining Danish Onxeo shares de-registered from Euronext Securities. Upon deregistration, these Danish Onxeo shares will be cancelled and replaced by a physical certificate (the "Yellow Certificate") that will allow shareholders to receive French Onxeo shares from Nordea if and when they decide, at their own cost. If Danish Onxeo Shareholders objecting to the automatic exchange fail to collect (and ultimately convert) their Yellow Certificate granted to them at the de-registration, they would lose the possibility to trade their Onxeo shares.

On August 30, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported the closing of its rights offering and the final results thereof (Press release, Navidea Biopharmaceuticals, AUG 30, 2022, View Source [SID1234618778]).

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Navidea received aggregate gross cash proceeds of approximately $6.2 million in the rights offering. If exercised, additional gross proceeds of up to $11.6 million may be received through the exercise of warrants issued in the rights offering. The warrants are exercisable immediately, expire five years from the date of issuance and have an exercise price of $0.50 per share. In order to help maximize Navidea’s ability to use its net operating losses and other tax benefits in future years, Navidea’s board exercised its discretion to limit the number of units that John K. Scott, Jr., vice chairman of Navidea’s board, could purchase pursuant to the exchange and cancellation of his shares of Series F and Series G preferred stock. The rights offering resulted in the sale of 4,250 units pursuant to the exchange and cancellation of all outstanding shares of Navidea’s Series D and Series F preferred stock and no shares of Series G preferred stock were permitted to be exchanged by Mr. Scott.

Maxim Group LLC acted as dealer-manager for the rights offering.

The rights offering was made pursuant to the Company’s registration statement on Form S-1, which was declared effective by the U.S. Securities and Exchange Commission on August 3, 2022, and the prospectus supplement dated August 18, 2022. Subscription rights that were not exercised by 5:00 p.m., Eastern Time, on August 24, 2022, have expired.

The Company also announced it will host a conference call and webcast on Thursday, September 8, 2022 at 4:00 p.m. (EDT) to discuss the rights offering, clinical developments and financial results for the second quarter ended June 30, 2022.

Dr. Michael Rosol, Chief Medical Officer, Erika Eves, Vice President of Finance and Administration, Alexander Cappello, Board Chair, and John K. Scott, Jr., Board Vice Chair, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.

To participate in the call and webcast, please refer to the information below:

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On August 30, 2022 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical‑stage T-cell reprogramming company dedicated to developing curative cell therapies for patients with solid tumors, reported that members of its senior management team will participate in a fireside chat at the Morgan Stanley 20th Annual Global Healthcare Conference on Monday, September 12, at 1:05 p.m. ET (Press release, Lyell Immunopharma, AUG 30, 2022, View Source [SID1234618777]).

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A live webcast of the fireside chat can be accessed through the investor relations section of the Company’s website at www.lyell.com. A replay of the webcast will be available on the Company’s website for 90 days following the presentation.