On July 5, 2022 Nordic Nanovector ASA (OSE: NANOV) reported an update on PARADIGME, its Phase 2b trial of Betalutin (177Lu lilotomab satetraxetan) in 3rd-line relapsed and anti-CD20 refractory follicular lymphoma (3L R and R FL) (Press release, Nordic Nanovector, JUL 5, 2022, View Source [SID1234616506]). Following a comprehensive review and independent data evaluation of PARADIGME and a subsequent request for regulatory agency interaction, the Board of Directors (Board) has taken the difficult decision to discontinue the study. No further patients will be enrolled into PARADIGME.

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The PARADIGME trial enrolled a total of 109 patients. The Company will now ensure a wind-down of PARADIGME in a structured manner ensuring patients receive the best possible care during this period.

While Betalutin, at the selected dose of 15 MBq/kg after a pre-dose of 40 mg lilotomab (40/15), has continued to display an attractive safety profile and positive signs of efficacy in some patients, the Board considers that the observed profile does not fully meet the objectives set out for the PARADIGME study. Only one out of three patients responded to the treatment with the average duration of the response of approximately six months. As a result, the Board is of the opinion that the demonstrated profile is no longer sufficiently competitive to bring Betalutin to the market in the third line relapsed and refractory FL indication, within a timeframe that makes financial and commercial sense for the Company.

The Company still believes there could be a market for Betalutin in light of its safety profile, promising efficacy in earlier lines of therapy and unique feature of being delivered as a one-time dose. However, a potential new development programme would need to be conducted in a different patient population and line of treatment. The Company will therefore explore potential partnerships and will also seek advice from the US Food and Drug Administration (FDA) to discuss if there could be a possible way forward for Betalutin in an alternative setting.

The Company will now focus its efforts and resources on developing its pipeline of proprietary CD37-targeting products from which Nordic Nanovector believes it can create value for shareholders over the longer term. These pipeline opportunities include:

Humalutin, a radioimmunotherapy candidate based on a chimeric anti-CD37 antibody and the beta-emitting radionuclide lutetium-177 for non-Hodgkin lymphoma (NHL).
Alpha37, an alpha-emitting radioimmunotherapy candidate based on a chimeric anti-CD37 antibody conjugated to lead-212, currently being explored with partner OranoMed for relapsed/refractory chronic lymphocytic leukaemia.
A portfolio of fully humanized anti-CD37 antibodies with potential in haematological cancers and autoimmune diseases.
A CD37 DOTA CAR-T cell opportunity in haematological cancers, which is the subject of a research collaboration with the University of Pennsylvania.
Following the decision to discontinue PARADIGME, the Board has also decided to implement a restructuring of the Company with immediate effect with the purpose of reducing costs where necessary to enable support of essential activities associated with development of the pipeline.

The Company’s cash position at the end of Q2 2022 was approximately NOK 280m (end of Q1 NOK 356.3m). Full Q2 results will now be reported on 31 August.

Chairman, Jan H. Egberts commented: "The decision to discontinue PARADIGME is extremely disappointing not only for the Nordic Nanovector team, but also for patients, healthcare providers and our shareholders as there continues to be an unmet medical need in frail and elderly patients with Follicular Lymphoma. The new independently reviewed data from PARADIGME, in an increasingly competitive market and with the slow speed of recruitment makes progressing PARADIGME further very difficult. Consequently, the Board no longer sees a viable path to commercialisation in the current indication that would make sense for the Company and its shareholders. We are extremely grateful to all the clinical investigators and patients who have participated in PARADIGME.

CEO, Erik Skullerud commented: Our focus will now shift to our pipeline of other CD37-targeting assets, which give us multiple shots on goal, including Humalutin, Alpha37, a portfolio of fully humanized anti-CD37 antibodies and the CD37 CAR-T. We look forward to communicating our development plans for these assets in more detail in the coming months."

Nordic Nanovector will host a webcast at 08.30 CEST on Wednesday 6 July, elaborating on the strategic decision to stop PARADIGME and including a Q&A session. To join the webcast please sign up via our website www.nordicnanovector.com.

On July 5, 2022, Adamis Pharmaceuticals Corporation, a Delaware corporation (the "Company"), reported that entered into a Securities Purchase Agreement (the "Purchase Agreement") with Lincoln Park Capital Fund, LLC (the "Investor" or the "Purchaser"), pursuant to which the Company issued on July 5, 2022 (the "Closing Date"), in a private placement transaction (the "Offering" or the "Transaction"), an aggregate of 3,000 shares (the "Shares") of Series C Convertible Preferred Stock, par value $0.0001 per share (the "Series C Preferred"), together with warrants (the "Warrants") to purchase up to an aggregate of 750,000 shares (the "Warrant Shares") of common stock of the Company ("Common Stock") at an exercise price of $0.47 per share (subject to adjustment as provided in the Warrants, the "Exercise Price"), for an aggregate subscription amount equal to $300,000 (Filing, 8-K, Adamis Pharmaceuticals, JUL 5, 2022, View Source [SID1234616495]). The Warrant becomes exercisable commencing January 3, 2023, and has a term ending on January 5, 2028.

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The Company previously filed a preliminary proxy statement with the Securities and Exchange Commission (the "SEC" or the "Commission") relating to its upcoming 2022 annual meeting of stockholders (the "Meeting"). As disclosed in the preliminary proxy statement, one of the items to be considered by the Company’s stockholders at the Meeting is a proposal to adopt and approve a proposed amendment to the Company’s Restated Certificate of Incorporation and authorize the Board of Directors of the Company (the "Board"), in its sole discretion, to effect a reverse stock split of the outstanding shares of Common Stock at any time on or before December 31, 2022, at a reverse stock split ratio ranging from 1-for-2 to 1-for-15, as determined by the Board at a later date. The Purchase Agreement requires that the Company convene, no later than August 15, 2022 (assuming no review of the Company’s proxy statement by the Commission), an annual meeting or special meeting of stockholders for the purpose of presenting to the Company’s stockholders a proposal (the "Proposal") to approve a reverse stock split of its outstanding Common Stock (the "Reverse Stock Split"), with the recommendation of the Board that the Proposal be approved, and that the Company use reasonable best efforts to obtain approval of the Proposal.

Pursuant to the Purchase Agreement, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock (the "Certificate of Designation") with the Secretary of State of Delaware designating the rights, preferences and limitations of the Series C Preferred. The Certificate of Designation provides, among other things, that except as otherwise provided in the Certificate of Designation or as otherwise required by law, the Series C Preferred will have no voting rights (other than the right to vote as a class on certain matters as provided in the Certificate of Designation). However, pursuant to the Certificate of Designation, each share of Series C Preferred entitles the holder thereof (i) to vote on the Proposal and any proposal to adjourn any meeting of stockholders called for the purpose of voting on the Proposal, and (ii) to 1,000,000 votes per share of Series C Preferred on the Proposal and any such adjournment proposal. The Series C Preferred shall, except as required by law, vote together with the Common Stock (and other issued and outstanding shares of preferred stock entitled to vote), as a single class; provided, however, that such shares of Series C Preferred shall, to the extent cast on the Proposal or any such adjournment proposal, be automatically and without further action of the holders thereof voted in the same proportion as the shares of Common Stock (excluding any shares of Common Stock that are not voted) and any other issued and outstanding shares of preferred stock of the Company entitled to vote (other than the Series C Preferred or shares of such other preferred stock, if any, not voted) are voted on the Proposal. The Purchaser has agreed in the Purchase Agreement to vote the shares of Series C Preferred purchased in the Offering in favor of the Proposal, in the manner and to the extent set forth in the Certificate of Designation, in a manner that "mirrors" the proportions on which the shares of Common Stock (excluding any shares of Common Stock that are not voted) and any other issued and outstanding shares of preferred stock of the Company entitled to vote (excluding the Series C Preferred and shares of such other preferred stock, if any, not voted) are voted on the Proposal.

On July 5, 2022 OBI Pharma, a Taiwan biopharma company (TPEx: 4174), reported discontinuation of the Phase 1/2 Study* for OBI 888, a Globo H antibody, upon completion of enrollment in our investigative sites (Press release, OBI Pharma, JUL 5, 2022, View Source [SID1234616494]).

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"We are pleased that the preliminary data from our Phase 1/2 study demonstrated that OBI 888 is a safe and well tolerated product and showed some trends of efficacy. However, due to the higher antibody amount required for the OBI-888 treatment compared to the ADC, OBI-999, and an unexpected low drug yield at the large manufacturing scale, OBI-888 no longer fulfills our goal of developing cost-effective therapies for cancer patients. We have therefore decided to discontinue OBI-888 development and focus on our novel cancer pipeline under Phase 3 (Adagloxad Simolenin-vaccine) and Phase 2 (OBI 999-ADC, OBI 833-vaccine and OBI 3424-small molecule) clinical development. The OBI-888 clinical study report is estimated to be finalized in Q4, 2022 and presented at a future medical conference.

"OBI Pharma is excited to develop and validate our novel anti-Globo H, AKR1C3 and Trop 2 pipeline to fulfill unmet medical needs of cancer patients," stated, Michael Chang, OBI Pharma Chairman and CEO.

On July 5, 2022 GSK plc (LSE/NYSE: GSK) reported that it will as a consequence of its proposed demerger of the Consumer Healthcare business on 18 July 2022 disclose its Q2 2022 results on 27 July 2022 in accordance with the requirements of IFRS 5 – ‘Non-current Assets Held for Sale and Discontinued Operations’ (Press release, GlaxoSmithKline, JUL 5, 2022, View Source [SID1234616491]). GSK has now satisfied the formal criteria for treating Consumer Healthcare as a ‘Discontinued operation’ effective from 30 June 2022, accordingly it will no longer present the Consumer Healthcare business within ‘Continuing operations’ and will also disclose the assets and liabilities of the Consumer Healthcare business as assets and liabilities held for sale/distribution. The GSK Group (‘Group’) will continue to consolidate the business for reporting purposes until the demerger of the Consumer Healthcare business has completed. Details of the demerger are included in the published Prospectus and Circular for the proposed demerger of the Consumer Healthcare business to form Haleon plc (‘Haleon’).

Requirements of IFRS 5 – ‘Non-current Assets Held for Sale and Discontinued Operations’

GSK has satisfied the requirements under IFRS 5 to treat the Consumer Healthcare business as a ‘disposal group’ effective from 30 June 2022, as it is expected that the carrying amount of the disposal group will be recovered principally through disposal and a distribution, it is available for distribution in its present condition (subject only to the steps to be completed that are usual and customary for the demerger of a business) and it is considered highly probable (the expected date of the demerger being 18 July 2022).

As a consequence of meeting these formal criteria, the Consumer Healthcare business will no longer be presented as ‘Continuing operations’, which will result in the following changes to the presentation of the Q2 2022 results on 27 July 2022:

● Turnover, cost of sales, SG&A expenses, research and development expenses, royalty income, other income and expenses, operating profit, profit before taxation, profit after taxation from continuing operations and Adjusted[1] results of the Group will be presented on the basis of the ‘Continuing operations’ of the Group, with the component of the post-tax Group results attributable to ‘Discontinued operations’ presented as a single line item in the Income Statement. The Total post-tax results of the Group will include ‘Continuing’ and ‘Discontinued operations’.

● The earnings per share of the Group will be presented separately between the earnings per share attributable to ‘Continuing operations’ and earnings per share attributable to ‘Discontinued operations’. Adjusted earnings per share will only be presented for ‘Continuing operations’. Earnings per share for Q2 2022 and for prior periods will be adjusted to reflect the impact of the GSK share consolidation expected to take place following the demerger but prior to the Q2 results announcement on 27 July 2022. The earnings per share figures presented below are based on the current pre-consolidation GSK share capital structure.

● Comparative income statement information will be re-presented on a consistent basis;

● GSK will no longer present a Consumer Healthcare segment and those items previously reported within the Consumer Healthcare segment that do not form part of the ‘Discontinued operations’ of the Group will be shown as part of ‘Continuing operations’ and reported within either the Commercial Operations segment or Corporate and unallocated costs, as appropriate;

● Disclosure of the Total turnover, expenses, pre-tax profit and tax expense of the ‘Discontinued operations’ will be reported as an additional disclosure on a Total basis only;

●The respective totals of the net cash inflow from operations, the net cash inflow from operating activities, the net cash flow from investing activities and the net cash flow from financing activities will be shown split between ‘Continuing operations’ and ‘Discontinued operations’. Free cash flow[2] will be presented only for ‘Continuing operations’;

● The assets and liabilities of the Consumer Healthcare ‘disposal group’ will be presented on the face of the Group balance sheet as assets held for sale/distribution and liabilities held for sale/ distribution respectively as current assets and liabilities. Analysis of the main categories of assets and liabilities reported as assets and liabilities held for sale/distribution will be presented as a note to the financial statements.

Impact of the application of the requirements of IFRS 5

The application of the requirements of IFRS 5 has no impact on the total post-tax results of the Group in the presentation of the restated historical information. However, as a result of the reclassification of the assets and liabilities of the Consumer Healthcare business (the ‘disposal group’) to assets and liabilities held for sale/ distribution with effect from 30 June 2022, they are held at the lower of carrying amount and fair value less costs to distribute and from that point onwards, depreciation and amortisation ceases on those tangible and intangible assets reclassified as part of the assets held for sale/distribution.

The application of IFRS 5 also has no impact on the total reported cash flows of the Group, although under the requirements of IFRS 5, the total for each category of the reported cash flows of the Group (net cash inflow from operations, cash flow from operating activities, cash flow from investing activities and cash flow from financing activities) should be presented split between ‘Continuing’ and ‘Discontinued operations’.

As a result of the presentational changes, cash generated from operations for the full year 2021 was £7,249 million for ‘Continuing operations’ (Q1 2021: £406 million; Q1 2022: £2,353 million) and cash generated from operations was £1,994 million for ‘Discontinued operations’ (Q1 2021: £80 million; Q1 2022: £402 million).

Net cash inflow from continuing operating activities for the full year 2021 was £6,277 million (Q1 2021: £316 million; Q1 2022: £2,207 million) and net operating cash flows attributable to discontinued activities was £1,675 million (Q1 2021: £15 million; Q1 2022: £335 million).

Net increase/(decrease) in cash and bank overdrafts from ‘Continuing operations’ for the full year 2021 was £(2,505) million (Q1 2021: £(900) million; Q1 2022: £283 million) and net increase/(decrease) in cash and bank overdrafts attributable to ‘Discontinued operations’ was £1,091 million (Q1 2021: £(193) million; Q1 2022: £6,639 million).

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Impact on the Group’s reportable segments

The Group presents its segmental results based on the Adjusted results of the Group from ‘Continuing operations’ and will therefore exclude the Consumer Healthcare business from Q2 2022. As a result, the Group will no longer report a Consumer Healthcare segment. The Group will continue to report the results of the Commercial Operations segment and the Research and Development segment.

As a result of reporting the results of the continuing operations of GSK and no longer reporting the Consumer Healthcare segment, the results of the Commercial Operations segment and those costs shown under Corporate and unallocated costs for prior periods have been revised. This reflects the following principal changes:

● Certain revenues and costs reported within the Consumer Healthcare segment will be split between the ‘Continuing operations’ and ‘Discontinued operations’ of the Group income statement, primarily reflecting contract manufacturing that will continue to be performed by GSK on behalf of the Haleon group after the demerger. The value of the sales and related costs that will be included in the ‘Continuing operations’ of the Group will be reported as part of the Commercial Operations segment;

● The Consumer Healthcare segment included some markets that were not within the perimeter of the Consumer Healthcare joint venture with Pfizer and will not be part of the Consumer Healthcare business to be demerged. These will be reported as part of the Commercial Operations segment.

● Corporate costs that were allocated to the Consumer Healthcare segment and will continue to be incurred by GSK after the demerger. These costs will be reported within the Corporate and unallocated costs as ‘Continuing operations’. Corporate costs incurred by GSK in prior periods on behalf of Consumer Healthcare that have been transferred to Haleon group companies ahead of the demerger will be reported as part of ‘Discontinued operations’.

The impact of these ‘Continuing operations’ sales and costs previously reported in the Consumer Healthcare segment and that do not form part of the ‘Discontinued operations’ do not materially change the reported performance of the Commercial Operations segment.

The tables below set out the revised format for reporting the income statement under the requirements of IFRS 5 that will be applied from the Q2 2022 results, as applied to the Q1 2021, Q2 2021, Q3 2021, Q4 2021 and full year 2021 and the Q1 2022 results.

On July 5, 2022 Lyra Therapeutics, Inc. (Nasdaq: LYRA), a clinical-stage therapeutics company leveraging its proprietary XTreo platform to enable precise, sustained and local delivery of medications to the ear, nose and throat (ENT) passages and other diseased tissues, reported that Richard Nieman, MD, has been appointed Chief Medical Officer, effective July 11, 2022 (Press release, Lyra Therapeutics, JUL 5, 2022, View Source [SID1234616488]). Dr. Nieman brings more than 25 years of experience in drug development and medical affairs, with a proven track record in developing medicines through commercialization and beyond.

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"We’re pleased to welcome Dr. Nieman as our Chief Medical Officer," said Maria Palasis, PhD, CEO of Lyra Therapeutics. "Dr. Nieman joins the Lyra team at a critical time with our lead candidate LYR-210 in pivotal Phase 3 trials. Having successfully developed and launched numerous innovative medicines for patients and their families during the course of his career, his experience building and leading medical organizations will be invaluable as we work to bring new treatments to patients with chronic rhinosinusitis (CRS)."

"I’m thrilled to be taking on this role during such an exciting time in Lyra’s growth and evolution with late-stage clinical programs," said Dr. Nieman. "There is a significant need for effective treatments for patients suffering with CRS, and I look forward to working with the Lyra team to build on the compelling data to date and contributing my abilities and experience as the company drives towards commercialization."

Dr. Nieman, a respiratory physician (pulmonologist) with deep pharmaceutical medicine experience, has had prior leadership roles as SVP & Worldwide Medical Head of Immunology at Bristol Myers Squibb (BMS), Head of R&D China at BMS, Global Medical Officer & Head of Medical at Teva, and Head of Asia Pacific Medical at Bayer. At Teva, he led the company’s medical and heath economic and outcome research (HEOR) function of 550 professionals and was a member of the Specialty Executive Team. In addition to his U.S. experience and credentials, Richard has also spent significant time working in China, throughout Asia and in Europe. He has been involved in bringing numerous important medicines to the market in the U.S. and Europe, including Cinquair in asthma, Copaxone 40 mg 3x/week in multiple sclerosis, Austedo in movement disorders, Ajovy in migraine and Xarelto in thrombosis and stroke prevention. Richard is a Fellow of the UK Royal College of Physicians, a Visiting Senior Lecturer at the School of Cancer and Pharmaceutical Sciences, Kings College, London, and was a Visiting Professor at Fudan University School of Public Health in Shanghai, China. He has published extensively and trained and practiced medicine in the UK. Dr. Nieman assumes the role of Chief Medical Officer previously held by Dr. Robert Kern, who will continue to work closely with the Company in the role of Chief Clinical Advisor.

Lyra has approved the issuance of an equity-based award pursuant to its 2022 Inducement Award Plan to Dr. Nieman upon the commencement of his employment. The inducement grant was approved by a majority of the Company’s independent directors and was made as a material inducement to Dr. Nieman’s acceptance of employment with Lyra in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of his employment compensation. The inducement grant consists of a non-qualified stock option to purchase an aggregate of 230,000 shares of the Company’s common stock. The inducement grant is subject to the terms and conditions of the award agreement covering the performance stock option grant and the Company’s 2022 Inducement Award Plan.