Ariceum Therapeutics Q4 2022 Investor and Scientific Conference Attendance 

On September 15, 2022 Ariceum Therapeutics (Ariceum), a private biotech company developing a radiopharmaceutical product for the diagnosis and systemic targeted radiation therapy of certain hard-to-treat cancers, reported that its senior management team will be attending and hosting meetings at the following investor and scientific conferences in the fourth quarter of 2022 (Press release, Ariceum Therapeutics, SEP 15, 2022, View Source [SID1234619569])

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Terachem 2022: The Fourth International Symposium on Technetium and Other Radiometals in Chemistry and Medicine
14-17 September 2022, Forum Brixen, Bressanone, Italy

9th Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference (ITOC)
22-24 September 2022, Klinikum der Universität München, Munich, Germany

Optimum 14th Annual Healthcare Investor Conference
6 October 2022, Wellcome Collection, London, UK

European Association of Nuclear Medicine (EANM) 35th Annual Congress
15-19 October 2022, Barcelona International Convention Centre, Barcelona, Spain

BIO-Europe 2022
24-26 October 2022, Leipzig Messe, Leipzig, Germany

4th Targeted Radiopharmaceuticals EU Summit Europe
6-8 December 2022, Leonard Royal, Amsterdam, Netherlands

Presentation by: Chief Executive Officer, Manfred Rüdiger, Ariceum Therapeutics
Title: New Life for Satoreotide-The Antagonist Moves
Date & Time: 6 December, 12.00pm CET

European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Annual Congress
7-9 December 2022, Palexpo exhibition centre, Geneva, Switzerland

Vernalis Research, a fully owned subsidiary of HitGen Inc., and Contera Pharma A/S announce a strategic collaboration in the field of RNA-targeting small molecules in neurology

On September 14, 2022 Vernalis Research ("Vernalis"), a fully owned subsidiary of HitGen Inc., and Contera Pharma A/S ("Contera") reported a strategic drug discovery collaboration on an undisclosed target (Press release, Vernalis, SEP 14, 2022, View Source;utm_medium=rss&utm_campaign=vernalis-research-a-fully-owned-subsidiary-of-hitgen-inc-and-contera-pharma-a-s-announce-a-strategic-collaboration-in-the-field-of-rna-targeting-small-molecules-in-neurology [SID1234621490]).

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Under the terms of the agreement, Vernalis and Contera will use their respective expertise in fragment and structure-based drug design and RNA-based drug development within neuroscience to design small molecules against a particularly challenging target for a rare neurologic disorder. All costs of activities until a predefined milestone will be shared between the partners. Should that first stage of the collaboration be successful, the partners will have the option to extend the collaboration and Vernalis will be entitled to receive research funding, downstream milestones and royalties on candidates resulting from the partnership. Contera will be responsible for development and commercialization of these candidates. The partners also have the option to extend the collaboration beyond the initial target.

Mike Wood, Managing Director of Vernalis said: "This strategic partnership marks the entry of Vernalis into the exciting field of RNA-targeting small molecules. We are extremely pleased to work with Contera on this promising target and we look forward to expanding our collaboration to multiple targets in the field of neurology."

Kenneth Vielsted Christensen, CSO of Contera, said: "We are pleased to announce this agreement which marks the expansion of our drug discovery efforts within the exciting field of RNA therapeutics. RNA-targeting small molecules is an area of high attention and entering this field will allow us to broaden both our target and indication space. The partnership with Vernalis, which is at the forefront of drug discovery innovation, enables us to drug previously undruggable neurology targets by adding small molecules targeting RNA to our existing in-house ASO and siRNA capabilities. Vernalis, a world leader in drug discovery, is a strong partner and the perfect match for us in our efforts to discover and develop novel RNA therapeutics for patients suffering from neurological disorders".

Dr. Jin Li, Chairman of the Board and Chief Executive Officer of HitGen Inc., commented: "It is pleasing to see this collaboration between Vernalis and Contera. Targeting RNAs by small molecules or RNAi has become an exciting approach to developing innovative medicines for many diseases affecting human health. The technologies and expertise available at Vernalis and HitGen are highly relevant in this field. I look forward to seeing further progress from the collaboration.

MediciNova Receives Issue Notification for a New Patent Covering MN-166 (ibudilast) for the Treatment of Glioblastoma

On September 14, 2022 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that it has received an Issue Notification from the U.S. Patent and Trademark Office for a new patent which covers MN-166 (ibudilast) for the treatment of glioblastoma (Press release, MediciNova, SEP 14, 2022, https://investors.medicinova.com/news-releases/news-release-details/medicinova-receives-issue-notification-new-patent-covering-mn [SID1234619587]).

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This new patent is expected to expire no earlier than February 2039. The allowed claims cover a method of treating a patient diagnosed with glioblastoma or recurrent glioblastoma, wherein the patient expresses unmethylated MGMT, using MN-166 (ibudilast) in combination with one or more other therapeutic agents including temozolomide (TMZ), carmustine, bevacizumab, procarbazine, hydroxyurea, irinotecan, lomustine, nimotuzumab, sirolimus, mipsagargin, cabozantinib, onartuzumab, patupilone (epothilone B), and recombinant oncolytic poliovirus (PVS-RIPO). The allowed claims cover a wide range of doses of MN-166 (ibudilast) as well as the other therapeutic agents. The allowed claims also cover different types of glioblastoma including classical glioblastoma, proneural glioblastoma, mesenchymal glioblastoma, and neural glioblastoma.

Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc. commented, "We are very pleased to receive the issue notification for this new patent as it offers additional coverage compared to our other two patents covering glioblastoma. We have an ongoing clinical trial of MN-166 in combination with temozolomide for the treatment of recurrent glioblastoma at the Dana-Farber Cancer Institute, Harvard Medical School. Results of our glioblastoma animal model study showed that median survival was longer in the group that received combination treatment with MN-166 plus temozolomide compared to the group that received the standard treatment of temozolomide alone, and this data was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. Encouragingly, the FDA granted orphan-drug designation to MN-166 as adjunctive therapy to temozolomide for the treatment of glioblastoma based on this data."

About Glioblastoma

According to the American Association of Neurological Surgeons, glioblastoma is an aggressive brain cancer that often results in death during the first 15 months after diagnosis. Glioblastoma develops from glial cells (astrocytes and oligodendrocytes), grows rapidly, and commonly spreads into nearby brain tissue. Glioblastoma is classified as Grade IV, the highest grade, in the World Health Organization (WHO) brain tumor grading system. The American Brain Tumor Association reports that glioblastoma represents about 15% of all primary brain tumors and approximately 10,000 cases of glioblastoma are diagnosed each year in the U.S. Despite decades of advancements in neuroimaging, neurosurgery, chemotherapy and radiation therapy, only modest improvements have been achieved and the prognosis has not improved for individuals diagnosed with glioblastoma. Median survival is about 11-15 months for adults with more aggressive glioblastoma (IDH-wildtype) who receive standard treatment of surgery, temozolomide, and radiation therapy.

About MN-166 (ibudilast)

MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS).

Sermonix Pharmaceuticals Shares Details of First-Ever Known Durable Complete Clinical Response in a Metastatic ER+/HER2- Breast Cancer Patient With an ESR1 Mutation After Prior CDK4/6 Inhibitor Treatment Via Single-Agent Hormonally Based Regimen

On September 14, 2022 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat ESR1-mutated metastatic breast and gynecological cancers, reported shared a case report detailing the first-ever known finding of a durable complete response that could be characterized as complete clinical remission in a metastatic estrogen receptor-positive (ER+)/HER2- breast cancer patient with an ESR1 mutation after prior CDK4/6 inhibitor treatment upon participation in any single-agent hormonally based therapy (Press release, Sermonix Pharmaceuticals, SEP 14, 2022, View Source [SID1234619585]).

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The case report, "Durable Complete Remission of Metastatic ER+/HER2- Breast Cancer After Lasofoxifene Therapy," was initially shared Sept. 9 at the ninth-annual Metastatic Breast Cancer Research Conference in Park City, Utah. Lasofoxifene is Sermonix’s lead investigational drug.

The durable complete response (CR) was reported during Sermonix’s Phase 2 Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE 1, NCT03781063) study. The open-label, randomized study evaluated the efficacy of oral lasofoxifene versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation and progression-free survival as the primary endpoint. Top-line ELAINE 1 data was presented Sept. 10 during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 in Paris. Although not statistically significant, the results of the study numerically favored lasofoxifene.

The patient was recruited to the ELAINE 1 study and started treatment on Dec. 16, 2020. Her first radiological assessment, eight weeks after lasofoxifene initiation via PET-FDG scan, revealed no pathological uptake in her pleural lesions, a sum diameter of 14 mm (55% reduction) and significant reduction of the bony lesion in the ilium with no new pathological findings. Scans at Week 16 revealed further improvement up to complete radiological disappearance of all measurable and non-measurable lesions. Radiological complete response was maintained at 80 weeks (June 29, 2022).

"Achieving a complete response in metastatic breast cancer with endocrine treatment post CDK4/6 inhibitor is exceedingly uncommon, particularly with single-agent endocrine therapy," said Dr. Einav Nili Gal-Yam, M.D., Ph.D., ELAINE 1 principal investigator and head of the Breast Oncology Institute at Chaim Sheba Medical Center in Ramat Gan, Israel. "This is a very gratifying result, pointing to lasofoxifene’s potentially significant role in addressing the unmet needs of patients with ESR1 mutations. We look forward to the continued clinical development of this drug."

About Lasofoxifene
Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.

Bausch Health Announces Early Exchange Offer Results for Exchange Offers and Consent Solicitations

On September 14, 2022 Bausch Health Companies Inc. (NYSE/TSX: BHC) (the "Company") reported the results to date of its previously announced offers (the "Exchange Offers") to exchange the existing senior notes set forth in the table below (the "Existing Senior Notes") for up to an aggregate principal amount of $4.0 billion (subject to increase or decrease by the Offerors (as defined below), the "Maximum New Secured Notes Amount") of New Secured Notes (as defined below) and the related solicitations of consents (the "Consent Solicitations" and, together with the Exchange Offers, the "Offers") to amend certain provisions of the indentures (the "Proposed Amendments") with respect to the respective applicable series of Existing Senior Notes (Press release, Bausch Health, SEP 14, 2022, View Source [SID1234619572]). The terms and conditions of the offers and consent solicitations are described in an Exchange Offer Memorandum and Consent Solicitation Statement, dated August 30, 2022 (the "Exchange Offer Memorandum"). All terms and conditions of the Offers remain unchanged as set forth in the Exchange Offer Memorandum.

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Based on the aggregate principal amount of the Existing Senior Notes validly tendered (and not validly withdrawn) in the Offers as of the Early Tender Time and subject to the terms and conditions set forth in the Exchange Offer Memorandum, including the applicable Acceptance Priority Level, the Level 3 Tender Cap, the Exchange Consideration Reallocation (each, as defined in the Exchange Offer Memorandum) and proration, we would expect approximately $3,119 million of New Secured Notes to be issued in the Offers, consisting of approximately (i) $1,768 million in aggregate principal amount of new 11.00% First Lien Secured Notes due 2028 (the "New First Lien Notes"), (ii) $351 million in aggregate principal amount of new 14.00% Second Lien Secured Notes due 2030 (the "New Second Lien Notes" and, together with the New First Lien Notes, the "New BHC Secured Notes"), in each case, to be issued by the Company, and (iii) $1,000 million in aggregate principal amount of new 9.00% Senior Secured Notes due 2028 (the "Intermediate Holdco Secured Notes" and, together with the New BHC Secured Notes, the "New Secured Notes") to be issued by 1375209 B.C. Ltd. (the "Holdco Issuer" and, together with the Company, the "Offerors"), an existing wholly-owned unrestricted subsidiary of the Company that holds 38.6% of the issued and outstanding common shares of Bausch + Lomb Corporation. However, such principal amounts may be adjusted as a result of any additional participation from Eligible Holders tendering Existing Senior Notes in the Offers after the Early Tender Time and at or prior to the Expiration Time.

All Existing Senior Notes of a series validly tendered at or before the Expiration Time having a higher Acceptance Priority Level will be accepted before any Existing Senior Notes of another series tendered at or before the Expiration Time having a lower Acceptance Priority Level are accepted, even if the Existing Senior Notes having a lower Acceptance Priority Level were tendered prior to the Early Tender Time and the Existing Senior Notes having a higher Acceptance Priority Level were tendered after the Early Tender Time but on or prior to the Expiration Time. Accordingly, Existing Senior Notes validly tendered at or before the applicable Early Tender Time may be subject to proration if the Offerors accept Existing Senior Notes tendered after the applicable Early Tender Time but on or prior to the Expiration Time that have a higher Acceptance Priority Level than such Existing Senior Notes.

In addition, as of the Early Tender Time, the Company and BHA have received the requisite number of consents to adopt the Proposed Amendments with respect to the following series of Existing Senior Notes:
(i) 9.25% Senior Notes due 2026, (ii) 8.50% Senior Notes due 2027, (iii) 5.00% Senior Notes due 2028 and (iv) 7.00% Senior Notes due 2028. Pursuant to the terms set forth in the Exchange Offer Memorandum, the Company or BHA, as the case may be, intends to enter into a supplemental indenture with the respective trustee for each such series of Existing Senior Notes to effectuate the applicable Proposed Amendments, which would become operative upon the settlement date of the Offers; provided that, as described in the Exchange Offer Memorandum, if any series of Existing Senior Notes are subject to proration, the Consent Solicitation with respect to such series shall be terminated, the supplemental indenture shall not become operative with respect to such series and the terms of the existing indenture governing such series shall continue to apply.
Withdrawal rights for the Offers expired as of 5:00 p.m., New York City time, on September 13, 2022 (the "Withdrawal Deadline"). Because the Withdrawal Deadline is not being extended, holders may not withdraw previously tendered Existing Senior Notes or revoke any related consents, and any tenders and consents after the Early Tender Time may not be withdrawn or revoked, in each case, except as may be required by law.
Each Offer will expire at 11:59 p.m., New York City time on September 27, 2022, or any other date and time to which the Offerors extend such Offer in their sole discretion (such date and time for such Offer, as it may be extended, the "Expiration Time"), unless earlier terminated. Subject to the terms of the Offers, including the Maximum New Secured Notes Amount and the proration, Existing Senior Notes validly tendered after the Early Tender Time but on or prior to the Expiration Time and accepted for purchase will be entitled to receive the applicable Exchange Consideration set forth in the Exchange Offer Memorandum (but not the applicable Early Exchange Premium described therein) plus accrued and unpaid interest to the settlement date. Subject to all conditions of the Offers having been either satisfied or waived by the Offerors, the settlement date is expected to be within three business days following the Expiration Time or as promptly as practicable thereafter.
Each Offer is a separate offer and/or solicitation, and each may be individually amended, extended, terminated or withdrawn, subject to certain conditions and applicable law, at any time in the Offerors’ sole discretion, subject to the consent rights of the Supporting Holders (as defined in the Exchange Offer Memorandum), and without amending, extending, terminating or withdrawing any other Offer. No Offer is conditioned upon any minimum principal amount of Existing Senior Notes of any series being tendered nor the consummation of any other Offer. Additionally, notwithstanding any other provision of the Offers, the Offerors’ obligations to accept and exchange any of the Existing Senior Notes validly tendered pursuant to an Offer is subject to the satisfaction or waiver of certain conditions, as described in the Exchange Offer Memorandum, and each Offeror expressly reserves its right, subject to applicable law, to terminate any Offer and/or Consent Solicitation at any time.
The Offers are being made, and the applicable series of New Secured Notes are being offered, only to holders of the Existing Senior Notes who are either (a) persons other than "U.S. persons" as defined in Regulation S, and who agree to purchase the New Secured Notes outside of the United States, and who are otherwise in compliance with the requirements of Regulation S; or (b) persons who are reasonably believed to be both (i) "qualified institutional buyers" as defined in Rule 144A under the U.S. Securities Act of 1933, as amended (the "Securities Act") and to whom the New Secured Notes are offered in the United States in a transaction not involving a public offering, pursuant to Section 4(a)(2) of the Securities Act and (ii) qualified purchasers (as defined in Section 2(a)(51) of the U.S. Investment Company Act of 1940, as amended); provided that, in each case, if such holder (i) is a resident in Canada, such holder is required to complete, sign and submit to the exchange agent a Canadian holder form, which may be obtained from the information agent, or (ii) is in the European Economic Area or the United Kingdom, such holder is a "qualified investor" and is not a "retail investor". With respect to holders in the European Economic Area, a "retail investor" means a person who is one (or more) of: (i) a "retail client" as defined in point (11) of Article 4(1) of Directive 2014/65/EU (as amended, "MiFID II"); or (ii) a "customer" within the meaning of Directive (EU) 2016/97, where that customer would not qualify as a professional client as defined in point (10) of Article 4(1) of MiFID II; or (iii) not a "qualified investor" as defined in Regulation (EU) 2017/1129. The holders of Existing Senior Notes who have certified to the Offerors that they are eligible to participate in the Offers and Consent Solicitations pursuant to at least one of the foregoing conditions are referred to as "Eligible Holders." Eligible Holders may go to www.dfking.com/bhc to confirm their eligibility.
Full details of the terms and conditions of the Offers are described in the Exchange Offer Memorandum. The Offers are only being made pursuant to, and the information in this press release is qualified in its entirety by reference to, the Exchange Offer Memorandum, which is being sent by the Offerors to Eligible Holders of the Existing Senior Notes. Eligible Holders of the Existing Senior Notes are encouraged to read these documents, as they contain important information regarding the Exchange Offers and the Consent Solicitations. This press release is neither an offer to purchase nor a solicitation of an offer to buy any Existing Senior Notes in the Exchange Offers or the Consent Solicitations.
Requests for the Exchange Offer Memorandum and other documents relating to the Offers may be directed to D.F. King & Co., Inc., the exchange agent and information agent for the Offers, at (212) 232-3233 (for banks and brokers only) or (877) 478-5045 (toll-free) (for all others) or [email protected].
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None of the Company, the Holdco Issuer, any of their respective subsidiaries or affiliates, or any of their respective officers, boards of directors or directors, the dealer manager and solicitation agent, the exchange agent and information agent or any trustee is making any recommendation as to whether Eligible Holders should tender any Existing Senior Notes in response to the Exchange Offers or deliver any consents pursuant to the Consent Solicitations and no one has been authorized by any of them to make such a recommendation. Eligible holders must make their own decision as to whether to tender their Existing Senior Notes and deliver consents, and, if so, the principal amount of Existing Senior Notes as to which action is to be taken.
The Offers are not being made to Eligible Holders of Existing Senior Notes in any jurisdiction in which the making or acceptance thereof would not be in compliance with the securities, blue sky or other laws of such jurisdiction. In any jurisdiction in which the Offers are required to be made by a licensed broker or dealer, the Offers will be deemed to be made on behalf of the Company, the Holdco Issuer and BHA, as applicable, by the dealer manager and solicitation agent, or one or more registered brokers or dealers that are licensed under the laws of such jurisdiction.
The New Secured Notes have not been and will not be registered under the Securities Act, or any state securities laws and may not be offered or sold in the United States, except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws. The New Secured Notes have not been and will not be qualified for sale to the public by prospectus under applicable Canadian securities laws and, accordingly, any issuance of New Secured Notes in Canada will be made on a basis which is exempt from the prospectus requirements of such securities laws.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy the New Secured Notes in the United States and shall not constitute an offer, solicitation or sale of the New Secured Notes in any jurisdiction where such offering or sale would be unlawful. There shall not be any sale of the New Secured Notes in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.