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].
3
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.

Transcenta Received IND Clearance from FDA for Its First-In-Class Gremlin1 Targeting Antibody TST003 for the Treatment of Solid Tumors

On September 14, 2022 Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, reported that TST003, its first-in-class, high affinity humanized monoclonal antibody targeting Gremlin1, has received IND clearance from U.S. Food and Drug Administration (FDA) (Press release, Transcenta, SEP 14, 2022, View Source [SID1234619568]).

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Gremlin1, a member of the TGF-β super family, is highly expressed by stromal cells in diverse human carcinomas, such as esophageal cancer, pancreatic cancer, gastric cancer, colon cancer, lung cancer, breast cancer and prostate cancer and is associated with tumorigenesis, contributing to the proliferation, migration, invasion and metastasis of cancer cells. TST003 has displayed significant anti-tumor activities both in vitro and in vivo in preclinical studies. TST003 has the potential to become a novel cancer treatment, either as monotherapy or in combination with immune checkpoint inhibitor and/or other anti-tumor agents.

In May 2022, Nature Cancer published the study results by Transcenta and Shanghai Jiao Tong University scientists on the potential application of the its first-in-class Gremlin1 targeting antibody in the treatment of androgen receptor-negative/low prostate cancer. The study results revealed that Gremlin1 protein can promote lineage plasticity and drive castration resistance in prostate cancer. Gremlin1-specific antibodies can effectively control tumor growth in androgen receptor-negative/low prostate cancer. The study also demonstrated a synergistic activity between the anti-Gremlin1 antibody and enzalutamide against patient-derived castration-resistant prostate cancer models in vitro and in vivo.

"Targeting Gremlin1 with our antibody TST003 has the potential to be transformative in the treatment of high unmet need cancer indications, such as castration resistant prostate cancer. We look forward to initiating our first time in human clinical study which is designed to address key questions to optimize TST003 clinical development plan." said Dr. Caroline Germa, Transcenta’s Executive Vice President, Global Medicine Development and Chief Medical Officer.

About TST003

TST003 is a potentially first-in-class antibody drug candidate around the world targeting a novel immune regulatory protein produced by tumor-associated fibroblasts or tumor cells with mesenchymal phenotype. In preclinical studies, TST003 has demonstrated anti-tumor activities either as a single agent or in combination with targeted agent in "target-expressing" patient-derived xenografts (PDX) tumor model. In addition, TST003 displayed anti-tumor activities as a single agent and enhanced the anti-tumor activity of checkpoint inhibitor in multiple syngeneic tumor models.

Gracell Biotechnologies to Participate in Three Upcoming Investor Conferences

On September 14, 2022 Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to discovering and developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that the management team will participate in and attend one-on-one meetings at three investor conferences in September 2022 as follows (Press release, Gracell Biotechnologies, SEP 14, 2022, View Source [SID1234619566]):

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Citi Hong Kong China Corporate Day – Virtual
One-on-one meetings: Tuesday, September 20, 2022 – Wednesday, September 21, 2022

Cantor Oncology, Hematology & HemeOnc Conference
Panel Presentation: Wednesday, September 28 at 4:15 p.m. ET
One-on-one meetings: Wednesday, September 28, 2022
Location: New York, NY

Jefferies Cell & Genetic Medicine Summit
Fireside Chat: Friday, September 30 at 2:00 p.m. ET
One-on-one meetings: Friday, September 30, 2022
Location: New York, NY

A webcast of the fireside chat will be available on the News and Events section of Gracell’s investor website. A replay of the webcast will be available for 30 days following the event.

IDEAYA Announces Pricing of Public Offering of Common Stock

On September 14, 2022 IDEAYA Biosciences, Inc. ( Nasdaq: IDYA) reported the pricing of an underwritten public offering of 7,619,048 shares of its common stock at a public offering price of $10.50 per share, before underwriting discounts and commissions (Press release, Ideaya Biosciences, SEP 14, 2022, View Source [SID1234619565]). In addition, IDEAYA has granted the underwriters a 30-day option to purchase up to an additional 1,142,857 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by IDEAYA, are expected to be approximately $80.0 million, excluding any exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on or about September 19, 2022, subject to the satisfaction of customary closing conditions.

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J.P. Morgan, Jefferies, Citigroup and Guggenheim Securities are acting as joint book-running managers for the offering. Wedbush PacGrow is acting as lead manager for the offering.

The securities described above are being offered by IDEAYA pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the U.S. Securities and Exchange Commission, or the SEC. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement, copies of which may be obtained, when available, by request from: J.P. Morgan, by mail at J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 866-803-9204, or by email at [email protected]; Jefferies, by mail at Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, or by telephone at 877-547-6340 or 877-821-7388, or by email at [email protected]; Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146; or Guggenheim Securities, by mail at Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, or by telephone at (212) 518-5548 or by email at [email protected].

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