On November 18, 2020 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology"), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported the pricing of its initial public offering of 11,000,000 shares of its common stock at a price to the public of $19.00 per share (Press release, Olema Oncology, NOV 18, 2020, View Source [SID1234571463]). The gross proceeds to Olema Oncology from the offering, before deducting the underwriting discounts and commissions and offering expenses, are expected to be $209.0 million. All of the shares are being offered by Olema Oncology. In addition, Olema Oncology has granted the underwriters a 30-day option to purchase up to an additional 1,650,000 shares of its common stock at the initial public offering price, less the underwriting discounts and commissions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The shares are expected to begin trading on the Nasdaq Global Select Market on November 19, 2020, under the ticker symbol "OLMA." The offering is expected to close on November 23, 2020, subject to customary closing conditions.

J.P. Morgan Securities LLC, Jefferies LLC and Cowen and Company, LLC are acting as active joint book-running managers for the offering. Canaccord Genuity LLC is also acting as a book-running manager.

Registration statements relating to these securities were filed with the U.S. Securities and Exchange Commission (SEC) and became effective on November 18, 2020. Copies of the registration statements can be accessed through the SEC’s website at www.sec.gov. This offering is being made only by means of a written prospectus, forming a part of the effective registration statement. Copies of the final prospectus relating to the initial public offering can be obtained, when available, from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at (212) 834-4533 or by email at [email protected]; Jefferies LLC, Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, by telephone at (877) 821-7388 or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at +1 (833) 297-2926 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, 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.

On November 18, 2020 AUM Biosciences (AUM), a global, clinical stage healthcare company focused on discovering, acquiring and developing novel oncology therapeutics and Newsoara Biopharma reported that the companies have entered into a 5-year strategic partnership to co-develop up to 6 oncology drugs in AUM’s pipeline (Press release, AUM BioSciences, NOV 18, 2020, View Source [SID1234571396]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The partnership combines AUM’s world-class discovery and clinical development capabilities with Newsoara’s strong discovery, development, and manufacturing capabilities in China.

Under the terms of the Agreement, AUM will receive an undisclosed collaboration fee upon closing. AUM will license exclusive greater China rights of AUM001, AUM302 and AUM003 upon closing of this Agreement, and up to a further 3 candidates for a maximum of 6 oncology drugs.

AUM will receive up to $135 Million in near term development, regulatory, commercial milestones and up to double-digit royalty payments. Newsoara will be responsible for all development and commercialisation and will contribute for potential R&D funding for current and future investigational compounds in greater China.

AUM and Newsoara will co-discover and co-fund first-in-class therapeutics for mutually agreed novel targets. AUM retains worldwide rights ex-greater China and Newsoara retains greater China rights for these newly discovered compounds.

Newsoara’s CEO, Benny Li will join AUM’s Board of Directors.

"Newsoara is an ideal partner for AUM with its focus to provide novel and differentiated therapies for unmet medical needs in China ," said Vishal Doshi, CEO, AUM Biosciences. "This collaboration is foundational for AUM and will allow us to act as one team to maximize the clinical and commercial potential of AUM’s molecules, greatly amplifying and expediting the opportunities in our pipeline. This partnership accelerates AUM’s path to becoming an independent, fully integrated biopharmaceutical company."

AUM is building a diverse portfolio of small molecule therapeutics that target critical biological pathways. A core component of AUM’s strategy is mandating biomarkers and leveraging AI to systematically discover and develop targeted cancer therapies. Additionally, AUM has a strong focus on the development of intra-portfolio combinations that include small molecules. Through its "Asia to Global" Strategy, including this partnership, AUM will expedite drug development to meet unmet medical needs for patients globally.

"We are very pleased to build on Newsoara’s growing presence in China with this important new strategic collaboration with AUM," said Benny Li, CEO, Newsoara Biopharma. "Newsoara is committed to developing first-in-class programs for patients and our agreement with AUM further demonstrates that commitment. By gaining access to each other’s diverse pipeline and AUM’s clear strengths and world-class experts in discovery and development, we believe that our partnership with AUM will significantly accelerate our progress in developing next generation therapies for patients."

On November 18, 2020 Elevation Oncology, a clinical-stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported a Series B financing of $65 million led by new investors, venBio Partners and Cormorant Asset Management, and the promotion of Shawn M. Leland, PharmD, RPh, the Company’s founder, to Chief Executive Officer (Press release, Elevation Oncology, NOV 18, 2020, View Source [SID1234571381]). Additional participants in the financing include Boxer Capital of Tavistock Group, Janus Henderson, Samsara Biocapital, and Vivo Capital, as well as all of Elevation Oncology’s existing investors: Aisling Capital, Vertex Ventures HC, Qiming Venture Partners USA, Driehaus Capital Management, and BVF Partners.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Andrew Phillips, PhD from Cormorant Asset Management, and Richard Gaster, MD, PhD from venBio Partners, will join the Elevation Oncology Board of Directors in conjunction with the new financing.

"We welcome Andy and Rich to our Board of Directors and are encouraged by the support of a highly sophisticated investor group committed to helping us continue to pursue our mission," said Dr. Leland. "At the core of Elevation Oncology is the belief that patients deserve the right clinical team and the right genomic tests to match the right therapeutics to the unique genomic profile of each tumor. We look forward to continuing to work closely with our Board and Scientific Advisors to innovate and accelerate the development of precision oncology therapeutics to realize this vision."

Dr. Leland founded Elevation Oncology in July 2019, is a member of its Board of Directors, and previously served as the Company’s Chief Business Officer. He has over a decade of experience in medical affairs and business development for the pharmaceutical/biotech industry, with a focus on building collaborations to realize the full potential of targeted and personalized therapeutics. He has been involved in global transactions totaling more than $450 million in upfront payments and milestone payments at Eli Lilly, ARIAD Pharmaceuticals, Argos Therapeutics and Verastem Oncology. Steve Elms, Managing Partner of Aisling Capital, who was serving as Interim CEO of Elevation Oncology, will remain Chair of the Company’s Board of Directors.

"Shawn has been instrumental in the founding and success of Elevation Oncology to date," said Mr. Elms. "On behalf of the entire Board of Directors, I express our great confidence in the future of Elevation Oncology under Shawn’s leadership. The proceeds raised with the Series B positions the Company well to deliver on our mission of developing precision therapeutics for patients with genomically defined cancers."

Elevation Oncology’s lead development program, the Phase 2 CRESTONE study, is evaluating the HER3 monoclonal antibody seribantumab for the treatment of patients with tumors harboring an NRG1 gene fusion. The Company is actively evaluating opportunities for pipeline expansion, prioritizing targeted therapy approaches in tumor types defined by genomic driver alterations.

"The progress that Elevation Oncology has made in the short time since its founding to establish a strong scientific rationale and an accelerated development path for seribantumab in patients with tumors harboring an NRG1 gene fusion is quite impressive," said Dr. Gaster, Partner at venBio. "We see the progress to date as indicative of Elevation Oncology’s long-term potential. I look forward to serving on Elevation’s Board of Directors as the Company continues to advance its mission to match unique genomic test results with a purpose-built precision medicine approach to enable an individualized treatment plan for each patient."

"Elevation Oncology’s commitment to innovation across the drug development lifecycle has drawn a distinguished group of collaborators who are able to broadly conduct genomic testing across the US, rapidly open up clinical trial sites, and ensure exemplary execution of the CRESTONE study," said Dr. Phillips, Managing Director at Cormorant. "I am very pleased to be joining the Company’s Board of Directors to support the continued and expanded application of these efforts towards the efficient acquisition, development, and approval of new therapeutics for patients with genomically defined cancers."

Proceeds from the Series B financing will be used to fund the completion of enrollment in the CRESTONE study and other corporate development activities.

On November 18, 2020 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported that it has launched an offering of a combined $1.75 billion aggregate principal amount of new senior notes due 2029 (the "2029 Notes") and new senior notes due 2031 (the "2031 Notes" and, together with the 2029 Notes, the "Notes") (Press release, Bausch Health, NOV 18, 2020, View Source [SID1234571380]). Bausch Health intends to use the proceeds from the offering of the Notes, along with cash on hand, to fund the conditional redemption (the "Redemption") in full of its outstanding €1.5 billion aggregate principal amount of 4.50% Senior Notes due 2023 (the "Existing Notes") and to pay related fees and expenses.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Notes will be guaranteed by each of the Company’s subsidiaries that are guarantors under the Company’s credit agreement and existing senior notes.

The Notes will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities law and may not be offered or sold in the United States absent registration or an applicable exemption from registration under the Securities Act and applicable state securities laws. The Notes will be offered in the United States only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act and outside the United States to non-U.S. persons pursuant to Regulation S under the Securities Act. The Notes have not been and will not be qualified for sale to the public by prospectus under applicable Canadian securities laws and, accordingly, any offer and sale of the Notes in Canada will be made on a basis, which is exempt from the prospectus requirements of such securities laws.

The Company also announced that it intends to issue a conditional notice of redemption today to redeem the full aggregate principal amount of outstanding Existing Notes. The Redemption will be conditioned upon the completion by the Company or its subsidiaries of one or more debt financings in an aggregate principal amount of at least $1.75 billion (the "Condition").

A copy of the conditional notice of redemption with respect to the Existing Notes will be issued to the record holders of the Existing Notes. Payment of the redemption price and surrender of the Existing Notes for redemption will be made through the facilities of the Depository Trust Company in accordance with the applicable procedures of the Depository Trust Company on Dec. 18, 2020, unless the Condition is not satisfied, in which case the redemption date will be delayed until the Condition is satisfied. The name and address of the paying agent are as follows: The Bank of New York Mellon Trust Company, N.A., c/o The Bank of New York Mellon; 111 Sanders Creek Parkway, East Syracuse, N.Y. 13057; Attn: Redemption Unit; Tel: (800) 254- 2826.

The foregoing transactions are subject to market and other conditions and are anticipated to close in the fourth quarter of 2020. However, there can be no assurance that the Company will be able to successfully complete the transactions, on the terms described above, or at all.

This news release is being issued pursuant to Rule 135c under the Securities Act and shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

On November 18, 2020 QBiotics Group Limited (QBiotics), a life sciences company developing novel anticancer and wound healing pharmaceuticals, reported that the U.S. Food and Drug Administration’s (U.S. FDA) Center for Veterinary Medicine (CVM) has approved its lead veterinary anticancer product, STELFONTA, making it the first FDA approved treatment for all grades of canine non-metastatic mast cell tumours (Press release, QBiotics, NOV 18, 2020, View Source [SID1234571378]). The news follows approvals for STELFONTA in early 2020 by the European Medicines Agency (EMA), the United Kingdoms’s Veterinary Medicines Directorate (VMD), and Swissmedic, with subsequent sales in all major European markets.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In the United States, STELFONTA (tigilanol tiglate injection) is indicated for the treatment of all non-metastatic cutaneous MCT and non-metastatic subcutaneous MCT, located at or distal to the elbow or the hock in dogs. MCTs are the most frequently diagnosed cancer in dogs, accounting for up to 21% of skin cancer cases[3].

Dr Chad Johannes, Assistant Professor of Oncology at Iowa State University, and consultant to QBiotics commented, "STELFONTA brings a novel therapeutic mechanism and intratumoural delivery route to veterinary medicine. The efficacy and durability of response data in dogs with mast cell tumours are very promising. While surgery will remain the mainstay, I do think STELFONTA will reshape how we approach local mast cell tumour control in many ways."

Dr Victoria Gordon, CEO and Managing Director of QBiotics, said, "FDA approval is a pivotal achievement for both STELFONTA and QBiotics. STELFONTA has the potential to be a category igniter – given it is easy to administer, provides 75% complete tumour resolution after just one injection, and dogs quickly regain pre-treatment quality of life. European sales of STELFONTA have been impressive, and we are excited to be working with Virbac to bring the drug to the US market to help treat the 3 million dogs there that each year are diagnosed with cancer."

Dr Gordon continued, "this approval also provides strong validation of our highly efficient business model, where veterinary product sales provide repeatable revenue for the company, and the strong veterinary data underpins our human drug development programme. Clinical efficacy and safety responses reported in canine patients are also being mirrored in our human patients. In a Phase I/IIa human safety trial, tigilanol tiglate, the active ingredient in STELFONTA, demonstrated antitumour responses in a range of solid tumours. This included complete responses (where the tumour is completely destroyed) in head and neck squamous cell carcinoma and melanoma. Notably, a maximum tolerated dose was not declared for this study. We are currently investigating the drug’s potential as both a monotherapy and an immune checkpoint inhibitor combination therapy through a series of Phase II clinical trials."

Tigilanol tiglate is a small molecule that largely acts through specific protein kinase C (PKC) activation[4], leading to rapid destruction of the tumour mass and the tumour’s blood supply, as well as stimulation of the immune system. Tumour destruction is followed by rapid healing of the site with minimal scarring.

QBiotics and its partner, Virbac, a global animal health company, will first launch STELFONTA to specialist U.S. veterinary oncologists over the coming months, followed by the launch to primary care veterinarians in early 2021.