On November 21, 2024 Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, reported that it has entered into a securities purchase agreement with certain investors to raise up to approximately $105 million in gross proceeds (Press release, Cidara Therapeutics, NOV 21, 2024, View Source [SID1234648543]). The private placement is being led by new investor, Venrock Healthcare Capital Partners, and includes significant participation by new and existing life sciences-focused investors, including RA Capital Management, TCGX, BVF Partners LP, Vivo Capital, Spruce Street Capital, Adage Capital Partners LP, and Checkpoint Capital.

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!

Pursuant to the terms of the securities purchase agreement, Cidara will issue an aggregate of 3,892,274 shares of its common stock at a purchase price of $14.912 per share. In lieu of shares of common stock, certain investors are purchasing pre-funded warrants to purchase an aggregate of 3,149,035 shares of common stock at a purchase price of $14.9119 per pre-funded warrant, which equals the purchase price per share of common stock, less the $0.0001 per share exercise price of each pre-funded warrant. The private placement is expected to close on or about November 25, 2024, subject to satisfaction of customary closing conditions.

Cidara intends to use the net proceeds from the private placement to fund research and development of product candidates, working capital and general corporate purposes.

RBC Capital Markets acted as the sole placement agent for the private placement. Guggenheim Securities acted as financial advisor to the Company.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering, and the securities have not been registered under the Securities Act of 1933, as amended (the Securities Act), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Cidara has agreed to file a registration statement with the Securities and Exchange Commission (SEC) registering the resale of the shares of common stock purchased in the private placement and shares of common stock underlying the pre-funded warrants.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

On November 21, 2024 BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) a clinical-stage biotech company that develops novel immunotherapies to transform cancer care, reported that the first patient was dosed in its Phase 1/2 study (ClinicalTrials.gov identifier: NCT06471673 ) to evaluate the safety and efficacy of Bria-OTS, BriaCell’s personalized next generation immunotherapy (Press release, BriaCell Therapeutics, NOV 21, 2024, View Source [SID1234648542]). The study will investigate Bria-OTS alone and in combination with immune check point inhibitor tislelizumab (manufactured and supplied by BeiGene, Ltd. ) for the treatment of metastatic breast cancer. Bria-OTS is an enhanced form of Bria-IMT, currently in pivotal Phase 3 study for metastatic breast cancer.

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!

"Oncologists have been looking for treatments for our metastatic cancer patients who progress after treatment with antibody-drug-conjugates (ADCs) and immune check point inhibitors (CPIs)," stated Sant P. Chawla, MD, FRACP, Head of the Sarcoma Oncology Center in Santa Monica, CA, and Principal Investigator for the Bria-OTS study. "We are very impressed by the survival and clinical benefit data we have seen with Bria-IMT and are looking forward to helping develop this novel platform with the goal of improving patient outcomes."

"Dosing the first patient with Bria-OTS is a significant milestone for both BriaCell and cancer patients," stated Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. "This represents a new chapter in cancer immunotherapy. This groundbreaking technology is a major advancement over prior approaches to cellular immunotherapy."

"Designed for superior efficacy and synergy with immune checkpoint inhibitors, Bria-OTS is a personalized and off-the-shelf cancer therapy," stated William V. Williams, MD, BriaCell’s President & CEO. "We are delighted that Dr. Chawla and his team of experts at the Sarcoma Oncology Center are supporting BriaCell as we bring our novel immunotherapy platform one step closer to delivering safe and effective treatment options for patients with melanoma, prostate and lung cancers."

The Phase 1/2 clinical trial will initially evaluate the safety and efficacy of Bria-OTS as monotherapy and, later, in combination with tislelizumab in advanced breast cancer. Key inclusion criteria include metastatic or locally recurrent breast cancer and at least two failed prior attempts of systemic therapy (e.g., chemotherapy). The study design will include a dose escalation monotherapy phase followed by an expansion phase that will include combination therapy with tislelizumab . Additionally, BriaCell plans to evaluate Bria-OTS+, a more advanced version of the immunotherapy platform, in prostate and other cancers.

On November 21, 2024 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, and Ayrmid Ltd. ("Ayrmid"), the parent company of Gamida Cell Ltd., reported that on November 20, 2024, the companies entered into a license agreement for motixafortide (commercially sold in the U.S. as APHEXDA), BioLineRx’s FDA-approved stem cell mobilization agent indicated in combination with filgrastim (G-CSF) for collection and subsequent autologous transplantation in patients with multiple myeloma (Press release, BioLineRx, NOV 21, 2024, View Source [SID1234648539]).

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!

Under the terms of the agreement, BioLineRx granted Ayrmid an exclusive license to develop and commercialize APHEXDA (motixafortide) across all indications, excluding solid tumor indications, and in all territories other than Asia. BioLineRx previously granted an exclusive license agreement to Gloria Biosciences for APHEXDA (motixafortide) in the Asia region.

In exchange for the license, BioLineRx will receive a $10 million upfront payment and is also eligible to receive up to an additional $87 million of potential commercial milestones, plus royalties ranging from 18% to 23% on net sales of APHEXDA.

Ayrmid will add APHEXDA to its commercial portfolio, which also includes Gamida Cell’s OMISIRGE, the first and only FDA-approved, nicotinamide (NAM)-modified cell therapy for patients with hematologic malignancies in need of a stem cell transplant. As part of this transaction, Ayrmid expects to transition certain members of BioLineRx’s U.S.-based commercial organization, who will support both stem cell transplant drugs.

Through this transaction, BioLineRx will significantly reduce its long-term debt and operational expenses, which will be reviewed in detail during the company’s upcoming Q3 results conference call and webcast.

BioLineRx also entered into a share purchase agreement for a $9 million equity investment from certain funds managed by Highbridge Capital Management, LLC. This investment and the combined future potential commercial milestones from licensing agreements with Ayrmid and Gloria Biosciences, as well as royalties on net sales, are expected to provide a strong foundation for BioLineRx to advance its pipeline and identify potential additional assets for development. The equity investment is expected to close today, November 21, 2024, subject to the satisfaction of customary closing conditions.

BioLineRx will continue the development of motixafortide for pancreatic ductal adenocarcinoma (PDAC) through meaningful collaborations, including an active Phase 2b PDAC study led by Columbia University, and supported equally by BioLineRx and Regeneron, as well as a planned Phase 2b PDAC study in China led by Gloria Biosciences.

"Since APHEXDA’s launch last year, patients and transplant centers continue to see the tremendous benefits it can provide, and I could not be prouder of our commercial organization that has proven its value," stated Philip Serlin, Chief Executive Officer of BioLineRx. "Our agreement with Ayrmid, and their vision of creating a strong commercial transplant portfolio, makes them the ideal partner to realize APHEXDA’s full commercial potential. BioLineRx will now leverage its proven expertise in drug development, with a continued focus on oncology and rare diseases. This new path forward aligns with our core strengths and allows us the opportunity to create enduring value for all stakeholders."

Dr. Joe Wiley, Chief Executive Officer of Ayrmid Ltd, added, "APHEXDA represents a significant advancement in improving the lives of multiple myeloma patients as they progress along the stem cell transplant journey. APHEXDA complements our existing portfolio by supporting OMISIRGE’s growth, doubling our transplant portfolio, and enhancing the capabilities Gamida Cell has already established in cell therapy. Our growing momentum positions us well for continued expansion in the U.S. and beyond, marking a key step in our journey as we continue to build on our success, strengthen our commitment to the transplant community, and execute our long-term strategy."

The equity investment offering is being made by BioLineRx pursuant to its shelf registration statement on Form F-3 (File No. 333-276323) previously filed with the Securities and Exchange Commission (the "SEC") and declared effective by the SEC on January 5, 2024, and only by means of a prospectus and prospectus supplement. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov.

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

MTS Health Partners, L.P. served as the exclusive financial advisor to BioLineRx Ltd. in connection with the transaction.

Moelis & Company LLC served as the exclusive financial advisor to Ayrmid Ltd. in connection with the transaction.

On November 20, 2024 Valora Therapeutics Inc. ("Valora"), a biotechnology company pioneering a novel approach to immunotherapy, reported the successful closing of its seed funding round (Press release, Valora Therapeutics, NOV 20, 2024, View Source [SID1234648535]). The investment was co-led by Avalon BioVentures, a top-tier investor group with a long history of nurturing groundbreaking life science companies from inception to exit, together with Bregua Corporation and TigerGene, investors recognized for their expertise in supporting innovative biotech companies. Additional participation was provided by Alexandria Venture Investments and Correlation Ventures. This significant investment will propel the advancement of Valora’s proprietary AbLec platform to develop novel immunotherapeutics.

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 AbLec platform represents a significant leap forward in manipulating glycoimmunology and unlocking new paradigms in immunotherapy. I look forward to providing scientific support to Valora as it advances lead molecules toward clinical development."

Valora’s AbLec (Antibody-Lectin chimera) platform is expected to offer a fresh perspective on restoring proper immunological competency. By precisely targeting specific sugar molecules on cells, AbLecs modulate glyco-immune checkpoints—a key control point in the body’s immune response. This innovative approach holds significant potential for developing first-in-class and best-in-class therapeutics in oncology, autoimmune diseases, and other therapeutic areas. The technology is exclusively licensed from Stanford University. It builds upon the transformative work performed at the Stanford laboratory of Dr. Carolyn Bertozzi, recipient of the 2022 Nobel Prize in Chemistry, and a world leader in glycobiology, together with Dr. Jessica Stark, who is currently an Assistant Professor of Biological Engineering and Chemical Engineering at the Massachusetts Institute of Technology. Both Drs. Carolyn Bertozzi and Jessica Stark are scientific founders and advisors for Valora.

"We are incredibly honored to partner with highly recognized investors and Valora’s scientific founders, Dr. Carolyn Bertozzi and Dr. Jessica Stark, to develop the AbLec platform as a trailblazing approach for next-generation immunomodulators," said Miguel Garcia-Guzman, Ph.D., Valora’s CEO. "This funding allows us to accelerate our R&D efforts, optimizing the AbLec platform and advancing AbLec therapeutics toward the clinic. We take great pride in the work we do at Valora and are deeply grateful for the support of our investors."

Dr. Stark added, "The AbLec platform represents a significant leap forward in manipulating glycoimmunology and unlocking new paradigms in immunotherapy. I look forward to providing scientific support to Valora as it advances lead molecules toward clinical development."

The seed funding will enable Valora to further explore and develop the full potential of the AbLec platform, validating specific mechanisms of action, and advancing lead molecules into preclinical development. Valora has established its R&D operations at the Avalon BioVentures Accelerator in San Diego, California, providing access to a supportive ecosystem of biotech experts and resources.

Sandy Madigan, Ph.D., Managing Partner at Avalon BioVentures and a Board Member of Valora Therapeutics, stated, "We are excited to co-lead the seed funding round for Valora. We believe Valora has the team and resources to lead the development of novel AbLec therapeutics and to rapidly advance this groundbreaking technology toward the clinic."

Stefan Heller, Ph.D., who represents Bregua Corporation on the Board of Valora Therapeutics, added, "We are excited to collaborate with Valora’s team to advance the AbLec platform for developing novel therapies. This innovative approach has promising potential for creating leading-edge treatments across a range of therapeutic areas."

Audrey Warner, Partner at TigerGene and Director of Valora Therapeutics concluded, "We are very excited to partner with Valora’s team to explore the promise of glyco-immune checkpoint modulation and deliver innovative biological therapeutics to alleviate patient suffering across a multitude of indications."

On November 20, 2024 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported that its management team will participate at the following investor conferences (Press release, Personalis, NOV 20, 2024, View Source [SID1234648534]):

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!

– Piper Sandler 36th Annual Healthcare Conference
Date: Tuesday, December 3, 2024
Fireside Chat Time: 12:30 pm Eastern Time
Location: The Lotte New York Palace in New York, NY

– TD Cowen Diagnosing Tomorrow: Tools & Technologies for the Next Decade
Date: Thursday, December 12, 2024
Panel Topic: MRD – The Future Tech Stack
Panel Time: 1:30 pm Eastern Time
Location: One Vanderbilt in New York, NY