On October 1, 2024 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, reported that it has entered into a definitive securities purchase agreement with accredited investors for a private placement that is expected to result in gross proceeds of approximately $12.4 million to IN8bio, before deducting placement agent fees and other offering expenses (Press release, In8bio, OCT 1, 2024, View Source [SID1234646978]). The net proceeds from this financing are expected to fund the Company’s current operating plan into 2026.

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The private placement was led by an existing healthcare-focused institutional investor and included a large mutual fund company and other existing and new institutional investors.

Under the terms of the securities purchase agreement, the Company will sell units comprised of an aggregate of 25,759,595 shares of the Company’s common stock, par value $0.0001 per share, pre-funded warrants to purchase 5,646,853 shares of common stock and warrants to purchase up to 31,406,448 shares of common stock (the "Series C Warrants"). The units will be sold at a purchase price of $0.395 per unit (or $0.3949 per unit with respect to units that include pre-funded warrants in lieu of common stock). The pre-funded warrants will have an exercise price of $0.0001 per share. The Series C Warrants will have an exercise price of $0.27 per share.

IN8bio intends to use the net proceeds from the private placement to fund the clinical development of INB-100 and future product candidates and for working capital and other general corporate purposes. The proceeds will support the continued enrollment of patients in the expansion cohort with a new target total enrollment of approximately 25 patients at the recommended Phase 2 dose. IN8bio expects to complete this additional enrollment in the first half of 2025, with long-term follow-up results anticipated in late 2025 and in 2026. To affirm the improvements in relapse free and overall survival observed to date and to further de-risk a future registrational randomized control trial, IN8bio will also seek to add a parallel control cohort to prospectively assess leukemia patients and enable comparison between patients receiving INB-100 to those who only receive standard haplotransplantation.

The closing of the private placement is subject to customary closing conditions and is expected to occur on or about October 4, 2024.

Newbridge Securities Corporation acted as the sole placement agent for the private placement.

The offer and sale of the foregoing securities is being made in a private placement pursuant to an exemption under the Securities Act of 1933, as amended (the "Securities Act"), and the Securities have not been registered under the Securities Act or applicable state securities laws. The Securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy the Securities, nor shall there be any sale of the 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.

On October 1, 2024 Heidelberg Pharma AG (FSE: HPHA), a clinical stage company developing innovative Antibody Drug Conjugates (ADCs), reported that new clinical data from its lead Amanitin-based ADC candidate, HDP-101, were presented at the International Myeloma Society (IMS) Annual Meeting, held in Rio de Janeiro, Brazil on 27 September 2024 (Press release, Heidelberg Pharma, OCT 1, 2024, View Source [SID1234646977]).

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HDP-101 is being evaluated in an ongoing Phase I/IIa clinical trial in the indication of relapsed or refractory multiple myeloma, a bone marrow cancer with a high unmet medical need. Clinical data from the fifth cohort demonstrated complete remission in one patient who had been heavily pre-treated. This patient showed an objective improvement ("partial response") in the 2nd cycle of treatment and complete remission was confirmed after the 11th cycle.

In addition, several patients showed promising biological activity and an objective improvement demonstrating the potential of HDP-101 as a treatment option for patients with the disease.

Following the presentation at IMS, Heidelberg Pharma will host an R&D webinar on 15 October 2024 at 17:00 CEST/ 11:00 EDT, for investors, analysts, and media.

The R&D webinar will feature presentations by the Heidelberg Pharma management team, alongside Key Opinion Leaders (KOLs) in the myeloma field: Shambavi Richard, MD, Associate Professor Icahn School of Medicine at Mount Sinai Hospital, New York, USA and Robert Z. Orlowski, MD, PhD, (Ad Interim) Director of Myeloma, and Professor of Medicine in the Departments of Lymphoma/Myeloma and Experimental Therapeutics, University of Texas, Houston, Texas, and principal investigator at MD Anderson Cancer Center, Houston, Texas, USA.

Webinar participants will have the opportunity to submit questions in advance of the webinar or ask questions live during the event.

On October 1, 2024 Curium, a world leader in nuclear medicine, reported that it has entered into a strategic partnership with PDRadiopharma Inc, a wholly-owned subsidiary of PeptiDream, for the clinical development, regulatory filing, and commercialization in Japan of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T (Press release, Curium Pharma, OCT 1, 2024, View Source [SID1234646974]). The two agents 177Lu-PSMA-I&T and 64Cu-PSMA-I&T target prostate specific membrane antigen (PSMA) expressed on prostate cancer cells and are being investigated for prostate cancer treatment and diagnostics. Both target tumors with high levels of PSMA expression and thus potentially forming a theranostic (therapeutic & diagnostic) pair.

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Under the terms of the partnership, Curium and PDRadiopharma will jointly collaborate on clinical development activities of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T in Japan, with PDRadiopharma leading regulatory filing, manufacturing, commercialization, and distribution activities in Japan. Curium will continue to lead global development of the two agents and support PDRadiopharma through technology transfer to support the set-up of manufacturing lines in Japan – including a high throughput Copper 64 manufacturing line based on Curium’s proprietary technology.

Patrick C. Reid, President & CEO of PeptiDream commented: "Targeted radiopharmaceuticals are rapidly revolutionizing how we both diagnose and treat cancer. At PeptiDream and PDRadiopharma we are focused on expanding our pipeline of these powerful targeted therapies, and we are thrilled to be able to accelerate those efforts by partnering with Curium to bring their highly promising prostate cancer targeting radiopharmaceuticals to patients in Japan."

Masato Murakami, President of PDRadiopharma & CMO of PeptiDream commented: "We are excited to partner with Curium in the development of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T, highly promising products for both the diagnosis and treatment of PSMA-expressing prostate cancer. We look forward to working with Curium to deliver these much-needed agents to prostate cancer patients in Japan as quickly as possible."

Chaitanya Tatineni, Curium’s CEO International Markets commented: "As a global innovator in the field of radiopharmaceuticals with a promising late-stage oncology pipeline, Curium is delighted to partner with PDRadiopharma which has more than four decades of experience in Japan. Curium and PDRadiopharma plan to leverage their complementary strengths to accelerate the development of innovative products for the benefit of prostate cancer patients in Japan."

Prostate cancer continues to be widely prevalent in Japan. Annually, there are approximately 90,000 – 100,000 new cases, with patients with metastatic castration-resistant prostate cancer having an overall survival rate of approximately three years in clinical trial settings, and even shorter in the real-world, and there remains a significant unmet medical need for therapies.

177Lu-PSMA-I&T, a PSMA inhibitor conjugated with the radioisotope Lutetium 177, is currently being tested by Curium in a global pivotal Phase 3 ECLIPSE trial (ClinicalTrials.gov identifier; NCT05204927). ECLIPSE is a multi-center, open-label, randomized clinical trial comparing the safety and efficacy of 177Lu-PSMA-I&T versus hormone therapy in patients with metastatic castration-resistant prostate cancer. The ECLIPSE trial enrolled over 400 patients, across 51 trial sites in the United States and Europe.

64Cu-PSMA-I&T PET is currently being investigated in 2 multicenter Phase 3 trials; SOLAR RECUR testing the diagnostic performance in men with biochemical recurrence of prostate cancer (ClinicalTrials.gov identifier NCT06235099) and SOLAR STAGE testing the diagnostic performance in men with newly diagnosed unfavorable intermediate- to high-risk prostate cancer (ClinicalTrials.gov identifier; NCT06235151). The first in human Phase 1/2 SOLAR trial met the co-primary endpoints of region-level correct localization rate and patient-level correct detection rate in patients with histologically-proven metastatic prostate cancer. PSMA-targeted PET/CT imaging is increasingly emerging as a highly sensitive method for detection of locally recurrent or metastatic lesions in the context of biochemical recurrence and for localization of primary prostate cancer.

Curium and PDRadiopharma have a long-standing relationship in the radiopharmaceutical field.

On October 1, 2024 Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (Chemomab), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, reported that senior management will participate in two upcoming investor conferences (Press release, Chemomab, OCT 1, 2024, View Source [SID1234646973]).

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Chemomab management will meet with investors at the Third Annual ROTH Healthcare Opportunities Conference at the Metropolitan Club in New York City on October 9, 2024, and Chemomab co-founder and Chief Executive Officer Dr. Adi Mor will participate in a fireside chat with senior biotechnology analyst Michael Okunewitch at the Maxim Healthcare Virtual Summit on October 16, 2024 at 9:00 am ET.

These conferences are by invitation only. A recording of the Maxim Healthcare Summit fireside chat will be available via a link on the Chemomab investor relations website after the conference completes.

Chemomab Participation in Third Annual ROTH Healthcare Opportunities Conference

Date: October 9, 2024
Time: 900 am ET-5:00 pm ET
Venue: Metropolitan Club, New York City
Format: One-on-one meetings with investors
Information: View Source

Chemomab Participation in 2024 Maxim Healthcare Virtual Summit
Date: October 16, 2024
Time: 9:00 am ET
Venue: Virtual
Format: Fireside chat with CEO Dr. Adi Mor
Link: Recording will be available at investors.chemomab.com post-conference.
Information: https://m-vest.com/events/healthcare-10152024

On October 1, 2024 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported the pricing of a best-efforts offering of 5,128,500 common shares and warrants to purchase up to 5,128,500 common shares at a combined offering price of $0.975 per share and associated warrant, priced at-the-market under Nasdaq rules (Press release, BriaCell Therapeutics, OCT 1, 2024, View Source [SID1234646972]). The warrants will have an exercise price of $0.85 per share and will be immediately exercisable upon issuance for a period of five years following the date of issuance. All of the common shares and associated warrants in the offering are being offered by the Company. Total gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $5 million. The offering is expected to close on October 2, 2024, subject to satisfaction of customary closing conditions. The Company is relying upon the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as Nasdaq.

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The Company intends to use the net proceeds from the offering for working capital requirements, general corporate purposes, and the advancement of business objectives.

ThinkEquity is acting as sole placement agent for the offering.

The securities described above are being offered and sold by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-276650), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on January 22, 2024 and declared effective on January 31, 2024. The offering is being made only by means of a written prospectus. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and can be accessed for free on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

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 an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.