On January 29, 2024 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported the pricing of a public offering of (i) 4,375,000 shares of its common stock or pre-funded warrants in lieu thereof and (ii) two classes of warrants to purchase up to an aggregate of 8,750,000 shares of its common stock (the "Common Warrants") at a purchase price of $2.06 per share and associated Common Warrants (Press release, Panbela Therapeutics, JAN 29, 2024, View Source [SID1234639683]). The Common Warrants will have an exercise price of $2.06 per share, are exercisable upon issuance, and will expire five years following the date of issuance. The Common Warrants do not have any alternative cashless exercise or other provisions to adjust their exercise price beyond customary proportionate adjustments for recapitalizations and similar events. The offering is expected to close on or about January 31, 2024, subject to customary closing conditions.

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Roth Capital Partners is acting as sole placement agent of the offering.

Gross proceeds, before deducting placement agent fees and commissions and offering expenses, are expected to be approximately $9.0 million. The company intends to use the net proceeds from the offering for the continued clinical development of its product candidates, working capital, business development and other general corporate purposes, which may include repayment of debt.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-276367), as amended, that was declared effective by the U.S. Securities and Exchange Commission ("SEC"), on January 26, 2024. The offering is being made solely by means of a prospectus. Copies of the accompanying prospectus relating to and describing the terms of the offering may be obtained, when available, at the SEC’s website at www.sec.gov or by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660 or by email at [email protected].

This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any 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 registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

On January 29, 2024 NANOBIOTIX (Euronext : NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported achievement of operational requirements in NANORAY-312, an ongoing pivotal Phase 3 study evaluating potential first-in-class radioenhancer NBTXR3 for elderly patients with head and neck cancer, resulting in a $20M milestone payment from strategic partner Janssen Pharmaceutica NV ("Janssen"), a Johnson & Johnson company (Press release, Nanobiotix, JAN 29, 2024, View Source [SID1234639682]).

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"This first milestone payment related to our ongoing pivotal Phase 3 study evaluating NBTXR3 for patients with head and neck cancer represents another step forward in our pathway to bring NBTXR3 to registration," said Laurent Levy, Nanobiotix co-founder and chairman of the executive board. "We look forward to continued collaboration with Janssen as we work to deliver the potential benefits of NBTXR3 to millions of patients around the world."

This $20M represents the first applicable development milestone from the global licensing agreement executed between Nanobiotix and Janssen (For more details, please consult the press release dated 4 December 2023).

About NBTXR3
NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas for which the product received a European CE mark in 2019. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in NANORAY-312—a global, randomized phase III study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the phase III study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several phase I and phase II studies evaluating NBTXR3 across tumor types and therapeutic combinations. In 2023 Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV.

On January 29, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported favorable early efficacy results from the first patient enrolled in the Phase 1 Deltacel-01 clinical trial with Deltacel for treating stage 4 metastatic non-small cell lung cancer (NSCLC) (Press release, Kiromic, JAN 29, 2024, View Source [SID1234639681]).

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Favorable preliminary evidence demonstrates Deltacel’s efficacy in controlling the growth of NSCLC. Deltacel continues to be well-tolerated, further confirming the early safety assessment reported on January 5th. The first patient was enrolled at the Beverly Hills Cancer Center (BHCC) and was confirmed to suffer from an actively progressing disease three days prior to beginning treatment. The CT scan performed six weeks later confirmed stabilization of the disease, indicating a preliminary progression-free survival of one and one-half months. Kiromic plans to provide updates as more data becomes available from follow-up monitoring activities and as additional subjects are enrolled in the study.

"We are delighted to share these best-case scenario, preliminary efficacy results following recently announced favorable safety and tolerability data in this patient. It is a significant clinical milestone in a deadly cancer that counts more than 2 million new diagnoses globally each year and is almost three times as deadly as breast and ovarian cancers," said Pietro Bersani, Chief Executive Officer of Kiromic. "Our initial results with Deltacel offer a glimpse of hope and are a testament to our dedication to improving patient outcomes with this challenging disease. We look forward to sharing more detailed data as our trial progresses and remain committed to the rigorous investigation of Deltacel’s potential in treating NSCLC."

"The first patient treated in the Deltacel-01 study continues to do well. We remain hopeful regarding the treatment outcome with subsequent patients and look forward to working with Kiromic to advance enrollment in this study," said Afshin Eli Gabayan, M.D., Medical Oncologist, Medical Director, and Principal Investigator at Beverly Hills Cancer Center.

About Deltacel-01

In Kiromic’s open-label Phase 1 clinical trial, titled "Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer" (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the study is to evaluate safety, while secondary measurements include objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rates.

About Deltacel

Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of stage 4 metastatic NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic’s GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial clinical focus on NSCLC, which represents about 80% to 85% of lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.

On January 29, 2024 Immunocore Holdings plc (Nasdaq: IMCR), reported its intention to offer, subject to market and other conditions, $300.0 million aggregate principal amount of convertible senior notes due 2030 (the "notes") in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Immunocore, JAN 29, 2024, View Source [SID1234639680]). Immunocore also expects to grant the initial purchasers of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date the notes are first issued, up to an additional $45.0 million aggregate principal amount of the notes.

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The notes will be senior, unsecured obligations of Immunocore, will accrue interest payable semi-annually in arrears and will mature on February 1, 2030, unless earlier converted, redeemed or repurchased. Upon conversion, Immunocore will deliver ordinary shares represented by American Depositary Shares (the "ADSs") (each currently representing one of Immunocore’s ordinary shares), together with, if applicable, a cash payment in lieu of delivering any fractional ADS, at the then-applicable conversion rate. The interest rate, initial conversion rate and other terms of the notes will be determined at the pricing of the offering.

Immunocore intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, to accelerate its clinical pipeline and for ongoing commercial expansion. In addition, Immunocore intends to repay in full loans outstanding under its loan agreement with investment funds managed by Pharmakon Advisors, LP. Immunocore intends to use any remaining proceeds for other working capital and general corporate purposes.

The offer and sale of the notes, the ADSs deliverable upon conversion of the notes and the ordinary shares represented thereby have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes, such ADSs and such shares cannot be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the notes, the ADSs deliverable upon conversion of the notes or the ordinary shares represented thereby, nor will there be any sale of the notes, such ADSs or such shares, in any state or other jurisdiction in which such offer, sale or solicitation would be unlawful.

On January 29, 2024 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that the Company will focus its resources in two strategic areas: (1) prioritize the clinical development of a randomized trial for its HB-200 program in human papillomavirus 16 positive (HPV16+) head and neck squamous cell carcinoma (HNSCC) and (2) its two Gilead-partnered infectious disease cure programs for hepatitis B and human immunodeficiency virus (Press release, Hookipa Pharma, JAN 29, 2024, View Source [SID1234639679]).

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In the first-line setting HB-200, in combination with pembrolizumab, has demonstrated best-in-class antigen specific T cell activation and has doubled the historic objective response rates of standard of care treatment alone. The totality of the HB-200 data presents a clear opportunity for HOOKIPA to advance this program in a randomized trial starting in mid-2024.

"HOOKIPA has a tremendous opportunity to transform treatment of multiple disease areas using an entirely new class of medicines," said Joern Aldag, Chief Executive Officer at HOOKIPA. "As we move forward with our randomized trial for HB-200 in combination with pembrolizumab, we have made an important decision to focus our resources and pursue this opportunity in earnest. We will focus on clinical delivery and execution so that we can help address a significant unmet need for patients with advanced HPV16+ head and neck cancer."

The Company also announced that it has received notification from Roche of their decision to terminate the collaboration and licensing agreement for HOOKIPA’s HB-700 program in KRAS mutated cancers. To date, HOOKIPA has met all go-forward criteria under the agreement and remains eligible for a final milestone payment associated with IND submission. Effective April 25, 2024, HOOKIPA will regain full control of the associated intellectual property portfolio and have full collaboration and licensing rights for this program. As part of its strategic refocus, HOOKIPA will pause development activities related to HB-300 and most of its preclinical research activities.

HOOKIPA will reduce its workforce by approximately 30 percent and rebalance its cost structure in alignment with the new prioritization of the Company’s programs. HOOKIPA maintains a strong cash position of $117.5 million1 as of December 31, 2023, and believes that the planned reductions will help to conserve resources and better align its organization in direct support of late-stage clinical development efforts.

Pipeline Update and Upcoming Catalysts-

The strategic priorities for HOOKIPA are to advance its clinical programs including HB-200 and its two Gilead-partnered infectious disease programs. The Company is planning to submit an IND for HB-700 in the first quarter of 2024 and will begin searching for a collaboration partner. At this time, the company will not pursue further preclinical programs into development and pause further development of its HB-300 to conserve capital and ensure pipeline success and operational efficiency.

Program Indication Upcoming Catalysts
Oncology Programs
HB-200 HPV16+ HNSCC
Additional first-line data for HB-200 in combination with pembrolizumab (1H 2024)
Initiation of randomized trial (mid-2024)
HB-700 KRAS
IND submission (1Q 2024)
Publication of preclinical research (1H 2024)
Search for new collaboration partner

Infectious Disease Programs: Gilead-Partnered
HB-400 HBV
Gilead-led: Phase 1b actively enrolling
Next milestone: Phase 2 initiation (Timing TBD)
HB-500 HIV
Initiation of Phase 1 trial
First patient dosed, milestone payment (1H 2024)

Paused Programs
HB-300 Prostate Cancer
Paused and utilize capital to support HB-200 development
Preclinical Multiple targets

Cash position as of December 31, 2023, is unaudited