Celyad Oncology provides fourth quarter 2023 business update and 2024 outlook

On January 16, 2024 Celyad Oncology (Euronext: CYAD) (the "Company"), reported a fourth quarter 2023 business update and an outlook for 2024 (Press release, Celyad, JAN 16, 2024, View Source [SID1234639255]).

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Michel Lussier, interim Chief Executive Officer of Celyad Oncology, commented: "2023 has been a very important year for Celyad Oncology, after the changes that occurred in 2022. Our research team has made a remarkable progress to broaden the range of cancer indications that could be targeted by chimeric antigen receptor (CAR) T-cells and to tackle the main limitations of current CAR T-cell therapies. We have shared new data at several scientific and business conferences along the year, and published in high impact peer-reviewed journals. We are eager to see the impact of our efforts to unleash the power of our IP estate and stay at the forefront of next-generation CAR T-cell development."

2023 corporate accomplishments

On August 24, 2023, the Company announced that it obtained commitments from Fortress, Tolefi and other longstanding existing shareholders to subscribe to a capital increase of up to €9.8 million in 2 tranches:
A first tranche of 2.0 million was disbursed in the context of authorized capital as of September 4, 2023; and
A second tranche subscribed by Fortress was approved by the extraordinary shareholders’ meeting of November 14, 2023. Following this private placement, the Company believes that its existing cash and cash equivalents should be sufficient, based on the current scope of activities, to fund operating expenses and capital expenditure requirements into the second quarter of 2025.
2023 operational highlights

Multiplex short hairpin ribonucleic acid (shRNA) non-gene edited technology – All along 2023, we have collected and presented data validating our shRNA multiplexing approach:
We developed a chimeric micro-RNA (miRNA) cluster to enable multiplexing of shRNAs, designed for easy, efficient, and tunable downregulation of up to four target genes simultaneously in CAR T-cells;
Results detailing the technical aspects of the development of this platform have been published in Molecular Therapy – Nucleic Acids (Mol Ther Nucleic Acids. 2023, 34:102038). This publication has raised much interest from the community and was subjected to an editorial comment in the same volume of the Journal (Mol Ther Nucleic Acids. 2023, 34:102077);
Additional data which demonstrate feasibility of this approach in the context of allogeneic cell therapies or with the aim to create therapies able to overcome the coinhibitory effects of exhaustion markers were presented at several scientific conferences. Posters are available on the company’s website, at View Source
Multispecific NKG2D-based CAR T-cell platform – In 2023, we have compiled and presented data validating our multispecific approach targeting NKG2D ligands (NKG2DL):
We have developed different CD19/NKG2DL, BCMA/NKG2DL and PSMA/NKG2DL multispecific CAR T-cells, utilizing both tandem constructs – that encompass the extracellular domain of the natural NKG2D receptor fused to a scFv targeting CD19, BCMA or PSMA, or dual constructs – that co-express the NKG2D-based CAR with an anti-CD19, anti-BCMA or anti-PSMA CAR, respectively;
Our data provides the proof-of-concept that NKG2DL are valuable targets in a multispecific CAR approach and demonstrate our CD19/NKG2DL multispecific CAR T-cells are highly effective to counteract relapses due to CD19 antigen loss in vivo. In vitro data generated with BCMA/NKG2DL and PSMA/NKG2DL multispecific CAR T-cells further validate this approach in other hematological and solid indications. Posters are available on the company’s website, at View Source
Financial highlights

As of December 31, 2023, the Company had cash and cash equivalents of €3.0 million and short-term investments of €4.0 million. The Company projects that its existing cash, cash equivalents and short-term investments should be sufficient to fund operating expenses and capital expenditure requirements into the second quarter of 2025. Therefore, the Company continues to project that its existing cash and cash equivalents will be sufficient to fund its estimated operating and capital expenditures over at least the next 12 months from the date of this press release.

Outlook for 2024

More data and evidence in the context of the multispecific CAR T-cell platform and shRNA multiplexing approach will be shared in the first half of 2024, with the aim to develop assets ready for a potential initiation of clinical trials either by the Company and/or through strategic partnerships afterwards.
Celyad Oncology will attend the 7th CAR-TCR Europe summit in London, UK (February 27-29, 2024), the must-attend forum to brainstorm and stay at the forefront of cell therapy innovations.
Financial Calendar 2024

April 5th, 2024 Full Year 2023 Financial Results
May 6th, 2024 Annual shareholders meeting
August 6th, 2024 First Half 2024 Interim Results
The financial calendar is communicated on an indicative basis and may be subject to change.

Cellectis announces the drawdown of the second tranche of €15 million under the credit facility agreement entered with the European Investment Bank (EIB)

On January 16, 2024 Cellectis (Euronext Growth: ALCLS – NASDAQ: CLLS) (the "Company"), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported that it has drawn down the second tranche of €15 million ("Tranche B") under the credit facility agreement for up to €40 million entered into with the European Investment Bank (the "EIB) on December 28, 2022 (the "Finance Contract") (Press release, Cellectis, JAN 16, 2024, View Source [SID1234639254]). Tranche B is expected to be disbursed by the EIB by January 25, 2024. The Company plans to use the proceeds of Tranche B towards the development of its pipeline of allogeneic CAR T-cell product candidates: UCART22, UCART20x22, and UCART123.

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As a condition to the disbursement of Tranche B the Company issued 1,460,053 warrants to the benefit of the EIB, in accordance with the terms of the 14th resolution of the shareholders’ meeting held on June 27, 2023 and articles L. 228-91 and seq. of the French Commercial Code (the "Tranche B Warrants").

Each Tranche B Warrant allows the EIB to subscribe for one ordinary share of the Company, at a price of €2.53, corresponding to 99% of the volume-weighted average price of the Company’s ordinary shares over the last 3 trading days preceding the decision of the board of directors of the Company to issue the Tranche B Warrants. The total number of shares issuable upon exercise of the Tranche B Warrants represents circa 2% of the Company’s outstanding share capital as at their issuance date.

Tranche B will mature six years from its disbursement date and will accrue interest at a rate of 7% per annum capitalized annually and payable at maturity.

The other terms of the Tranche B Warrants and prepayment events of Tranche B under the Finance Contract are as set forth in the Company’s press release of April 4, 2023 and Form 6-K filed with the U.S. Securities and Exchange Commission on such date.

The Finance Agreement allows the Company to drawdown a third tranche, of a maximum amount of €5 million, subject to certain conditions, including issuance of a specified number of additional warrants to the benefit of the EIB.

BullFrog AI Announces Issuance of Australian Patent Protecting Novel Prodrugs of Mebendazole and Their Use in Treating Cancer

On January 16, 2024 BullFrog AI Holdings, Inc. (NASDAQ: BFRG; BFRGW) ("BullFrog AI" or the "Company"), a technology-enabled drug development company using artificial intelligence (AI) and machine learning to enable the successful development of pharmaceuticals and biologics, reported that the Australian Patent Office has issued Patent No. 2019216757 protecting the Company’s novel prodrugs derived from mebendazole and their use in treating cancers and other diseases (Press release, Bullfrog AI, JAN 16, 2024, View Source [SID1234639253]). This follows the July 2023 announcement of the issuance of U.S. Patent No. 11,712,435 for this invention (link), with issuance of patents expected in additional territories in the future.

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The patented compounds exhibit improved solubility and oral bioavailability relative to the parent drug, thereby addressing a key difficulty associated with the potential use of mebendazole for oncology indications, and include BF-223, a key asset in the Company’s pipeline of in-licensed drugs. The Company previously announced positive results from a preclinical study demonstrating that BF-223 has anticancer activity in an animal model for glioblastoma (link).

"This patent grant further strengthens intellectual property protection of this key asset in our pipeline," said Vin Singh, founder and CEO of BullFrog AI. "Mebendazole has shown promise in treating various types of cancer, and the results of our preclinical study evaluating BF-223 in an animal model of glioblastoma support our thesis that prodrugs of mebendazole may provide enhanced therapeutic potential, thereby improving the likelihood of clinical success. We look forward to working with strategic partners to monetize this promising asset for the treatment of glioblastoma and other oncology indications."

BIO-TECHNE TO HOST CONFERENCE CALL ON FEBRUARY 1, 2024, TO ANNOUNCE SECOND QUARTER FISCAL 2024 FINANCIAL RESULTS

On January 16, 2024 Bio-Techne Corporation (NASDAQ: TECH) reported that management will host a conference call and webcast on Thursday, February 1, 2024, at 8:00 a.m. CST to review second quarter fiscal 2024 financial results (Press release, Bio-Techne, JAN 16, 2024, https://investors.bio-techne.com/news/detail/401/bio-techne-to-host-conference-call-on-february-1-2024-to-announce-second-quarter-fiscal-2024-financial-results [SID1234639252]).

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Access to the discussion may be obtained as follows:

Time:

8:00 a.m. CST

Date:

February 1, 2024

Dial-in:

1-877-407-9208 or 1-201-493-6784 (for international callers)

Conference ID:

13743935

Webcast:

View Source

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-844-512-2921 or 1-412-317-6671 (for international callers) and referencing Conference ID 13743935.

The replay will be available from 11:00 a.m. CST on Thursday, February 1, 2024, until 11:00 p.m. CST on Friday, March 1, 2024.

Bexion Pharmaceuticals, Inc. Announces Poster Presentation at ASCO GI 2024

On January 16, 2024 Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing a new generation of biologic therapy to treat solid tumor cancers and chemotherapy-induced peripheral neuropathy (CIPN), reported a Trials in Progress poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI), being held January 18-20, 2024, in San Francisco, CA (Press release, Bexion, JAN 16, 2024, View Source [SID1234639251]). Poster details are included below.

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Poster Details:

Session Title: Trials in Progress Poster Session C: Cancers of the Colon, Rectum, and Anus
Session Date: January 20th, 2024
Abstract Number: TPS224
Abstract Title: "BXQ-350: A phase 1b/2 placebo controlled, double blinded study on the efficacy and safety of BXQ-350 in combination with mFOLFOX7 and bevacizumab in newly diagnosed metastatic colorectal carcinoma (mCRC)."

"We are excited to present our ongoing trial of BXQ-350 in mCRC during the 2024 ASCO (Free ASCO Whitepaper) GI Symposium" said Scott Shively, CEO and President of Bexion Pharmaceuticals. "BXQ-350 in combination with FOLFOX and bevacizumab offers a unique opportunity to improve outcomes for 1st line patients with mCRC. We look forward to sharing progress with investigators and leaders at the conference."

About BXQ-350
Bexion’s lead drug candidate is BXQ-350, a first-in-class biologic containing the multifunctional, sphingolipid activator protein, Saposin C, and a phospholipid. BXQ-350 has pre-clinical antitumor effects in vitro and in vivo, particularly in colorectal, brain and other solid tumors. Two Phase 1 clinical trials, one in adults and one in pediatric DIPG patients, demonstrated a strong safety profile for BXQ-350 with evidence of single agent activity across multiple solid tumors. Additionally, other clinical and non-clinical data suggest BXQ-350 has activity in chemotherapy-induced peripheral neuropathy.