On November 22, 2024, BioXcel Therapeutics, Inc. (the "Company") reported to have entered into an underwriting agreement (the "Underwriting Agreement") with Canaccord Genuity LLC, as underwriter (the "Underwriter"), in connection with the issuance and sale by the Company in a public offering of (i) 5,600,000 shares of the Company’s common stock, par value $0.001 per share ("Common Stock"), and accompanying warrants to purchase 5,600,000 shares of Common Stock, at a combined public offering price of $0.48 per share, and, in lieu thereof to certain investors, (ii) pre-funded warrants to purchase 9,000,000 shares of Common Stock, and accompanying warrants to purchase 9,000,000 shares of Common Stock, at a combined public offering price of $0.479 per pre-funded warrant, which equals the public offering price per share of Common Stock and accompanying warrant less the $0.001 exercise price per share of the pre-funded warrants, less underwriting discounts and commissions, pursuant to an effective shelf registration statement on Form S-3 (Registration No. 333-275261) and a related prospectus supplement filed with the Securities and Exchange Commission (the "SEC") (Filing, 8-K, BioXcel Therapeutics, NOV 22, 2024, View Source [SID1234648604]).

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Each of the warrants in the offering is subject to customary beneficial ownership limitations on exercisability, is exercisable at any time after the date of issuance of such warrant and, in the case of the accompanying warrants, will expire on the fifth anniversary of the date of issuance. Each of the accompanying warrants will have an exercise price of $0.48 per underlying share of Common Stock.

The Company received net proceeds from the offering of approximately $6.2 million, after deducting underwriting discounts and commissions and estimated offering expenses, excluding the proceeds, if any, from exercise of any of the warrants. The Company intends to use the net proceeds of the offering to fund the SERENITY At-Home trial, prepare for the initiation of the TRANQUILITY In-Care trial, working capital and general corporate purposes. The Company expects the net proceeds from this offering combined with existing cash and cash equivalents will be sufficient to fund operations and service debt obligations into the first quarter of 2025. Our expectations regarding our anticipated cash runway into the first quarter of 2025 will be affected by many factors, our ability to execute our current business plan, the progress of our clinical trials and regulatory interactions. These expectations are based on estimates and the judgment of management. The Company’s cash runway may not extend as far as forecasted and anticipated cash needs could be greater than expected.

The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions.

The foregoing description of the Underwriting Agreement, the pre-funded warrants and the accompanying warrants are not complete and is qualified in its entirety by reference to the full text of the Underwriting Agreement, the Form of Pre-funded Warrant and the Form of Warrant, copies of which are filed as Exhibit 1.1, 4.1 and 4.2, respectively, to this Current Report on Form 8-K and is incorporated by reference herein. An opinion of Honigman LLP regarding the validity of the shares to be issued and sold in the offering by the Company is filed as Exhibits 5.1 to this Current Report on Form 8-K and is incorporated by reference herein.

On November 21, 2024, the exercise price of warrants to purchase 8,545,398 shares of common stock previously issued in March 2024 was reduced to $0.571 per share.

On November 22, 2024 The Children’s Inn at the National Institutes of Health (NIH) reported that Gilead Sciences Inc. has awarded The Inn a $1 million grant to support its renovation and expansion (Press release, Gilead Sciences, NOV 22, 2024, View Source [SID1234648584]). The grant will fund a welcome center in the new wing of The Inn of Tomorrow, a $50-plus million project for which The Inn recently held a groundbreaking ceremony. As the first point of contact, The Gilead Sciences Welcome Center is designed to ensure young patients from around the world participating in groundbreaking clinical trials at NIH feel welcomed immediately upon their arrival at The Inn.

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"Gilead is a valued partner whose therapeutic interests have intersected with The Inn’s since our beginning. With this grant, we look forward to transforming our space with new capabilities to support young patients, their families, and NIH researchers at every step along the journey from hopes to cures."

"We are grateful for Gilead’s continuing partnership with The Inn," said Jennie Lucca, The Inn’s CEO. "Gilead is a valued partner whose therapeutic interests have intersected with The Inn’s since our beginning. With this grant, we look forward to transforming our space with new capabilities to support young patients, their families, and NIH researchers at every step along the journey from hopes to cures."

A commitment to health equity and equitable access to NIH pediatric clinical trials are driving forces behind The Inn of Tomorrow. The Inn seeks to remove barriers to potentially lifesaving clinical research studies for diverse families, ensure all families find a "place like home" at The Inn by designing culturally inclusive programs, and use the health equity lens to determine how environment helps patients in their journey to optimal health.

"Gilead is proud to work with The Children’s Inn on their ongoing efforts to provide essential support services to these young patients and their families," said Carmen Villar, Vice President, ESG and Corporate Citizenship, Gilead Sciences. "Our contribution demonstrates our continued commitment to supporting communities and advancing health equity."

Construction on the project is scheduled to start in early 2025. In addition to the new welcome center in the 15,000-square-foot addition, The Inn of Tomorrow will incorporate improved accessibility features throughout, resulting in a state-of-the-art residential facility that reflects best practices in healthcare and hospitality. When completed in 2027, the project will expand The Inn’s capacity to serve more and younger patients – increasing annual capacity by 25% from 2,400 to 3,000 families.

On November 22, 2024 OverT Bio, an NYC-based cell therapy company, reported that it has been awarded a $120,000 G-Rex Grant from ScaleReadyTM, in collaboration with Wilson Wolf Manufacturing, Bio-Techne Corporation (NASDAQ: TECH), and CellReadyTM (Press release, OverT Bio, NOV 22, 2024, View Source [SID1234648585]). This grant will support OverT Bio’s ongoing development efforts that will lead to next generation cell therapies for solid tumors, based on innovative data-driven discovery platforms OverTargetTM and OverTCRTM.

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"This grant, including its access to newly developed GMP closed system products and ScaleReady’s expertise, will help us accelerate the development of our products in a way that will ensure future scalability and cost-effectiveness of these potential medicines."

The G-Rex Grant is part of ScaleReady’s $20 million grant program aimed at advancing Cell and Gene Therapy (CGT) development and manufacturing. The G-Rex Grant Program offers recipients significant no-cost support allowing for expeditious optimization of cell manufacturing processes.

"We are pleased to receive ScaleReady’s support and their recognition of the potentially high impact our technology has to advance our shared mission of bringing new life-saving therapeutics to cancer patients," stated Mat Legut, PhD, CEO of OverT Bio. "This grant, including its access to newly developed GMP closed system products and ScaleReady’s expertise, will help us accelerate the development of our products in a way that will ensure future scalability and cost-effectiveness of these potential medicines."

"Our support of OverT Bio is yet another example of how our G-Rex Grant Program is being used to facilitate advancement of the field of cell and gene-modified cell therapy," said Josh Ludwig, Commercial Director of ScaleReady. "The G-Rex Grant Program augments ScaleReady’s primary purpose of providing every CGT company with the ability to save time and money while building a strong value proposition for continued investment on favorable terms."

On November 21, 2024 Skyhawk Therapeutics, Inc., a clinical-stage biotechnology company developing novel small molecule therapies designed to modulate critical RNA targets, reported that the Company will deliver a poster presentation highlighting preclinical data that support SKY-1214 as a potential treatment for relapsed/refractory (R/R) multiple myeloma (MM) and non-Hodgkin’s lymphoma (NHL) at the upcoming 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place December 7-10, 2024 in San Diego, California (Press release, Skyhawk Therapeutics, NOV 21, 2024, View Source [SID1234648552]).

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Details for the poster presentation are as follows:

Title: "SKY-1214, a Small Molecule Splicing Modulator

Targeting FANCL and FANCI, Provides a New

Mechanism of Action Targeting Multiple

Myeloma and Non-Hodgkin’s Lymphoma"

Presenter: Steven Taylor, PhD, Head of Business Development and Operations

Session Name: 605. Molecular Pharmacology and Drug Resistance:

Lymphoid Neoplasms: Poster II

Poster Number: 2784

Date/Time: Sunday, December 8, 2024 from 6:00 PM – 8:00 PM PST

Location: San Diego Convention Center, Halls G-H

"Having already shown strong monotherapy potential, we are pleased to be sharing these encouraging preclinical data that demonstrate SKY-1214’s anti-cancer activity in combination with key existing and emerging treatment options," said Clint Musil, CEO at Skyhawk. "The increasing number of patients with relapsed/refractory multiple myeloma and Large B-cell Lymphoma after chemotherapy and immunotherapies necessitates new, effective and convenient therapies that will increasingly be used in combination. The understanding of RNA biology and the capacity to develop oral drugs for "undruggable" protein targets opens a new opportunity to address these treatment needs."

About SKY-1214

SKY-1214 is a first-in-class, oral FANCL/FANCI targeting RNA splicing modulator being developed for difficult to treat multiple myeloma (MM) and non-Hodgkin’s lymphoma (NHL). FANCL/FANCI are critical components of the Fanconi anemia DNA damage repair pathway, which MM and NHL tumor cells use to maintain their genome integrity. Skyhawk has observed anti-tumor activity for SKY-1214 in several preclinical cell models, including those representing prevalent high-risk cytogenetic alterations. SKY-1214 also demonstrated anti-tumor activity in human tumor cell-derived xenograft mouse models correlating with FANCL/FANCI mRNA reduction. Combinations of SKY-1214 with commonly used and emerging treatments for MM and NHL resulted in additive and synergistic effects, demonstrated tumor regressions, and showed enhanced durability of effect upon treatment cessation. SKY-1214 has completed IND-enabling studies.

On November 21, 2024 BPGbio, Inc., a leading biology-first, AI-powered clinical-stage biopharma company focused on mitochondrial biology and protein homeostasis, reported that it will co-present two pivotal studies with Stanford Medicine’s Department of Neurology at the Society for Neuro-Oncology (SNO) 2024 Annual Meeting, taking place November 21-24, 2024, in Houston, Texas (Press release, BPGbio, NOV 21, 2024, View Source [SID1234648568]). The presentations will highlight BPM31510 and BRG399—potential glioblastoma multiforme (GBM) therapies that were identified by the company’s proprietary NAi Interrogative Biology Platform, a causal AI-powered system designed to reveal hidden cause-and-effect relationships within patient biology.

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The first study, titled "Optimizing brain cancer therapy: balancing tumor eradication and normal tissue preservation with BPM31510," explores BPM31510’s superior ability to preserve healthy cells compared to standard cancer treatments in mouse, rat, and human glioblastoma cell lines. The study demonstrates BPM31510’s ability to effectively target and diminish cancer cells while selectively allowing the growth of healthy brain cells, an effect that standard treatments fail to achieve. Researchers also showed that the BPM31510 significantly improved survival in glioma implanted mice and rats compared to the control group, mirroring the results from the ongoing phase 2b trial on BPM31510 for GBM and highlighting BPM31510’s potential in brain cancer therapy.

The second study, titled "Improved anti-glioblastoma efficacy by BRG399, a novel oral microtubule binding agent," presents findings on BRG399’s anti-cancer activity. BRG399, a novel pan-cancer therapy, works by disrupting the cell division process in both solid and liquid tumors. BRG399 was also found to induce an immune memory response, protecting against tumor recurrence. The study confirmed that BRG399 can cross into the brain, target tumor cells, and improve survival in rat glioma models.

"Standard cancer treatments that focus solely on destroying tumors often harm healthy tissue in the process," said Seema Nagpal, M.D., principal investigator of the BPM31510 GBM phase 2b trial and Clinical Professor of Neurology and Neurological Sciences at Stanford Medicine. "These new treatments are taking novel targeted approaches on glioma cancer cells and we are excited to share the encouraging results from our studies with our peers and industry researchers."

"Our ongoing clinical and preclinical trials for BPM31510 and BRG399 are continuously deepening our understanding of these promising therapies," said Niven R. Narain, Ph.D., President and CEO of BPGbio. "By putting biology first, our NAi Platform has enabled us to optimize every aspect of these therapies, from dosing and timing to patient selection and potential indication expansion opportunities."

Poster Presentation Details:

Optimizing brain cancer therapy: balancing tumor eradication and normal tissue preservation with BPM31510
Date and Time: November 22, 2024, 7:30 p.m. – 9:30 p.m. CST
Location: Hall B3, George R. Brown Convention Center, Houston, Texas
Presenter: Abbas Khojasteh, Ph.D.
Abstract Number: DDDR-13

Improved anti-glioblastoma efficacy by BRG399, a novel oral microtubule binding agent
Date and Time: November 22, 2024, 7:30 p.m. – 9:30 p.m. CST
Location: Hall B3, George R. Brown Convention Center, Houston, Texas
Presenter: Stephane Gesta, Ph.D.
Abstract Number: DDDR-14
About BPM31510

BPM31510IV is BPGbio’s lead candidate in late-stage development for aggressive solid tumors such as glioblastoma multiforme (GBM) and pancreatic cancer. Other topical and oral formulations of the investigational agent are also being developed as a potential treatment for several rare diseases. The compound has demonstrated a tolerable safety profile and shown potential clinical benefits across multiple disease indications. Validated by BPGbio’s NAi Interrogative Biology platform, BPM31510 induces a hallmark shift in the tumor microenvironment (TME) by modulating mitochondrial oxidative phosphorylation in aggressive tumors, leading to cancer cell death. In many mitochondrial diseases, restoring CoQ10 levels can overcome the effect of mutations in genes that lead to mitochondrial dysfunction. BPM31510 has been granted Orphan Drug Designation by the FDA for GBM, pancreatic cancer, and epidermolysis bullosa (EB), as well as Rare Pediatric Disease Designation for primary CoQ10 deficiency and EB.

About BRG399

BRG399 is a BPGbio-developed candidate being studied for its therapeutic potential as a treatment for solid and liquid tumor cancers as well as diseases associated with inflammation. This experimental drug, a first-in-class, anti-mitotic agent with broad-spectrum anti-cancer activity and favorable pharmacological properties for clinical testing, is being designed for oral delivery. BRG399 is leading the new oncology drug pipeline for BPGbio which includes drug candidates uniquely targeting E2 enzymes.