On March 26, 2024 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), an AI-driven innovator of precision antibody immunotherapies, reported that it has entered into a securities purchase agreement for a private investment in public equity ("PIPE") financing that is expected to result in gross proceeds to the Company of approximately $15.0 million, before deducting placement agent fees and offering expenses (Press release, iBioPharma, MAR 26, 2024, View Source [SID1234641447]).

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The fully subscribed PIPE financing included participation from ADAR1 Capital Management, Lynx1 Capital Management, Ikarian Capital and other institutional and accredited investors. The Company intends to use the net proceeds from the offering for general corporate purposes, including research and development and working capital. The Company also expects the net proceeds will extend its cash runway to fund its operating plan through fiscal year 2025.

"We appreciate the support of this outstanding group of healthcare specialist investors that shares the vision of leveraging our cutting-edge AI/Machine learning platform to deliver best-in-class drugs," said iBio’s Chief Executive Officer and Chief Scientific Officer, Martin Brenner, DVM, Ph.D.

Pursuant to the terms of the securities purchase agreement, the Company is selling an aggregate of 5,287,278 shares of common stock (or pre-funded warrant in lieu thereof) and common warrants to purchase up to 5,287,278 shares of common stock at a purchase price of $2.85 per share (or pre-funded warrant in lieu thereof), subject to certain beneficial ownership limitations set by each holder. The warrants issued in the offering are exercisable six (6) months upon issuance at an exercise price of $2.64 per share and will expire five years from the date of issuance.

Chardan acted as the sole placement agent for the PIPE financing.

The unregistered shares of common stock, pre-funded warrants and warrants sold in the PIPE financing described above were offered under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act") and Regulation D promulgated thereunder and, along with the shares of common stock underlying the pre-funded warrants and warrants, have not been registered under the Act or applicable state securities laws. Accordingly, the shares of common stock, the pre-funded warrants, the warrants and the shares of common stock underlying the pre-funded warrants and warrants may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. Pursuant to the terms of the securities purchase agreement with the investors, the Company has agreed to file one or more registration statements with the SEC covering the resale of the unregistered shares of common stock and the shares issuable upon exercise of the unregistered pre-funded warrants and warrants.

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.

On March 26, 2024 FibroGen, Inc. (NASDAQ: FGEN) reported that Thane Wettig, Chief Executive Officer, will participate in a corporate presentation at the 23rd Annual Needham Virtual Healthcare Conference on Tuesday, April 9, 2024, from 3:00-3:40 PM Eastern Time (Press release, FibroGen, MAR 26, 2024, View Source [SID1234641446]). Company management will also participate in virtual one-on-one meetings with investors during the conference.

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The live audio webcast of the event will be available to investors and other interested parties on the "Events & Presentations" section of the FibroGen Investor webpage at www.fibrogen.com. A replay will be available for 30 days.

On March 26, 2024 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders, reported a corporate update and provided financial results for the fourth quarter of 2023 and fiscal year ended December 31, 2023 (Press release, Enveric Biosciences, MAR 26, 2024, View Source [SID1234641445]).

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"The fourth quarter of 2023 and early 2024 was a significant period for Enveric, highlighted by the selection of EB-003 as our lead development candidate. We believe EB-003 is a groundbreaking, neuroplastogen drug candidate that offers the potential to treat severe mental health disorders without the hallucinogenic effect typically associated with psychedelic-based molecules," said Joseph Tucker, Ph.D., Director and CEO of Enveric. "Based on numerous discussions with large pharmaceutical companies, mental health professionals, and leading researchers, we believe it is evident that widespread market acceptance of psychedelic-inspired drugs will ultimately be determined by the ability to administer such medications in an outpatient setting. We believe minimizing the hallucinatory effect will be key to seizing this opportunity and was critical in our decision to select EB-003 as our lead product candidate of the EVM301 series. We now look forward to advancing preclinical activities in early 2024 in support of filing an IND for EB-003 as we seek to introduce a new treatment paradigm for depression and anxiety disorders."

Dr. Tucker continued, "The decision to designate EB-003 as our lead candidate was the culmination of an extensive design and evaluation process. This effort included the creation of more than one thousand compounds around which we have built a substantial intellectual property estate, increasing the attractiveness of these molecules for further development. Already in 2024, we have seen returns on this strategy in the form of out-licensing agreements as partners recognize the value of our innovative compounds that are protected with strong intellectual property and have the potential to exapand therapeutic options for patients with depression and anxiety. We will attempt to pursue additional out-licensing and partnership opportunities throughout the year as we continue to advance discussions with multiple possible partner companies."

Dr. Tucker concluded, "During the fourth quarter, we also continued to progress IND-enabling preclinical work for EB-002, completing important repeat-dose toxicology studies, genotoxicity studies, as well as cardiac, respiratory markers, and CNS safety pharmacology studies. We expect to finalize all preclinical activities for EB-002 soon, making the asset Phase 1 ready in 2024."

FOURTH QUARTER AND YEAR END UPDATES

Pipeline Advances and Highlight

Selected EB-003 as lead drug candidate from the Company’s next-generation EVM301 Series based on the molecule’s pharmacological properties and it’s potential to be a first-in-class treatment that addresses difficult-to-treat mental health disorders.
Presented two posters at the 6th Neuropsychiatric Drug Development Summit and two posters at the Canadian Chemical Engineering Conference (CSChE 2023) providing an update on the Company’s near-term selection EB-003 and highlighting key preclinical examinations of EB-002, a novel prodrug of psilocin.
Published cover article in the Journal of Medicinal Chemistry, a peer-reviewed journal published by the American Chemical Society, describing the development EB-002.
Progressed preclinical development of psilocin prodrug, EB-002, with GLP-toxicology and safety pharmacology studies, repeat dose toxicology studies, as well as cardiac, respiratory, CNS safety pharmacology studies, an in vitro hERG current study, and genotoxicity studies.
Expanded Business Development and Out-Licensing Opportunities in 2023 and 2024

Signed three non-binding term sheets with an undisclosed biotechnology company to pursue the out-licensing of three classes of compounds; future development and sales milestone payments and execution fees for the three licenses could total up to $200 million.
Signed two non-binding term sheets with a second undisclosed biotechnology company to pursue the out-licensing of cannabinoid conjugate compounds for pharmaceutical and non-pharmaceutical applications for the treatement of joint diseases; future development and sales milestone payments and execution fees for the two licenses could total up to $61 million.
Surpassed one thousand synthesized compounds discovered and characterized in our PsybraryTM portfolio of novel psychedelic-inspired molecules, following the acceleration of our AI-backed platform tailored for specific applications in the management of mental health disorders.
Continued to strengthen our intellectual property portfolio, receiving ten patent issuances from the United States Patent and Trademark Office.
FOURTH QUARTER AND FISCAL YEAR ENDED 2023 FINANCIAL RESULTS

Net loss attributable to stockholders was $3.44 million for the fourth quarter ended December 31, 2023, including $1.48 million in net non-cash expense, with a basic and diluted loss per share of $1.46, as compared to a net loss of $8.80 million, including $4.48 million in net non-cash expense, with a basic and diluted loss per share of $4.89 for the quarter ended December 31, 2022.

On December 28, 2023, the Company completed a warrant inducement transaction with two investors in which existing warrants were repriced and exercised and new warrants were issued to the investors. The cash proceeds from that transaction were received on January 4, 2024. Subsequently, on February 29, 2024, approximately 90% of the new warrants were also exercised. The gross proceeds to the Company from the two warrant exercises totaled approximately $4.5 million.

On March 26, 2024 Domain Therapeutics ("Domain" or "the Company"), a global clinical-stage biopharmaceutical company developing innovative drug candidates in immuno-oncology targeting G Protein-Coupled Receptors (GPCRs), reported that latest preclinical data on DT-9045, a novel protease-activated receptor 2 (PAR2) Negative Allosteric Modulator candidate, will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024 in San Diego, California (Press release, Domain Therapeutics, MAR 26, 2024, View Source [SID1234641444]).

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Date/Time: 7 April 2024 1:30 PM – 5:00 PM PST – Section 27
Abstract number: 684 / 30
Poster session: PO.ET09.05 – Novel Antitumor Agents 2
Title: DT-9045, a novel PAR2 inhibitor with best-in-class properties that reduces resistance to both EGFR-targeting therapies and immunotherapy in oncology models
The abstract will be made available in the online Proceedings of the AACR (Free AACR Whitepaper).

PAR2 is one of the genes most significantly linked to resistance against immune checkpoint blockage (ICB) and T cells dysfunction in cancer patients. Its upregulation across a variety of cancer types and expression on diverse cells within the tumor microenvironment underscore PAR2’s critical role in cancer development.

Leveraging its integrated precision research approach, backed by over 20 years of solid GPCR expertise, Domain has developed a novel highly potent and selective PAR2 inhibitor, DT-9045. This first-in-class Negative Allosteric Modulator has shown unparalleled potential in oncology and immuno-oncology. Remarkably, when compared to its most advanced competitors positioned in other therapeutic areas, this candidate has demonstrated clear differentiated features. Moreover, several proof-of-concept studies have shown strong potency in models resistant to EGFR-targeting therapies and immunotherapy opening solid perspectives of strategic clinical positioning and revenues generation in tumor types that constitute a high medical unmet need.

DT-9045 is a small molecule, orally available, insurmountable, biased, and active in tumor-like conditions (high concentration of activating proteases and acidic pH). IND-enabling studies are currently ongoing to advance the candidate toward the clinic.

Stephan Schann, Chief Scientific Officer of Domain Therapeutics, commented: "We are excited to present our newest findings on DT-9045 at AACR (Free AACR Whitepaper). The results not only confirm the immense potential of our PAR2 inhibitor to change the way we treat cancer, but also emphasize its high potency and efficacy against several drug resistance, offering cancer patients clear therapeutic perspectives in immuno-oncology. More broadly, they reflect our deep commitment to precision research, pioneering innovative new GPCR targets in immunosuppression, designing clear competitive properties to deliver game-changing candidates. We eagerly anticipate advancing this groundbreaking research, with a focus on addressing a substantial unmet medical need for cancer patients."

This progress, follows the announcement in June 2023 when DT-9045 was nominated as a first-in-class clinical PAR2 antagonist. It has shown great therapeutic potential in enhancing the efficacy to immunotherapy aiming to substantially improve treatment outcomes for non-responding cancer patients.

On March 26, 2024 Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported recent business highlights and financial results for the fourth quarter and full year ended December 31, 2023 (Press release, Delcath Systems, MAR 26, 2024, View Source [SID1234641443]).

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Recent Business Highlights
During and since the fourth quarter, Delcath:

Announced the first commercial use of HEPZATO KIT for the treatment of metastatic uveal melanoma (mUM) at Moffitt Cancer Center;
Activated three treating sites which are fully trained to treat commercial patients with a fourth expected to be active before the end of the first quarter and an additional three sites expected to become active in the first few weeks of the second quarter of 2024;
Updated site activation guidance from 15 active sites to a total of 20 active sites by the end of 2024;
Received notification that a permanent, product-specific J-code (J9248) and transitional pass-through payment status for HEPZATO, was established by the Centers for Medicare & Medicaid Services (CMS) and will become effective on April 1, 2024;
Finalized its patient access program and launched websites relating to the HEPZATO KIT, including HEPZATOKIT.com, HEPZATOKITREMS.com, and HEPZATOKITACCESS.com, to support the commercial launch;
Raised $7.0 million in a private placement transaction with certain accredited investors comprised of existing investors, Delcath senior executives, and members of its Board of Directors;
Appointed Martha S. Rook, Ph.D as Chief Operating Officer on March 18, 2024. Ms. Rook is an experienced industry leader who brings more than 25 years of academic and industry experience in molecular biology, diagnostics development, biologics process development and combination products manufacturing; and
Announced publication by independent investigators of:
A retrospective comparative study of CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP) and Selective Internal Radiation Therapy (SIRT) citing a statistically significant difference in median overall survival with 301 days for SIRT and 516 days for PHP; and
A clinical study entitled "Quality of Life After Melphalan Hepatic Perfusion for Uveal Melanoma" in which the authors concluded utilizing Delcath’s CHEMOSAT to administer high-dose melphalan to the liver is well tolerated by patients and does not negatively affect their quality of life.
"We have made tremendous progress since the January launch of HEPZATO KIT in the US," said Gerard Michel, Delcath’s Chief Executive Officer. "We have successfully secured a product specific J-Code and, with over 90 preceptorships completed by healthcare professionals across approximately 20 institutions in the US, are on track to train and activate 20 sites by year end. Furthermore, we have strengthened our balance sheet with additional investment from senior management and existing investors. I am proud of the team’s success in providing access to a new treatment for patients suffering from metastatic uveal melanoma."

Fourth Quarter and Full Year 2023 Results
Cash, cash equivalents and investment totaled $32.5 million as of December 31, 2023. Subsequent to year-end, on March 19, 2024, the company closed a $7.0 million private placement financing.

Total revenue for the quarter and year-ended December 31, 2023, was approximately $0.5 million and $2.1 million, respectively, compared to $0.6 million and $2.7 million for the same periods in the prior year, respectively, from our sales of CHEMOSAT in Europe.

Research and development expenses for the quarter and year-ended December 31, 2023, were $4.7 million and $17.5 million, respectively, compared to $4.4 and $18.6 million, respectively, for the same periods in the prior year. The change in research and development expenses is primarily due to a decrease in clinical trial activities and expenses related to the FDA inspection offset by an increase in personnel related expenses.

Selling, general and administrative expenses for the quarter and year-ended December 31, 2023, increased to $7.0 million and $22.1 million, respectively, compared to $3.8 million and $17.3 million, respectively for the same periods in the prior year. The increase primarily relates to activities to prepare for a commercial launch including marketing-related expenses and additional personnel in the commercial team.