On March 19, 2024 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported a Research & Development (R&D) Day focusing on its core AI-Immunology platform (Press release, Evaxion Biotech, MAR 19, 2024, View Source [SID1234641262]). The event will be hosted at our facilities in Hørsholm, Denmark, between 14.00 – 18.00 CET / 9.00 a.m. – 1.00 p.m. EST and can be accessed remotely here.

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The R&D Day features a series of talks providing in-depth insights into Evaxion’s clinically validated AI-Immunology platform for vaccine target discovery, design and development. AI-Immunology consists of a collection of in-house developed AI building blocks that can be intelligently combined into AI prediction models to address complex healthcare issues related to the immune system. With the AI prediction models, PIONEER, ObsERV, EDEN and RAVEN, we can identify clinically relevant vaccine targets within hours.

Christian Kanstrup, CEO of Evaxion, expresses enthusiasm: "We have been looking forward to this exciting day and welcome everyone interested in learning more about our technology and its potential for saving and improving lives. We believe that we hold a truly differentiated position driven by our validated AI-Immunology platform and the multi-disciplinary capability set we have built around it. The potential of AI-Immunology is evidenced by our strong pipeline of vaccine candidates and existing partnerships."

The presentations during the day will, among other things, cover:

The innovative modular architecture of AI-Immunology, where AI building blocks can be combined into AI prediction models, enhancing scalability
Insights into the novel AI-Immunology building block, EvaxMHC, which is used across the platform, significantly enhancing the predictive capabilities
The clinical validation of the predictive capabilities of the PIONEER model showing a statistically significant improvement in progression-free survival in metastatic melanoma patients
The novel tumor target sources, named Endogenous Retroviruses (ERVs), showing high relevance in low tumor mutation burden cancers, allowing for potentially more effective personal cancer vaccines
The EDEN model outperforms reverse vaccinology finding novel targets in hours instead of years. The EDEN designed EVX-B2 vaccine candidate showing stronger protection than a vaccine candidate developed by GSK’s Gonorrhea
RAVEN introduces novel vaccine concepts to enhance the effectiveness of T-cell-based vaccines
The ObsERV model allows for a novel precision vaccine approach toward addressing cancers which cannot be targeted with standard immunotherapies
Following the R&D Day, a replay of the event presentations will be available on our website.

About AI-Immunology 

AI-Immunology is a scalable and adaptable artificial intelligence technology platform at the forefront of vaccine discovery for infectious diseases and cancers. By integrating the collective power of proprietary AI models PIONEER, EDEN, RAVEN, and ObsERV, the platform can model the complexity of the patient’s immune system. AI-Immunology advanced computational modelling swiftly and uniquely identifies, predicts, and designs vaccine candidates, revolutionizing the landscape of immunotherapy by offering a holistic and personalized approach to combat fast-evolving pathogens and malignant cells.

On March 19, 2024 Cantex Pharmaceuticals, Inc., a clinical stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions for which new treatments are urgently needed, reported that the Company’s CEO, Stephen Marcus, M.D., will be an expert speaker at 5th Annual Glioblastoma Drug Development Summit, which will be held March 26-28 at the Hilton Boston Logan Airport (Press release, Cantex, MAR 19, 2024, View Source [SID1234641279]).

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In a podium presentation titled, "Delving into a Clinical Update on Azeliragon for GBM – Implementable Lessons for Small Molecule Success," Dr. Marcus will update the Company’s progress with its two ongoing azeliragon Phase 2 clinical trials. In those clinical trials, azeliragon is being studied in combination with radiation therapy with or without temozolomide in patients with newly diagnosed glioblastoma (GBM). In addition, Dr. Marcus will also highlight azeliragon’s potential effect on cerebral edema and its potential ability to reduce dexamethasone dosing in GBM treatment.

GBM is a highly malignant primary brain tumor for which current therapeutic options provide a limited life extension benefit. In 2023, Cantex received Food and Drug Administration Orphan Drug Designation for azeliragon for the treatment of glioblastoma. FDA Orphan Drug Designation provides Cantex with seven years of azeliragon marketing exclusivity from the time of product launch for the orphan indication, and several other important benefits, including assistance in the drug development process, tax credits for clinical costs, and exemptions from certain FDA fees.

"We look forward to meeting with esteemed colleagues and researchers to discuss the many important advances being made to combat this challenging and devastating form of cancer and azeliragon’s progress in our two Phase 2 GBM clinical trials," said Dr. Marcus. "We are excited to discuss this novel clinical candidate and its unique mechanism of action, which we believe has the potential to impact several devastating cancers that continue to challenge researchers, oncologists, and patients."

Details of the event are as follows:

Event:

5th Annual Glioblastoma Drug Development Summit

Presentation Title:

Delving into a Clinical Update on Azeliragon for GBM- Implementable Lessons for Small Molecule Success

Date & Time:

11:30 a.m. ET, March 27, 2024

Location:

Hilton Boston Logan Airport, Boston, MA

Registration:

https://glioblastoma-drugdevelopment.com/register/

During the conference, Dr. Marcus will conduct one-on-one meetings to review the Company’s business and clinical development strategy, recent corporate achievements, and upcoming milestones.

About Azeliragon

Azeliragon is an orally administered capsule, taken once daily, that inhibits interactions of the receptor for advanced glycation end products (known as RAGE) with certain ligands, including HMGB1 and S100 proteins in the tumor microenvironment. Azeliragon was discovered by and originally under development for Alzheimer’s disease by vTv Therapeutics Inc. (NASDAQ: VTVT) from which Cantex licensed worldwide rights to azeliragon. Clinical safety data from these trials, involving more than 2000 individuals dosed for periods up to 18 months, indicate that azeliragon is very well tolerated.

Cantex has ongoing Phase 2 clinical trials in glioblastoma, brain metastasis, pancreatic cancer, breast cancer, and a Phase 3 trial in hospitalized patients with pneumonia to prevent acute kidney injury. These trials are based on azeliragon’s robust preclinical data as well as its extensive clinical safety information from randomized placebo-controlled clinical trials.

On March 19, 2024 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, reported the pricing of an underwritten offering of 14,545,454 shares of its common stock at an offering price of $5.50 per share (Press release, Fate Therapeutics, MAR 19, 2024, View Source [SID1234641263]). The offering includes participation from new and existing institutional investors, including Adage Capital Partners LP., Boxer Capital, Deep Track Capital, OrbiMed, Suvretta Capital and a life-sciences focused investor.

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In addition, the Company announced the pricing of a concurrent private placement of pre-funded warrants to purchase 3,636,364 shares of its common stock at a purchase price of $5.499 per pre-funded warrant, which represents the offering price per share of common stock less the $0.001 exercise price per share of each pre-funded warrant, to certain institutional and other accredited investors affiliated with or managed by Redmile Group, LLC.

The gross proceeds from the underwritten offering and private placement are expected to be approximately $100.0 million before deducting underwriting discounts and commissions and other offering expenses. BofA Securities, Jefferies, and Leerink Partners are acting as the joint bookrunning managers for the underwritten offering.

All of the shares and pre-funded warrants are to be sold by the Company. The financing is expected to close on or about March 21, 2024, subject to customary closing conditions.

The Company intends to use the net proceeds from the underwritten offering and concurrent private placement for funding clinical trials and nonclinical studies of the Company’s product candidates, manufacturing expenses associated with the development of the Company’s product candidates, the conduct of preclinical research and development, and for other working capital and general corporate purposes.

A shelf registration statement on Form S-3 (File No. 333-275402) relating to the underwritten offering of the securities described above was filed with the Securities and Exchange Commission (the "SEC") on November 8, 2023 and became effective on November 27, 2023. A final prospectus supplement relating to and describing the terms of the underwritten offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. When available, copies of the final prospectus supplement may also be obtained from BofA Securities, Inc. NC1-022-02-25, 201 North Tryon Street, Charlotte, NC 28255-0001, Attn: Prospectus Department or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected]; or Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected].

The pre-funded warrants to be sold in the concurrent private placement have not been registered under the Securities Act or under any state securities laws and, unless so registered may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws. The securities sold in the private placement will be issued in reliance upon the exemption from registration pursuant to Section 4(a)(2) under the Securities Act in a transaction not involving a public offering of such securities.

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

On March 19, 2024 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported financial results and operational highlights for the fourth quarter and year ended December 31, 2023 (Press release, Adicet Bio, MAR 19, 2024, View Source [SID1234641280]).

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"We are excited to explore the potential of our gamma delta T cell platform in autoimmune diseases following the FDA’s IND clearance of ADI-001 in lupus nephritis," said Chen Schor, President and Chief Executive Officer at Adicet Bio. "We believe ADI-001 is ideally suited for the treatment of autoimmune diseases given its robust B-cell depletion consistent with other autologous CAR T therapies tested in autoimmune diseases, its tissue tropism potential in autoimmune diseases, and the safety and efficacy data observed in our Phase 1 study. In addition, ADI-001’s off-the-shelf availability and safety profile has the potential to make cell therapy for autoimmune diseases available to patients in community setting. We look forward to initiating the Phase 1 study in lupus nephritis in the second quarter of 2024 and are on track to expand the program to additional autoimmune indications."

Mr. Schor continued: "In addition, we are continuing to enroll MCL patients in our ongoing Phase 1 study of ADI-001 in relapsed or refractory non-Hodgkin’s lymphoma. With the completion of the successful capital raise and other net proceeds from stock sales under the at-the-market program in January, extending our cash runway into the second half of 2026, we are well-positioned to continue clinical execution across our pipeline through multiple upcoming milestones."

Fourth Quarter 2023 and Recent Operational Highlights:

Autoimmune diseases

IND clearance for ADI-001 in lupus nephritis. In December 2023, the FDA cleared the Company’s IND application for ADI-001 in lupus nephritis. Adicet plans to initiate a Phase 1 study to evaluate the safety and efficacy of ADI-001 in lupus nephritis during the second quarter of 2024. Preliminary clinical data from the trial are expected in the fourth quarter of 2024 or first quarter of 2025, pending study site activation progression and patient enrollment.
Expansion of ADI-001 development in autoimmune diseases. Adicet expects to expand into additional autoimmune indications in the near future. The Company anticipates providing preliminary clinical data in the fourth quarter of 2024 or first half of 2025, subject to clearance of INDs in those indications as well as successful site initiation and patient enrollment in the relevant clinical protocols.
Hematologic malignancies and solid tumor indications

Continuing to advance ADI-001 in Phase 1 GLEAN study in mantle cell lymphoma (MCL). The Phase 1 study of ADI-001 in relapsed or refractory non-Hodgkin’s lymphoma (NHL) is ongoing, with enrollment focused on the MCL patient population, which demonstrated the greatest clinical benefit in the June 2023 clinical update. Adicet expects to provide a clinical update on safety, efficacy and 6-month complete response data in MCL patients in the second half of 2024.
Advancing ADI-270 preclinical development in solid tumors. ADI-270 is designed to home to solid tumors, with a highly specific targeting moiety for CD70 and an armoring technology of dominant negative TGF beta receptor to address immunosuppressive factors in the tumor microenvironment. Adicet remains on track to file an IND for ADI-270 in renal cell carcinoma in the second quarter of 2024 and expects to provide clinical data from a Phase 1 study in the first half of 2025, following regulatory clearance and subject to study initiation progress.
Presented persistence and pharmacodynamic data from ADI-001 Phase 1 study at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. In December 2023, Adicet presented new pharmacokinetic and pharmacodynamic data from the Phase 1 study of ADI-001 at the ASH (Free ASH Whitepaper) Annual Meeting. The data demonstrated robust dose-dependent expansion and persistence in patients with relapsed or refractory aggressive B-cell NHL. ADI-001’s strong exposure and persistence profile observed in the study to date further validates Adicet’s gamma delta T cell technology.
Corporate updates

Hired Benjamin Hsu, M.D., Ph.D., as Vice President Clinical Development – Autoimmune. In March 2024, Adicet appointed Dr. Benjamin Hsu, M.D., Ph.D., as Vice President Clinical Development. Dr. Hsu brings over 20 years of experience in the biotech and pharmaceutical industry with extensive expertise in immunology and rheumatology clinical development. Dr. Hsu will lead the clinical design and execution of the clinical development plan for Adicet’s gamma delta T cell therapies for autoimmune diseases.
Extended projected cash runway into 2H 2026. In January 2024, Adicet successfully raised $91.8 million in net proceeds through an underwritten public offering and received $19.3 million in net proceeds under its at-the-market (ATM) program.
Financial Results for Fourth Quarter and Full Year 2023:

Three months Ended December 31, 2023

Research and Development (R&D) Expenses: R&D expenses were $24.8 million for the three months ended December 31, 2023, compared to $25.0 million during the same period in 2022. The $0.2 million decrease was primarily driven by a $2.7 million decrease in expenses related to contract development manufacturing organizations (CDMOs), contract research organizations (CROs) and consultant costs related to our lead product candidate ADI-001. This decrease was partially offset by an increase of $1.3 million in payroll and personnel expenses, an increase of $0.7 million in lab expenses and an increase of $0.6 million in facility and other expenses.
General and Administrative (G&A) Expenses: G&A expenses were $6.8 million for the three months ended December 31, 2023, compared to $6.6 million during the same period in 2022. The $0.2 million increase was primarily driven by an increase of $0.9 million in payroll and personnel expenses. This increase was partially offset by a $0.4 million decrease in professional fees and a $0.4 million decrease in facility and other expenses.
Net Loss: Net loss for the three months ended December 31, 2023 was $29.5 million, or a net loss of $0.69 per basic and diluted share, including non-cash stock-based compensation expense of $4.9 million, as compared to a net loss of $29.9 million, or a net loss of $0.72 per basic and diluted share, including non-cash stock-based compensation expense of $4.3 million during the same period in 2022.
Twelve Months Ended December 31, 2023

Research and Development (R&D) Expenses: R&D expenses were $106.0 million for the year ended December 31, 2023, compared to $71.2 million for the year ended December 31, 2022. The $34.8 million increase was primarily driven by an $11.5 million increase in payroll and personnel expenses resulting from an increase in overall headcount, a net $10.7 million increase in expenses related to CDMOs, CROs and consultant costs related to our lead product candidate ADI-001, a $8.5 million increase in facility and other expenses and a $4.1 million increase in lab expenses.
General and Administrative (G&A) Expenses: G&A expenses were $26.5 million for the year ended December 31, 2023, compared to $26.3 million for the year ended December 31, 2022. The $0.2 million increase was primarily driven by a $3.3 million increase in payroll and personnel expenses, which includes an increase in stock-based compensation of $1.2 million, salaries and benefits of $1.0 million and contractor fees of $0.9 million and an increase in recruiting fees of $0.3 million. These increases were primarily due to increased headcount for the period. The overall increase was partially offset by a $2.6 million decrease in facilities and other related expenses.
Goodwill Impairment: Goodwill was impaired by $19.5 million during the year ended December 31, 2023 following the results of an interim impairment test conducted during the period. This represented the entire remaining balance of goodwill.

Net Loss: Net loss for the year ended December 31, 2023 was $142.7 million, or a net loss of $3.31 per basic and diluted share, including non-cash stock-based compensation expense of $20.3 million, as compared to a net loss of $69.8 million, or a net loss of $1.70 per basic and diluted share, including non-cash stock-based compensation expense of $17.1 million during the same period in 2022.

Cash Position: Cash and cash equivalents were $159.7 million as of December 31, 2023, compared to $257.7 million as of December 31, 2022. Subsequent to December 31, 2023, the Company received $91.8 million of net proceeds from an underwritten public offering and $19.3 million of net proceeds under its ATM program. The Company expects that its cash and cash equivalents as of December 31, 2023, together with the proceeds raised subsequent to year end, will be sufficient to fund its operating expenses into the second half of 2026.

On March 19, 2024 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that it has entered into definitive agreements for the sale and issuance of 1,542,112 shares of common stock (or prefunded warrants in lieu thereof) of the Company and warrants to purchase up to 1,542,112 shares of common stock at a combined offering price of $4.215 per share of common stock (or per prefunded warrant in lieu thereof) and accompanying warrant, in a registered direct offering priced at-the-market under the Nasdaq rules (Press release, Genprex, MAR 19, 2024, View Source [SID1234641264]). The warrants have an exercise price of $4.09 per share, will be exercisable on the date of issuance, and will expire five years following the date of issuance. The closing of the offering is expected to occur on or about March 21, 2024, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to Genprex from this offering are expected to be approximately $6.5 million, before deducting the placement agent’s fees and other offering expenses. Genprex intends to use the net proceeds from this offering for working capital and general corporate purposes.

A "shelf" registration statement (File Number 333-271386) relating to the offered securities was filed with the Securities and Exchange Commission ("SEC") on April 21, 2023 and was declared effective on June 9, 2023. The offering of the securities is being made only by means of a prospectus, including a prospectus supplement, forming a part of an effective registration statement. A prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC. Electronic copies of the prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The Company also has agreed to amend certain existing warrants to purchase up to an aggregate of 194,248 shares of the Company’s common stock that were previously issued to investors in March 2023 and July 2023, with exercise prices of $44.00 and $35.40 per share and expiration dates of March 1, 2028 and July 21, 2028 for $0.125 per amended warrant, effective upon the closing of the offering, such that the amended warrants will have a reduced exercise price of $4.09 per share and an expiration date of five years from the closing of the offering.

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.