On March 19, 2024 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported the pricing of an underwritten offering consisting of 41,999,998 shares of its common stock at a price of $3.00 per share and pre-funded warrants to purchase 8,002,668 shares of its common stock (Press release, Geron, MAR 19, 2024, View Source [SID1234641265]). The pre-funded warrants are being sold at a price of $2.999 per pre-funded warrant. All of the securities in the offering are to be sold by Geron. The offering included participation from RA Capital Management, Fairmount, OrbiMed, Farallon Capital Management, Adage Capital Partners, L.P., Boxer Capital, Vivo Capital, Deep Track Capital, and multiple large investment management firms, in addition to other new and existing investors. The offering is expected to close on or about March 21, 2024, subject to the satisfaction of customary closing conditions.

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The gross proceeds to Geron from this underwritten offering, before deducting the underwriting discount and other estimated offering expenses, are expected to be approximately $150.0 million. Geron currently intends to use the net proceeds from this offering, together with its existing cash, cash equivalents, and current and noncurrent marketable securities, to fund the potential commercialization of imetelstat in low or intermediate-1 risk myelodysplastic syndromes in the U.S, and potential launch and commercialization of imetelstat in low or intermediate-1 risk myelodysplastic syndromes in the EU, subject to receipt of regulatory approvals, as well as continued development and potential regulatory submissions for imetelstat in relapsed/refractory myelofibrosis. Geron intends to use the remaining proceeds, if any, for working capital and general corporate purposes.

TD Cowen, Stifel and Barclays are acting as joint book-running managers for the offering. Wedbush PacGrow is acting as co-manager for the offering.

An automatically effective shelf registration statement on Form S-3 relating to the offering of the shares of common stock and pre-funded warrants described above was filed with the Securities and Exchange Commission (SEC) on January 4, 2023. A prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Cowen and Company, LLC, 599 Lexington Avenue, New York, NY 10022, by email at [email protected] or by telephone at (833) 297-2926; and Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at 415-364-2720 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will 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 the registration or qualification under the securities laws of any such state or other jurisdiction.

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.

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 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 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported fourth quarter and full year 2023 financial results and provided a business update (Press release, Cyclacel, MAR 19, 2024, View Source [SID1234641261]).

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"Following the recently announced precision medicine strategy for oral fadraciclib, our CDK2/9 inhibitor, we have determined the recommended Phase 2 dose (RP2D) and are ready to start proof-of-concept studies," said Spiro Rombotis, President and Chief Executive Officer. "We expect two key data readouts for fadraciclib this year. These include pharmacokinetic (PK), pharmacodynamic (PD), safety and activity data from the dose escalation part of the 065-101 Phase 1/2 study. In addition, we expect to report initial clinical activity from the Phase 2 proof of concept part, evaluating cohorts of patients selected for their mutational profile and/or Phase 1 activity in various solid tumors and lymphoma. At the upcoming AACR (Free AACR Whitepaper) Annual Meeting 2024, independent investigators will present preclinical proof-of-concept data for fadraciclib further demonstrating fadraciclib’s differentiated properties from other next generation CDK inhibitors."

"We have observed CDKN2A/CDKN2B alterations, including loss of function, in multiple, pretreated patients with various cancers, including gynecological, hepatobiliary, lung, and pancreatic, who benefitted from fadraciclib monotherapy. In addition, we have observed clinical activity in patients with T cell lymphoma, said Brian Schwartz, M.D., interim Chief Medical Officer. "We expect to report final Phase 1 results including details on patient genomic profiles at an upcoming medical conference. A precision medicine strategy is also emerging for plogosertib, our PLK1 inhibitor. Preclinical data from independent groups have shown that certain ARID1A- and SMARCA-mutated cancers may benefit from treatment with plogosertib. Before testing this hypothesis in our 140-101 dose escalation study, we plan to switch to a new oral formulation of plogosertib with improved bioavailability. We are excited about the potential precision medicine strategies for both our clinical programs, with initial data from the fadraciclib Phase 2 proof-of-concept study."

Key Highlights for 2024

· First patient dosed with oral fadraciclib in Phase 2 proof-of-concept part of 065-101 study in patients with advanced solid tumors and lymphoma
· Report final data from dose escalation stage from the 065-101 study of oral fadraciclib in patients with advanced solid tumors and lymphoma
· Report interim data from initial cohorts in Phase 2 open label, proof-of-concept part of 065-101 study with oral fadraciclib in patients with advanced solid tumors and lymphoma
· Independent investigators to report preclinical proof-of-concept data for fadraciclib at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024

Financial Highlights

As of December 31, 2023, pro forma cash and cash equivalents totaled $6.3 million, including $2.9 million of United Kingdom research & development tax credits which were received after the end of the year. Cash and cash equivalents as of December 31, 2023, totaled $3.4 million, compared to $18.4 million as of December 31, 2022. Net cash used in operating activities was $16.1 million for the twelve months ended December 31, 2023 compared to $20.8 million for the same period of 2022. The Company estimates that its available cash, including the United Kingdom research & development tax credit of $2.9 million, will fund currently planned programs into the second quarter of 2024.

Research and development (R&D) expenses were $3.5 million and $19.2 million for the three months and year ended December 31, 2023, as compared to $6.7 million and $20.3 million for the same period in 2022. R&D expenses relating to fadraciclib were $2.7 million and $13.4 million for the three months and year ended December 31, 2023, as compared to $5.3 million and $14.0 million for the same period in 2022 due to decrease in clinical trial costs offset by an increase in manufacturing and other non-clinical expenditures. R&D expenses related to plogosertib were $0.7 million and $5.0 million for the three months and year ended December 31, 2023, as compared to $1.3 million and $5.5 million for the same period in 2022 due to decrease in manufacturing and other non-clinical expenditures.

General and administrative expenses for the three months and year ended December 31, 2023, were $1.9 million and $6.7 million, compared to $2.1 million and $7.4 million for the same period of the previous year due to a decrease in professional fees.

Total other income, net, for the three months and year ended December 31, 2023, were an expense of $0.3 million and expense of $0.1 million, compared to an expense of $0.2 million and income of $1.7 million for the same period of the previous year. The decrease of $1.8 million for the year ended December 31, 2023, is primarily related to royalty income received in the previous year.

United Kingdom research & development tax credits for the three months and year ended December 31, 2023 were $0.4 million and $3.0 million compared to $1.6 million and $4.7 million for the same period of the previous year and are directly correlated to qualifying research and development expenditure.

Net loss for the three months and year ended December 31, 2023, was $5.3 million and $22.6 million (including stock based compensation expense of $0.3 million and $1.5 million respectively), compared to $7.4 million and $21.2 million (including stock based compensation expense of $0.3 million and $1.5 million respectively) for the same period in 2022.