Phio Pharmaceuticals Announces Closing of $2 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

On April 20, 2023 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL RNAi platform technology is designed to make immune cells more effective in killing tumor cells, reported the closing of its previously announced registered direct offering of 353,983 shares of common stock, at a purchase price of $5.65 per share, priced at-the-market under Nasdaq rules (Press release, Phio Pharmaceuticals, APR 20, 2023, View Source [SID1234630354]). In a concurrent private placement, Phio also issued to the investors unregistered Series A warrants to purchase up to an aggregate of 353,983 shares of common stock and unregistered Series B warrants to purchase up to an aggregate of 353,983 shares of common stock.

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

Each series of warrants has an exercise price of $5.40 per share and are exercisable immediately. The Series A warrants have a term of five and one-half years from the date of issuance and the Series B warrants have a term of eighteen months from the date of issuance.

Gross proceeds to the Company from the offering are approximately $2.0 million, before deducting the placement agent’s fees and other offering expenses payable by Phio. Phio intends to use the net proceeds from the offering for the development of its immuno-oncology programs, working capital and general corporate purposes.

The shares of common stock (but excluding the unregistered warrants issued in the concurrent private placement and the shares of common stock underlying such unregistered warrants) were offered and sold by the Company pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-256100), including a base prospectus, previously filed with the Securities and Exchange Commission (SEC) on May 13, 2021 and declared effective by the SEC on May 21, 2021. A final prospectus supplement and an accompanying base prospectus relating to the shares of common stock were filed with the SEC and are available on the SEC’s website located at View Source Electronic copies of the final prospectus supplement and accompanying base prospectus may also be obtained 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 unregistered warrants described above were offered in a transaction not involving a public offering and have not been registered under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and/or Rule 506(b) of Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the unregistered warrants and underlying shares of common stock may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

In connection with the offering, the Company amended certain existing warrants to purchase up to an aggregate of 191,619 shares of the Company’s common stock that were previously issued in April 2018 through January 2021 at exercise prices ranging from $26.52 to $2,079.00, such that each of the amended warrants have an exercise price of $5.40 per share, at an additional offering price of $0.125 per amended warrant.

This press release shall not constitute an offer to sell or a 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 the registration or qualification under the securities laws of any such state or jurisdiction.

Kineta, Inc. Announces $6 Million Registered Direct Offering Priced At-The-Market under Nasdaq Rules

On April 20, 2023 Kineta, Inc. (Nasdaq: KA) (the "Company" or "Kineta"), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported that it has entered into a definitive agreement for the purchase and sale of 1,425,179 shares of the Company’s common stock (or pre-funded warrants in lieu thereof) at a purchase price of $4.21 per share of common stock (or pre-funded warrant in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Kineta, APR 20, 2023, View Source;utm_medium=rss&utm_campaign=kineta-inc-announces-6-million-registered-direct-offering-priced-at-the-market-under-nasdaq-rules [SID1234630353]). In a concurrent private placement, the Company will issue unregistered warrants to purchase up to 1,425,179 shares of common stock with an exercise price of $4.08 per share which will be immediately exercisable for a period of five years following issuance. The closing of the offering is expected to occur on or about April 24, 2023, 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 from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $6 million. The Company intends to use the net proceeds from this offering for working capital purposes.

The shares of common stock, pre-funded warrants and shares of common stock underlying the pre-funded warrants (but not the warrants or the shares of common stock underlying the warrants) described above are being offered pursuant to a "shelf" registration statement on Form S-3 (File No. 333-269340), previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on January 30, 2023. The offering of the shares of common stock and pre-funded warrants is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the prospectus supplement, when available, may be obtained on the SEC’s website at View Source and may also be obtained 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 warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall 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.

ISA Pharmaceuticals to Attend and Present at Upcoming Scientific and Business Conferences

On April 20, 2023 ISA reported that it will be participating and presenting in person, at the following scientific and business conferences in May and June of 2023 (Press release, ISA Pharmaceuticals, APR 20, 2023, View Source [SID1234630352]).

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ISA’s versatile synthetic long peptide (SLP) immunotherapy platform is yielding multiple, highly promising clinical stage immunotherapeutics for the treatment of different cancer types and infectious diseases. It has demonstrated to be best-in-class technology to strongly and specifically activate the human immune system. SLP immunotherapeutics have been tested in multiple human clinical proof-of-concept and phase 2 trials, both as monotherapies and in combination with checkpoint inhibitors or standard-of-care chemotherapy.

LSX World Congress

Date: 3-4 May 2023, London, UK

Attending: Gerben Moolhuizen

CIMT 2023

Date: 3-5 May 2023, Mainz, Germany

Poster presentation to be announced

Attending: Esmé van der Gracht

Bio€quity Europe

Date: 14-16 May 2023, Dublin, Ireland

Company Presentation by: Gerben Moolhuizen

Attending: Gerben Moolhuizen, Anton Mat

ASCO Annual Meeting

Date: 2-6 June 2023, Boston, US

Poster presentation to be announced

Attending: Gerben Moolhuizen, Cornelis (Kees) Melief, Leon Hooftman

BIO International Convention

Date: 5-8 June, Boston, US

Attending: Anton Mat

EASL Congress

Date: 21-24 June 2023, Vienna, Austria

Attending: Anton Mat

If you would like to meet with the ISA Pharmaceuticals team at any of the above events, please contact us at [email protected]. For more information.

Geron Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On April 20, 2023 Geron Corporation (Nasdaq: GERN) reported that it has granted non-statutory stock options to purchase an aggregate of 1,684,220 shares of Geron common stock as inducements to newly hired employees in connection with commencement of employment with the Company (Press release, Geron, APR 20, 2023, View Source [SID1234630350]).

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The stock options were granted on April 19, 2023 at an exercise price of $2.49 per share, which is equal to the closing price of Geron common stock on the date of grant. Stock options representing an aggregate of 1,586,000 shares have a 10-year term and vest over four years, with 12.5% of the shares underlying the options vesting on the six-month anniversary of commencement of employment for the respective employees and the remaining shares vesting over the following 42 months in equal installments of whole shares, subject to continued employment with Geron through the applicable vesting dates. Stock options representing an aggregate of 98,220 shares have a 10-year term and vest in full upon achievement of certain regulatory milestones, subject to continued employment with Geron through the applicable vesting dates. All of the stock options were granted as material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and are subject to the terms and conditions of the stock option agreements covering the grants and Geron’s 2018 Inducement Award Plan, which was adopted December 14, 2018 and provides for the granting of stock options to new employees.

Plus Therapeutics Reports First Quarter 2023 Financial Results and Business Highlights

On April 20, 2023 Plus Therapeutics, Inc.(Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, reported financial results for the first quarter ended March 31, 2023, and provided an overview of recent business highlights (Press release, PLUS THERAPEUTICS, APR 20, 2023, View Source [SID1234630347]).

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"Our team has continued the strong momentum from 2022 through the first quarter of 2023," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "Our 2023 focus is on trial site expansion, patient enrollment and key data readouts for our lead GBM and LM trials, as well as initiating our pediatric trial. Furthermore, we will continue to operate in a capital efficient manner, combining cash on hand with available discretionary sources of capital, existing non-dilutive grant funding and potential new grants we are seeking in 2023."

Q1 HIGHLIGHTS AND MILESTONE ACHIEVEMENTS


Completed Part A of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of leptomeningeal metastases (LM).

Increased enrollment in the ReSPECT-GBM trials including both the Phase 1/2a dose escalation trial and in the Phase 2b trial for small- to medium-sized tumors.

Enrolled the required three patients in cohort 8 of the Phase 1/2a dose escalation arm at a dose of 41.5 millicuries of radiation in 16.3 milliliters.

Added Northwestern Memorial Hospital in Chicago, a world-class medical center and leader in clinical research as an enrolling ReSPECT-LM site.

FIRST QUARTER 2023 FINANCIAL RESULTS


The Company’s cash balance was $12.7 million at March 31, 2023, compared to $18.1 million at December 31, 2022.

The Company recognized $506,000 of grant revenue in the first quarter of 2023, which represents the Cancer Prevention & Research Institute of Texas’ (CPRIT) share of costs incurred in the development of rhenium (186Re) obisbemeda for the treatment of patients with LM.

Total operating expenses for the first quarter of 2023 were $5.2 million, compared to total operating expenses of $3.9 million for the same period the prior year. The increase is due primarily to a $750,000 license payment to NanoTx Corp for successfully meeting a key clinical milestone and related clinical expenses due to increased enrollment in the Company’s lead development programs.

In addition to current cash on hand, the Company benefits from grant awards of $3 million from the National Institutes of Health (NIH) and $17.6 million from CPRIT. The Company also has discretionary, or stockholder approved access to capital from its ATM and equity line of credit of at least $49 million. In aggregate, these capital sources could provide sufficient capital to fund currently planned and anticipated activities through 2025, if fully utilized.

Net loss for the first quarter of 2023 was $4.8 million, or $(0.14) per share, compared to a net loss of $4.1 million, or $(0.19) per share, for the same period the prior year.

UPCOMING EVENTS AND MILESTONES

During 2023, the Company expects to accomplish the following key business objectives:


Publish ReSPECT-GBM Phase 1 data in a peer-reviewed journal.

Present safety and efficacy data from ReSPECT-GBM trials in the second half of 2023.

Present safety and efficacy data of Phase 1/Part A of the ReSPECT-LM trial in the second half of 2023.

Initiate the Phase 1/Part B of the ReSPECT-LM trial in the second half of 2023 following a U.S. Food and Drug Administration (FDA) type C meeting.

Complete key enrollment and site expansion activities in the ReSPECT-GBM Phase 2b trial for full trial enrollment by year-end 2024.

Initiate the Phase 1 ReSPECT-PBC trial for pediatric patients with ependymoma and high-grade glioma.

Determine the appropriate FDA regulatory designation for the 186RNL-BAM technology and complete key development activities.

Complete key preclinical synergistic drug combination studies of rhenium (186Re) obisbemeda and systemic therapies for GBM and LM.

Submit multiple grant applications to secure non-dilutive capital to support expansion of the Company’s drug development pipeline.

FIRST QUARTER 2023 RESULTS CONFERENCE CALL

The Company will hold a conference call and live audio webcast at 5:00 p.m. Eastern Time today to discuss its financial results and provide a general business update.

A live webcast will be available at ir.plustherapeutics.com/events.

Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.

Following the live call, a replay will be available on the Company’s website under the ‘For Investor’section. The webcast will be available on the Company’s website for 90 days following the live call.