On February 25, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported it has entered into a securities purchase agreement with an institutional investor for the purchase and sale of 3,271,029 shares of common stock (or pre-funded warrants in lieu thereof) in a registered direct offering and warrants to purchase up to 6,542,058 shares of common stock in a concurrent private placement (together with the registered direct offering, the "Offering") at a combined purchase price of $1.07 per share and accompanying warrants (Press release, Moleculin, FEB 25, 2025, View Source [SID1234650540]). The warrants issued pursuant to the concurrent private placement will have an exercise price of $1.07 per share, will be exercisable upon the receipt of shareholder approval following the date of issuance and will expire 5 years from the initial exercise date.

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Roth Capital Partners is acting as the exclusive placement agent for the Offering.

The closing of the Offering is expected to occur on or about February 26, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds from the Offering are expected to be approximately $3.5 million before deducting placement agent fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the Offering for working capital and general corporate purposes.

The common stock (or pre-funded warrants in lieu thereof) will be issued in a registered direct offering pursuant to an effective shelf registration statement on Form S-3 (File No. 333-280064) previously filed with the U.S. Securities and Exchange Commission (the "SEC"), under the Securities Act of 1933, as amended (the "Securities Act"), and declared effective by the SEC on July 1, 2024. The warrants will be issued in a concurrent private placement. A prospectus supplement describing the terms of the proposed registered direct offering will be filed with the SEC and once filed, will be available on the SEC’s website located at View Source or by contacting Roth Capital Partners, LLC at 888 San Clemente Drive, Newport Beach CA 92660, by phone at (800) 678-9147.

The private placement of the warrants and the underlying shares will be made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act and/or Regulation D thereunder. Accordingly, the securities issued in the concurrent private placement 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 the 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.

On February 25, 2025 Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel oncology therapies that address emerging targets in oncology, reported a strategic reorganization that will extend Ryvu’s cash runway to H2 2026 to focus on driving the RVU120 clinical program and the early pipeline to key data inflection points (Press release, Ryvu Therapeutics, FEB 25, 2025, View Source [SID1234650558]).

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Paweł Przewięźlikowski, Chief Executive Officer and the largest shareholder of Ryvu said:
"We remain focused on advancing our first-in-class clinical blood cancer program RVU120, as well as promising early-stage assets. Considering our cash position, revenue projections, cost structure and the demanding market environment, we decided to optimize expenses so that the company has sufficient cash runway to generate key data for RVU120 and the preclinical pipeline, expecting that our achievements over the next year will support future cash inflows."

Pipeline Focus in 2025-2026

Ryvu continues to pursue its mission of delivering efficacious medicines to cancer patients and, accordingly, will continue to focus on first-in-class and best-in-class novel therapeutics that have the potential to help patients and deliver value to shareholders.

RVU120: emphasis on rapid study enrollment and quality data generation in 2025

Three Phase II studies of RVU120 are in progress as planned: RIVER-81 (combination study with venetoclax in patients with AML), POTAMI-61 (monotherapy/combination study with ruxolitinib in patients with myelofibrosis) and REMARK (monotherapy study in patients with LR-MDS).
The Phase II RIVER-52 study of RVU120 monotherapy in patients with AML or HR-MDS, will not enroll new patients to focus investment on the other RVU120 development paths. Currently enrolled patients will continue to receive treatment per protocol.
The decision to progress RIVER-81 and suspend enrollment in RIVER-52 was based on data analysis and feedback from advisory boards in February 2025.
The next data update for RVU120 is planned in Q2 2025.
RVU305: IND/CTA-enabling studies are ongoing and planned to be completed in H2 2025.

Preclinical discovery and research: Ryvu will pursue a dual-pronged strategy, each of which has the potential to generate multiple oncology medicines.

ONCO Prime – novel small molecule precision medicine: as part of its proprietary ONCO Prime platform, Ryvu will continue to advance several novel precision oncology targets, including synthetic lethality targets. ONCO Prime combines data from patient-derived cells and isogenic cell lines to discover first-in-class oncology targets in defined patient populations. ONCO Prime is supported by a grant of approximately PLN 26 million from the Polish Agency for Enterprise Development.
ADCs (antibody-drug conjugates) with novel payloads: Ryvu will continue to develop ADCs with next-generation novel payloads, including synthetically lethal and immunomodulatory mechanisms. Ryvu will work on novel ADCs internally and through the existing collaboration with Exelixis (STING-based ADCs). The WRN program, which previously was focused on standalone development, will be developed as a novel ADC payload to differentiate on efficacy, resistance profile and safety versus competitors. Ryvu’s ADC research and development will also be supported by grant funding totaling approximately PLN 13 million.
Ryvu continues to advance three key biopharma partnerships; in each of these partnerships, Ryvu is fully reimbursed for its expenses and has the potential to earn multiple financial milestones:

Menarini: On behalf of and in partnership with Menarini, Ryvu is conducting the Phase II JASPIS-01 study of dapolsertib (MEN1703, SEL24) in patients with diffuse large B-cell lymphoma (DLBCL). Dapolsertib is a PIM/FLT3 inhibitor discovered by Ryvu and licensed to Menarini.
BioNTech: BioNTech and Ryvu continue their multi-target research collaboration on undisclosed targets within the small molecule immune-modulatory field.
Exelixis: Exelixis and Ryvu are working collaboratively to advance novel ADCs with STING payloads licensed from Ryvu.
Operational Reorganization and Cash Position

To focus on achieving meaningful catalysts, Ryvu is extending its cash runway from Q1 to H2 2026. As part of the pipeline focus outlined above, Ryvu is reducing its current workforce by approximately 30%. After these reductions, Ryvu will employ approximately 200 colleagues. Ryvu is dedicated to providing affected employees with support during this reorganization. With this cash runway, Ryvu expects to deliver key clinical data on RVU120 and progress in the preclinical pipeline that could potentially support partnering or internal development.
As of February 23, 2025 Ryvu held approximately €46 million (PLN 192 million) in cash and other financial assets. In addition, the company has secured approximately €22 million (PLN 91 million) in non-dilutive grant funding.

Investor Webinar

Ryvu management will host a webinar today, February 25, at 10:15 am CET. The webinar can be accessed at the following link: View Source

On February 25, 2025 BridgeBio Pharma, Inc. (Nasdaq: BBIO) (the "Company," "we" or "BridgeBio") reported the pricing of $500 million aggregate principal amount of 1.75% convertible senior notes due 2031 (the "notes") in a private offering (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, BridgeBio, FEB 25, 2025, View Source [SID1234650624]). In connection with the offering, the Company granted the initial purchasers an option to purchase up to an additional $75 million aggregate principal amount of notes. The sale of the notes is expected to close on February 28, 2025, subject to customary closing conditions.

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The Company estimates that the net proceeds from the sale of the notes will be approximately $489.5 million (or approximately $563.0 million if the initial purchasers exercise their option to purchase additional notes in full), after deducting the initial purchasers’ discounts and estimated offering expenses payable by the Company. The Company intends to use a portion of the net proceeds from the offering to repay all outstanding borrowings under and terminate its Financing Agreement, dated as of January 17, 2024, with the lenders party thereto and Blue Owl Corporation, as administrative agent, as amended (the "Financing Agreement"), and pay any fees related thereto. The termination of the Financing Agreement, which accounted for approximately $51.5 million of cash paid for interest in 2024 and contains various restrictive covenants, will provide the Company with reduced pro forma interest expense and greater operational flexibility.

The Company intends to use approximately $48.3 million of the remaining net proceeds from the offering to repurchase 1,405,411 shares of its common stock from certain purchasers of the notes in privately negotiated transactions effected through one of the initial purchasers or an affiliate thereof and entered into concurrently with the pricing of the notes (such transactions, the "share repurchases"). The agreed to purchase price per share of the Company’s common stock in the share repurchases is equal to the last reported sale price of the Company’s common stock of $34.35 per share on the Nasdaq Global Select Market on February 25, 2025. The share repurchases could increase (or reduce the size of any decrease in) the market price of the Company’s common stock, and could have resulted in a higher effective conversion price for the notes. The Company expects to use the remaining net proceeds from the offering for general corporate purposes.

The notes will bear interest at a rate of 1.75% per year, payable semi-annually in arrears on March 1 and September 1 of each year, beginning September 1, 2025. The notes will mature on March 1, 2031, unless earlier converted, redeemed or repurchased. Prior to December 2, 2030, the notes will be convertible only upon satisfaction of certain conditions and during certain periods. Thereafter, the notes will be convertible at any time until the close of business on the second scheduled trading day immediately preceding the maturity date. The notes will be convertible at the option of the holders, subject to certain conditions and during certain periods, into cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, with the form of consideration determined at the Company’s election.

The conversion rate will initially be 20.0773 shares of the Company’s common stock per $1,000 principal amount of notes (equivalent to an initial conversion price of approximately $49.81 per share of the Company’s common stock). The initial conversion price of the notes represents a premium of approximately 45.0% over the last reported sale price of the Company’s common stock of $34.35 per share on February 25, 2025.

The Company may not redeem the notes prior to March 6, 2028. On or after March 6, 2028 and on or before the 41st scheduled trading day immediately before the maturity date of the notes, the Company may redeem for cash all or any portion of the notes, at its option at any time, and from time to time, if (i) the last reported sale price per share of the Company’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive), including the trading day immediately preceding the date on which the Company provides notice of redemption, during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which the Company provides notice of redemption and (ii) certain other conditions are satisfied. The redemption price will be equal to 100% of the principal amount of the notes being redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

Holders of the notes will have the right to require the Company to repurchase all or a portion of their notes at 100% of their principal amount, plus any accrued and unpaid interest, upon the occurrence of certain events.

When issued, the notes will be the Company’s senior unsecured obligations and will rank senior in right of payment to any of the Company’s unsecured indebtedness that is expressly subordinated in right of payment to the notes; equal in right of payment to any of the Company’s unsecured indebtedness that is not so subordinated; effectively junior in right of payment to any of the Company’s secured indebtedness and obligations to the extent of the value of the assets securing such indebtedness; and structurally junior to all indebtedness and other liabilities (including trade payables) of the Company’s subsidiaries.

The notes and the shares of common stock issuable upon conversion of the notes, if any, are not being registered under the Securities Act, or the securities laws of any other jurisdiction. The notes and the shares of common stock issuable upon conversion of the notes, if any, may not be offered or sold in the United States except in transactions exempt from, or not subject to, the registration requirements of the Securities Act and any applicable state securities laws.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, 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 such jurisdiction.

On February 25, 2025 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported final overall survival data from the completed randomized controlled phase 2 clinical trial of CAN-2409 plus valacyclovir (prodrug), together with standard of care (SoC) chemoradiation, followed by resection, in patients with borderline resectable PDAC (Press release, Candel Therapeutics, FEB 25, 2025, View Source [SID1234650521]).

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Final data of the randomized controlled clinical trial, updated with an additional nine months of follow-up, confirmed a durable improvement in survival for patients treated with CAN-2409 plus SoC therapy (n=7) compared to SoC alone (n=6). Notably, long-term survivors in the CAN-2409 arm, remaining alive at 66.0, 63.6, and 35.8-months post-enrollment experienced disease recurrence but, in contrast to patients in the control arm with disease recurrence, responded to salvage chemotherapy and have experienced extended and ongoing post-progression survival at the time of the data cutoff (February 20, 2025), further highlighting the sustained benefit of CAN-2409 in this aggressive disease setting.

"Pancreatic cancer remains one of the most difficult to treat diseases," said W. Garrett Nichols, MD, MS, Candel’s Chief Medical Officer. "Patients with borderline resectable PDAC often have undetectable metastases that are not cleared with current standard of care neoadjuvant chemoradiation and surgery. CAN-2409 is a first-in-class multimodal immunotherapy candidate designed for in situ vaccination against the patient’s tumor, which offers the potential to control this disease and to prolong survival, thus improving outcomes following this dismal prognosis."

Data highlights:

•
Prolonged and sustained survival was observed in this randomized controlled clinical trial after experimental treatment with CAN-2409 compared to the control group in patients with borderline resectable PDAC

o
Estimated median overall survival after enrollment was 31.4 months in the CAN-2409 group (n=7) versus only 12.5 months in the control group (n=6).

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Median survival post-progression was 21.2 months in patients who received CAN-2409 compared to 7.2 months in the control arm.
o
Importantly, three out of seven patients who received CAN-2409 were still alive at the time of data cut-off with a survival of 66.0, 63.6, and 35.8 months, respectively, after enrollment; survival from the time of diagnosis for these patients was 73.5, 68.8, and 41.3 months, respectively. Of these, the first patient had stage IV metastatic disease detected during surgery, the second had residual tumor present at the resection margin, and the third had adenocarcinoma with negative resection margins. In contrast, only one out of six patients randomized to SoC chemotherapy arm remained alive at the data cut-off (61.2 months from enrollment and 65.5 months from diagnosis); histologic analysis at resection showed intraepithelial neoplasia (without evidence of residual invasive adenocarcinoma) in this patient, which is associated with improved prognosis.

o
Previous analysis at 24 months showed survival rates of 71.4% in patients treated with CAN-2409 compared to 16.7% in the control group.

•
Previous analysis of blood and resected tumors showed consistent and robust activation of the immune response after experimental treatment with CAN-2409

o
In pancreatic tissue of patients treated with CAN-2409 plus prodrug, together with SoC (but not SoC alone), dense aggregates of CD8+ granzyme B+ cytotoxic tumor infiltrating lymphocytes, dendritic cells, and B cells were observed in the tumor microenvironment.

o
Increased levels of soluble granzymes B and H, along with pro-inflammatory cytokines, including IFN-γ, were detected in peripheral blood following CAN-2409 treatment, but not in the control arm, supporting CAN-2409’s ability to drive a potent systemic anti-tumoral immune response.

•
CAN-2409 continued to be associated with a favorable safety/tolerability profile

o
The addition of CAN-2409 regimen to SoC was generally well-tolerated, with no dose-limiting toxicities, including no cases of pancreatitis.

"The notable benefits observed with CAN-2409 in this clinical trial, including evidence of a long tail of survival, highlights the transformative potential of this biological multimodal immunotherapy in difficult to treat cancers", said Paul Peter Tak, MD, PhD, FMedSci, CEO and President of Candel. "Recently, the Company announced positive, statistically significant topline data for CAN-2409 based on a large, randomized, placebo-controlled clinical trial in localized prostate cancer. The data presented today support the potential of CAN-2409 across various solid tumors, by showing its potential to alter the balance between the pancreatic tumor and the anti-tumor immune response, even in patients with residual tumor, improving long-term survival in a subset of the patients. Based on these promising findings, the Company has decided to prepare for a larger, late-stage randomized controlled clinical trial of CAN-2409 in PDAC."

The FDA previously granted Fast Track Designation and Orphan Drug Designation to the Company for CAN-2409 in combination with valacyclovir for the treatment of patients with PDAC.

About CAN-2409

CAN-2409, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s specific tumor and induce an individualized, systemic immune response against the tumor. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ vaccination against a variety of tumor antigens. Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity, as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors, have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with CAN-2409 with a favorable tolerability profile to date, supporting the potential for combination with other therapeutic strategies.

Currently, Candel is evaluating CAN-2409 in non-small cell lung cancer (NSCLC), PDAC, and localized, non-metastatic prostate cancer. In December 2024, Candel announced that CAN-2409 achieved its primary endpoint in a pivotal phase 3 clinical trial in men with intermediate-to-high-risk, localized prostate cancer, demonstrating statistically significant improvement in disease-free survival when added to SoC radiation therapy +/- androgen deprivation therapy. CAN-2409 plus prodrug has been granted Fast Track Designation by the FDA for the treatment of PDAC, stage III/IV NSCLC in patients who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy, and localized prostate cancer. The FDA has also granted Orphan Drug Designation to CAN-2409 for the treatment of PDAC. Candel’s pivotal phase 3 clinical trial in localized prostate cancer was conducted under a Special Protocol Assessment (SPA) agreed with the FDA.

On February 25, 2025 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, reported its participation in the following investor conferences (Press release, Nkarta, FEB 25, 2025, View Source [SID1234650541]):

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TD Cowen 45th Annual Health Care Conference
March 3, 2025
3:10 p.m. ET – fireside chat

Leerink Partners 2025 Global Healthcare Conference
March 10, 2025
3:00 p.m. ET – fireside chat

A simultaneous webcast of the events will be available on the Investors section of Nkarta’s website, www.nkartatx.com, and a replay will be archived on the website for approximately 90 days.