On April 4, 2025, Lipella Pharmaceuticals Inc. (the "Company") entered into an At The Market Offering Agreement (the "ATM Agreement") with H.C. Wainwright & Co., LLC ("Wainwright"), to sell shares of its common stock, par value $0.0001 per share (the "Common Stock") having an aggregate sales price of up to $2,641,881 (the "Shares"), from time to time, through an "at the market offering" program under which Wainwright will act as sales agent (Filing, 8-K, Lipella Pharmaceuticals, APR 4, 2025, View Source [SID1234651819]). The sales, if any, of the Shares made under the ATM Agreement will be made by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415 promulgated under the Securities Act of 1933, as amended.

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The Company has agreed to pay Wainwright a cash commission equal to 3.0% of the aggregate gross proceeds from sales of the Shares and has agreed to provide Wainwright with customary indemnification and contribution rights. The Company has also agreed to reimburse Wainwright for certain specified expenses not to exceed $100,000 in connection with entering into the ATM Agreement. The ATM Agreement contains customary representations and warranties and conditions to the sale of the Shares pursuant thereto.

The Company is not obligated to sell any of the Shares under the ATM Agreement and no assurance can be given that the Company will sell any Shares under the ATM Agreement, or if such sales occur, no assurance can be given as to the price or number of Shares that will be sold, or the dates on which any such sales will take place. The Company or Wainwright may at any time suspend solicitation and offers of Shares thereunder and the ATM Agreement may be terminated by either the Company or Wainwright, as permitted therein. The Company currently intends to use all proceeds raised in connection with the sale of Shares for working capital and general corporate purposes.

The Shares will be issued pursuant to the prospectus supplement (the "Prospectus Supplement"), dated April 4, 2025, to the base prospectus included in the Company’s shelf registration statement on Form S-3 (File No. 333- 276815) filed by the Company with the U.S. Securities and Exchange Commission ("SEC") on February 1, 2024, and declared effective by the SEC on February 8, 2024 (the "Registration Statement").

This Current Report on Form 8-K (this "Form 8-K") shall not constitute an offer to sell or a solicitation of an offer to buy any shares of Common Stock, nor shall there by any sale of shares of Common Stock in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

The foregoing description of the ATM Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which is attached hereto as Exhibit 10.1 and which is incorporated herein in its entirety by reference. The representations, warranties and covenants contained in such agreement were made only for purposes of such agreement and as of specific date, were solely for the benefit of the parties to such agreement and may be subject to limitations agreed upon by the contracting parties. The Company is filing the opinion of its counsel, Sullivan & Worcester LLP, relating to the legality of the issuance and sale of the Shares as Exhibit 5.1 hereto. Exhibit 5.1 is incorporated herein by reference and into the Registration Statement.

On April 4. 2025, Sonnet BioTherapeutics Holdings, Inc. (the "Company") announced positive safety results of SON-1010 at the highest dose combined with atezolizumab (Tecentriq) in the Phase 1b/2a clinical trial in adult patients with advanced solid tumors or platinum-resistant ovarian cancer (PROC) (the "SB221 study") (Press release, Sonnet BioTherapeutics, APR 4, 2025, View Source [SID1234651805]). Based on positive feedback from a formal evaluation by the Safety Review Committee (SRC) for the SB221 study, the study can now advance to the expansion phase, which will study the preliminary effect of the combination at the maximum tolerated dose (MTD), before proceeding to a Phase 2a randomized comparison with the standard of care in patients with PROC.

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The SB221 study was designed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of increasing doses of SON-1010 administered with atezolizumab. The primary goal for the first part of the study was to establish the MTD in combination with the immune checkpoint inhibitor (ICI). A total of 19 subjects were treated during dose escalation and one patient with PROC had a partial response at the highest dose.

The SB221 SRC review at the completion of dose expansion in combination with atezolizumab concluded that fatigue, fevers, and gastrointestinal symptoms were the most common adverse effects; no dose-limiting toxicity or cytokine release syndrome were seen. The only related serious adverse event (SAE) during dose escalation was Grade 2 pneumonitis, which is a known adverse event with atezolizumab. One patient with PROC had a 44% tumor size reduction, indicating a partial response (PR), along with a more than 2-fold reduction in the CA 125 ovarian cancer biomarker. SON-1010 monotherapy in the SB101 study led to a PR at the same MTD in a patient with sarcoma.

All enrolled patients have advanced solid tumors and all patients at the higher doses have PROC, including those enrolled in a final 1200 ng/kg dose-escalation cohort. The SB221 trial employed a ‘desensitizing’ first dose of 300 ng/kg to take advantage of the known tachyphylaxis with rhIL-12, with the intention of minimizing toxicity while allowing for higher maintenance doses. The safety and toxicity profile that has developed is typical for a Phase 1 oncology trial, with the majority of adverse events (AEs) being reported as mild and transient and there has been no evidence of cytokine release syndrome. Of the 19 patients dosed to date, 8 of the 15 evaluable patients (53%) had SD at the first follow-up CT scan and 5 of the 15 evaluable patients (33%) remained stable at four months, suggesting SON-1010 is showing clinical benefit. While the follow-up is still early, four of those 15 patients were still on trial at 6 months, including 3 with SD and one with an unconfirmed PD. As noted, one of the PROC patients in the highest SON-1010 dose cohort had a PR at 2 months.

On April 4, 2025 Aptevo Therapeutics Inc. (Nasdaq:APVO) ("Aptevo" or the "Company"), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported the closing of its previously announced offering of 1,764,710 shares of the Company’s common stock in a registered direct offering and warrants to purchase up to 3,529,420 shares of common stock in a concurrent private placement (together with the registered direct offering, the "offering") at a combined purchase price of $1.19 per share and accompanying warrant (Press release, Aptevo Therapeutics, APR 4, 2025, View Source [SID1234651806]). The warrants issued pursuant to the concurrent private placement have an exercise price of $1.19 per share, will be exercisable upon the receipt of stockholder approval and will expire 5 years from the date of stockholder approval.

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Roth Capital Partners acted as the exclusive placement agent for the offering.

Gross proceeds from the offering were approximately $2.1 million, before deducting the placement agent’s fees and other estimated offering expenses payable by the Company. Aptevo intends to use the net proceeds from the proposed offering for the continued clinical development of its product candidates, working capital, and other general corporate purposes.

A shelf registration statement on Form S-3 (File No. 333-284969) relating to the shares of common stock issued in the registered direct offering was previously filed with the Securities and Exchange Commission (the "SEC") and is currently effective. The registered direct offering was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement, relating to the registered direct offering that will be filed with the SEC. The warrants were issued in a concurrent private placement. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC’s website 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 or by email at [email protected].

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 cannot 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 does not constitute an offer to sell, or the solicitation of an offer to buy, the shares of common stock or warrants, nor will there be any sale of the shares of common stock or warrants in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

The Company also amended certain existing warrants that were previously issued on December 12, 2024 to purchase up to 1,647,088 shares of the Company’s common stock and have an exercise price of $9.53 per share, effective upon the closing of the offering, such existing warrants have a reduced exercise price of $1.19 per share, shall become exercisable upon stockholder approval and will expire 5 years from the date of stockholder approval.

On April 4, 2025 SkylineDx, an innovative diagnostics company specializing in molecular diagnostics for oncology, inflammatory, and infectious diseases, reported that Dr. Teresa Amaral, MD, PhD, Head of Skin Cancer Clinical Trials Center, University of Tübingen, Germany, will present groundbreaking new data at the 2025 World Congress of Melanoma (WCM) (Press release, SkylineDx, APR 4, 2025, View Source [SID1234651807]). The presentation will highlight the Merlin CP-GEP (Clinicopathologic and Gene Expression Profile) test’s ability to identify high-risk melanoma patients who did not undergo sentinel lymph node biopsy (SLNB), a critical gap in current melanoma staging methods – showing CP-GEP’s potential in predicting relapse and other long-term survival outcomes [1-2].

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Key Findings from the Study:

Merlin CP-GEP test successfully stratified 930 stage I/II melanoma patients: 879 (94.5%) were Merlin Low-Risk and 51 (5.5%) were Merlin High-Risk.
Patients identified as Low-Risk showed an impressive 5-year and 10-year relapse-free survival (RFS) rate of 96% and 94.5% respectively.
Patients in the Merlin (CP-GEP) High-Risk group were around 20 times more likely to experience a recurrence, compared to the Merlin Low-Risk group. Their 5-year and 10-year RFS was 37.5% for both endpoints. Additionally, High-Risk patients showed significantly increased rates of distant metastasis and melanoma-specific death, reinforcing the clinical value of CP-GEP in identifying patients at risk for recurrence.
While SLNB remains the standard for melanoma staging, many patients classified as low-risk based on traditional methods still experience relapse or even death. The CP-GEP model, which combines gene expression data with clinical factors age and tumor thickness, effectively identified two distinct risk groups among patients who did not undergo SLNB.

Dr. Teresa Amaral shared her thoughts on the study: "The results of this study highlight the potential of the Merlin CP-GEP test to redefine risk assessment for melanoma patients. By identifying high-risk individuals who may not have undergone SLNB, we can better personalize treatment decisions, ultimately improving long-term outcomes for patients."

Dr. Jvalini Dwarkasing, Chief Scientific Officer at SkylineDx, commented, "These results highlight the power of CP-GEP in helping clinicians identify high-risk patients, even in the absence of SLNB status. Additional research is needed but potentially the Merlin High-Risk patients could benefit from systemic therapy to overcome their risk of recurrence, as their RFS is similar to that of patients who are currently eligible for immunotherapy."

SkylineDx remains committed to advancing innovative molecular diagnostic solutions that offer better insights and more personalized treatment options for melanoma patients, ultimately improving their chances for a better outcome.

About the advanced cutaneous melanoma GEP test (Merlin CP-GEP test)

CP-GEP is a non-invasive prediction model for cutaneous melanoma patients and is the only commercially available GEP test that combines clinicopathologic (CP) variables with gene expression profiling (GEP) into a single integrated algorithm. This CP-GEP model is also the only GEP test that provides a binary stratification of all patients based on being High or Low Risk for metastasis and thereby assign them to the appropriate surgical action categories as listed in evidence-based cancer treatment, prevention and screening guidelines. The advanced CP-GEP model was developed by Mayo Clinic and SkylineDx BV and is the latest commercially launched GEP test, which has been clinically validated in multiple studies on a global basis. More information (including references) may be obtained at www.falconprogram.com and www.merlinmelanomatest.com. The test has been launched in the United States and Europe as Merlin test. SkylineDx collaborates with diagnostic service providers globally to bring this test to market and increase patient access.

On April 4, 2025 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported that Immunome management will participate in a fireside chat at the 24th Annual Needham Virtual Healthcare Conference on Thursday, April 10, 2025 at 12:45 p.m. Eastern Time (Press release, Immunome, APR 4, 2025, View Source [SID1234651808]).

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Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company’s website at www.immunome.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.