On February 19, 2025 Sonnet BioTherapeutics Holdings, Inc. (the "Company" or "Sonnet") (NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, reported its plans to advance the development of its proprietary Antibody Drug Conjugate (ADC) platform which was designed to circumvent many of the technical challenges associated with ADCs (Press release, Sonnet BioTherapeutics, FEB 19, 2025, View Source [SID1234650381]). Additionally, the Company announced the release of a Virtual Investor "What This Means" segment to discuss plans for its ADC platform.

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"In order to increase our value proposition to cancer patients, in addition to our existing FHAB platform we have developed a bolt-on ADC platform that takes advantage of our FHAB targeting domain and flexible docking peptides, which offer controllable DAR capacity," commented Pankaj Mohan, Ph.D., Founder and Chief Executive Officer of Sonnet. "Further, we believe our ADC platform is differentiated from other ADCs by stable structural integrity, extended conjugation site flexibility, potential for enhanced tumor penetration and retention with the FHAB domain, and potential to select and conjugate one of several possible payloads having different mechanisms of action (MOA) for killing cancer cells. With a plug-and-play ADC platform, we could generate a number of ADC candidates, and thus, we are seeking value-driven discovery partnerships."

The initial proof-of-concept (POC) construct was designated as SON-5010, which is produced through a two-step process whereby the targeting scaffold and payload domains are either expressed and purified from mammalian cells or chemically synthesized, respectively, and then joined to create the final ADC conjugate using a chemical linkage process. The SON-5010 ADC construct is comprised of an anti-HER2-FHAB-anti-HER2 targeting scaffold linked to a docking peptide that has 3 equally spaced lysine residues which serve as conjugation sites for monomethyl auristatin E (MMAE), a synthetic antineoplastic agent that disrupts the microtubule network and suppresses cell proliferation and mitosis, including G2/M arrest. This initial SON-5010 ADC was used in a head-to-head comparison with an approved product, Kadcyla, which has a very similar anti-HER2 targeting domain and linker chemistry but is conjugated with a different toxin payload known as mertansine (DM1) and a trastuzumab-MMAE complex, consisting of a humanized anti-HER2 receptor monoclonal antibody with the same linker chemistry and 3x MMAE DAR payload as SON-5010.

John Cini, Ph.D., Co-Founder and Chief Scientific Officer commented, "Sonnet is excited about the early POC data shown by this novel plug-and-play, non-IgG ADC format that incorporates Sonnet’s albumin binding scFv into the targeting scaffold. The binding of albumin in this particular ADC format provides the differentiated potential for accumulation of the FHAB-ADC complex into the tumor. The SON-5010 ADC was produced with the same linker chemistry and MMAEx3 as in trastuzumab (Herceptin) and has shown in vitro human serum stability at 37oC and similar cellular cytotoxicity results. In a direct in vivo comparison with Kadcyla and Herceptin at 10mg/kg in the BT-474 HER2+ carcinoma breast tumor mouse model, SON-5010 demonstrated similar tumor reduction activity and no detectable toxicity. The potential diverse application of Sonnet’s ADC platform could be applied with a wide variety of linkers and toxins, resulting in complete controllable DAR. Further, Sonnet’s ADC platform has the ability to show bispecific or tri-specific tumor targeting capability when associated with the FHAB scFv, which could potentially improve its ADC clinical efficiency."

Dr. Stephen McAndrew, Ph.D., Chief Business Officer commented, "We believe this ADC platform differentiates itself by offering the potential for flexibility around multiple targeting scaffolds, controllable DARs and choice of payload. We plan to continue global prosecution of our intellectual property around this ADC platform while we seek discovery partnership opportunities aimed at developing proprietary ADC drug candidates."

On February 18, 2025 Eli Lilly and Company (NYSE: LLY) reported it will participate in TD Cowen’s 45th Annual Health Care Conference on March 4, 2025. Jake Van Naarden, executive vice president and president, Lilly Oncology, will take part in a fireside chat at 1:50 p.m., Eastern time (Press release, Eli Lilly, FEB 18, 2025, View Source [SID1234650334]).

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

On February 18, 2025 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported that it has entered into definitive agreements for the purchase and sale of an aggregate of 1,810,000 shares of common stock at a purchase price of $1.50 per share, in a private placement to accredited investors and certain Company directors (Press release, MAIA Biotechnology, FEB 18, 2025, View Source [SID1234650352]). Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $1.87 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing one year following issuance and have a term of six years from the initial issuance date. The securities being sold to the Company director participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about February 20, 2025, subject to the satisfaction of customary closing conditions.

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The gross proceeds from the offering are expected to be $2,715,000, prior to offering expenses payable by the Company. The Company intends to use the net proceeds received from the private placement to fund the starting cost for Part C of the Phase II trial THIO -101 and for working capital.

The securities 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 these securities, 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 18, 2025 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company") reported its financial and operating results for the fourth quarter and full year ended December 31, 2024, provided an update on its recent corporate activities and reiterated its 2025 financial guidance (Press release, Halozyme, FEB 18, 2025, View Source [SID1234650335]).

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"I am excited to announce that the significant growth we achieved throughout the year culminated in two important milestones for the Company: achievement of more than $1 billion in total revenue and reaching a cumulative one million patients with our ENHANZE drug delivery technology. Our 2024 royalty revenue exceeded guidance driven by continued strong growth of DARZALEX SC and Phesgo, with modest initial contribution from VYVGART Hytrulo resulting from growing adoption and use primarily from its first indication for generalized myasthenia gravis. These three products will continue to drive our 2025 royalty revenues, with VYVGART Hytrulo becoming the largest dollar growth contributor in 2025," said Dr. Helen Torley, president and chief executive officer of Halozyme.

"I am also pleased that we achieved four additional, significant ENHANZE regulatory product and indication approvals in the U.S. and EU in 2024 for VYVGART Hytrulo for CIDP, Tecentriq Hybreza, Ocrevus Zunovo and Opdivo Qvantiq, positioning Halozyme for strong continued growth, post 2025, once coverage reimbursement and access are fully established," said Dr. Torley.

"Our leadership position in rapid subcutaneous drug delivery and long-term growth was further fortified with five new ENHANZE nominations from argenx and ViiV and an extension of our ENHANZE patent in Europe out to 2029, with a similar patent submitted in the U.S. Our 2025 guidance reflects our confidence in continuing robust total revenue, royalty revenue, adjusted EBITDA and non-GAAP EPS growth," Dr. Torley concluded.

Fourth Quarter and Recent Corporate Highlights:
•Reiterating 2025 financial guidance previously announced on January 8, 2025 including total revenue of $1,150 million to $1,225 million, representing year-over-year growth of 13% to 21%, adjusted EBITDA of $755 million to $805 million, representing year-over-year growth of 19% to 27% and non-GAAP diluted earnings per share of $4.95 to $5.35, representing year-over-year growth of 17% to 26%.
•In December 2024, Halozyme entered into an Accelerated Share Repurchase agreement to repurchase $250.0 million of its common stock under the $750 million approved program from February 2024.

Fourth Quarter and Recent Partner Highlights:
•In February 2025, Janssen-Cilag International NV, a Johnson & Johnson company, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending an extension of marketing authorization for a subcutaneous ("SC") formulation of RYBREVANT (amivantamab) with ENHANZE in combination with LAZCLUZE (lazertinib) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy.
•In December 2024, Bristol Myers Squibb announced the U.S Food and Drug Administration ("FDA") approved Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) with ENHANZE for SC use in most previously approved adult, solid tumor IV Opdivo (nivolumab) indications resulting in the recognition of a $20.0 million milestone payment, and in January 2025, Opdivo Qvantig was made available to patients.
•In December 2024, argenx announced the Ministry of Health, Labour and Welfare ("MHLW") in Japan approved VYVDURA for the treatment of patients with chronic inflammatory demyelinating polyneuropathy ("CIDP").
•In December 2024, Takeda announced the MHLW in Japan approved HYQVIA with ENHANZE for patients with agammaglobulinemia or hypogammaglobulinemia disorders characterized by very low or absent levels of antibodies and an increased risk of serious recurring infection caused by primary immunodeficiency or secondary immunodeficiency.
•In November 2024, Zai Lab Limited (argenx commercial partner for China) announced the National Medical Products Administration approved VYVGART Hytrulo for the treatment of patients with CIDP.
•In November 2024, Janssen announced the submission of regulatory applications to the FDA and European Medicines Agency ("EMA") seeking approval of a new indication for DARZALEX FASPRO in the U.S. and DARZALEX SC in the EU as a monotherapy for the treatment of adult patients with high-risk smoldering multiple myeloma.
•In October 2024, argenx initiated two studies evaluating VYVGART Hytrulo with ENHANZE, a Phase 3 study for adult patients with ocular myasthenia gravis and a Phase 2 study for kidney transplant recipients with antibody mediated rejection.

•In October 2024, Janssen announced the European Commission approved DARZALEX SC for the treatment of patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant in combination with bortezomib, lenalidomide and dexamethasone.

Fourth Quarter and Full Year 2024 Financial Highlights:
•Revenue was $298.0 million, compared to $230.0 million in the fourth quarter of 2023. The 30% year-over-year increase was primarily driven by royalty revenue growth and higher revenues under collaborative agreements mainly due to the timing of milestones achieved. Revenue for the quarter included $170.4 million in royalties, an increase of 40% compared to $122.1 million in the fourth quarter of 2023, primarily attributable to increases in revenue of DARZALEX SC, VYVGART Hytrulo and Phesgo.
Total revenue for the full year was $1,015.3 million, compared to $829.3 million in 2023, representing 22% year-over-year growth. The increase was primarily driven by royalty revenue growth, higher revenues under collaborative agreements mainly due to the timing of milestones achieved and higher sales of our proprietary products.
•Cost of sales was $42.1 million, compared to $52.3 million in the fourth quarter of 2023. The decrease was primarily due to lower bulk rHuPH20 sales.
Cost of sales for the full year was $159.4 million, compared to $192.4 million in 2023. The decrease was primarily due to lower bulk rHuPH20 and device sales, partially offset by higher proprietary product sales.
•Amortization of intangibles expense was $17.8 million, compared to $17.8 million in the fourth quarter of 2023.
Amortization of intangibles expense for the full year was $71.0 million, compared to $73.8 million in 2023. The decrease was primarily due to an impairment charge of $2.5 million recognized in the prior year to fully impair the TLANDO product rights intangible asset.
•Research and development expense was $20.4 million, compared to $21.3 million in the fourth quarter of 2023.
Research and development expense for the full year was $79.0 million, compared to $76.4 million in 2023. The increase was primarily due to planned investments in ENHANZE related to the development of our new high-yield rHuPH20 manufacturing processes.
•Selling, general and administrative expense was $42.2 million, compared to $37.6 million in the fourth quarter of 2023. The increase was primarily due to increased compensation expense and consulting and professional service fees.
Selling, general and administrative expense for the full year was $154.3 million, compared to $149.2 million in 2023. The increase was primarily due to increased compensation expense and consulting and professional service fees, partially offset by planned reductions in commercial marketing expense.
•Operating income was $175.5 million, compared to $101.0 million in the fourth quarter of 2023.
Operating income for the full year was $551.5 million, compared to $337.6 million in 2023.
•Net income was $137.0 million, compared to $85.4 million in the fourth quarter of 2023.
Net income for the full year was $444.1 million, compared to $281.6 million in 2023.
•EBITDA was $195.8 million, compared to $121.7 million in the fourth quarter of 2023. Adjusted EBITDA was $195.8 million, compared to $121.7 million in the fourth quarter of 2023.1
EBITDA for the full year was $632.2 million, compared to EBITDA of $435.6 million in 2023. Adjusted EBITDA for the full year was $632.2 million, compared to $426.2 million in 2023.

•GAAP diluted earnings per share was $1.06, compared to $0.65 in the fourth quarter of 2023. Non-GAAP diluted earnings per share was $1.26, compared to $0.82 in the fourth quarter of 2023.1
GAAP diluted earnings per share for the full year was $3.43, compared to $2.10 in 2023. Non-GAAP diluted earnings per share for the full year was $4.23, compared to $2.77 in 2023.1
•Cash, cash equivalents and marketable securities were $596.1 million on December 31, 2024, compared to $336.0 million on December 31, 2023. The increase was primarily a result of cash generated from operations.

Financial Outlook for 2025
The Company is reiterating its financial guidance for 2025, which was initially provided on January 8, 2025. For the full year 2025, the Company expects:

•Total revenue of $1,150 million to $1,225 million, representing growth of 13% to 21% over 2024 total revenue, primarily driven by increases in royalty revenue and product sales from XYOSTED.
•Revenue from royalties of $725 million to $750 million, representing growth of 27% to 31% over 2024.
•Adjusted EBITDA of $755 million to $805 million, representing growth of 19% to 27% over 2024.
•Non-GAAP diluted earnings per share of $4.95 to $5.35, representing growth of 17% to 26% over 2024. The Company’s earnings per share guidance does not consider the impact of potential future share repurchases.

Table 1. 2025 Financial Guidance

Guidance Range
Total Revenue
$1,150 to $1,225 million
Royalty Revenue
$725 to $750 million
Adjusted EBITDA
$755 to $805 million
Non-GAAP Diluted EPS
$4.95 to $5.35

On February 18, 2025 CEL-SCI Corporation (NYSE American: CVM) reported financial results for three months ended December 31, 2024, as well as key recent clinical and corporate developments (Press release, Cel-Sci, FEB 18, 2025, View Source [SID1234650353]).

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"CEL-SCI is very uniquely positioned at this moment as an immuno-oncology company with a vast amount of data from the largest Phase 3 head and neck cancer study ever performed, with statistically significant evidence that our drug can successfully fight cancer and extend lives in head and neck cancer," stated CEL-SCI CEO, Geert Kersten. "We hope to deliver a new standard of care to patients while substantially transforming our company’s valuation to reflect what we believe to be the intrinsic value of our cancer drug. The statistical analysis shows that our very soon to be initiated small confirmatory Registration Study has a very high chance of success and we will have indications of efficacy as early as 2026. Should the pre-surgical tumor responses mirror what we saw in the Phase 3 data, we believe we will be on the path for accelerated and/or conditional approval for Multikine next year."

Corporate and Clinical Developments include:

The U.S. FDA concurred with CEL-SCI’s plan to use of PD-L1 as a biomarker to select patients for a Phase 3 confirmatory trial. The study is designed to confirm the observation in our previous head and neck cancer Phase 3 trial that patients with low PD-L1 expression are most likely to have favorable outcomes from Multikine therapy. These patients, when treated with Multikine in the completed Phase 3 study, had a 5-year survival of 73% vs. 45% in the control group with a p-value of 0.0015. PD-L1 is a widely used biomarker for cancer patient selection for checkpoint inhibitors, which appear to work best for patients with high PD-L1 expression. Since Multikine has been shown to be more effective in patients with low PD-L1 expression, Multikine is uniquely positioned to benefit an estimated 70% of head and neck patients who have low PD-L1 expression.
The strong data from our completed Phase 3 study and the biological rationale for the use of Multikine in the treatment of head and neck cancer suggest a high likelihood of success for the confirmatory Registration Study. These data and rationale include:
Multikine shows pre-surgical tumor regression in head and neck cancer in just 3 weeks – confirmed by pathology at surgery:
Multikine led to significant rates of tumor regression prior to surgery.
There was no tumor regression observed in the control group that did not receive Multikine.
Pre-surgical tumor regressions confirmed at surgery forecast survival benefit.
The patient population for the Registration Study is likely to show significant survival prolongation.
Phase 3 Registration Study patient population selection is based on:
Strong statistical significance with respect to overall survival vs controls in 114 patients in the Phase 3 study.
Analysis of the patients in this group was pre-defined in the statistical analysis plan (SAP).
Strong biological rationale for the results seen in these patients based on Multikine’s mechanism of action (MOA) which brings about a strong and sustainable immune response and does not require overcoming PD-L1 blockade.
Ergomed, a clinical research organization (CRO) with a strong track record of fast enrollment and high-quality study delivery, is selected as the CRO for CEL-SCI’s confirmatory Registration Study. Ergomed has been a strategic partner and collaborator with CEL-SCI for over 10 years and was instrumental in successfully completing the prior Phase 3 study.
Financial Results

During the three months ended December 31, 2024, research and development expenses were $4.4 million, approximately the same as the three months ended December 31, 2023. General and administrative expenses for the first quarter of fiscal 2025 were $2.5 million compared to $2.1 million in the first quarter of fiscal 2023. Net loss was $7.1 million for three months ended December 31, 2024 compared to $6.7 million in the prior year period. Cash spent during the quarter was $5.1 million. Net loss per common share narrowed by 21% to $0.11 for the three months ended December 31, 2024, compared to $0.14 for the three months ended December 31, 2023.