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 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 Plus Therapeutics, Inc. (the "Company") reported the company entered into a Securities Purchase and Exchange Agreement (the "SPEA") with certain existing accredited investors (the "Purchasers") (Filing, Cytori Therapeutics, FEB 18, 2025, View Source [SID1234650333]). Pursuant to the SPEA, on the Closing Date the Company issued secured convertible promissory notes (the "Funding Notes") in the aggregate principal amount of $3,362,251 together with common stock purchase warrants (the "Warrants") to purchase 3,002,009 shares of the Company common stock, par value $0.001 (the "Common Stock") at an exercise price of $1.12 per share (the "Warrant Exercise Price"). The aggregate purchase price for the Funding Note and Warrants was approximately $3.7 million (the "Aggregate Purchase Price") and included payment of $0.125 per Warrant in accordance with the Nasdaq Listing Rules.

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The Funding Notes mature on February 13, 2026, and bear interest at a rate of 10% per annum, subject to increase upon Events of Default.

The Warrants are exercisable for five-years from the date of issuance.

Secured Interest

The obligations of the Company under the SPEA and the Notes (as defined below) are secured by a pledge of substantially all of assets of the Company pursuant to a security agreement, dated as of the Closing Date, among the Company, CNSide Diagnostics, LLC (a subsidiary of the Company, "CNSide"), and Iroquois Master Fund Ltd., as collateral agent for the Purchasers (the "Security Agreement), subject to certain exceptions. The Security Agreement contains certain customary affirmative and negative covenants, including limitations on the Company’s and CNSide’s ability to dispose of assets, subject to customary exceptions. The repayment of the Company’s obligations under the SPEA and Notes are guaranteed pursuant to a subsidiary guarantee, dated as of the Closing Date (the "Subsidiary Guarantee"), by and among CNSide and the Purchasers.

Mandatory Conversion

In the event of a Common Stock financing by the Company on or before March 31, 2025, in which the Company receives at least $10.0 million in gross proceeds and that meets certain other conditions specified in the SPEA (a "Qualified Financing"), at the election of the Company seventy-five percent of the principal amount and interest of the Funding Notes, or at the election of the Purchaser, all of the principal amount and interest of the Funding Notes, will convert into the securities issued in the Qualified Financing (the "Mandatory Conversion"). The Mandatory Conversion does not apply, however, in the event that per share of Common Stock price in the Qualified Financing is $2.00 or greater (the "Maximum Amount").

Upon a consummation of a Qualified Financing, any portion of the Funding Notes not mandatorily converted in the Qualified Financing by the Company, at each Purchaser’s option, will either be voluntarily converted into such securities issued in the Qualified Financing or redeemed in cash.

Voluntary Conversion

Each Funding Note is convertible at any time after the Closing Date, at the option of each Purchaser, subject to certain exceptions set forth in the Funding Notes, into shares of Common Stock, or to comply with certain beneficial ownership limitations, into pre-funded warrants (the "Pre-Funded Warrants"), exercisable immediately at an exercise price of $0.001 per share. The initial conversion price for the Funding Notes is $1.12 per share (the "Conversion Price").

Anti-Dilution

Subject to obtaining stockholder approval, the Conversion Price and the Warrant Exercise Price are subject to anti-dilution protection upon any subsequent transaction at a fixed price lower than the Conversion Price or Warrant Exercise Price, as applicable, then in effect and standard adjustments in the event of any stock split, stock dividend, stock combination, recapitalization or other similar transaction.

Covenants

The Funding Notes provide for certain customary negative covenants regarding the incurrence of certain indebtedness, the creation of liens, the repayment of indebtedness, the payment of cash or assets in respect of dividends, distributions or redemptions, and the transfer of assets, among other matters.

Company Optional Redemption Rights

Subject to Equity Conditions (as such term is defined in the Funding Notes), each Funding Note may be prepaid, at the option of the Company, in whole or in part, by paying in cash to the Purchaser the Mandatory Default Amount (as such term is defined in the Funding Notes) or 120% of the principal amount of the Funding Note, together with any accrued and unpaid interest and unpaid late charges thereon. In addition, the Company may prepay each Funding Note upon a Fundamental Transaction (as such term is defined in the Funding Notes) or a Change of Control Transaction (as such term is defined in the Funding Notes), provided that shares of Common Stock issuable pursuant to the Funding Notes are then registered under an effective registration statement, by paying to the Purchasers the Mandatory Default Amount.

Terms of the SPEA

The SPEA contains certain representations and warranties, covenants and indemnities customary for similar transactions.

Under the SPEA, the Company agreed, among other conditions, to not effect or enter an agreement to effect any variable rate transaction, except for certain exempt issuances of equity securities, until the later of the two year anniversary of the Closing Date or such date that the Notes are no longer outstanding. The Company also agreed to hold a stockholder meeting by no later than May 30, 2025, to seek approvals for future adjustments of the Warrant Exercise Price and Conversion Price for anti-dilution adjustments and similar matters, the reduction of the exercise price of the Warrants by $0.125, the extension of the period of exercise for the Series B common warrants issued pursuant to the May 2024 Purchase Agreement until five years from the original issue date of those warrants, and other matters necessary for compliance with Nasdaq Listing Rule 5635(d) (the "Stockholder Approvals"). Pursuant to the SPEA, the Company will be obligated to continue to seek the Stockholder Approvals at least three times each year until the Stockholder Approvals are obtained.

In addition, the Company granted the Purchasers participation rights in future offerings of Common Stock or Common Stock Equivalents (as such term is defined in the SPEA) for cash consideration, during the later of 18 months after the Closing Date or such time as less than 50% of the Warrants remain outstanding, in an amount of up to 50% of the securities being sold in such offerings.

Exchange Notes

As previously disclosed, the Company entered into that certain securities purchase agreement, dated May 5, 2024, as amended on May 8, 2024 (the "May 2024 Purchase Agreement"), with the Purchasers, among other investors, for the private placement of securities, including Series A common warrants ("Series A Warrants") to purchase an aggregate of up to 3,591,532 shares of common stock. The May 2024 Purchase Agreement included certain limitations and restrictions on the Company’s ability to issue securities and provided the Purchasers and the other investors signatories to the May 2024 Purchase Agreement participation rights in future equity and equity-linked offerings of securities, subject to certain limited exceptions (the "Financing Restrictions"). On the Closing Date, pursuant to the SPEA, the Company issued to the Purchases secured convertible promissory notes in the aggregate amount of $3,188,922 (the "Exchange Notes" and together with the Funding Notes, the "Notes") in exchange for cancellation of the Series A Warrants of the Purchasers, and the Purchasers entered into a second amendment to the May 2024 Purchase Agreement to eliminate the Financing Restrictions (the "Financing Waiver").

The terms and conditions of the Exchange Notes are substantially identical in all material respects to the Funding Notes, except that the Mandatory Conversion applies to all of the principal amount of the Exchange Notes instead of being limited to seventy-five percent, and the Maximum Amount does not apply. The Security Agreement and Subsidiary Guarantee also apply to the obligations under the Exchange Notes.

Registration Rights Agreement

In connection with the SPEA, the Company entered into a registration rights agreement (the "Registration Rights Agreement"), dated as of the Closing Date, with the Purchasers, pursuant to which the Company agreed to prepare and file a registration statement with the Securities and Exchange Commission (the "Commission") covering the resale of the shares of Common Stock issuable pursuant to the Notes and Warrants (the "Registration Statement") at the earlier of the fifteenth calendar day after the Company has filed its Annual Report on Form 10-K for the calendar year ended December 31, 2024, or April 15, 2025 (the "Filing Due Date"), and to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than June 30, 2025 (the "Effectiveness Due Date"), provided, however, that the Effectiveness Due Date for the shares of common stock issuable under the Exchange Notes is the earlier of the fifteenth calendar day after the Company has filed its Annual Report on Form 10-K for the calendar year ended December 31, 2024, or April 15, 2025. In addition, pursuant to the Registration Rights Agreement, the Company is required to use its reasonable best efforts to keep the Registration Statement continuously effective from the date on which the Commission declares the Registration Statement to be effective until such date that all Registrable Securities (as such term is defined in the Registration Rights Agreement) covered by the Registration Statement have been sold pursuant to a registration statement under the Securities Act of 1933, as amended (the "Securities Act"), under Rule 144 as promulgated by the Commission under the Securities Act ("Rule 144"), or otherwise shall have ceased to be Registrable Securities.

In the event that (i) the Company fails to file the Registration Statement by the Filing Due Date, (ii) the Company fails to file with the Commission a request for acceleration of the Registration Statement within 5 Trading Days (as such term is defined in the Registration Rights Agreement) of the date that the Company is notified by the Commission that such Registration Statement will not be "reviewed" or will not be subject to further review, (iii) the Registration Statement is not declared effective on or prior to the Effectiveness Due Date, (iv) after being declared effective, (A) the Registration Statement ceases to remain continuously effective as to all Registrable Securities for which it is required to be effective, or (B) the holders are not permitted to utilize the prospectus in the Registration Statement to sell Registrable Securities, other than certain allowed delays, or (v) an allowed delay exceeds beyond the length permitted for an allowed delay, then the Company has agreed (unless the Registrable Securities are freely tradable pursuant to Rule 144) to make payments to each Purchaser as liquidated damages in an amount equal to 1% of the aggregate amount invested by each such holder in the Registrable Securities, subject to a 12% cap in the aggregate as set forth in the Registration Rights Agreement.

The Company has granted the Purchasers customary indemnification rights in connection with the Registration Rights Agreement. The Purchasers have also granted the Company customary indemnification rights in connection with the Registration Rights Agreement.

The foregoing descriptions of the SPEA, Funding Notes, Exchange Notes, Security Agreement, Subsidiary Guarantee, Warrants, Pre-Funded Warrants, Financing Waiver, and Registration Rights Agreement are qualified in their entirety by reference to the full text of such documents, copies of which are attached hereto as exhibits, and each of which is incorporated herein in its entirety by reference. The representations, warranties and covenants contained in such agreements were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements and may be subject to limitations agreed upon by the contracting parties.

Item 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.

The information set forth in Item 1.01 above relating to the SPEA and Notes is incorporated herein by reference.

Item 3.02 Unregistered Sales of Equity Securities.

The information set forth in Item 1.01 of this Current Report on Form 8-K regarding the sale and issuance of the securities is incorporated herein by reference into this Item 3.02.

The Company issued the Exchange Notes in reliance on the exemption from registration afforded by Section 3(a)(9) of the Securities Act, The Company otherwise sold the securities to "accredited investors," as that term is defined in the Securities Act, in reliance on the exemption from registration afforded by Section 4(a)(2) thereof and Rule 506 of Regulation D thereunder, and corresponding provisions of state securities or "blue sky" laws. The Purchasers represented that they were acquiring the securities pursuant to the SPEA for investment only and not with a view towards the resale or distribution thereof in violation of the Securities Act. Accordingly, the securities issued pursuant to the SPEA have not been registered under the Securities Act and such securities may not be offered or sold in the United States absent registration or an exemption from registration under the Securities Act and any applicable state securities laws.

Neither this Current Report on Form 8-K, nor the exhibits attached hereto, is an offer to sell or the solicitation of an offer to buy the securities described herein.

Item 7.01 Regulation FD Disclosure.

On February 18, 2025, the Company issued a press release announcing the private placement and exchange described above and a $2.0 million advance payment from the Cancer Prevention and Research Institute of Texas (CPRIT), as part of its existing $17.6 million grant.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number
Description of Document

4.1 Form of Pre-Funded Warrant
4.2 Form of Warrant issued pursuant to the Securities Purchase and Exchange Agreement, dated February 13, 2025, by and among Plus Therapeutics, Inc. and the purchasers named therein
10.1* Securities Purchase and Exchange Agreement, dated February 13, 2025, by and among Plus Therapeutics, Inc. and the purchasers named therein
10.2 Form of Secured Convertible Note for Funding Notes issued pursuant to the Securities Purchase and Exchange Agreement, dated February 13, 2025, by and among Plus Therapeutics, Inc. and the purchasers named therein
10.3 Form of Secured Convertible Note for Exchange Notes issued pursuant to the Securities Purchase and Exchange Agreement, dated February 13, 2025, by and among Plus Therapeutics, Inc. and the purchasers named therein
10.4* Security Agreement, dated February 13, 2025, by and among Plus Therapeutics, Inc., CNSide Diagnostics, LLC, and Iroquois Master Fund Ltd., as collateral agent for the purchasers named therein
10.5 Subsidiary Guarantee, dated as of February 13, 2025, by and among CNSide Diagnostics, LLC and the purchasers named therein
10.6 Registration Rights Agreement, dated February 13, 2025, by and among Plus Therapeutics, Inc. and the purchasers named therein
10.7 Second Amendment to Securities Purchase Agreement, dated May 5, 2024, as amended on May 9, 2024, by and among Plus Therapeutics, Inc. and the purchasers named therein
104 Cover Page Interactive Data File (embedded with the Inline XBRL document)

*
Schedules and exhibits have been Omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company hereby undertakes to furnish supplemental copies of any of the Omitted schedules or exhibits upon request by the Securities and Exchange Commission; provided that the Company may request confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended, for any schedules or exhibits so furnished.

On February 18, 2025 Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, reported that Frank Karbe has been appointed Chief Financial Officer (CFO), effective February 24, 2025 (Press release, Cidara Therapeutics, FEB 18, 2025, View Source [SID1234650332]). Mr. Karbe will succeed Preetam Shah, Ph.D., MBA, who is departing to pursue other professional opportunities. Dr. Shah will serve as a consultant to the Company.

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"We are pleased to welcome Frank to the team as we advance our long-acting influenza antiviral drug CD388 through the end of this flu season in the Phase 2b NAVIGATE study and plan for Phase 3 and beyond." said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "We expect that Frank’s extensive experience as a leader in the biopharma industry and proven track record for transitioning companies to multi-billion-dollar commercial organizations will prove invaluable to the strategic vision of Cidara. On behalf of the entire Cidara team, I thank Preetam for his guidance and dedication which helped position Cidara for success. We wish him luck in his future endeavors."

Mr. Karbe added, "Cidara is at an important stage in the company’s evolution, with its novel DFC candidate, CD388, showing immense potential as a universal influenza preventative. Influenza continues to drive significant morbidity and mortality despite the availability of vaccines and antiviral treatments. I am excited to join the Cidara team and look forward to leveraging my experience to drive the company’s growth and bring CD388 to the tens of millions of patients who can benefit from it."

Mr. Karbe is a widely experienced senior executive with over 25 years of leadership experience in life sciences, healthcare, and technology. Most recently, he served as Chief Executive Officer and President of Better Therapeutics, where he led the company to the first-ever FDA authorization of a digital therapeutic for the treatment of type 2 diabetes. Previously, as President and Chief Financial Officer of Myovant Sciences, Mr. Karbe played a pivotal role in scaling the company from a startup to a publicly listed company with 500+ employees and two FDA approved products in under five years, raising over $2 billion in capital and securing a $4 billion partnership with Pfizer. He also served for over a decade as Executive Vice President and Chief Financial Officer at Exelixis, where he drove the company’s transformation from discovery to commercialization. Earlier in his career, he worked as an investment banker for Goldman Sachs, focusing on corporate finance and mergers & acquisitions in the life sciences industry.

On February 18, 2025 Celyad Oncology (Euronext: CYAD) (the "Company"), reported the publication of the preclinical data of the non-gene edited allogeneic CYAD-211 and clinical data from the Phase I IMMUNICY-1 clinical study which evaluated CYAD-211 in relapsed or refractory (r/r) multiple myeloma (MM) patients (Press release, Celyad, FEB 18, 2025, View Source [SID1234650331]). The findings were published in the International Journal of Molecular Science (IJMS).

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CYAD-211 is the Company’s first allogeneic chimeric antigen receptor (CAR) T-cell candidate, engineered to co-express a B-cell maturation antigen (BCMA)-specific CAR and a microRNA-based single shRNA which interferes with the expression of the CD3ζ component of the T-cell receptor (TCR) complex, evaluated clinically.

The IJMS publication includes preclinical data which showcases the knockdown of CD3ζ efficiently removed the TCR complex from the cell surface, and inhibited TCR mediated activation in vitro and in vivo. The publication also presents clinical data of the dose-escalation segment of the IMMUNICY-1 phase-I clinical trial (NCT04613557) in patients with r/r MM. Importantly, data highlighted an overall good safety profile and some clinical responses, with no signs of graft-versus-host disease (GvHD), demonstrating the effectiveness and safeness of the technology to abrogate the risk of GvHD.

Overall, these data provides the proof-of-concept of the safe administration of CAR T-cells engineered using a miRNA-based shRNA technology. CYAD-211 is the first allogeneic CAR T-cell candidate using a non-gene edited approach to achieve allogenicity. This differentiated strategy provides key advantages by being easily implemented, safe, efficient, tunable, and with the possibility to modulate multiple target genes simultaneously.