On March 28, 2025, Nektar Therapeutics (the "Company") entered into an Equity Distribution Agreement (the "Agreement") with Piper Sandler & Co. ("Piper") and BTIG, LLC ("BTIG"), pursuant to which the Company may offer and sell, from time to time in its sole discretion, shares of its common stock, par value $0.0001 per share (the "Common Stock"), having an aggregate offering price of up to $75,000,000 (the "Shares"), through Piper and BTIG as its sales agents (Filing, Nektar Therapeutics, MAR 28, 2025, View Source [SID1234651582]). The Shares will be offered and sold pursuant to the Company’s Registration Statement on Form S-3 filed by the Company on March 28, 2025 (the "Registration Statement") and the sales agreement prospectus supplement that forms a part of such Registration Statement, following such time, if ever, as the Registration Statement is declared effective by the Securities and Exchange Commission. The issuance and sale, if any, of the Shares may be by any method permitted by law deemed to be an "at-the-market offering" as defined in Rule 415 of the Securities Act of 1933, as amended, including, without limitation, sales made directly on the Nasdaq Capital Market, or on any other existing trading market for the Common Stock.

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The Company is not obligated to make any sales of Common Stock, and Piper and BTIG are not required to sell any specific number or dollar amount of shares of the Common Stock, under the Agreement. The Company and each of Piper and BTIG may suspend or terminate the offering of Shares upon notice to Piper and BTIG or the Company, as applicable, and subject to other conditions.

Subject to the Company’s request to sell Shares, Piper and BTIG will act as the Company’s sales agents and use commercially reasonable efforts to sell on the Company’s behalf, from time to time consistent with its normal trading and sales practices, such Shares based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay Piper and BTIG a commission fee of 3.0% of the gross sales price of any Shares sold through Piper or BTIG, as applicable, under the Agreement, and also has provided Piper and BTIG with customary indemnification and contribution rights.

The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is filed herewith and incorporated herein by reference.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On March 28, 2025 LAVA Therapeutics N.V. (NASDAQ: LVTX, "LAVA," "the Company"), a clinical-stage immuno-oncology company focused on developing its proprietary Gammabody platform of bispecific gamma delta T cell engagers, reported recent corporate highlights and financial results for the fourth quarter and year ended December 31, 2024 (Press release, Lava Therapeutics, MAR 28, 2025, View Source [SID1234651581]).

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"LAVA’s approach to maximize shareholder value in 2025 will focus on evaluating strategic options while continuing to enroll patients in our ongoing Phase 1 study of LAVA-1266, and supporting our pharma partnerships," said Steve Hurly, Chief Executive Officer of LAVA. "The Phase 1 study of LAVA-1266 as a potential treatment for acute myeloid leukemia and myelodysplastic syndrome is progressing. Looking ahead, with a strong cash balance, we believe LAVA is well-positioned to unlock strategic opportunities, and we look forward to updating investors with our progress throughout the year."

Portfolio Highlights

LAVA-1266 – Phase 1 Trial (ACTRN12624001214527)

Designed to target CD123+ tumor cells for the treatment of hematological malignancies

· Key indications: Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)

· Current Status: LAVA is enrolling patients in the second dose level at 300 µg in a first-in-human Phase 1, open label, multi-center study in Australia. The study includes a dose escalation and dose expansion segment to evaluate LAVA-1266 in approximately 50 adults with CD123+ relapsed/refractory AML or intermediate, high or extremely high risk MDS.

The study is evaluating safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and preliminary anti-tumor activity.

Johnson & Johnson (J&J) Partnered Program (JNJ-89853413) – Phase 1 Trial (NCT06618001)

Designed to target CD33 and gamma delta T cells with a bispecific gamma delta T cell engager

· Key Indications: Include hematological cancers

· Current Status: J&J is enrolling patients in a Phase 1, open label, multi-center study underway in Canada and Spain. The study includes a dose escalation and dose expansion segment to evaluate JNJ-89853413 in approximately 100 adults with relapsed/refractory AML or moderate or higher risk MDS. The study is evaluating safety, tolerability, PK, PD, immunogenicity and preliminary anti-tumor activity.

J&J presented preclinical data for JNJ-89853413 at the Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) (ASH 2024) on December 7, 2024 (Abstract 2054).

· Milestone: Development milestone of $5 million received from J&J in Q4 2024 related to the IND filing for JNJ-89853413

Pfizer Partnered Program (PF08046052) – Phase 1 Trial (NCT05983133)

Potential first-in-class epidermal growth factor receptor (EGFR) and bispecific gamma delta T cell receptor-targeted therapy for solid tumors

· Key Indications: Include colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) and pancreatic ductal adenocarcinoma (PDAC)

· Current Status: Pfizer is enrolling patients in a Phase 1 open label, multi-center study, underway in the U.S. and UK. The study will include dose escalation and dose expansion segments to evaluate PF08046052 in approximately 275 subjects with metastatic, non-resectable solid tumor cancers. The study will evaluate safety, tolerability, PK, immunogenicity and preliminary anti-tumor activity.

· Milestone: Clinical development milestone of $7 million received from Pfizer in Q1 2024

Fourth Quarter and Year-End 2024 Financial Results

· In February 2025, the Company adopted a restructuring plan to extend its capital resources in connection with initiating a process to evaluate strategic alternatives. As part of the restructuring plan, the Company’s board of directors approved a reduction of approximately 30% of the Company’s global workforce to better align resources with the Company’s focus on the evaluation of strategic options and the Phase 1 study for LAVA-1266. The Company expects approximately $1.0 million of expenses related to the restructuring to be incurred during the six months ended June 30, 2025, of which approximately $0.3 million of cash payments are expected to be made during 2025.

· As of December 31, 2024, LAVA had cash, cash equivalents, and investments of $76.6 million, compared to cash, cash equivalents, and investments of $95.6 million as of December 31, 2023. The Company believes its current cash, cash equivalents and investments will be sufficient to fund operations into 2027.

· Revenue from contracts with customers was $5.0 million and $0.4 million for the quarters ended December 31, 2024 and 2023, respectively, and $12.0 million and $6.8 million for the years ended December 31, 2024 and 2023, respectively. The increase in revenue for the quarter ended December 31, 2024 compared to 2023 was primarily due to the $5.0 million milestone related to J&J’s IND filing in October 2024. The increase in revenue for the year ended December 31, 2024 compared to 2023 was primarily related to $7.0 million the Company recognized in revenue in connection with its agreement with Pfizer related to the achievement of a clinical development milestone and $5.0 million the Company recognized as revenue in connection with J&J’s IND filing. In comparison, in 2023, revenue included $4.3 million related to the Company’s agreement with Pfizer and $2.5 million related to the Company’s agreement with J&J.

· Cost of sales of goods and providing services was zero and $0.2 million for the quarters ended December 31, 2024 and 2023, respectively, and zero and $3.5 million for the years ended December 31, 2024 and 2023, respectively. The cost in 2023 was due to the initial drug supply delivery to Pfizer and related stability studies.
· Research and development expenses were $8.6 million and $2.3 million for the quarters ended December 31, 2024 and 2023, respectively, and $28.5 million and $32.6 million for the years ended December 31, 2024 and 2023, respectively. The increase for the quarter ended December 31, 2024, as compared to December 31, 2023, was primarily due to costs associated with the discontinuation of LAVA-1207, announced in December 2024. The decrease for the year ended December 31, 2024, as compared to December 31, 2023, was primarily due to reduced manufacturing scale-up costs and headcount reductions that occurred in the second half of 2023, offset by costs associated with the discontinuation of LAVA-1207.

· General and administrative expenses were $3.3 million for each of the quarters ended December 31, 2024 and 2023, and $13.2 million and $14.1 million for the years ended December 31, 2024 and 2023, respectively. The decrease for the year ended December 31, 2024, as compared to December 31, 2023, was primarily due to lower share-based compensation expense as a result of fewer options issued and a reduction in the Company’s share price.

· Net loss was $3.8 million and $6.4 million for the quarters ended December 31, 2024 and 2023, respectively, or $0.14 and $0.24 net loss per share for the quarters ended December 31, 2024 and 2023, respectively. Net losses were $25.1 million and $41.9 million for the years ended December 31, 2024 and 2023, respectively, or $0.94 and $1.57 net loss per share for the years ended December 31, 2024 and 2023, respectively.

LAVA Therapeutics N.V.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts) (unaudited)

Three Months Ended Year Ended
December 31, December 31,
2024 2023 2024 2023
Revenue:
Revenue from contracts with customers $ 4,990 $ 353 $ 11,982 $ 6,769
Total revenue 4,990 353 11,982 6,769
Cost and expenses:
Cost of revenue — (155 ) — (3,482 )
Research and development (8,568 ) (2,302 ) (28,450 ) (32,559 )
General and administrative (3,344 ) (3,300 ) (13,225 ) (14,122 )
Total cost and expenses (11,912 ) (5,758 ) (41,675 ) (50,163 )
Operating loss (6,922 ) (5,405 ) (29,693 ) (43,394 )
Other income (expense), net
Interest income 863 1,002 3,758 3,672
Interest expense (125 ) (117 ) (515 ) (470 )
Foreign currency exchange gain (loss), net 2,688 (1,851 ) 1,966 (1,422 )
Total other income (expense), net 3,427 (966 ) 5,209 1,780
Net loss before taxes (3,495 ) (6,370 ) (24,484 ) (41,614 )
Income tax expense, net (379 ) (37 ) (630 ) (257 )
Net loss $ (3,874 ) $ (6,408 ) $ (25,114 ) $ (41,871 )
Other comprehensive (expense) income:
Foreign currency translation adjustment (2,054 ) 2,159 (1,758 ) 2,075
Comprehensive loss $ (5,928 ) $ (4,249 ) $ (26,872 ) $ (39,796 )

Net loss per share, basic and diluted $ (0.14 ) $ (0.24 ) $ (0.94 ) $ (1.57 )
Weighted-average common shares outstanding, basic and diluted 26,866,931 26,769,937 26,834,422 26,732,556

LAVA Therapeutics N.V.
Condensed Consolidated Balance Sheets
(in thousands) (unaudited)

As of December 31,
2024 2023
Assets
Current assets:
Cash and cash equivalents $ 35,015 $ 44,231
Short-term investments 41,561 51,340
Prepaid expenses 1,072 1,627
Other current assets 1,649 1,699
Total current assets 79,297 98,897
Property and equipment, net 1,002 1,602
Operating lease right-of-use assets 441 855
Other non-current assets 91 319
Total assets $ 80,831 $ 101,673
Liabilities and shareholders’ equity
Current liabilities:
Accounts payable $ 2,722 $ 4,446
Accrued expenses and other current liabilities 10,083 4,751
Borrowings 4,886 5,282
Current portion of operating lease liabilities 315 415
Total current liabilities 18,006 14,894
Non-current portion of deferred revenue 35,000 35,000
Non-current portion of operating lease liabilities 80 415
Total liabilities 53,086 50,309
Commitments and contingencies
Shareholders’ equity:
Common stock 3,717 3,715
Additional paid-in capital 211,656 208,405
Accumulated deficit (174,973 ) (149,859 )
Accumulated other comprehensive loss (12,655 ) (10,897 )
Total shareholders’ equity 27,745 51,364
Total liabilities and shareholders’ equity $ 80,831 $ 101,673

On March 28, 2025 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (NASDAQ: IPA), an AI-driven biotherapeutic research and technology company, reported financial results for the third quarter ("Q3") of its 2025 fiscal year ("FY25"), which ended January 31, 2025. All numbers are expressed in Canadian dollars, unless otherwise noted (Press release, ImmunoPrecise Antibodies, MAR 28, 2025, View Source [SID1234651580]).

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"As we continue to revolutionize the AI-enabled drug discovery sector, our recent milestones underscore the growing recognition of our innovative AI and growth potential. Notably, we’ve secured a strategic partnership valued at $8-10 million USD with a leading biotech company, leveraging our proprietary B-cell Select technology and AI-driven capabilities to enhance our development and optimization processes. These AI-driven development and optimization capabilities are accelerating the advancement of novel therapies, positioning us at the forefront of innovation. Our collaborations with Vultr, AMD and other Leading Providers of Advanced GPU technologies further enhance our lab-in-a-loop drug discovery and development capabilities, not only driving cost-effectiveness for our pharma partners but also increasing our competitiveness in securing future collaborations. This strategic alignment is positively impacting both our top line and gross profit margins in the AI sector, as we continue to drive robust growth and expand our presence in the rapidly evolving AI healthcare landscape. We are excited about the potential of these current partnerships and looks forward to forming new collaborations that will further accelerate our mission to transform the future of healthcare through AI-driven innovation," stated Dr. Jennifer Bath, President and CEO.

"While BioStrand’s AI revenue currently represents a modest portion of our total topline, it stands out for its remarkably high gross margins—exceeding 90% in recent quarters, a level of profitability that is truly exceptional in our industry. This positive dynamic reveals one of the most important yet underappreciated financial drivers of our business: as AI revenues scale, so does the path to profitability at an accelerated pace. Unlike traditional project-based services, IPA’s AI-driven offerings generate significant leverage and recurring value, creating a robust foundation for sustainable growth. This margin profile—combined with accelerating adoption—positions IPA’s AI segment as a powerful engine for long-term shareholder value and a key catalyst for our future success," stated Joseph Scheffler, Interim CFO.

Third Quarter Corporate Update and Recent Business Highlights

•
Entered into a USD $8M–$10M partnership with a USD $3 billion market cap global biotechnology company to co-develop Antibody-Drug Conjugates (ADCs) and bispecific antibodies, reinforcing demand for IPA’s B-Cell and AI-powered platforms.
•
Expanded AI infrastructure through strategic collaborations with Vultr, AMD and other leading providers of advanced GPU technologies enabling high-performance GPU computing for generative AI.
•
Corporate headquarters relocated to Austin, Texas: Expanding IPA’s U.S. footprint in the heart of a thriving AI, biotech, and semiconductor ecosystem. This strategic move takes advantage of Texas’s zero corporate income tax, allowing us to reinvest savings in business expansion and innovation. Additionally, the state’s robust economy and skilled workforce will support our growth ambitions, positioning us for increased competitiveness and profitability in the rapidly evolving AI healthcare landscape.
•
Resilience in Challenging Market Conditions: Our year-to-date revenue stability and high margin profile, including BioStrand’s 131.8% year-over-year revenue growth and 97% gross margin, underscore IPA’s solid financial position and ability to navigate difficult market conditions effectively.
•
Announced key leadership changes, including the appointment of Joseph Scheffler as Interim CFO and Dr. Kamil Isaev to the Board of Directors, enhancing financial oversight and business strategy.
•
Completed a USD $8.8 million At-the-Market (ATM) equity raise and announced the full conversion of the Yorkville debenture, strengthening IPA’s balance sheet and removing near-term convertible debt.
•
Pioneered AI-designed GLP-1 therapeutics for diabetes and metabolic disorders, using unique nucleic acid-based delivery technology and the LENSai platform to enhance efficacy, safety, and patient compliance.
•
Realigned pipeline strategy, launching a new AI-powered therapeutic development pipeline driven by first principles thinking and proprietary machine learning models.
•
Revealed multiple ADC lead candidates with demonstrated tumor-killing capabilities, potentially positioning IPA in the high-growth $20B antibody-drug conjugate market.
•
Insider Confidence Reinforced: Key members of IPA’s leadership and BioStrand co-founders acquired 763,120 shares on the open market—an aggregate investment of USD $306,000—demonstrating strong internal conviction in the Company’s long-term strategy and AI-driven growth trajectory.

Second Quarter FY25 Financial Results

•
Revenue: Total revenue was $6.2 million, compared to revenue of $6.2 million in fiscal year 2024 ("FY24") Q3. Project revenue generated $5.6 million, including projects using IPA’s proprietary B Cell Select platform and IPA’s proprietary LENSai platform, compared to $5.8 million in FY24 Q3. Product sales and cryostorage revenue were $0.6 million, compared to $0.4 million in FY24 Q3.

•
Research & Development (R&D) Expenses: R&D expenses were $1.1 million, compared to $1.0 million in FY24 Q3, reflecting increased salary and benefits related to the build of the Company’s LENSai platform. 
•
Sales & Marketing (S&M) Expenses: S&M expenses were $1.3 million, compared to $0.6 million in FY24 Q3 and includes S&M expenses related to social media and digital campaigns. S&M costs related to BioStrand LENSai.
•
General & Administrative (G&A) Expenses: G&A expenses were $3.6 million, compared to $4.2 million in FY24 Q3.  
•
Impairment: The Company recorded an impairment charge of $21.2 million related to BioStrand’s intangible assets. This adjustment reflects a delay in expected cash flows and resulted in full impairment of the remaining intangible assets after . the Company recorded an impairment charge of $15.0 million related to BioStrand in fiscal 2024. Despite this change in valuation, IPA remains committed to its strategic investments and long-term growth plans.
•
Net Loss: Net loss of $21.5 million, or $(0.66) per share on a basic and diluted basis, as compared to a net loss of $2.7 million or $(0.10) on a basic and diluted basis in FY24 Q3.
•
Liquidity: Cash totaled $12.9 million as of January 31, 2025, compared to $3.5 million as of April 30, 2024.

*All financial figures are in Canadian Dollars (CAD) unless otherwise stated.

Conference Call and Webcast Details

The Company will host a live conference call and webcast to discuss these results and provide a corporate update on Friday, March 28, 2025, at 10:30AM ET.

The conference call will be webcast live and available for replay via a link provided in the Events section of the Company’s IR pages at View Source

***Participant Dial-In Details***

Participants call one of the allocated dial-in numbers (below) and advise the Operator of either the Conference ID 3224490 or Conference Name.

USA / International Toll +1 (646) 307-1963
USA – Toll-Free (800) 715-9871
Canada – Toll-Free (800) 715-9871

***Webcast Details***

Attendee URL:
View Source

Please call the conference telephone number five minutes prior to the start time. An operator will register your name and organization.

Anyone listening to the call is encouraged to read the company’s periodic reports available on the company’s profile at www.sedarplus.com and www.sec.gov, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On March 28, 2025 HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between inflammation and age-related diseases, reported financial results and recent business highlights for its fourth quarter and fiscal year ended December 31, 2024 (Press release, HCW Biologics, MAR 28, 2025, View Source [SID1234651579]).

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Dr. Hing Wong, Founder and CEO, stated, "We are more passionate than ever about our desire to create breakthrough immunotherapeutic treatments for diseases with no known cures, especially pancreatic, ovarian cancer and other age-related diseases. We have received clearance to begin clinical trials in alopecia areata, our first-quality-of-life indication, with one of our lead molecules, HCW9302. In non-human primate studies, HCW9302 is well tolerated at the dose level of effectively expanding regulatory T ("Treg") cells. Our surrogate efficacious marker for HCW9302 in treated patients is the expansion of Treg cells after subcutaneous administration."

Further, Dr. Wong provided insights to the Company’s preclinical programs, adding, "Our preclinical programs are also promising. In the fourth quarter of 2024, the Company revealed its new drug discovery and development platform, with a novel scaffolding or "backbone" of proteins called T-cell Receptor β Chain constant region ("TRBC"). The TRBC drug discovery and development platform leverages the Company’s in-depth knowledge of T cell and natural killer ("NK") cell immunology. The Company has constructed 50 proprietary compounds with the TRBC platform for the treatment of hematologic and solid tumors, virally infected cells, and cellular senescence diseases associated with aging."

Dr. Wong explained, "Our expanded portfolio now includes constructs with immune-cell engagers targeting cell-surface antigens associated with diseased cells and multifunctional immunotherapeutic fusions which improve the performance of immune checkpoint inhibitors. They exhibit remarkably target-specific anti-tumor activity and tolerability in relevant animal models." He continued, "We believe that some of our TRBC-based molecules could be a game-changer for Cell and Gene Based Therapies ("CGTs") by significantly reducing cost and improving the clinical efficacy of engineered effector cells for CGT. Based on preclinical studies, it appears they also support the rapidly developing "in-vivo" CAR-T manufacturing approach for CGT. We are excited to share the data in future scientific publications and invited presentations. We believe that we are uniquely positioned for a strong clinical development pipeline through our own programs and with corporate partnerships."

Business Highlights

Business Development Transactions

•
The Company’s clinical development strategy is to select certain proprietary molecules for development through out-licensing arrangements and other business development transactions. The Company continually assesses its portfolio of molecules in order to identify potential business development opportunities.
•
On November 17, 2024, the Company entered an exclusive worldwide licensing agreement with WY Biotech Co. Ltd. ("WY Biotech"), which was amended in 2025. Under the amended agreement, the Company expects to receive $7.0 million in June 2025. The WY Biotech license agreement grants WY Biotech the exclusive, world-wide license to use and apply HCW11-006 for in vivo applications. HCW11-006 is a preclinical drug. Under the terms of the license agreement, the Company has opt-in rights to reclaim the Americas market, including United States, Canada, Central America, and South America, at no cost which may be exercised after WY Biotech completes a Phase 1 clinical trial.
•
The next major business development program will focus on Immune-Cell Engagers, including T-Cell Engagers. In light of recent transactions demonstrating the strong interest in this class of therapeutics by larger pharmaceutical with the necessary clinical development expertise, the Company intends to develop these molecules through corporate partnering and out-licensing arrangements.

Financing Transactions

•
In 2024, the Company raised $16.3 million:
o
On February 20, 2024, it raised $2.5 million in a private placement of common stock with officers and directors.
o
In multiple closings throughout 2024, it raised $6.9 million in Senior Notes, which are secured by the Company’s shares of Wugen common stock. The Company received shares of Wugen stock as an upfront licensing fee for the Wugen exclusive worldwide license for some of the Company’s proprietary molecules.
o
On November 18, 2024, the Company entered a $6.9 million securities purchase agreement with an institutional investor, involving a registered direct offering and a concurrent private placement of common stock and warrants.
•
On February 20, 2025, the Company entered into an Equity Purchase Agreement with Square Gate Capital Master Fund, LLC – Series 4 ("Square Gate"), pursuant to which the Company will have the right, but not the obligation, to sell to Square Gate, and Square Gate will have the obligation to purchase from the Company, up to $20,000,000 (with a potential increase of an additional $20,000,000) worth of the Company’s shares of common stock, at the Company’s sole discretion, over the next 36 months, subject to certain conditions precedent and other limitations.

Compliance with Nasdaq Listing Rules

•
During 2024, the Company received three deficiency notices from the Listing Staff of The Nasdaq Stock Market (the "Exchange") related to the Company’s stock price of trading shares and the market value of the Company. On March 3, 2025, the Nasdaq Hearings Panel (the "Panel") granted the Company an extension in which to regain compliance with all Nasdaq continued listing rules. As a result of the extension, the Panel granted the Company’s request for continued listing on the Exchange, provided that the Company demonstrates compliance with the Bid Price Rule by April 28, 2025, and all other Exchange continued listing rules by June 15, 2025.
•
On March 31, 2025, the Company will hold a Special Meeting of the Stockholders to obtain stockholder approval for three proposals critical for the success of the compliance plan presented to the Panel, including a reverse stock split, use of the full line of the Equity Line of Credit, and approval of the terms to convert the Senior Notes issued in 2024 into equity.

Clinical Development Results

•
On January 28, 2025, the Company received clearance of its IND from the FDA to initiate a first-in-human Phase 1 dose escalation clinical trial to evaluate one of its lead drug candidates, HCW9302, in patients with moderate-to-severe alopecia areata, a common autoimmune disease in humans that currently has no curative FDA approved treatments.
•
As of December 31, 2024, the Company was required to close the Phase 2 clinical study to evaluate HCW9218 in combination with neoadjuvant chemotherapy in ovarian cancer sponsored by the University of Pittsburgh Medical Center, as required under the Settlement Agreement, due to lack of enrollment.

Financial Results

•
Revenues: Revenues for the fourth quarters ended December 31, 2023 and 2024 were $1.3 million and $394,804, respectively. Revenues for the years ended December 31, 2023 and 2024 were $2.8 million and $2.6 million, respectively. Revenues in both periods were derived exclusively from the sale of licensed molecules to the Company’s licensee, Wugen. The licensed molecules are one of the components used by Wugen in manufacturing their immunotherapeutic products.
•
Research and development (R&D) expenses: R&D expenses for the fourth quarters ended December 31, 2023 and 2024 were $2.1 million and $1.0 million, respectively, a decrease of $1.1 million, or 51%. R&D expenses for the years ended December 31, 2023 and 2024 were $7.7 million and $6.4 million, respectively, a decrease of $1.3 million, or 17%. R&D expenses were comparatively higher in the reporting periods of 2023 because there were two ongoing clinical trials to evaluate HCW9218 in cancer indications, and IND-enabling studies required for the IND application for HCW9302, including toxicology studies. For the year ended December 31, 2024, the decrease in R&D expenses compared to the comparable period in 2023 was partially offset by an increase in manufacturing costs for replenishing supply of the high-expressing cell line of HCW9101.
•
General and administrative (G&A) expenses: G&A expenses for the quarters ended December 31, 2023 and 2024 were $1.7 million and $2.0 million, respectively, an increase of $367,320, or 22%. G&A expenses for the years ended December 31, 2023 and 2024 were $6.8 million and $6.8 million, respectively, an increase of $60,081, or 1%. Changes in G&A expenses reflect cost cutting measures effected by the Company in the second quarter of 2024, offset by increases in professional fees, facilities and office expenses, and financing expenses.
•
Legal expenses: Legal expenses for the quarter ended December 31, 2023 and 2024 were $2.0 million and $148,949, respectively, a decrease of $1.8 million, or 92%. Legal expenses for the twelve months ended December 31, 2023 and 2024 were $6.6 million and $15.9 million, respectively, an increase of $9.3 million, or 142%. The increase in legal expenses related to preparation of testimony and evidence for the hearing and the hearing itself in connection to the Arbitration with ImmunityBio and its affiliates. On July 13, 2024, the parties entered into a Settlement Agreement and General Release, and the Arbitration and related Complaint were dismissed on December 24, 2024. The Company is engaged in discussions with the law firms involved with this matter to arrange a reasonable payment plan with respect to those legal fees.
•
Reserve for credit losses and other expenses: In the year ended December 31, 2023, the Company recognized a reserve for credit losses related to a $5.3 million interest reserve deposit that was not refunded as required by the lender after the Company terminated their credit agreement. In the year ended December 31, 2024, the Company recognized a $1.3 million loss resulting from the misdirection of funds held in Company accounts to a fraudulent account controlled by a third party.
•
Net loss: Net loss for the fourth quarters ended December 31, 2023 and 2024 was $10.7 million and $3.4 million, respectively. Net loss for the years ended December 31, 2023 and 2024 was $25.0 million and $30.0 million, respectively, including legal fees incurred in connection with the Arbitration discussed above.

On March 28, 2025 FibroGen, Inc. (NASDAQ: FGEN) reported the peer-reviewed publication titled "A Phase 1, First-in-Human Study of FOR46 (FG-3246), an Immune-Modulating Antibody-Drug Conjugate Targeting CD46, in Patients with Metastatic Castration Resistant Prostate Cancer" in the Journal of Clinical Oncology (Press release, FibroGen, MAR 28, 2025, View Source [SID1234651578]). The manuscript includes the complete results from the Fortis Therapeutics-sponsored Phase 1 study of FOR46 (now known as FG-3246), a potential first-in-class anti-CD46 antibody drug conjugate (ADC) with an MMAE-containing payload, in patients with metastatic castration-resistant prostate cancer (mCRPC).

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"I am excited to see the results from the Phase 1 monotherapy study of FOR46 (FG-3246) published in the Journal of Clinical Oncology. This is the first clinical trial targeting CD46 in patients with prostate cancer, and the totality of the data highlights the promising potential of FG-3246 anti-cancer activity, especially when considering the unselected, heavily pre-treated patient population in the trial. The trial results provide key insights into the potential clinical impact of targeting CD46 in the treatment of mCRPC and support its further development in this disease space with high unmet need," said Dr. Rahul Aggarwal, Professor of Medicine at the University of California San Francisco, and Principal Investigator of the study.

"We are looking forward to advancing FG-3246 in the clinic and remain on track for initiating the Phase 2 monotherapy study by mid-2025 as well as disclosing topline results from the combination trial of FG-3246 and enzalutamide in the second half of 2025," added Thane Wettig, Chief Executive Officer of FibroGen. "FG-3246 represents a potential first-in-class, non-PSMA approach to treating mCRPC and we, along with the medical community, are excited about the potential for CD46 to become a next generation target in the prostate cancer treatment paradigm."

This Phase 1 study was a multi-center, first-in-human, open label dose escalation and expansion study evaluating the safety, tolerability, and anti-tumor activity as measured by the decline of prostate-specific antigen (PSA) from baseline, objective tumor response rate in patients with measurable disease, and radiographic progression free survival (rPFS). The completed Phase 1 trial includes a total of 56 patients from the dose-escalation and dose-expansion cohorts. Notably, patients were biomarker unselected and heavily pre-treated, having received a median of 5 lines of therapy prior to receiving FG-3246.

Key highlights from the publication include:

The maximally tolerated dose of FG-3246 was 2.7 mg/kg by adjusted body weight (AjBW) every 3 weeks
The most frequent adverse events were consistent with other MMAE-based ADCs and included infusion related reactions (48.2%), neutropenia (41.1%), and peripheral neuropathy (32.1%).
Ocular adverse events were infrequent, which may be a distinguishing feature compared with other MMAE-based ADCs
Efficacy observed in the RECIST-evaluable set of 25 patients:
Confirmed objective response rate was 20% with median duration of response of 7.5 months
All objective responses observed at a starting dose of 2.7 mg/kg or higher
Disease control rate was 80% with duration of treatment exceeding 24 weeks in 12 patients (48%)
PSA50 response rate of 36% in 39 evaluable patients
Of eight evaluable patients who received docetaxel in the castration-sensitive setting, four (50%) achieved a confirmed PSA50 response
Median radiographic progression-free survival of 8.7 months in all 40 subjects in the efficacy analysis set
Of 15 evaluable baseline tumors, 12 (80%) were positive for CD46 expression by immunohistochemistry
FG-3246 responders were found to have a significantly higher frequency of effector T cells and lower frequency of immunosuppressive myeloid cells
The Company anticipates initiating the Phase 2 monotherapy dose optimization study of FG-3246 in patients with mCRPC by mid-2025.

FG-3246 is also being evaluated in combination with enzalutamide in an investigator-sponsored study with topline results from the Phase 2 portion of the study anticipated in 2H 2025.

About the Phase 1 Study
FOR46-001 (NCT03575819) is a Phase 1, dose-escalation study sponsored by Fortis Therapeutics to evaluate multiple doses of IV-administered FG-3246 (also known as FOR46) in patients with mCRPC who have progressive disease on at least one ARSI, followed by a dose-expansion cohort, to evaluate the safety, tolerability, PK, biological activity, and preliminary evidence of anti-tumor activity of FG-3246 in this patient population.

Thirty-three (33) patients were enrolled in the dose-escalation phase of the study at doses between 0.1 mg/kg and 3.0 mg/kg every three weeks (Q3W), with adjusted body weight dosing (AjBW) used at most dose levels above 2.1 mg/kg. Safety and tolerability of FG-3246 were evaluated in the dose-escalation period of the study.

Twenty-three (23) patients were enrolled in the dose-expansion period of the study; 18 patients with adenocarcinoma mCRPC (Cohort 1) and five patients with neuroendocrine prostate cancer (Cohort 2). All patients in the expansion cohorts were treated at 2.7 mg/kg AjBW to a maximum of 270 mg every three weeks.

The safety profile of FG-3246 was characterized, and anti-tumor activity of FG-3246 in adenocarcinoma patients dosed at ≥ 1.2 mg/kg was evaluated.

About Metastatic Castration-Resistant Prostate Cancer
Prostate cancer is the second most common malignancy in men, contributing significantly to male mortality rates. Approximately 13% of men will be diagnosed with prostate cancer at some point during their lifetime. There are about 65,000 drug treatable mCRPC cases in the U.S. annually and 5-year survival in mCRPC is approximately 30%1.

About FG-3246
FG-3246 (also known as FOR46) is a potential first-in-class, fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by FibroGen for metastatic castration-resistant prostate cancer and other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies. FG-3246 is currently in an ongoing Phase 1/2 study being conducted at UCSF to evaluate it in combination with enzalutamide with topline data from the Phase 2 portion of the study expected in the second half of 2025, and a biomarker trial using a PET biomarker for CD46 using the same antibody backbone. We anticipate the initiation of the Phase 2 monotherapy dose optimization trial in metastatic castration-resistant prostate cancer by mid-2025. FG-3246 is an investigational drug and not approved for marketing by any regulatory authority.