On May 6, 2025 Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the Company") reported financial results for the first quarter ended March 31, 2025, and provided a corporate update (Press release, Protagonist, MAY 6, 2025, View Source [SID1234652591]).

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"Protagonist is off to a very strong 2025 with multiple transformational events in the first quarter for our two late-stage partnered assets, rusfertide and icotrokinra which are progressing to NDA filings by year end," said Dinesh V. Patel, Ph.D., the Company’s President and CEO. "We look forward to presenting data from rusfertide’s Phase 3 VERIFY study at a plenary session at ASCO (Free ASCO Whitepaper) on June 1st. We’re very pleased with the highly positive results from the icotrokinra Phase 2b ANTHEM study in ulcerative colitis which lay the foundation for additional studies in both UC and Crohn’s. We are continuing to increasingly focus on advancement of our pre-clinical candidates including the oral IL-17 antagonist PN-881, as well as additional candidates emerging from our oral anti-obesity and oral hepcidin programs. We are fortunate to be in a very strong cash position, allowing us to independently and rapidly progress our early-stage pipeline into value-creating clinical safety and proof-of-concept studies starting with PN-881 in 2025."

First Quarter 2025 Recent Developments and Upcoming Milestones

Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood Disorders

Abstract accepted for presentation at the Plenary Session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).

· Data from the Phase 3 VERIFY trial of rusfertide in PV has been accepted for a prestigious oral presentation during the plenary session on Sunday, June 1 at 2:09PM CDT at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

· The Company will host an investor conference call Monday, June 2, 2025, at 8AM EDT to discuss data shared during the plenary presentation:

Conference Call and Webcast Details

US-based Investors: 1-877-300-8521

International Investors:1-412-317-6026

Conference Call ID: 10199589

The webcast link for the event can be found here: View Source;tp_key=360d3b714d

A replay of the presentation will be available on the Company’s Investor Relations Events and Presentations webpage following the event.

· On March 3rd, the Company announced positive topline results from the Phase 3 VERIFY study. Key findings include:

o Study met primary endpoint with a significantly higher proportion of clinical responders1 on rusfertide compared to placebo during weeks 20-32 (p<0.0001)
o Study met all four key secondary endpoints (weeks 0-32)
– Phlebotomy rate – EU primary endpoint (p<0.0001)
– Hematocrit control
– Patient-reported outcomes of PROMIS Fatigue and MFSAF TSS-7
o Safety profile consistent with previous rusfertide studies, with no new safety signals

Icotrokinra (JNJ-2113): Oral IL-23 Receptor Antagonist

o On April 10th, data from the adolescent cohort of the Phase 3 ICONIC-LEAD study in moderate-to-severe plaque psoriasis was presented as a late-breaking abstract at the 2025 World Congress of Pediatric Dermatology (WCPD).

o On March 10th, positive topline results from ANTHEM-UC, a Phase 2b study of icotrokinra in adults with moderately to severely active ulcerative colitis (UC) were announced. The full data set is expected at a medical conference later this year.

o On March 8th, data from the adult cohort of the Phase 3 ICONIC-LEAD study in moderate-to-severe plaque psoriasis were presented as a late-breaking abstract at the 2025 American Academy of Dermatology (AAD) Annual Meeting.

First Quarter 2025 Financial Results

· Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2025, were $697.9 million as compared to $559.2 million as of December 31, 2024.

Three Months Ended
March 31,
(in thousands, except per share amounts) 2025 2024

(Unaudited)
License and collaboration revenue $ 28,321 $ 254,953
Research and development expense $ 35,893 $ 33,734
General and administrative expense $ 11,738 $ 14,910
Income tax expense $ – $ 3,326
Net (loss) income $ (11,655 ) $ 207,340
Basic (loss) earnings per share $ (0.19 ) $ 3.41
Diluted (loss) earnings per share $ (0.19 ) $ 3.26

· License and Collaboration Revenue: License and collaboration revenue of $28.3 million for the period ended March 31, 2025, consisted of: (i) $22.8 million related to proportional recognition of the $25 million milestone earned in Q1 2025 but payable following completion of the VERIFY clinical study report, and (ii) $5.5 million allocated to development services provided by us under the agreement during the period. License and collaboration revenue of $255.0 million for the period ended March 31, 2024 consisted of: (i) $254.1 million of the $300.0 million transaction price for the Takeda Collaboration Agreement allocated to the rusfertide license delivered to Takeda upon effectiveness of the agreement on March 15, 2024, and (ii) $0.9 million allocated to development services provided by us under the agreement during the last two weeks of March 2024.

· Research and Development ("R&D") Expenses: The increase in R&D expenses from the prior year period was primarily due to an increase in pre-clinical and drug discovery research expenses, partially offset by a decrease in rusfertide expenses related to the Phase 3 VERIFY clinical trial.

· General and Administrative ("G&A") Expenses: The decrease in G&A expenses from the prior year period was primarily due to $4.6 million in advisory and legal fees related to the Takeda collaboration, partially offset by an increase in stock-based compensation expense.

· Income Tax Expense: Income tax expense of $3.3 million for the period ended March 31, 2024, consisted of tax related to the upfront payment earned under the Takeda collaboration agreement.

· Net (Loss) Income: Net loss was $11.7 million, or $0.19 per basic and diluted share, for the first quarter of 2025 as compared to net income of $207.3 million, or $3.41 per basic share and $3.26 per diluted share, for the first quarter of 2024.

On May 6, 2025 Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, reported its financial results for first quarter ended March 31, 2025, and provided an update on its clinical development pipeline and other corporate developments (Press release, Prelude Therapeutics, MAY 6, 2025, View Source [SID1234652590]).

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"The first quarter of 2025 represented another strong period of execution across our organization," stated Kris Vaddi, Ph.D., Chief Executive Officer of Prelude. "We are making rapid progress with the development of our SMARCA2 degraders and are on track to determine the most optimal path forward for the overall program as we continue to strengthen our knowledge and understanding of potential opportunities for these novel, first-in-class drug candidates in highly aggressive SMARCA4 mutated cancers."

Continued Vaddi, "Additionally, we were very pleased to present at the most recent American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, the first preclinical data from our highly selective, oral KAT6A degraders. Selectively degrading KAT6A may hold the key to enhancing the efficacy and improving the safety profile for cancer patients beyond what has previously been demonstrated by non-selective KAT6A/B inhibitors. Our goal is to advance these potential growth driving assets towards points of value inflection in a strategic and financially disciplined manner."

Clinical Program Updates and Upcoming Milestones

PRT3789 – A first-in-class, highly selective, intravenous SMARCA2 Degrader

PRT3789 is designed to treat patients with a SMARCA4 mutation. Patients with SMARCA4-mutated cancer, a particularly aggressive form of the disease, have a very poor clinical prognosis. Approximately 10% of all non-small cell lung cancers and 5% of all cancers broadly, harbor a SMARCA4 mutation. In NSCLC, these patients tend to have poor response to standard of care chemoimmunotherapy and are largely ineligible for other targeted therapies. We believe that this represents an area of high unmet medical need.

PRT3789 is in Phase 1 clinical development in patients with biomarker selected SMARCA4-mutated cancers. The Company has completed enrollment of monotherapy dose escalation at the 665 mg once weekly IV dose and has selected 500 mg once weekly as the recommended Phase 2 dose. In addition, the Company has completed dose escalation in the combination of PRT3789 with docetaxel and is nearing completion of backfill cohorts. Updated data from the trial is expected to be presented at a major medical meeting in the second half of 2025.

The Company is enrolling patients in a Phase 2 clinical trial evaluating PRT3789 in combination with KEYTRUDA (pembrolizumab) in patients with SMARCA4-mutated cancers, per the previously announced collaboration with Merck (known as MSD outside of the US and Canada).

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Interim Phase 1 data presented at the 2025 Japanese Society of Medical Oncology Annual Meeting

As previously reported, the Company presented an encore oral presentation titled: PRT3789, a First-in-Class Intravenous SMARCA2 Degrader, in Advanced Solid Tumors with a SMARCA4 Mutation: Phase 1 Trial at the 2025 Japanese Society of Medical Oncology Annual Meeting on March 8, 2025, highlighting the favorable safety profile and responses seen in both NSCLC and upper GI cancers. The presentation can be found at Publications – Prelude Therapeutics.

PRT7732 – A potent, highly selective and orally bioavailable SMARCA2 Degrader

PRT7732 is a highly selective and orally bioavailable SMARCA2 degrader with a distinct chemical composition to PRT3789. In the fourth quarter of 2024, the Company initiated and enrolled the first patients in a phase 1 multi-dose escalation trial of PRT7732 (NCT06560645) in biomarker selected SMARCA4 mutated cancers. Enrollment has advanced rapidly, and the company is currently enrolling patients in the fifth dose escalation cohort (60 mg once daily). The Company expects to provide an initial first-in-human data update at a major medical meeting in the second half of 2025.

Highly selective KAT6A oral degrader program

Prelude discovered and is developing a series of highly potent, selective and orally bioavailable KAT6A degraders, which the Company believes is the industry’s first report of a KAT6 degrader based on currently published patents and literature. Optimized lead compounds are advancing to candidate nomination in the second quarter of 2025 with intent to file an IND in 2026. KAT6 is a clinically validated target with promising activity in breast cancer and other solid tumors. Recently, a dual KAT6A/B inhibitor demonstrated robust clinical activity in combination with fulvestrant in previously treated ER+/HER2- breast cancer patients, albeit with potential safety and tolerability considerations, in particular neutropenia.1 Hematologic toxicity is believed to be driven by the dual inhibition of KAT6A and KAT6B.

Prelude believes that selectively degrading KAT6A has the potential for improved efficacy, tolerability and combinability with other agents. The Company recently presented preclinical data validating this hypothesis at the AACR (Free AACR Whitepaper) Annual Meeting 2025. The presentation can be found at Publications – Prelude Therapeutics.

Precision ADCs with SMARCA2/4 dual degrader payload

Prelude is developing potent SMARCA2/4 dual degraders that robustly inhibit cancer cell growth and induce cell death across multiple cancer types as payloads for precision ADCs. The Company presented the first preclinical data from its precision ADC platform at the 36th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium in October. These data demonstrated that SMARCA2/4 dual degrader antibody conjugates have potential for significantly better in vivo efficacy and tolerability when compared to a traditional cytotoxic ADCs when tested head-to-head in xenograft models. Prelude and its partner AbCellera anticipate nominating the first development candidate from this program in 2025. The presentation can be found at Publications – Prelude Therapeutics.

Upcoming Investor Conference

The Company will participate in the Citizens 2025 Life Sciences Conference taking place in New York. On Wednesday, May 7, 2025 at 11:00 AM ET, Kris Vaddi, Ph.D., Chief Executive Officer, and Jane Huang, M.D., President and Chief Medical Officer, and Peggy Scherle, Ph.D., Chief Scientific Officer, will participate in a fireside chat.

A live webcast of the fireside chat can be accessed on the Company’s website under Events and Presentations. The recording will be archived and available on the Company’s website for 90 days.

First Quarter 2025 Financial Results 

Cash, Cash Equivalents, Restricted Cash and Marketable Securities:

Cash, cash equivalents, restricted cash and marketable securities as of March 31, 2025 were $103.1 million. The Company anticipates that its existing cash, cash equivalents, restricted cash and marketable securities will fund Prelude’s operations into the second quarter of 2026. 

Research and Development (R&D) Expenses:

For the first quarter of 2025, R&D expense increased to $28.8 million from $27.4 million for the prior year period. Included in the R&D expense for the three months ended March 31, 2025 was $2.3 million of non-cash expense related to stock-based compensation expense, including employee stock options, compared to $3.0 million for the three months ended March 31, 2024. Research and development expenses increased primarily due to an increase in expense related to our SMARCA2 clinical trials. Research and development expenses may fluctuate from period to period depending upon the stage of certain projects and the level of preclinical and clinical trial-related activities.

General and Administrative (G&A) Expenses:

For the first quarter of 2025, G&A expenses decreased to $5.8 million from $6.9 million for the prior year period. Included in general and administrative expenses for the three months ended March 31, 2025, was $1.6 million of non-cash expense related to stock-based compensation expense, including employee stock options, compared to $2.5 million for the three months ended March 31, 2024. The decrease in general and administrative expenses was primarily due to a decrease in stock-based compensation due to lower valuation on more recent grants due to the decrease in our stock price.

Net Loss:

For the three months ended March 31, 2025, net loss was $32.1 million, or $0.42 per share compared to $31.4 million, or $0.42 per share, for the prior year period. Included in the net loss for the three months ended March 31, 2025, was $3.8 million of non-cash expenses related to the impact of expensing share-based payments, including employee stock options, as compared to $5.5 million for the same period in 2024.

On May 6, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial results for the first quarter of 2025 ended March 31, 2025, and provided recent business highlights (Press release, Personalis, MAY 6, 2025, View Source [SID1234652589]).

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Recent Business Highlights

•
Delivered 2,184 total molecular tests in the first quarter of 2025, an increase of 52%, compared with 1,441 tests delivered in the fourth quarter of 2024, signifying increasing adoption of Personalis’ technology

•
Highlighted compelling performance of NeXT Personal for resectable Stage I-IV colorectal cancer (CRC) in a study of 71 patients with British Columbia Cancer and an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in Chicago in April

•
100% of patients that eventually recurred were detected as ctDNA positive by NeXT Personal, prior to detection on imaging

•
87% of eventual clinical recurrences were detectable within the early landmark window, 2 to 8 weeks after surgery, with 85% detectable by 4 weeks

•
64% of the positive detections in the landmark window were in the ultrasensitive range, below 100 parts per million

•
100% of challenging distant metastatic recurrences prior to imaging were detected, including lung metastasis

•
Published pivotal breast cancer study (Royal Marsden) using NeXT Personal in the Annals of Oncology and dossier submission was made to Medicare for reimbursement in early-stage breast cancer

•
Published results from TRACERx study in Nature Medicine, showing ctDNA levels linked to lung cancer recurrence and highlighting NeXT Personal’s detection in early-stage patients

"This year is off to a great start, with strong first quarter testing growth, and we remain confident that our "Win-in-MRD" strategy is working," said Chris Hall, Chief Executive Officer and President. "We crossed the milestone of 2,000 tests delivered and submitted breast cancer data for Medicare coverage with expectations of a favorable outcome by the end of the year. In addition, we showed compelling clinical evidence in colorectal cancer suggesting our ultrasensitive approach can provide a leap in performance. We are pleased with how rapidly NeXT Personal is growing in the marketplace."

First Quarter 2025 Financial Results Compared with 2024
•
Revenue of $20.6 million for the first quarter of 2025 compared with $19.5 million, an increase of 6%, primarily due to the growth in revenue from pharma tests and services and population sequencing from the U.S. Department of Veterans Affairs Million Veterans Program (VA MVP) •
Pharma tests and services, and other customers of $13.6 million for the first quarter of 2025 compared with $9.8 million, an increase of 39%

•
Population sequencing and enterprise sales of $6.7 million for the first quarter of 2025 compared with $9.5 million, a decrease of 29% due to the expected decline in volume from Natera

•
Gross margin of 35.0% for the first quarter of 2025 compared with 28.1%, an increase of 6.9% primarily due to favorable revenue mix from the increase in pharma tests and services combined with lower enterprise sales

•
Net loss of $15.8 million, and net loss per share of $0.18 based on a weighted-average basic and diluted share count of 87.5 million in the first quarter 2025 compared with a net loss of $13.0 million, and net loss per share of $0.26 based on a weighted-average basic and diluted share count of 50.7 million

•
Cash, cash equivalents, and short-term investments of $185.7 million as of March 31, 2025

•
Raised $17.8 million in net proceeds from selling common stock under the Company’s At-The-Market (ATM) program at a weighted-average price of $5.89 per share during the first quarter of 2025

•
Cash usage of $20.5 million from operations and capital equipment additions in the first quarter of 2025

Second Quarter and Full Year 2025 Outlook

Personalis expects the following for the second quarter of 2025:

•
Total company revenue to be in the range of $19.5 to $20.5 million

•
Revenue from pharma tests and services, and all other customers to be in the range of $13 to $14 million

•
Revenue from population sequencing and enterprise sales of approximately $6.5 million

Personalis expects the following for the full year of 2025 (no change to our prior revenue guidance):

•
Total company revenue in the range of $80 to $90 million

•
Revenue from pharma tests and services, and all other customers in the range of $62 to $64 million

•
Revenue from population sequencing and enterprise sales in the range of $15 to $16 million

•
Revenue from clinical tests reimbursed in the range of $3 to $10 million

•
Gross margin in the range of 22% to 24% (increased from our 21% to 23% prior guidance), which is lower than the 32% gross margin for the full year of 2024 as we invest to drive clinical usage ahead of reimbursement.

•
Net loss of approximately $83 million (decreased from our $85 million prior guidance)

•
Cash usage of approximately $75 million (decreased from our $75 to $80 million prior guidance), which is an increase from the $47 million used in the full year of 2024 primarily due to investments in the next phase of our "Win in MRD" strategy, inclusive of growing our test volume, expanding clinical studies, and investing in commercial capabilities to drive growth

Webcast and Conference Call Information

Personalis will host a conference call to discuss the first quarter financial results, as well as plans for 2025, after market close on Tuesday, May 6, 2025, at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live by dialing 877-413-2411 for domestic callers or 201-389-0882 for international callers. The live webinar can be accessed at View Source A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

On May 6, 2025 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor for the treatment of neurofibromatosis type 1 (NF1) and other MAPK pathway driven cancer indications, reported positive interim pharmacodynamic (PD) data from its ongoing Phase 1 trial of PAS-004 in advanced cancer patients (Press release, Pasithea Therapeutics, MAY 6, 2025, View Source [SID1234652588]). The data includes results from cohorts 3 and 4A, evaluating 8mg and 15mg capsules, as well as cohort 4B evaluating 4mg tablets, and demonstrates strong target engagement consistent with PAS-004’s favorable pharmacological profile.

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Inhibition of ERK phosphorylation (pERK) is widely recognized as a gold-standard PD biomarker for assessing MEK inhibitor activity. To evaluate target engagement, pERK levels were measured in peripheral blood mononuclear cells (PBMCs) collected from patients at baseline and steady-state at day 22.

Preliminary results demonstrate robust pERK inhibition, with reductions in pERK levels of up to 91% even at the 8mg dose level, in line with a previous developed PK/PD model, confirming substantial target engagement in patients receiving PAS-004.

Pharmacodynamic activity is supported by encouraging preliminary clinical observations, with several patients achieving stable disease and tumor shrinkage while on PAS-004 treament. Notably, one patient in cohort 4A (15mg capsule) with stage 4 KRAS G12R-mutated pancreatic cancer, having progressive disease while on three prior lines of therapy, achieved a tumor volume reduction of -9.8% over 5 months of PAS-004 treatment and currently remains on study.

"With today’s update, we are pleased that PAS-004 has demonstrated clinically meaningful reductions in pERK levels at dose levels that are both well-tolerated and safe, with no rash observed," said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. "We believe PAS-004’s profile offers the potential to finely modulate MAPK pathway activity, enabled by its previously reported long half-life and favorable pharmacokinetic (PK) profile with a Cmax/Cmin ratio below 2. We’re also encouraged by the emerging clinical signals we’re seeing across multiple cancer types and look forward to sharing further safety, PK and PD data in the coming months."

The ongoing Phase 1 clinical trial is a multi-center, open-label, dose escalation 3+3 study design to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition (NCT06299839).

On May 6, 2025 Pasithea Therapeutics, Corp. ("Pasithea," or the "Company") (Nasdaq: KTTA; KTTAW), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, reported the pricing of a public offering of 3,571,428 shares of the Company’s common stock (or pre-funded warrants in lieu thereof) and accompanying Series C warrants to purchase up to 3,571,428 shares of common stock and Series D warrants to purchase up to 3,571,428 shares of common stock, at a combined offering price of $1.40 per share of common stock (or per pre-funded warrant in lieu thereof) and accompanying warrants (Press release, Pasithea Therapeutics, MAY 6, 2025, View Source [SID1234652587]).

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The Series C common warrants will have an exercise price of $1.40 per share and will be exercisable upon issuance and will expire five years thereafter. The Series D common warrants will have an exercise price of $1.40 per share and will be exercisable upon issuance and will expire 18 months thereafter. The closing of the offering is expected to occur on or about May 7, 2025, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering are expected to be approximately $5.0 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for general corporate purposes, which includes, without limitation, ongoing research and pre-clinical studies, clinical trials, the development of new biological and pharmaceutical technologies, investing in or acquiring companies that are synergistic with or complementary to the Company’s technologies, licensing activities related to its current and future product candidates, and to the development of emerging technologies, investing in or acquiring companies that are developing emerging technologies, licensing activities, or the acquisition of other businesses and working capital.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-286889) originally filed with the Securities and Exchange Commission ("SEC") on May 1, 2025 and declared effective on May 6, 2025. The offering is being made only by means of a prospectus, which is part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. When available, electronic copies of the final prospectus may be obtained for free on the SEC’s website located at View Source and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.