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Potentially best-in-class RAS-targeting franchise advancing with both ERAS-0015 and ERAS-4001 expected to enter the clinic in 2025

Ongoing Phase 3 SEACRAFT-2 registrational trial progressing well with Stage 1 randomized data expected in H2 2025

Robust balance sheet with cash, cash equivalents, and marketable securities of $440 million as of December 31, 2024 is expected to fund operations into H2 2027

SAN DIEGO, March 20, 2025 (GLOBE NEWSWIRE) — Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today provided business updates and reported financial results for the fiscal quarter and full year ended December 31, 2024.

“In 2024, we prepared our RAS-targeting franchise to enter the clinic and further advanced our registrational program for naporafenib. The high enthusiasm for our RAS-targeting franchise is encouraging, particularly as our potential best-in-class pan-RAS molecular glue ERAS-0015 and our potential first-in-class pan-KRAS inhibitor ERAS-4001 approach the clinic. The high prevalence of KRAS alterations and the significant unmet need among these patients offer substantial opportunities for both candidates in key indications, namely colorectal, lung, pancreatic, and other solid tumor cancers,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “The SEACRAFT-2 trial is progressing well, and with FDA Fast Track Designation (FTD) granted in NRASm melanoma, this combination has the potential to be first-to-market in this area of high unmet need with no approved targeted therapies.”

Dr. Lim added, “We have an exciting year ahead focused on shutting down RAS and expect multiple value drivers in 2025 and beyond. In the second half of 2025, we expect Stage 1 randomized data from SEACRAFT-2 in patients with NRASm melanoma. For our RAS-targeting franchise, we expect investigational new drug (IND) submissions for ERAS-0015 in mid-second quarter and for ERAS-4001 in the second quarter of 2025. We continue to be well capitalized and capital efficient and have revised our cash runway guidance from the first half of 2027 to the second half of 2027.”

Research and Development (R&D) Highlights

RAS-Targeting Franchise

• Announced Progress Across RAS-Targeting Franchise: In October 2024, Erasca presented a program update for the pan-RAS molecular glue ERAS-0015 and pan-KRAS inhibitor ERAS-4001 as part of a virtual investor event. The updates highlighted the rapid progress observed across both programs including in-house confirmation of potential best-in-class profiles for both agents and completion of many key activities to support IND submissions.
• In-Licensed Potential Best-in-Class and First-in-Class RAS-Targeting Franchise: In May 2024, Erasca announced exclusive license agreements for two preclinical RAS programs—a potential best-in-class pan-RAS molecular glue (ERAS-0015) and a potential first-in-class pan-KRAS inhibitor (ERAS-4001). ERAS-0015 and ERAS-4001 are potent, orally bioavailable molecules with complementary RAS inhibitory mechanisms. ERAS-0015 has the potential to address unmet medical needs in approximately 2.7 million patients who are diagnosed annually worldwide with RAS-mutant tumors, including the more than 2.2 million patients with KRAS-mutant tumors whom ERAS-4001 could also address.

Naporafenib Program

• Presented Promising SEACRAFT-1 Phase 1b Data: In October 2024, Erasca announced promising initial Phase 1b data for naporafenib plus trametinib (MEKINIST^®) in the melanoma cohort of SEACRAFT-1 at the 36^th EORTC-NCI-AACR (ENA) Symposium on Molecular Targets and Cancer Therapeutics. Efficacy and tolerability data supported the rationale for pursuing an NRASm melanoma tissue-specific indication and reinforced the potential of the ongoing Phase 3 SEACRAFT-2 registrational trial, which was initiated in the second quarter of 2024.
• Analysis of Median Overall Survival (mOS) Data for Naporafenib and Trametinib: In March 2024, a pooled analysis of patients with NRASm melanoma dosed with the combination of naporafenib and trametinib at two different doses across two different trials (Phase 1b and Phase 2) showed an mOS of 13.0 and 14.1 months, respectively. The pooled dataset compared favorably relative to historical benchmarks.

Corporate Highlights

• Extended Cash Runway into H2 2027: In 2024, Erasca raised $251 million in equity financings, including a $45 million oversubscribed private placement financing and a $184 million oversubscribed underwritten offering, both of which were led by high-quality new and existing healthcare-focused investors and both of which helped extend our anticipated cash runway into the second half of 2027.

• Strengthened Leadership Team and RDCAB: Erasca strengthened its leadership team and Research, Development, and Commercial Advisory Board (RDCAB) with three key appointments. 
  • Michael Humphries, Ph.D., was appointed as vice president of medical affairs, bringing to Erasca over 15 years of medical affairs, clinical development, and drug discovery experience at Array Biopharma, Bayer Oncology, ARIAD Pharmaceuticals, Takeda, AnHeart Therapeutics, and Nuvation Bio. His leadership includes three U.S. launches of next-generation tyrosine kinase inhibitors in three variants of oncogene-addicted non-small cell lung cancer (NSCLC). In his most recent role at Nuvation Bio, Dr. Humphries served as vice president head of medical affairs where he built out the medical affairs strategy, infrastructure, culture, and personnel. He earned his Ph.D. in cell and developmental biology from the University of Colorado at Denver.
  • Yifah Yaron, M.D., Ph.D., was appointed as vice president of clinical development, bringing over 18 years of experience in clinical drug development focusing on oncology. She most recently led clinical teams at Harpoon Therapeutics (acquired by Merck), and served in clinical development roles at Cytomx Therapeutics, Exelixis, and Genentech. During her time at Exelixis, Dr. Yaron held increasing leadership responsibilities on the cabozantinib program, including serving as a member of the clinical filing team for the first indication in medullary thyroid cancer. Dr. Yaron completed an oncology fellowship at UCSF and an internal medicine residency at University of Rochester Strong Memorial Hospital. She earned her M.D. and Ph.D. degrees (Ph.D. in biological chemistry) as well as her B.S. in biology from the University of California, Los Angeles.
  • Jean-Michel Vernier, Ph.D., was appointed as senior chemistry advisor with 25+ years of drug discovery and development experience. He currently serves as senior vice president of chemistry at Radionetics Oncology and previously served as Erasca’s vice president of chemistry. He held positions of increasing responsibilities at several companies, including Ignyta, Ardea Biosciences, Merck Research Laboratories, and SIBIA Neurosciences. Throughout his career, Dr. Vernier has led departments engaged in early-stage drug discovery programs and drug substance GMP production. He has co-authored more than 30 peer-reviewed publications and is an inventor on more than 50 U.S. patents. Dr. Vernier earned his Ph.D. in synthetic organic chemistry from the University Louis Pasteur, Strasbourg, France, and was a postdoctoral fellow at Colorado State University.

Key Upcoming Milestones

• SEACRAFT-2: Randomized pivotal Phase 3 trial for naporafenib plus trametinib in patients with NRASm melanoma
  • Phase 3 Stage 1 randomized dose optimization data expected in H2 2025
• AURORAS-1: Phase 1 trial for ERAS-0015 (pan-RAS molecular glue) in patients with RASm solid tumors
  • IND filing expected in mid-Q2 2025
  • Initial Phase 1 monotherapy data in relevant tumor types expected in 2026
• BOREALIS-1: Phase 1 trial for ERAS-4001 (pan-KRAS inhibitor) in patients with KRASm solid tumors
  • IND filing expected in Q2 2025
  • Initial Phase 1 monotherapy data in relevant tumor types expected in 2026

Fourth Quarter and Full Year 2024 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $440.5 million as of December 31, 2024, compared to $322.0 million as of December 31, 2023.

Research and Development (R&D) Expenses: R&D expenses were $26.1 million for the quarter ended December 31, 2024, compared to $24.8 million for the quarter ended December 31, 2023. The increase was primarily driven by increases in expenses incurred in connection with clinical trials, preclinical studies, discovery activities, and outsourced services and consulting fees. R&D expenses were $115.4 million for the full year ended December 31, 2024, compared to $103.8 million for the full year ended December 31, 2023. Erasca also recorded $22.5 million of in-process R&D expense during the year ended December 31, 2024 for upfront payments under Erasca’s ERAS-0015 and ERAS-4001 license agreements.

General and Administrative (G&A) Expenses: G&A expenses were $9.6 million for the quarter ended December 31, 2024, compared to $9.1 million for the quarter ended December 31, 2023. The increase was primarily driven by an increase in personnel costs, including stock-based compensation expense. G&A expenses were $41.7 million for the full year ended December 31, 2024, compared to $37.7 million for the full year ended December 31, 2023.

Net Loss: Net loss was $32.2 million for the quarter ended December 31, 2024, compared to $29.7 million for the quarter ended December 31, 2023. For the full year ended December 31, 2024, Erasca reported a net loss of $161.7 million, or $(0.69) per basic and diluted share, compared to a net loss of $125.0 million, or $(0.83) per basic and diluted share, for the full year ended December 31, 2023.

About Erasca

At Erasca, our name is our mission: To erase cancer. We are a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers. Our company was co-founded by leading pioneers in precision oncology and RAS targeting to create novel therapies and combination regimens designed to comprehensively shut down the RAS/MAPK pathway for the treatment of patients with cancer. We have assembled one of the deepest RAS/MAPK pathway-focused pipeline in the industry. We believe our team’s capabilities and experience, further guided by our scientific advisory board which includes the world’s leading experts in the RAS/MAPK pathway, uniquely position us to achieve our bold mission of erasing cancer.

Cautionary Note Regarding Forward-Looking Statements

Erasca cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: our expectations regarding the potential therapeutic benefits and potential patient population for each of our product candidates, including naporafenib, ERAS-0015, and ERAS-4001; the planned advancement of our development pipeline, including the anticipated timing of data readouts for the SEACRAFT-2, AURORAS-1, and BOREALIS-1 trials; the anticipated timing of the IND submissions for the AURORAS-1 and BOREALIS-1 trials; and the sufficiency of our cash, cash equivalents, and marketable securities to fund operations into the second half of 2027. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: our approach to the discovery and development of product candidates based on our singular focus on shutting down the RAS/MAPK pathway, a novel and unproven approach; preliminary results of clinical trials are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data and more patient data become available; the analysis of pooled Phase 1 and Phase 2 naporafenib plus trametinib data covers two clinical trials with different designs and inclusion criteria, which cannot be directly compared, and therefore may not be a reliable indicator of survival data; due to differences between trial designs and subject characteristics, comparing clinical data across different trials may not be a reliable indicator of such data; results from preclinical studies or early clinical trials not necessarily being predictive of future results; we only have one product candidate in clinical development and all of our other development efforts are in the preclinical or development stage; our SEACRAFT trials may not support the registration of naporafenib; our assumptions around which programs may have a higher probability of success may not be accurate, and we may expend our limited resources to pursue a particular product candidate and/or indication and fail to capitalize on product candidates or indications with greater development or commercial potential; potential delays in the commencement, enrollment, data readout, and completion of clinical trials and preclinical studies; our dependence on third parties in connection with manufacturing, research, and preclinical and clinical testing; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization, or may result in recalls or product liability claims; unfavorable results from preclinical studies or clinical trials; the inability to realize any benefits from our current licenses, acquisitions, and collaborations, and any future licenses, acquisitions, or collaborations, and our ability to fulfill our obligations under such arrangements; regulatory developments in the United States and foreign countries; later developments with the FDA or EU health authorities may be inconsistent with the feedback received to date regarding our development plans and trial designs; Fast Track Designation may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive marketing approval; our ability to obtain and maintain intellectual property protection for our product candidates and maintain our rights under intellectual property licenses; our ability to fund our operating plans with our current cash, cash equivalents, and marketable securities; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K for the year ended December 31, 2024, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

MEKINIST^® is a registered trademark owned by or licensed to Novartis AG, its subsidiaries, or affiliates.

Contact:

Joyce Allaire
LifeSci Advisors, LLC
[email protected]

Source: Erasca, Inc.

GREENWICH, Conn., March 20, 2025 (GLOBE NEWSWIRE) — Oxford Lane Capital Corp. (NasdaqGS: OXLC) (NasdaqGS: OXLCP) (NasdaqGS: OXLCL) (NasdaqGS: OXLCO) (NasdaqGS: OXLCZ) (NasdaqGS: OXLCN) (NasdaqGS: OXLCI) (NasdaqGS: OXLCG) (the “Company”) today announced that its board of directors (the “Board”) has authorized a program to repurchase up to $150.0 million worth of the Company’s common stock in the open market (the “Share Repurchase Program”).

The timing, manner, price and amount of any share repurchases will be determined by the Company, in its discretion, based upon the evaluation of economic and market conditions, the Company’s stock price, applicable legal, contractual and regulatory requirements and other factors. The Share Repurchase Program is expected to be in effect until March 20, 2026, unless extended or until the aggregate repurchase amount has been expended. The Share Repurchase Program does not require the Company to repurchase any specific number of shares, and the Company cannot assure stockholders that any shares will be repurchased under the Share Repurchase Program. The Share Repurchase Program may be suspended, extended, modified or discontinued at any time.

The Company has cash on its balance sheet of over $300 million as of March 20, 2025, representing capital available for opportunistic investments and/or share repurchases in open market transactions through the Share Repurchase Program.

About Oxford Lane Capital Corp.

Oxford Lane Capital Corp. is a publicly-traded registered closed-end management investment company principally investing in debt and equity tranches of collateralized loan obligation (“CLO”) vehicles. CLO investments may also include warehouse facilities, which are financing structures intended to aggregate loans that may be used to form the basis of a CLO vehicle.

Forward-Looking Statements

This press release contains forward-looking statements subject to the inherent uncertainties in predicting future results and conditions. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “anticipates,” “expects,” “estimates” and similar expressions) should also be considered to be forward-looking statements. These statements are not guarantees of future performance, conditions or results and involve a number of risks and uncertainties. Certain factors could cause actual results and conditions to differ materially from those projected in these forward-looking statements. These factors are identified from time to time in our filings with the Securities and Exchange Commission. We undertake no obligation to update such statements to reflect subsequent events, except as may be required by law.

Contact:

Bruce Rubin
203-983-5280

• Enrollment completed in Phase 2a CBeyond™
   trial of CB1 inhibitor, nimacimab, in obesity and overweight
• Faster-than-expected enrollment enables full top-line Phase 2a data in late Q3/early Q4 2025, ahead of schedule; interim analysis removed
• Phase 2a dosing extended to 52 weeks to enhance long-term safety, tolerability, and efficacy data
• Cash runway projected through at least Q1 2027

SAN DIEGO, March 20, 2025 (GLOBE NEWSWIRE) — Skye Bioscience, Inc. (NASDAQ: SKYE) (“Skye” or the “Company”), a clinical stage biopharmaceutical company pioneering next-generation molecules that modulate G-protein-coupled receptors to treat obesity, overweight, and related conditions, today reported financial results for the fourth quarter and full year ended December 31, 2024, along with key accomplishments and upcoming milestones.

“Skye’s prime accomplishment in 2024 was the initiation and rapid advancement of its comprehensive Phase 2a clinical study of nimacimab, a novel and differentiated CB1 inhibitor,” said Punit Dhillon, President & CEO of Skye. “Maturation of the obesity therapeutics landscape, including expanding clinical evidence, M&A, and licensing, highlights the strategic importance of alternative mechanisms of action with attributes differentiated from incretins. We believe nimacimab’s product profile is well-positioned to potentially fulfill critical unmet needs in this rapidly evolving therapeutic area.

“Our team showed discipline in capital allocation and focus in executing the Company’s priorities. We surpassed our enrollment target ahead of schedule and have to-date executed the Phase 2a clinical plan on target and within our budget. We disclosed preclinical data in November 2024 which achieved significant dose-dependent weight loss, significant fat mass loss with lean mass preservation, and dose-dependent improvement in glucose tolerance. These outcomes are indicative of the potentially compelling attributes of Skye’s highly peripherally-restricted CB1 inhibitor. In 2025 and beyond we will continue to apply this discipline and focus. We are enthusiastic about our updated clinical development plan, which will dramatically speed up our path to important 52-week treatment data from this extension study. Robust data in 2025 and 2026 will be valuable to various stakeholders and inform our regulatory engagement for future studies and decision-making.”

Clinical Highlights: CBeyond™
 Phase 2 Obesity Trial

• CBeyond™
   trial completed enrollment of 136 patients: Study enrollment exceeded the initial target of 120, with data blinded through the completion of the 26-week treatment and 13-week follow-up period.
• Data Safety Monitoring Board reviews completed: Two independent data safety monitoring board reviews have been successfully completed.
• 16 US Clinical Sites: Welcomed a leading academic center of excellence in obesity as a clinical trial site during Q1 2025.
• Accelerated timeline for 26-week data
  to late Q3/early Q4 2025: Due to faster-than-anticipated enrollment the interim analysis has been removed and top line data is expected to be reported earlier than previously reported.
• Expansion of the CBeyond™
   trial: To obtain 52 weeks of treatment data, the trial extension increases the originally planned 26 weeks of treatment to provide a longer-term assessment of safety, tolerability and efficacy. The protocol extension will provide for continued assessment of both the nimacimab monotherapy (primary endpoint) and the nimacimab/GLP-1 combination cohort (exploratory endpoint).

Research & Development Highlights

• Vital role and sufficiency of peripherally-targeted CB1 inhibition: Initial data from our diet-induced obesity model in mice released in November 2024 confirms that central CB1 inhibition is not required, and supports our hypothesis that nimacimab’s peripherally-targeted CB1 inhibition drives significant weight loss and improved metabolic parameters, consistent with the compound’s differentiated mechanism of action. An ongoing effort to characterize various attributes of nimacimab’s capabilities as the most peripherally restricted CB1 inhibitor is expected to result in further preclinical data outcomes.
• Broadening metabolic pathway understanding: Current studies are leveraging translational models to demonstrate nimacimab’s role in modulating hormones, inflammatory mediators, lipid metabolism, and glycemic control. We believe that additional data expected in the coming quarters may further clarify nimacimab’s potential across a range of metabolic disorders.
• Next-generation GPCR programs: The Company is advancing development of next-generation GPCR-targeting molecules designed to address diverse metabolic disorders.

Manufacturing Highlights

• Strengthening manufacturing: Advancing activities in collaboration with contract manufacturing organizations to prepare for future clinical demand for nimacimab and further optimize its potential for the treatment of obesity, overweight, and related metabolic disorders.
• Optimizing scale-up processes: Evaluating modifications to upstream and downstream manufacturing processes to improve product yield and establish a commercial manufacturing process that is reliable and repeatable for large-scale commercial production.
• Advancing toward monthly dosing: We are working to optimize nimacimab’s formulation and delivery to transition from weekly to monthly dosing to potentially improve patient experience, adherence, and commercial viability.

Corporate


Highlights

• Chief Development Officer promotion: Skye recently promoted Tu Diep, to COO, recognizing his leadership throughout the Company. In this role, Mr. Diep is overseeing our development operations, CMC, corporate development and broader strategic execution.
• Strengthened the internal and external chemistry, manufacturing, and controls team: During 2024, Skye added to its team with seasoned individuals who bring significant experience in quality control and scale-up to nimacimab’s manufacturing processes.
• Resolved litigation matter: Skye settled its insurance litigation case and received $2 million in cash proceeds from its former D&O carrier in the fourth quarter of 2024.

Upcoming Milestones

• Q2 2025: Nimacimab preclinical data being presented at scientific/medical conferences.
• Q2 2025: Analyst event in conjunction with the Scientific Sessions of the American Diabetes Association (ADA) in June to introduce additional preclinical data, market research insights, and other aspects of the Company’s development program.
• Late Q3/early Q4 2025: Phase 2a CBeyond top-line data; full patient enrollment over 26 weeks of treatment and follow-up.

Fourth Quarter and Full
Year 2024 Financial Results:

Balance Sheet Highlights:

• In January and March 2024, Skye closed two private investment in public equity transactions which collectively resulted in approximately $83.6 million in net proceeds.
• Cash and cash equivalents totaled $68.4 million on December 31, 2024. The Company expects its current capital to fund projected operations and key clinical milestones through at least Q1 2027, including completion of its Phase 2a study for nimacimab and Phase 2b manufacturing but excluding the Phase 2b clinical study or manufacturing activities necessary to supply a Phase 3 clinical study.
• Elimination of all related party balances, including the conversion of $5 million of debt to equity.

Operating Results:

• R&D Expenses:

  Research and development (R&D) expenses for the three months ended December 31, 2024, were $7.8 million, as compared to $1.6 million for the same period in 2023. The increase was primarily due to contracted clinical and manufacturing costs associated with our Phase 2 clinical trial for nimacimab in obesity and employee related benefits.

  R&D expenses for the year ended December 31, 2024, were $18.7 million, as compared to $5.8 million for the same period in 2023. The increase was primarily due to contracted clinical and manufacturing costs associated with our Phase 2 clinical trial for nimacimab in obesity. The remainder of the increase resulted from increases in discovery research efforts, consulting fees, employee benefits driven by increases in headcount, and general expenses.

• G&A Expenses:

  General and administrative (G&A) expenses for the three months ended December 31, 2024, were $4.6 million, as compared to $2.5 million for the same period in 2023. The increase was primarily related to non-cash incentive stock-based compensation, payroll, benefits and other employee costs, professional services including fees for tax, audit, legal services, financial advisory services, and other general business expenses.

  G&A expenses for the year ended December 31, 2024, were $17.7 million, as compared to $7.9 million for the same period in 2023. The increase was primarily related to non-cash incentive stock-based compensation, professional services including fees for tax, audit, legal services, financial advisory services, patent prosecution for nimacimab intellectual property, other general business expenses.

• Net Loss:

  Net loss for the three months ended December 31, 2024, totaled $9.7 million, with non-cash share-based compensation expense of $2.1 million, compared to $4.4 million for the year ended 2023, with non-cash share-based compensation expense of $0.6 million.

  Net loss for the year ended December 31, 2024, totaled $26.6 million, with non-cash share-based compensation expense of $8.3 million, compared to $37.6 million for the year ended 2023, with non-cash share-based compensation expense of $1.0 million. The primary reason for the significant decrease related to the acquisition of the nimacimab in-process research and development asset for $21.2 million during the year ended December 31, 2023, all of which was expensed upon acquisition. In addition, during 2024 we recognized a $4.2 million gain from the partial derecognition of contingent liabilities and a $2.0 million gain from insurance recoveries related to legal proceedings, $3.0 million in interest income and a gain of $1.4 million from the sale of real estate.

Conference Call Details

Skye will host a conference call to discuss its FY 2024 and Q4 2024 results at 1:30 p.m. PT/4:30 p.m. ET today, March 20th. The live streaming of the call can be accessed at the Skye Investor Relations website, along with the Company’s earnings press release, financial tables, and investor presentation. Following the call, a replay and transcript will be available at the same website.

About Skye Bioscience

Skye is focused on unlocking new therapeutic pathways for metabolic health through the development of next-generation molecules that modulate G-protein coupled receptors. Skye’s strategy leverages biologic targets with substantial human proof of mechanism for the development of first-in-class therapeutics with clinical and commercial differentiation. Skye is conducting a Phase 2 clinical trial (ClinicalTrials.gov: NCT06577090) in obesity for nimacimab, a negative allosteric modulating antibody that peripherally inhibits CB1. This study is also assessing the combination of nimacimab and a GLP-1R agonist (Wegovy®). For more information, please visit: www.skyebioscience.com. Connect with us on X and LinkedIn.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding: Skye’s future plans and prospects, Skye’s product development plan for nimacimab; the planned timing for reporting of data from Skye’s phase 2a study of nimacimab in obesity; the therapeutic potential of nimacimab, including based on Skye’s diet induced obesity mouse model; the potential applications of nimacimab; expectations around nimacimab’s differentiated mechanism of action; expectations regarding the superior safety and tolerability profile of nimacimab relative to other small molecule CB1 inhibitors and the expected timing through which our current cash and cash equivalents will fund our operating plans. Such statements and other statements in this press release that are not descriptions of historical facts are forward-looking statements that are based on management’s current expectations and assumptions and are subject to risks and uncertainties. If such risks or uncertainties materialize or such assumptions prove incorrect, our business, operating results, financial condition, and stock price could be materially negatively affected. In some cases, forward-looking statements can be identified by terminology including “anticipated,” “plans,” “goal,” “focus,” “aims,” “intends,” “believes,” “expects,” “can,” “could,” “challenge,” “predictable,” “will,” “would,” “may” or the negative of these terms or other comparable terminology. We operate in a rapidly changing environment, and new risks emerge from time to time. As a result, it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements the Company may make. Risks and uncertainties that may cause actual results to differ materially include, among others, our capital resources, uncertainty regarding the results of future testing and development efforts and other risks that are described in the Company’s periodic filings with the Securities and Exchange Commission, including in the “Risk Factors” section of Skye’s most recent Annual Report on Form 10-K. Except as expressly required by law, Skye disclaims any intent or obligation to update these forward-looking statements.

Contacts

Investor Relations
[email protected]
(858) 410-0266

LifeSci Advisors, Mike Moyer
[email protected]
(617) 308-4306

Media Inquiries
LifeSci Communications, Michael Fitzhugh
[email protected]
(628) 234-3889

WAUWATOSA, Wis., March 20, 2025 (GLOBE NEWSWIRE) — On March 20, 2025, the Board of Directors of Waterstone Financial, Inc. (NASDAQ: WSBF) declared a regular quarterly cash dividend of $0.15 per common share.  The dividend is payable on May 1, 2025, to shareholders of record at the close of business on April 8, 2025.

About Waterstone Financial, Inc:

Waterstone Financial, Inc. is the savings and loan holding company for WaterStone Bank, a community-focused financial institution established in 1921. WaterStone Bank offers a comprehensive suite of personal and business banking products and operates 14 branch locations across southeastern Wisconsin. WaterStone Bank is also the parent company of WaterStone Mortgage Corporation, a national lender licensed in 48 states.

With a long-standing commitment to innovation, integrity, and community service, Waterstone Financial, Inc. supports the financial and homeownership goals of customers nationwide.

For more information about WaterStone Bank, go to wsbonline.com.

Contact: Mark R. Gerke
Chief Financial Officer
414-459-4012
[email protected]

BOSTON, March 20, 2025 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that it reacquired the rights to IMCIVREE^® (setmelanotide) in China, including mainland China, Hong Kong and Macau, as the Company agreed to terminate its 2021 licensing agreement with RareStone Group Ltd.

“Rhythm continues to execute on our strategy of developing setmelanotide and the next generation of MC4R agonists with the goal of making these treatments available to patients from around the world who may benefit,” David Meeker, MD, Chairman, CEO and President of Rhythm, said. “Our global trial of setmelanotide in patients with acquired hypothalamic obesity – which is on track for topline data readout in the second quarter of 2025 – is being conducted in North America, Europe and Japan, and this reacquisition of rights for China, Hong Kong and Macau means Rhythm now owns the global franchise. I want to thank the current management of RareStone for their efforts in reaching a mutually acceptable agreement.”

Under the agreement, Rhythm has agreed to repay $6.3 million in cash to RareStone. Rhythm also agreed to return all shares of RareStone that were acquired under the original agreement for no additional consideration.

About Rhythm Pharmaceuticals

Rhythm is a commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. Rhythm’s lead asset, IMCIVREE^® (setmelanotide), an MC4R agonist designed to treat hyperphagia and severe obesity, is approved by the U.S. Food and Drug Administration (FDA) to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency. Both the European Commission (EC) and the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) have authorized setmelanotide for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. Additionally, Rhythm is advancing a broad clinical development program for setmelanotide in other rare diseases, as well as investigational MC4R agonists LB54640 and RM-718, and a preclinical suite of small molecules for the treatment of congenital hyperinsulinism. Rhythm’s headquarters is in Boston, MA.

Setmelanotide Indication

In the United States, setmelanotide is indicated to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients aged 2 years and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS). In the European Union and the United Kingdom, setmelanotide is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. In the European Union and the United Kingdom, setmelanotide should be prescribed and supervised by a physician with expertise in obesity with underlying genetic etiology.

Limitations of Use

Setmelanotide is not indicated for the treatment of patients with the following conditions as setmelanotide would not be expected to be effective:

• Obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPR variants classified as benign or likely benign

• Other types of obesity not related to BBS or POMC, PCSK1, or LEPR deficiency, including obesity associated with other genetic syndromes and general (polygenic) obesity

Contraindication

Prior serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported.

WARNINGS AND PRECAUTIONS

Disturbance in Sexual Arousal: Spontaneous penile erections in males and sexual adverse reactions in females have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.

Depression and Suicidal Ideation: Depression, suicidal ideation and depressed mood have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur.

Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. If suspected, advise patients to promptly seek medical attention and discontinue IMCIVREE.

Skin Hyperpigmentation, Darkening of Pre-existing Nevi, and Development of New Melanocytic Nevi: Generalized or focal increases in skin pigmentation, darkening of pre-existing nevi, development of new melanocytic nevi and increase in size of existing melanocytic nevi have occurred. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new pigmented lesions.

Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative in Neonates and Low Birth Weight Infants: IMCIVREE is not approved for use in neonates or infants. Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low birth weight infants treated with benzyl alcohol preserved drugs.

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥20%) included skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection.

USE IN SPECIFIC POPULATIONS

Treatment with IMCIVREE is not recommended when breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.

To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at +1 (833) 789-6337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See section 4.8 of the Summary of Product Characteristics for information on reporting suspected adverse reactions in Europe.

Please see the full Prescribing Information for additional Important Safety Information.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the ability of setmelanotide to treat patients with hypothalamic obesity; the announcement of data from our clinical trials, including our Phase 3 trial evaluating setmelanotide for patients with acquired hypothalamic obesity; our plans and global strategy for commercialization of IMCIVREE, including in China, Hong Kong and Macau; and the timing of any of the foregoing. Statements using words such as “expect”, “anticipate”, “believe”, “may”, “will” and similar terms are also forward-looking statements. Such statements are subject to numerous risks, uncertainties and other important factors, including, but not limited, to our ability to enroll patients in clinical trials, the design and outcome of clinical trials, the ability to achieve necessary regulatory approvals, risks associated with data analysis and reporting, failure to identify and develop additional product candidates, unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, risks associated with the laws and regulations governing our international operations and the costs of any related compliance programs, the impact of competition, risks relating to product liability lawsuits, inability to maintain collaborations, or the failure of these collaborations, our reliance on third parties, risks relating to intellectual property, our ability to hire and retain necessary personnel, general economic conditions, risks related to internal control over financial reporting, and the other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and our other filings with the Securities and Exchange Commission. Except as required by law, we undertake no obligations to make any revisions to the forward-looking statements contained in this release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise.

Corporate Contact:

David Connolly
Head of Investor Relations and Corporate Communications
Rhythm Pharmaceuticals, Inc.
857-264-4280
[email protected]

Media Contact:

Sheryl Seapy
Real Chemistry
(949) 903-4750
[email protected]

– Previously reported MRD negative CR in 2 of 3 relapsed/refractory AML patients enrolled in first dose level and schedule of Phase 1 clinical trial of SENTI-202 maintaining remission –

       – Strengthened balance sheet with gross proceeds of approximately $47.6 million from private investment in public equity (PIPE) financing –

SOUTH SAN FRANCISCO, Calif., March 20, 2025 (GLOBE NEWSWIRE) — Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio” or the “Company”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today reported financial results for the fourth quarter of 2024 and provided a summary of recent pipeline and corporate highlights.

“With initial data from the clinical trial of SENTI-202, we are getting a glimpse into the potential profile of our gene circuit-enabled CAR-NK therapy for patients with AML. As we look toward 2025, we anticipate sharing additional data from this exciting trial,” said Timothy Lu, MD, PhD, Chief Executive Officer and Co-Founder of Senti Bio. “We are also grateful to have continued support from our investors, including those who participated in our successful PIPE financing in December 2024, and we look forward to demonstrating the potential of our next-generation cell therapies in oncology.”

PIPELINE AND CORPORATE HIGHLIGHTS

SENTI-202 for AML: The Company previously announced initial data from its ongoing Phase 1 clinical trial of SENTI-202 (NCT06325748) for the treatment of relapsed/refractory hematologic malignancies including acute myeloid leukemia (“AML”).

As
announced in December 2024, three AML patients had been treated at the lowest dose level (1.0 billion CAR+ NK cells per dose) and lowest dose schedule (3 doses per cycle) and two achieved complete remission (“CR”), confirmed by bone marrow biopsy, which includes blast reduction and recovery of blood cells to normal ranges. In addition, both patients were assessed as measurable residual disease (“MRD”) negative after treatment, which is defined as no detectable cancer cells present in a bone marrow sample by the most sensitive locally available method. As of this month, both patients remain in remission. Across all three patients for which data was announced, SENTI-202 was generally well-tolerated, with an adverse event profile consistent with the use of lymphodepleting chemotherapy in patients with AML.

Raised gross proceeds of $47.6 million in private investment in public equity (PIPE) financing: In early December 2024, the Company announced a $37.6 million PIPE financing, followed by an additional $10.0 million later that month as part of the same financing. The financing, which was led by Celadon Partners, with participation from New Enterprise Associates (NEA), Leaps by Bayer, Nantahala Capital, The Red Hook Fund LP, and other institutional and accredited investors, is expected to extend the Company’s financial runway into 2026. The Company plans to use the net proceeds of $45.1 million to fund the continued development of the SENTI-202 program and manufacturing ramp-up, other research and development activities, and for general corporate purposes.

Received CIRM Grant funds for clinical development of SENTI-202: In January 2025, the Company also received an additional $1.5 million from its $8 million grant from the California Institute for Regenerative Medicines (“CIRM”) that was first announced in July 2024, bringing the total CIRM amount received by the Company to $6.4 million.

Expanded senior leadership team: In February 2025, the Company announced the addition of strategic hires Jay Cross as Chief Financial Officer and Faraz Siddiqui as Senior Vice President of Technical Operations.

Appointed Fran Schulz and Feng Hsiung to the Board of Directors (“Board”): In December 2024, Fran Schulz was appointed to the Board. She has finance, strategic planning, operations, and transactions expertise in the life sciences industry. She serves as chairperson of the Board’s Audit Committee. In March 2025, Feng Hsiung was appointed to the Board and as a member of the Audit Committee. He has extensive business, finance, and investment experience from a career that included investment and portfolio management as well as investment banking.

FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS

• Cash and Cash Equivalents: As of December 31, 2024, Senti Bio held cash and cash equivalents of $48.3 million.
• R&D Expenses: Research and development expenses were $7.8 million for the quarter ended December 31, 2024, compared to $9.1 million for the same period in 2023. The decrease was primarily related to a reduction in headcount as the Company streamlined operations to prioritize SENTI-202 in 2024. For the full year of 2024, research and development expenses were $34.4 million.
• G&A Expenses: General and administrative expenses were $8.4 million for the quarter ended December 31, 2024, compared to $9.3 million for the same period in 2023. The decrease was mainly attributed to a reduction in headcount. For the full year of 2024, general and administrative expenses were $26.3 million.
• Net Loss: Net loss was $0.6 million, or $0.67 per basic and diluted share, for the quarter ended December 31, 2024. Net loss for the full-year 2024 was $52.8 million, or $12.03 per share, including non-cash stock-based compensation expense of $1.8 million.

About Senti Bio

Senti Bio is a clinical-stage biotechnology company developing a new generation of cell and gene therapies for patients living with incurable diseases. To achieve this, Senti Bio is leveraging a synthetic biology platform called Gene Circuits to create therapies with enhanced precision and control. These Gene Circuits are designed to precisely kill cancer cells, spare healthy cells, increase specificity to target cells and control the expression of drugs even after administration. Senti Bio’s wholly-owned pipeline includes off-the-shelf CAR-NK cells, outfitted with Gene Circuits, to target challenging liquid and solid tumor indications. Senti Bio’s lead program SENTI-202, a Logic Gated CD33 and/or FLT3-targeting hematologic cancer therapeutic candidate, demonstrated MRD-negative complete remissions in 2 of 3 patients in initial clinical data as of September 19, 2024, with 4+ and 3+ month durability as of December 2, 2024. Senti Bio has also preclinically demonstrated that its Gene Circuits can function in T cells, for example against solid tumor targets. Additionally, Senti Bio has preclinically demonstrated the potential breadth of Gene Circuits in other cell and gene therapy modalities, diseases outside of oncology, and continues to advance these capabilities through partnerships.

Forward-Looking Statements

This press release contains certain statements that are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally are identified by the words “believe,” “could,” “predict,” “continue,” “ongoing,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” “forecast,” “seek,” “target” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements are predictions, projections, and other statements about future events that are based on current expectations of Senti Bio’s management and assumptions, whether or not identified in this document, and, as a result, are subject to risks and uncertainties. Forward-looking statements include, but are not limited to, statements regarding future events, including the future development of our clinical and pre-clinical pipeline, success of our SENTI-202 clinical trial and financial projections and future financial and operating results. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by any investor as, a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Senti Bio. Many factors could cause actual future results to differ materially from the forward-looking statements in this document, including but not limited to: (i) changes in domestic and foreign business, market, financial, political and legal conditions, (ii) changes in the competitive and highly regulated industries in which Senti Bio operates, variations in operating performance across competitors, changes in laws and regulations affecting Senti Bio’s business, (iii) the ability to implement business plans, forecasts and other expectations, (iv) the risk of downturns and a changing regulatory landscape in Senti Bio’s highly competitive industry, (v) risks relating to the uncertainty of any projected financial information with respect to Senti Bio, (vi) risks related to uncertainty in the timing or results of Senti Bio’s clinical trial initiation and the progress of clinical trials, patient enrollment, and GMP manufacturing activities, (vii) Senti Bio’s dependence on fourth parties in connection with clinical trial startup, clinical studies, and GMP manufacturing activities, (viii) risks related to delays and other impacts from macroeconomic and geopolitical events, increasing rates of inflation and rising interest rates on business operations, (ix) risks related to the timing and utilization of Senti Bio’s grant from CIRM and net proceeds of the PIPE financing, and (x) the success of any future research and development efforts by Senti Bio. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of Senti Bio’s most recent Quarterly Report on Form 10-Q, filed with the U.S. Securities and Exchange Commission (“SEC”), and other documents filed by Senti Bio from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements in this document. There may be additional risks that Senti Bio does not presently know, or that Senti Bio currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements in this document. Forward-looking statements speak only as of the date they are made. Senti Bio anticipates that subsequent events and developments may cause Senti Bio’s assessments to change. Except as required by law, Senti Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise.