Tyra Biosciences Reports Fourth Quarter and Full Year 2024 Financial Results and Highlights

PR Newswire

– Three INDs cleared by US FDA for TYRA’s proprietary precision small molecules –

– TYRA-300 to be evaluated in three Phase 2 studies: SURF302 for Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC), BEACH301 for pediatric achondroplasia (ACH) and SURF301 for metastatic urothelial cancer (mUC) –

– Cash, cash equivalents, and marketable securities of $341.4 million at YE 2024; runway through at least 2027 –


CARLSBAD, Calif.
, March 27, 2025 /PRNewswire/ — Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, today reported financial results for the fourth quarter and full year ended December 31, 2024, and highlighted recent corporate progress.

“2024 was a momentous year for TYRA and the patient communities we serve, highlighted by the positive interim results from our SURF301 study, which demonstrated a combination of high anti-tumor activity with favorable tolerability results in very sick, heavily pre-treated cancer patients. Importantly, the oncology doses tested in SURF301 are significantly higher than those to be tested in BEACH301, giving us confidence as we advance TYRA-300 in ACH,” said Todd Harris, CEO of TYRA. “Our conviction in TYRA-300 has never been stronger and we are working diligently to advance this potential best-in-class agent for multiple high-value indications in oncology and skeletal dysplasia into three Phase 2 studies in NMIBC, ACH and mUC.”

Fourth Quarter and Full Year 2024 and Recent Corporate Highlights

TYRA-300

  • Advanced Clinical Evaluation of TYRA-300 into Three Phase 2 Studies. During 2024, TYRA progressed TYRA-300, an oral, investigational FGFR3-selective inhibitor, for the treatment of IR NMIBC, mUC and ACH, and achieved the following milestones:

    • Cleared Phase 2 NMIBC IND with US FDA – SURF302. TYRA expanded the clinical development of TYRA-300 into NMIBC to address the unmet needs in this cancer population for an efficacious, orally available therapy. SURF302 is an open-label Phase 2 clinical study evaluating the efficacy and safety of TYRA-300 in participants with FGFR3-altered low-grade, IR NMIBC. The study will enroll up to 90 participants at multiple sites primarily in the United States. Participants will be randomized initially to treatment with TYRA-300 at 50 mg once-daily (QD) (Cohort 1) or treatment with TYRA-300 at 60 mg QD (Cohort 2). Following a review of efficacy and safety, an additional dosing cohort may be evaluated. The primary endpoint is complete response (CR) rate at three months. Secondary endpoints include time to recurrence, the median duration of response, recurrence free survival (RFS), progression free survival (PFS), safety and tolerability.
    • Cleared Phase 2 ACH IND with US FDA – BEACH301. The study is a Phase 2, multicenter, open-label, dose-escalation/dose-expansion study evaluating TYRA-300 in children ages 3 to 10 with achondroplasia with open growth plates. The study will enroll children who are treatment-naïve (Cohort 1) and those who have received prior growth-accelerating therapy (Cohort 2) at multiple sites across the globe. Each of these cohorts is expected to enroll up to 10 participants per dose level (0.125, 0.25, 0.375, 0.50 mg/kg) for up to 12 months. The study will initially enroll a safety sentinel cohort of up to 3 treatment-naïve participants per dose level in children ages 5 to 10.
    • Reported Interim Clinical Proof-of-Concept Results in mUC Patients – SURF301. TYRA-300 demonstrated encouraging preliminary anti-tumor activity in a heavily pre-treated population: at ≥ 90 mg QD, 6 out of 11 (54.5%) patients with FGFR3+ mUC achieved a confirmed partial response (PR), with 100% disease control rate and sustained duration of activity; positive safety results were reported across all QD doses, with infrequent FGFR2/FGFR1-associated toxicities (data cutoff of August 15, 2024). TYRA-300 is being evaluated in Part B of SURF301 (NCT05544552) at potentially therapeutic QD doses in preparation for potential future Phase 2 studies.

TYRA-200

  • Advanced Phase 1 SURF201 Study. TYRA-200 is an FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations. SURF201 (Study in PrevioUsly treated and Resistant FGFR2+ Cholangiocarcinoma and Other Advanced Solid Tumors) (NCT06160752) is a multi-center, open label study designed to evaluate the safety, tolerability, and pharmacokinetics of TYRA-200 and determine the optimal and maximum tolerated dose and recommended Phase 2 dose, as well as evaluate the preliminary antitumor activity of TYRA-200. The SURF201 study is currently enrolling and dosing adults with unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating FGFR2 gene alterations.

TYRA-430


  • Cleared

     Phase 1 IND with US FDA – SURF431. TYRA-430 is an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. The Phase 1 study will be a multicenter, open-label, first-in-human study of TYRA-430 in advanced hepatocellular carcinoma (HCC) and other solid tumors with activating FGF/FGFR pathway aberrations (SURF431). We believe TYRA-430 has the potential to address a significant unmet need in HCC, where there are no approved biomarker-driven, targeted therapies.

Corporate

  • Strengthened Leadership Team and Board of Directors. In 2024, TYRA appointed Doug Warner, MD, as Chief Medical Officer, and Erik Goluboff, MD, as SVP, Clinical Development to lead the Company’s oncology strategy and clinical development plans. In 2025, TYRA appointed accomplished drug developer Adele Gulfo to its Board of Directors, Sinette Heys as SVP, Clinical Operations to lead the Company’s clinical operations team, and Will Charlton, MD, as SVP, Clinical Development to lead the Company’s skeletal dysplasia clinical development group.

SNÅP
 Platform and Pipeline

  • TYRA continued to advance its in-house precision medicine discovery engine, SNÅP, to develop therapies in targeted oncology and genetically defined conditions.

Fourth Quarter and Full-Year 2024 Financial Results

  • Cash, Cash Equivalents and Short-Term Investments. As of December 31, 2024, TYRA had cash, cash equivalents, and marketable securities of $341.4 million, compared to $203.5 million at the end of 2023. The increase was primarily due to the completion of a private placement financing for net proceeds of $199.6 million in the first quarter of 2024. The Company’s current cash, cash equivalents and marketable securities are expected to allow TYRA to execute on its plans through at least 2027.

  • Research and Development (R&D) Expenses. Research and development expenses for the three months ended December 31, 2024 were $22.2 million compared to $20.7 million for the same period in 2023, and $80.1 million for the full year 2024 compared to $62.5 million for the same period in 2023. The increases were primarily driven by increased expenses incurred in connection with our ongoing and planned clinical trials and personnel-related costs, including stock-based compensation, partially offset by decreased drug manufacturing and preclinical costs.

  • General and Administrative (G&A) Expenses. General and administrative expenses for the three months ended December 31, 2024 were $7.6 million compared to $5.0 million for the same period in 2023, and $24.1 million for the full year 2024 compared to $17.4 million for the same period in 2023. The increases were primarily driven by increased personnel-related costs, including stock-based compensation.

  • Net Loss. Fourth quarter 2024 net loss was $25.6 million compared to $22.8 million for the same period in 2023, and $86.5 million for the full year 2024 compared to $69.1 million for the same period in 2023.

Upcoming Anticipated Milestones and Events

  • BEACH301: dose first child with achondroplasia with TYRA-300 – Q2 2025
  • SURF302: dose first NMIBC patient with TYRA-300 – Q2 2025
  • SURF431: dose first HCC patient with TYRA-430 – Q2 2025

About TYRA-300

TYRA-300 is the Company’s lead precision medicine program stemming from its in-house SNÅP platform. TYRA-300 is an investigational, oral, FGFR3-selective inhibitor currently in development for the treatment of cancer and skeletal dysplasia, including achondroplasia and hypochondroplasia. In oncology, TYRA-300 is being evaluated in mUC and IR NMIBC. In mUC, TYRA-300 is being evaluated in a multi-center, open label Phase 1/2 clinical study, SURF301 (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors) (NCT05544552). The study is designed to determine the optimal and the recommended Phase 2 dose of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. In October 2024, TYRA reported interim clinical proof-of-concept data in mUC from SURF301. TYRA has received IND clearance from the US FDA to proceed with its SURF302 clinical trial in patients with IR NMIBC. In skeletal dysplasia, TYRA-300 has demonstrated positive preclinical results in achondroplasia and hypochondroplasia, and its BEACH301 clinical trial in children with achondroplasia is now recruiting.

About TYRA-200

TYRA-200 is an oral, investigational, FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations. The Phase 1 clinical study of TYRA-200, SURF201 (Study in PrevioUsly treated and Resistant FGFR2+ Cholangiocarcinoma and Other Advanced Solid Tumors) (NCT06160752), is a multi-center, open label study designed to evaluate the maximum tolerated dose (MTD) and the recommended Phase 2 dose of TYRA-200, as well as to evaluate the preliminary antitumor activity of TYRA-200. SURF201 is currently enrolling and dosing adults with advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating alterations in FGFR2.

About TYRA-430

TYRA-430 is an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. The US FDA has cleared Tyra’s IND to proceed with a Phase 1 clinical study of TYRA-430. The Phase 1 study will be a multicenter, open-label, first-in-human study of TYRA-430 in advanced HCC and other solid tumors with activating FGF/FGFR pathway aberrations (SURF431).

About Tyra Biosciences

Tyra Biosciences, Inc. (Nasdaq: TYRA) is a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in FGFR biology. The Company’s in-house precision medicine platform, SNÅP, enables rapid and precise drug design through iterative molecular SNÅPshots that help predict genetic alterations most likely to cause acquired resistance to existing therapies. TYRA’s expertise in FGFR biology has created a differentiated pipeline with three product candidates in clinical development in targeted oncology and genetically defined conditions. The Company’s lead precision medicine stemming from SNÅP, TYRA-300, is a potential first-in-class selective FGFR3 inhibitor that is designed to avoid the toxicities associated with inhibition of FGFR1, FGFR2 and FGFR4, while being agnostic for the FGFR3 gatekeeper mutations. TYRA-300 is expected to be evaluated in three Phase 2 studies: SURF302 for IR NMIBC, BEACH301 for pediatric achondroplasia and SURF301 for metastatic urothelial cancer. TYRA is also developing TYRA-200, an oral, investigational, FGFR1/2/3 inhibitor, in the SURF201 study for metastatic intrahepatic cholangiocarcinoma, and TYRA-430, an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. TYRA is based in Carlsbad, CA.

For more information about our science, pipeline and people, please visit www.tyra.bio and engage with us on LinkedIn.

Forward-Looking Statements

TYRA 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: the expected advancement of our pipeline and our growth; the potential to develop next-generation precision medicines and their potential to be first-in-class and/or best-in-class; the potential safety and therapeutic benefits of, and market opportunities for, our product candidates; the expected trial design, timing and phase of development of our product candidates, including timing for patient dosing; the potential for SNÅP to develop therapies; and our expected cash runway. 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: interim results of a clinical trial 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, as follow-up on the outcome of any particular patient continues and as more patient or final data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the potential for proof-of-concept results to fail to result in successful subsequent development of TYRA-300; later developments with the FDA may be inconsistent with prior feedback from the FDA; we are early in our development efforts, and the approach we are taking to discover and develop drugs based on our SNÅP platform is novel and unproven and it may never lead to product candidates that are successful in clinical development or approved products of commercial value; potential delays in the commencement, recruitment, enrollment, data readouts and completion of preclinical studies and clinical trials; results from preclinical studies or early clinical trials not necessarily being predictive of future results; our dependence on third parties in connection with manufacturing, research and preclinical testing; 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; acceptance by the FDA of INDs or of similar regulatory submissions by comparable foreign regulatory authorities for the conduct of clinical trials of our product candidates; an accelerated development or approval pathway may not be available for TYRA-300 or other product candidates and any such pathway may not lead to a faster development process; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization; the potential for our programs and prospects to be negatively impacted by developments relating to our competitors, including the results of studies or regulatory determinations relating to our competitors; unfavorable results from preclinical studies; regulatory developments in the United States and foreign countries; our ability to obtain and maintain intellectual property protection for our product candidates and proprietary technologies; we may use our capital resources sooner than we expect; unstable market and economic conditions may adversely affect our business and financial condition and the broader economy and biotechnology industry; 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 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.

Contact:

Amy Conrad

[email protected] 

 


Tyra Biosciences, Inc.


Condensed Balance Sheets

(in thousands)


December 31,


December 31,


2024


2023


Assets

Current assets:

Cash and cash equivalents

$

91,966

$

58,006

Marketable securities

249,475

145,463

Prepaid expenses and other current assets

6,022

8,202

Total current assets

347,463

211,671

Restricted cash

1,000

1,000

Property and equipment, net

1,651

1,628

Right-of-use assets

6,068

6,526

Other long-term assets

7,376

5,032

Total assets

$

363,558

$

225,857


Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable

$

590

$

4,662

Lease liabilities, current

412

280

Accrued expenses and other current liabilities

13,592

10,391

Total current liabilities

14,594

15,333

Lease liabilities, noncurrent

5,810

6,216

Other long-term liabilities

3

46

Total liabilities

20,407

21,595

Stockholders’ equity:

Preferred stock

Common stock

5

4

Additional paid-in capital

593,687

368,707

Accumulated other comprehensive income

770

381

Accumulated deficit

(251,311)

(164,830)

Total stockholders’ equity

343,151

204,262

Total liabilities and stockholders’ equity

$

363,558

$

225,857

 


Tyra Biosciences, Inc. 


Statements of Operations and Comprehensive Loss 

(in thousands, except share and per share data)

(unaudited)


Three Months Ended December 31,


Year Ended December 31,


2024


2023


2024


2023

Operating expenses:

Research and development

$

22,180

$

20,677

$

80,077

$

62,518

General and administrative

7,564

4,957

24,100

17,427

Total operating expenses

29,744

25,634

104,177

79,945

Loss from operations

(29,744)

(25,634)

(104,177)

(79,945)

Other income:

Interest and other income, net

4,173

2,804

17,696

10,811

Total other income

4,173

2,804

17,696

10,811

Net loss

(25,571)

(22,830)

(86,481)

(69,134)

Unrealized gain (loss) on marketable

   securities available-for-sale, net

(982)

381

389

381

Comprehensive loss

$

(26,553)

$

(22,449)

$

(86,092)

$

(68,753)

Net loss per share, basic and diluted

$

(0.43)

$

(0.53)

$

(1.51)

$

(1.62)

Weighted-average shares used to compute

   net loss per share, basic and diluted

59,060,385

42,965,744

57,217,746

42,704,876

 

 

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SOURCE Tyra Biosciences

Cohen & Steers Closed-End Funds Declare Distributions for April, May and June 2025

PR Newswire


NEW YORK
, March 27, 2025 /PRNewswire/ — The Boards of Directors of the Cohen & Steers Closed-End Funds announced today the monthly distributions for April, May and June 2025, as summarized in the charts below:


Ticker


Fund Name


Monthly
Dividend

FOF

Cohen & Steers Closed-End Opportunity Fund, Inc.

$0.087

LDP

Cohen & Steers Limited Duration Preferred and Income Fund, Inc.

$0.131

PSF

Cohen & Steers Select Preferred and Income Fund, Inc.

$0.126

PTA

Cohen & Steers Tax-Advantaged Preferred Securities and Income Fund

$0.134

RFI

Cohen & Steers Total Return Realty Fund, Inc.

$0.080

RLTY

Cohen & Steers Real Estate Opportunities and Income Fund

$0.110

RNP

Cohen & Steers REIT and Preferred and Income Fund, Inc.

$0.136

RQI

Cohen & Steers Quality Income Realty Fund, Inc.

$0.080

UTF

Cohen & Steers Infrastructure Fund, Inc.

$0.155

 

Distributions will be made on the following schedule:


Month


Ex-Dividend/
Record Date


Payable Date

April

April 8, 2025

April 30, 2025

May

May 13, 2025

May 30, 2025

June

June 10, 2025

June 30, 2025

 

Cohen & Steers Tax-Advantaged Preferred Securities and Income Fund, Cohen & Steers Real Estate Opportunities and Income Fund, Cohen & Steers Limited Duration Preferred and Income Fund, Inc., and Cohen & Steers Select Preferred and Income Fund, Inc. pay regular monthly cash distributions to common shareholders at a level rate that may be adjusted from time to time. Each of these fund’s distributions reflect net investment income and may also include net realized capital gains and/or return of capital. Return of capital includes distributions paid by a fund in excess of its net investment income. Such excess is distributed from the fund’s assets. Under federal tax regulations, some or all of the return of capital distributed by a fund may be taxed as ordinary income. The amount of monthly distributions may vary depending on a number of factors, including changes in portfolio and market conditions.

Cohen & Steers Closed-End Opportunity Fund, Inc., Cohen & Steers Total Return Realty Fund, Inc.,
Cohen & Steers REIT and Preferred and Income Fund, Inc.,
Cohen & Steers Infrastructure Fund, Inc., and Cohen & Steers Quality Income Realty Fund, Inc. only:

Cohen & Steers Closed-End Opportunity Fund, Inc., Cohen & Steers Total Return Realty Fund, Inc., Cohen & Steers REIT and Preferred and Income Fund, Inc., Cohen & Steers Infrastructure Fund, Inc., and Cohen & Steers Quality Income Realty Fund, Inc. (each, a “Fund” and collectively the “Funds”) declared their monthly distributions pursuant to such Fund’s managed distribution plans. Each Fund implemented a managed distribution policy in accordance with exemptive relief issued by the Securities and Exchange Commission. The policy gives each Fund greater flexibility to realize long-term capital gains throughout the year and to distribute those gains on a regular monthly basis to shareholders. Information can also be found on the Funds’ website at cohenandsteers.com. The Board of Directors of each Fund may amend, terminate or suspend the managed distribution policy at any time, which could have an adverse effect on the market price of each Fund’s shares.

Distributions of a fund’s investment in real estate investment trusts (REITs), master limited partnerships (MLPs) and/or closed-end funds (CEFs) may later be characterized as capital gains and/or a return of capital, depending on the character of the dividends reported to each fund after year-end by the REITs, MLPs and CEFs held by a fund.

Each Fund’s distributions may include net investment income, long-term capital gains, short-term capital gains and/or return of capital. Under the plan, prior to the payment date of the distribution every month, each Fund will issue a press release and a notice containing information about the amount and sources of the distribution and other related information to shareholders of record on the record date. Please note that the notice is not provided for tax reporting purposes but for informational purposes only. Information can also be found on the Funds’ website at cohenandsteers.com.

Shareholders should not use the information provided in preparing their tax returns. Shareholders will receive a Form 1099-DIV for the calendar year indicating how to report Fund distributions for federal income tax purposes.

Investors should consider the investment objectives, risks, charges and expense of the fund carefully before investing. You can obtain the fund’s most recent periodic reports, when available, and other regulatory filings by contacting your financial advisor or visiting cohenandsteers.com. These reports and other filings can be found on the Securities and Exchange Commission’s EDGAR Database. You should read these reports and other filings carefully before investing.

Website: https://www.cohenandsteers.com/
Symbol: (NYSE: CNS)

About Cohen & Steers. Cohen & Steers is a leading global investment manager specializing in real assets and alternative income, including listed and private real estate, preferred securities, infrastructure, resource equities, commodities, as well as multi-strategy solutions. Founded in 1986, the firm is headquartered in New York City, with offices in London, Dublin, Hong Kong, Tokyo and Singapore.


Forward-Looking Statements


This press release and other statements that Cohen & Steers may make may contain forward looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which reflect the company’s current views with respect to, among other things, its operations and financial performance. You can identify these forward-looking statements by the use of words such as “outlook,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “seeks,” “approximately,” “predicts,” “intends,” “plans,” “estimates,” “anticipates,” or the negative versions of these words or other comparable words. Such forward-looking statements are subject to various risks and uncertainties.

Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. The company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise.

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SOURCE Cohen & Steers, Inc.

The Lovesac Company Announces Fourth Quarter and Fiscal 2025 Conference Call Date

STAMFORD, Conn., March 27, 2025 (GLOBE NEWSWIRE) — The Lovesac Company (Nasdaq: LOVE) (“Lovesac” or the “Company”), the Designed for Life home and technology brand, today announced that its fourth quarter and fiscal 2025 financial results will be released before market open on Thursday, April 10, 2025. The Company will host a conference call at 8:30 a.m. Eastern Time to discuss the financial results.

Investors and analysts interested in participating in the call are invited to dial 877-407-3982 (international callers please dial 201-493-6780) approximately 10 minutes prior to the start of the call. A live audio webcast of the conference call will be available online at investor.lovesac.com.

A recorded replay of the conference call will be available within two hours of the conclusion of the call and can be accessed online at investor.lovesac.com for 90 days.


About The Lovesac Company

Based in Stamford, Connecticut, The Lovesac Company (NASDAQ: LOVE) is a technology driven company that designs, manufactures and sells unique, high-quality furniture derived through its proprietary Designed for Life approach which results in products that are built to last a lifetime and designed to evolve as customers’ lives do. The current product offering is comprised of modular couches called Sactionals, the Sactionals Reclining seat, premium foam beanbag chairs called Sacs, the PillowSac™ Accent Chair, an immersive surround sound home theater system called StealthTech, and an innovative sofa seating solution called EverCouch™. As a recipient of Repreve’s 7th Annual Champions of Sustainability Award, responsible production and innovation are at the center of the brand’s design philosophy with products protected by a robust portfolio of utility patents. Products are marketed and sold primarily online directly at www.lovesac.com, supported by a physical retail presence in the form of Lovesac branded showrooms, as well as through shop-in-shops and pop-up-shops with third party retailers. LOVESAC, DESIGNED FOR LIFE, SACTIONALS, SAC and STEALTHTECH, are trademarks of The Lovesac Company and are Registered in the U.S. Patent and Trademark Office.

Investor Relations Contacts:

Caitlin Churchill, ICR
(203) 682-8200
[email protected]



STRATA Skin Sciences Reports Fourth Quarter and Full-Year 2024 Financial Results and Provides a Corporate Update

HORSHAM, Pa., March 27, 2025 (GLOBE NEWSWIRE) — STRATA Skin Sciences, Inc. (“STRATA” or the “Company”) (NASDAQ: SSKN), a medical technology company dedicated to developing, commercializing, and marketing innovative products for the treatment of dermatologic conditions, announces its financial results for the quarter and year ended December 31, 2024, and provides a corporate update.


Fourth


Quarter


and


Full-Year


2024


Financial


Highlights

  • Revenue in the fourth quarter of 2024 was $9.6 million, up 10% from $8.7 million in the year-ago quarter
    • Global net recurring XTRAC® revenue in the fourth quarter was $5.5 million vs. $5.4 million in the prior year period, with international growth of 13% more than offsetting a slight decline in the domestic market
    • Average net revenue per domestic XTRAC® system increased to $5,906 (+6% YOY) on 864 systems in the fourth quarter vs. $5,555 per system on 923 systems in the comparable prior year period
    • Total Recurring revenue increased 3.0% to $5.8 million in the fourth quarter, driven by international growth and contribution from TheraClear
    • Equipment revenue of $3.8 million increased 23% vs. $3.1 million in the fourth quarter of 2023, representing our highest level in two years
  • Full year 2024, revenue of $33.6 million increased slightly vs. $33.4 million in 2023
    • While revenue for the full year was up only slightly, results improved significantly over the course of the year with Y/Y growth in the fourth quarter of 10%
    • For the full year, growth of 5% in the Equipment segment more than offset a decline of 2% in the Recurring segment
  • Gross margin of 60.1% in the fourth quarter of 2024, improved 480 bps vs. 55.3% in the fourth quarter of 2023
  • Adjusting for a one-time accrued expense of $1.8 million in the third quarter of 2024 and the impact of non-cash impairment in both years, operating expense of $22.7 million in 2024 declined 8.5% vs. $24.8 million in 2023
  • Implemented a turnaround, focusing on cost efficiency and improving revenue per device, and delivered meaningful improvements in both metrics
  • Drove efficiencies in Sales & Marketing to more than offset the increase in Direct-to-Consumer (DTC) spend associated with the reimplementation of the Company’s strategic revenue model
  • Implemented a strategy to remove and refurbish underutilized machines, driving a 67% year-over-year reduction in capex spend for full-year 2025, further conserving cash


2024


Corporate


Highlights

  • Renewed 3-year agreements with exclusive distributors in China and Japan – each agreement carries minimum unit placements and/or purchases of the XTRAC® and VTRAC® devices
  • Amended credit agreement with MidCap Financial Trust to ensure alignment with the Company’s current and future business projections
  • On July 23, 2024, closed a registered direct offering that raised $2.1 million in gross proceeds ($1.9 million in net proceeds) through the sale of 665,136 shares of common stock at an average purchase price of $3.16 per share, with participation from insiders and existing institutional shareholders
  • Received approval for the XTRAC Momentum™ 1.0 device in Japan and drove significant growth in international recurring revenue
  • Upgraded clinical team and implemented a consulting model focused on best practices within customer clinics. Early results show meaningful improvement in procedures per device and, in some cases, demand for additional placements
  • Filed a complaint against LaserOptek, and others, citing unfair competition under federal and state laws regarding the marketing and sales of competitive laser devices. On November 8, 2024  pursuant to a joint stipulation a court order was entered in the US District Court for the Eastern District of Pennsylvania enjoining LaserOptek, and all those acting at their direction from engaging in any sales, marketing or promotion of  Pallas lasers that states or implies, that treatments with Pallas lasers are reimbursable using CPT Codes 96920-96922, and also barred LaserOptek and others from engaging in any deceptive advertising  that includes any false or misleading statements regarding the Pallas lasers or STRATA’s lasers. On February 28, 2025, Strata filed a motion for civil contempt against LaserOptek for violating that court order.

“2024 was a year of execution for STRATA. Our fourth quarter results highlight the success we are having in implementing our strategy to shift our existing installed base from underperforming centers to more productive ones while utilizing our DTC and service model to help our customers succeed,” commented STRATA’s President and CEO Dr. Dolev Rafaeli. “We have reduced XTRAC® devices in our domestic installed base to 864, from 923 at the prior year end, resulting in average revenue per device increasing to $5,906 in the fourth quarter of 2024, up from $5,555 in the prior-year period, representing an increase of 6%. At the same time, our operating margins, adjusted for non-cash impairment charges in both periods, improved by 950 bps compared to the fourth quarter of 2023. On a full-year basis, our non-GAAP adjusted EBITDA, including the adjustment for the $1.8 million accrual we discussed last quarter, improved to $2.2 million versus $1.0 million in the prior year.

“With regard to our international markets, we have seen significant traction, with particular strength in the Equipment segment. During the fourth quarter, international sales increased to $4.1 million, which represents a sequential increase of 27% over the prior quarter and 41% over the prior year period, with the international portion of the Equipment segment up 45% over the fourth quarter of 2023,” concluded Dr, Rafaeli.


Fourth


Quarter 2024 Financial Results

Revenue for the fourth quarter of 2024 was $9.6 million, as compared to revenue of $8.7 million for the fourth quarter of 2023. Global recurring revenue for the fourth quarter of 2024 was $5.8 million, as compared to global recurring revenue of $5.6 million for the prior-year period. Equipment revenue was $3.8 million for the fourth quarter of 2024 versus $3.1 million for the fourth quarter of 2023.

Gross profit for the fourth quarter of 2024 was $5.8 million, or 60.1% of revenue, as compared to $4.8 million, or 55.3% of revenue, for the fourth quarter of 2023.

Selling and marketing costs for the fourth quarter of 2024 were $3.2 million, compared to $2.8 million in the year-ago period. General and administrative costs for the fourth quarter of 2024 were $2.7 million, compared to $2.8 million for the fourth quarter of 2023.

Net loss for the fourth quarter of 2024 was $4.5 million, or EPS of negative $1.18 per basic and diluted common share, as compared to a net loss of $3.8 million, or EPS of negative $1.09 per basic and diluted common share, in the fourth quarter of 2023.

Cash, cash equivalents, and restricted cash at December 31, 2024 were $8.6 million.


F


ull Year


2024 Financial Results

Revenue for the full year 2024 was $33.6 million, as compared to revenue of $33.4 million for the full year 2023. Global recurring revenue for the full year 2024 was $21.2 million, as compared to global recurring revenue of $21.5 million for the full year 2023. Equipment revenue was $12.4 million for the full year 2024, as compared to $11.8 million for the full year 2023.

Gross profit for the full year 2024 was $19.1 million, or 56.9% of revenue, as compared to $18.5 million, or 55.3% of revenue for the full year 2023.

Selling and marketing costs for the full year 2024 were $12.3 million, as compared to $13.0 million for the full year 2023. General and administrative costs for the full year 2024 were $11.3 million ($9.5 million adjusted for a one-time accrual of $1.8 million taken in the third quarter), as compared to $10.5 million for the full year 2023.

Impairment expense for the full year 2024 was $3.9 million, as compared to $2.3 million for the full year 2023.

Other expenses for the full year 2024 were $1.0 million compared to $2.3 million for the full year 2023.

Net loss for the full year 2024 was $10.1 million, including the $1.8 million accrual to general and administrative expenses in the third quarter, and the $3.9 million impairment expense. This resulted in a net loss of $2.65 per basic and diluted common share.


Fourth


Quarter


and Full Year


20


24 Earnings


Conference Call

STRATA management will host a conference call at 4:30 p.m. ET on Thursday, March 27, 2025, to review financial results and provide an update on corporate developments. Following management’s formal remarks, there will be a question-and-answer session.

To listen to the conference call, interested parties within the U.S. should dial 1-844-481-2523 (domestic) or 1-412-317-0552 (international). All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the STRATA Skin Sciences, Inc. conference call.

The conference call will also be available through a live webcast that can be accessed at STRATA Skin Sciences 4Q24 Earnings Webcast.

A telephonic replay of the call will be available until April 3, 2025 by dialing 1-877-344-7529 (or 1-412-317-0088 for international callers) and using replay access code 8210574. To access the replay using an international dial-in number, please see here.

A webcast earnings call replay will be available approximately one hour after the live call and remain accessible until September 24, 2025.

Non-GAAP Financial Measures

STRATA has determined to supplement its consolidated financial statements, prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”), presented elsewhere within this report, with certain non-GAAP measures of financial performance. These non-GAAP measures include non-GAAP gross profit, which excludes the non-cash expense of amortization of acquired intangible assets classified as cost of revenues, and non-GAAP adjusted EBITDA, “Earnings Before Interest, Taxes, Depreciation, and Amortization.”

These non-GAAP disclosures have limitations as an analytical tool, should not be viewed as a substitute for Gross Profit or Net Earnings (Loss) determined in accordance with U.S. GAAP, should not be considered in isolation or as a substitute for analysis of our results as reported under U.S. GAAP, nor are they necessarily comparable to non-GAAP performance measures that may be presented by other companies. STRATA considers these non-GAAP measures in addition to its results prepared under current accounting standards, but they are not a substitute for, nor superior to, U.S. GAAP measures. These non-GAAP measures are provided to enhance readers’ overall understanding of STRATA’s current financial performance and to provide further information for comparative purposes. This supplemental presentation should not be construed as an inference that the Company’s future results will be unaffected by similar adjustments to Gross Profit or Net Earnings (Loss) determined in accordance with U.S. GAAP. Specifically, STRATA believes the non-GAAP measures provide useful information to management and investors by isolating certain expenses, gains, and losses that may not be indicative of the Company’s core operating results and business outlook. In addition, STRATA believes non-GAAP measures enhance the comparability of results against prior periods.

Reconciliation to the most directly comparable U.S. GAAP measure of all non-GAAP measures included in this press release is as follows:

  Year Ended December 31,

(in thousands)
2024
  2023
       
Net loss $ (10,086 )   $ (10,830 )
       
Adjustments:      
Depreciation and amortization   4,968       5,553  
Amortization of operating lease right-of-use asset   339       349  
Loss on disposal of property and equipment   49       72  
Benefit from income taxes   (170 )     (92 )
Interest income   (242 )     (231 )
Interest expense   2,107       1,640  
Non-GAAP EBITDA   (3,035 )     (3,539 )
Impairment of goodwill   3,861       2,284  
Stock-based compensation   427       1,303  
Loss on debt extinguishment         909  
Employee retention credit   (864 )      
Non-GAAP adjusted EBITDA $ 389     $ 957  
One-time accrual for NY State Sales Tax   1,781        
Non-GAAP adjusted EBITDA normalized for one-time events   2,170       957  
               

XTRAC Gross Domestic Recurring Billings

XTRAC gross domestic recurring billings represent the amount invoiced to partner clinics when treatment codes are sold to the physician. It does not include normal GAAP adjustments, which are deferred revenue from prior quarters recorded as revenue in the current quarter, the deferral of revenue from the current quarter recorded as revenue in future quarters, adjustments for co-pay and other discounts. This excludes international recurring revenues.

The following is a reconciliation of non-GAAP XTRAC gross domestic billings to domestic recorded revenue for the third quarter and first nine months of 2024 and 2023 (in thousands), respectively:

  Three Months Ended
December
3
1
,


  YTD
    2024       2023       2024       2023  
Gross domestic recurring billings $4,871     $4,947     $18,996     $19,622  
Co-Pay adjustments   (84 )     (87 )     (331 )     (343 )
Other discounts   (6 )     (22 )     (81 )     (110 )
Deferred revenue from prior quarters   1,867       1,913       7,204       8,114  
Deferral of revenue to future quarters   (1,545 )     (1,624 )     (7,126 )     (7,567 )
GAAP Recorded domestic revenue $5,102     $5,127     $18,662     $19,716  
                               

About STRATA Skin Sciences, Inc.

STRATA Skin Sciences is a medical technology company dedicated to developing, commercializing, and marketing innovative products for the in-office treatment of various dermatologic conditions, such as psoriasis, vitiligo, and acne. Its products include the XTRAC® excimer laser, VTRAC® lamp systems, and the TheraClear®X Acne Therapy System.

STRATA is proud to offer these exciting technologies in the U.S. through its unique Partnership Program. STRATA’s popular partnership approach includes a fee per treatment cost structure versus an equipment purchase, installation and use of the device, on-site training for practice personnel, service and maintenance of the equipment, dedicated account and customer service associates, and co-op advertising support to help raise awareness and promote the program within the practice.

Safe Harbor

This press release includes “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995. These statements include but are not limited to the Company’s plans, objectives, expectations and intentions and may contain words such as “will,” “may,” “seeks,” and “expects,” that suggest future events or trends. These statements, the Company’s ability to launch and sell products recently acquired or to be developed in the future, the Company’s ability to develop social media marketing campaigns, direct to consumer marketing campaigns, and the Company’s ability to build a leading franchise in dermatology and aesthetics, are based on the Company’s current expectations and are inherently subject to significant uncertainties and changes in circumstances. Actual results may differ materially from the Company’s expectations due to financial, economic, business, competitive, market, regulatory, adverse market conditions labor supply shortages, or supply chain interruptions resulting from fiscal, political factors, international conflicts, responses, or conditions affecting the Company, the medical device industry and our customers and patients in general, as well as more specific risks and uncertainties set forth in the Company’s SEC reports on Forms 10-Q and 10-K. Given such uncertainties, any or all these forward-looking statements may prove to be incorrect or unreliable. The statements in this press release are made as of the date of this press release, even if subsequently made available by the Company on its website or otherwise. The Company does not undertake any obligation to update or revise these statements to reflect events or circumstances occurring after the date of this press release. The Company urges investors to carefully review its SEC disclosures available at www.sec.gov and www.strataskinsciences.com.

Investor Contact:

CORE IR
516-222-2560
[email protected]

 
STRATA Skin Sciences, Inc. and Subsidiary
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
   
  December 31,
  2024   2023
Assets      
Current assets:      
Cash and cash equivalents $ 7,261     $ 6,784  
Restricted cash   1,334       1,334  
Accounts receivable, net of allowance for credit losses of $563 and $222 at December 31, 2024 and 2023, respectively   5,253       4,440  
Inventories   2,246       2,673  
Prepaid expenses and other current assets   501       312  
Total current assets   16,595       15,543  
Property and equipment, net   10,061       11,778  
Operating lease right-of-use assets   1,264       626  
Intangible assets, net   5,348       7,319  
Goodwill   2,658       6,519  
Other assets   231       231  
Total assets $ 36,157     $ 42,016  
       
Liabilities and Stockholders’ Equity      
Current liabilities:      
Accounts payable $ 2,433     $ 3,343  
Accrued expenses and other current liabilities   8,593       6,306  
Deferred revenues   2,241       2,120  
Current portion of operating lease liabilities   328       352  
Current portion of contingent consideration   1,030       53  
Total current liabilities   14,625       12,174  
Long-term debt, net   15,192       15,044  
Deferred revenues and other liabilities   353       552  
Deferred tax liability         186  
Operating lease liabilities, net of current portion   919       237  
Contingent consideration, net of current portion   96       1,135  
Total liabilities   31,185       29,328  
Commitments and contingencies (Note 10)      
Stockholders’ equity:      
Series C convertible preferred stock, $0.10 par value; 10,000,000 shares authorized, no shares issued and outstanding          
Common stock, $0.001 par value; 150,000,000 shares authorized; 4,171,161 and 3,506,025 shares issued and outstanding at December 31, 2024 and 2023, respectively   4       4  
Additional paid-in capital   253,112       250,742  
Accumulated deficit   (248,553 )     (238,058 )
Total stockholders’ equity   4,972       12,688  
Total liabilities and stockholders’ equity $ 36,157     $ 42,016  
               

 
STRATA Skin Sciences, Inc. and Subsidiary
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
   
  Year Ended December 31,
  2024   2023
       
Revenues, net $ 33,562     $ 33,358  
Cost of revenues   14,481       14,897  
Gross profit   19,081       18,461  
Operating expenses:      
Engineering and product development   883       1,317  
Selling and marketing   12,289       12,956  
General and administrative   11,303       10,508  
Impairment of goodwill   3,861       2,284  
    28,336       27,065  
Loss from operations   (9,255 )     (8,604 )
Other (expense) income:      
Interest expense   (2,107 )     (1,640 )
Interest income   242       231  
Loss on debt extinguishment         (909 )
Other income   864        
    (1,001 )     (2,318 )
Loss before benefit from income taxes   (10,265 )     (10,922 )
Benefit from income taxes   170       92  
Net loss $ (10,086 )   $ (10,830 )
       
Net loss per share of common stock, basic and diluted $ (2.65 )   $ (3.10 )
Weighted average shares of common stock outstanding, basic and diluted   3,807,186       3,491,964  
               

 
STRATA Skin Sciences, Inc. and Subsidiary
Condensed Consolidated Statements of Cash Flows
(in thousands)
   
  Year Ended December 31,
  2024   2023
       
Cash flows from operating activities:      
Net loss $ (10,086 )   $ (10,830 )
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:      
Depreciation and amortization   4,968       5,553  
Impairment of goodwill   4,861       2,284  
Amortization of operating lease right-of-use assets   339       349  
Amortization of deferred financing costs and debt discount   148       140  
Change in allowance for credit losses   (182 )     (110 )
Stock-based compensation expense   427       1,303  
Loss on debt extinguishment         909  
Loss on disposal of property and equipment   49       72  
Inventory write-off   162        
Deferred income taxes   (186 )     (120 )
Changes in operating assets and liabilities:      
Accounts receivable   (631 )     141  
Inventories   572       689  
Prepaid expenses and other assets   (189 )     246  
Accounts payable   (954 )     (100 )
Accrued expenses and other liabilities   2,266       (197 )
Deferred revenues   (57 )     (472 )
Operating lease liabilities   (319 )     (376 )
Net cash provided by (used in) operating activities   188       (519 )
Cash flows from investing activities:      
Purchase of property and equipment   (1,636 )     (5,019 )
Net cash used in investing activities   (1,636 )     (5,019 )
Cash flows from financing activities:      
Proceeds from long-term debt         7,000  
Payment of deferred financing costs         (97 )
Payment of contingent consideration   (18 )     (42 )
Sale of common stock, net of offering costs   1,943        
Net cash provided by financing activities   1,925       6,861  
Net increase in cash, cash equivalents and restricted cash   477       1,323  
Cash, cash equivalents and restricted cash at beginning of year   8,118       6,795  
Cash, cash equivalents and restricted cash at end of year $ 8,595     $ 8,118  
       
Supplemental disclosure of cash flow information:      
Cash paid during the year for interest $ 1,973     $ 1,415  
Cash paid during the year for income taxes $ 23     $ 22  
Supplemental schedule of non-cash operating, investing and financing activities:      
Modification of common stock warrants $     $ 384  
Transfer of property and equipment to inventories $ 307     $ 267  
Change in intangible assets and fair value of contingent consideration $     $ 7,374  
Accrued exit fee recorded as debt discount $ 150     $ 450  
Accrued payment of contingent consideration $ 44     $ 18  
Operating lease right-of-use assets obtained in exchange for operating lease liabilities $ 977     $  
               



zSpace Reports Fourth Quarter and Full Year 2024 Financial Results

SAN JOSE, Calif., March 27, 2025 (GLOBE NEWSWIRE) — zSpace (NASDAQ: ZSPC) (“zSpace” or the “Company”), a leader in augmented and virtual reality solutions for education, is announcing its financial results for the three and twelve months ended December 31, 2024.

“We are thrilled to be announcing our first quarter as a public company,” said Paul Kellenberger, CEO of zSpace. “Throughout 2024, we achieved significant milestones, including our largest customer win to date with St. Louis Public Schools and the expansion of our Career Readiness Solution, featuring our innovative AI Career Coach.

“While we received IPO proceeds in early December, the late-quarter timing limited our ability to fulfill orders before year-end. As a result, we closed 2024 with $9.2 million in backlog, reflecting strong demand heading into 2025. With growing market opportunities and increasing adoption of immersive learning solutions, we remain focused on driving growth through deeper penetration in K-12 STEM and CTE markets, international expansion, and strategic investments in R&D and software acquisitions. Looking ahead, we are confident in our ability to build on our momentum and deliver long-term value for our shareholders.”

Fourth Quarter 2024 Financial Summary vs. Same Year-Ago Period

  • Revenue of $8.5 million vs. $12.1 million.
  • Gross margin of 40.7% vs. 34.7%.
  • Net loss of ($3.6) million vs. ($4.1) million.

Full Year 2024 Financial Summary vs. Same Year-Ago Period

  • Revenue of $38.1 million vs. $43.9 million.
  • Gross margin of 40.9% vs. 38.5%.
  • Net loss of $(20.8) million vs. $(13.0) million.

2024 Business Highlights

  • Secured $5 million deal with St. Louis Public Schools to provide a K-12 STEM solution, making it the Company’s largest customer win to date and demonstrating the Company’s impact on education at scale.
  • Expanded content offerings with the launch of the Career Readiness Solution, featuring a personalized “AI Career Coach,” which has been well-received by customers and addresses the growing demand for solutions bridging education and the workforce.
  • Received the Best of Show Award at ISTELive 24, the world’s largest annual K-12 education conference, from Tech & Learning for the Career Readiness Solution, reinforcing leadership in the education technology space.
  • On December 6, 2024, zSpace announced the completion of its initial public offering (IPO) of 1,875,000 shares of its common stock at $5.00. The shares of common stock began trading on the Nasdaq Global Market on December 5, 2024, under the ticker symbol “ZSPC”.

Fourth Quarter and Full Year 2024 Financial Results

Revenue in the fourth quarter of 2024 was $8.5 million compared to $12.1 million in the fourth quarter of 2023. For the full year 2024, revenue was $38.1 million compared to $43.9 million in 2023. The decreases were driven by capital constraints prior to the Company’s IPO, which limited its ability to fulfill backlog orders.

Annualized Contract Value (ACV) of renewable software at December 31, 2024, was $11.3 million, representing a 6% increase compared to $10.6 million a year ago. The increase was driven by the sales team’s execution to improve the software content on new deployments, and account management of renewing deals to drive retention and expansion among existing customers.

Net Dollar Revenue Retention (NDRR) at December 31, 2024, for customers with over $50,000 of ACV as of December 31, 2023, was 92%.

Bookings in the fourth quarter of 2024 were $5.3 million, down 3% compared to $5.5 million in the fourth quarter of 2023 (excluding China, the U.S. and rest-of-world, bookings were $5.3 million, up 5% year over year). For the full year 2024, bookings reached $41.5 million, an increase of 1% compared to $41.1 million a year ago (excluding China, the U.S. and rest-of-world, bookings were $39.9 million, up 7% year over year.)

Gross margin in the fourth quarter of 2024 was 40.7%, a 597-basis point improvement compared to 34.7% in the fourth quarter of 2023. For the full year 2024, gross margin was 40.9%, a 240-basis point improvement compared to 38.5% in 2023, attributable to a 5ppt mix shift from hardware to software and services during the year.

Operating expenses in the fourth quarter of 2024 were $6.2 million compared to $6.1 million in the fourth quarter of 2023. For the full year 2024, operating expenses were $33.2 million compared to $25.5 million a year ago. Excluding pre-IPO stock-based compensation expense, operating expenses were flat compared with a year ago.

Net loss in the fourth quarter of 2024 was ($3.6) million, compared to ($4.1) million in the fourth quarter of 2023. For the full year 2024, net loss was $(20.8) million, compared to ($13.0) million in 2023.

Balance Sheet

As of December 31, 2024, zSpace had approximately $4.9 million in cash and cash equivalents, compared to $3.1 million in cash and cash equivalents as of December 31, 2023.

Conference Call

zSpace will host a conference call at 8:00 a.m. ET / 5:00 a.m. PT on Friday, March 28, 2025, with the Company’s Chief Executive Officer, Paul Kellenberger, and the Company’s Chief Financial Officer, Erick DeOliveira. A live webcast of the call will be available on the Events and Presentations section of zSpace’s investor relations website.

To access the call by phone, please use this registration link and you will be provided with dial-in details.

To avoid delays, participants are encouraged to dial into the conference call 15 minutes ahead of the scheduled start time. A replay of the webcast will also be available for a limited time on the Company’s website.

About zSpace


zSpace, Inc.
 (NASDAQ: ZSPC) delivers innovative augmented and virtual reality (AR/VR) experiences that drive achievement in STEM, CTE, and career readiness programs. Trusted by over 3,500 school districts, technical centers, community colleges, and universities, zSpace allows students and teachers to experience learning in the classroom that may otherwise be dangerous, impossible, counterproductive, or expensive using traditional techniques. Headquartered in San Jose, California, zSpace holds over 70 patents and our hands-on “learning by doing” solutions have been shown to enhance the learning process and drive higher student test scores, as evidenced by a study on the utility of 3D virtual reality technologies for student knowledge gains published in the Journal of Computer Assisted Learning in 2021.

Key Metric Definitions

We monitor the following key metrics to help us evaluate our business, identify trends affecting our business, formulate business plans and make strategic decisions. The calculation of the key metrics discussed below may differ significantly from other similarly titled metrics used by other companies, analysts, investors and other industry participants.

We reference bookings in this press release, which is an internal operational measure of the business. Bookings represent customer orders that have hardware, software and service components. Bookings indicate future revenue, which lags based on product shipping date, monthly recognition of certain subscription revenue and service delivery completion.

We reference Annualized Contract Value (ACV) in this press release, which is an internal operational measure of the business. To monitor our ability to retain and grow our customer base for our software we monitor the annualized contract value of active renewable software licenses.

We reference Net Dollar Revenue Retention (NDRR) in this press release, which is an internal operational measure of the business. We calculate our NDRR as of a given period end by starting with the ACV from all customers with contracts of at least $50,000 of ACV as of 12 months prior to such period end (“Prior Period ACV”) and calculating the ACV from these same customers as of the current period end (“Current Period ACV”). Current Period ACV includes any upsells and is net of contraction or attrition over the trailing 12 months but excludes revenue from new customers in the current period. We then divide the total Current Period ACV by the total Prior Period ACV to arrive at our NDRR.

Bookings, ACV, and NDRR are non-GAAP financial measures (U.S. generally accepted accounting principles). These non-GAAP measures may not be comparable to similarly titled measures being disclosed by other companies. Management believes that presenting these non-GAAP financial measures provide investors with additional analytical tools which are useful in evaluating our operating results and the ongoing performance of our underlying businesses because they (i) provide meaningful supplemental information regarding financial performance by excluding impact of one-time items and other items affecting comparability between periods, (ii) permit investors to view performance using the same tools that management uses to budget, make operating and strategic decisions, and evaluate our core operating performance across periods, and (iii) otherwise provide supplemental information that may be useful to investors in evaluating our financial results. We do not, nor do we suggest that investors, consider such non-GAAP financial measures in isolation from, or as a substitute for, financial information prepared in accordance with GAAP.

Forward-Looking Statements

Certain statements contained in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of the Private Securities litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing dates. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors discussed in the “Risk Factors” section of the Company’s filings with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Any forward-looking statements contained in this press release speak only as of the date hereof, and zSpace, Inc. specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

Contacts

Press Contact:
Amanda Austin
[email protected]
408-498-4050

Investor Relations Contact:
Gateway Group
Cody Slach, Alex Thompson
949.574.3860
[email protected]

                       
  Three Months Ended December 31,       Year Ended December 31, 
  2024
     2023   2024      2023
Revenue $ 8,535     $ 12,053     $ 38,098     $ 43,922  
Cost of goods sold   5,063       7,870       22,529       27,028  
Gross profit   3,472       4,183       15,569       16,894  
Gross profit %   40.7%       34.7%       40.9%       38.5%  
Operating expenses:                          
Research and development   805       1,088       4,893       4,218  
Selling and marketing   3,783       3,054       15,915       12,898  
General and administrative   1,648       1,964       12,419       6,710  
Other operating expenses                     1,683  
Total operating expenses   6,236       6,106       33,227       25,509  
Loss from operations   (2,764 )     (1,923 )     (17,658 )     (8,615 )
Other (expense) income:                          
Interest expense   (580 )     (765 )     (2,815 )     (2,900 )
Other income (expense), net   25       100       43       23  
Loss on extinguishment of debt   (307 )     (1,541 )     (359 )     (1,541 )
Loss before income taxes   (3,626 )     (4,129 )     (20,789 )     (13,033 )
Income tax expense         5       34       3  
Net loss $ (3,626 )   $ (4,124 )   $ (20,823 )   $ (13,036 )
                       

  December 31,       December 31, 
  2024   2023
Selected Balance Sheet Information:            
Cash and cash equivalents $ 4,864     $ 3,128  
Accounts receivable, net $ 3,176     $ 5,040  
Inventory, net $ 3,238     $ 3,535  
Total Assets $ 13,532     $ 13,847  
Accounts payable & accrued expenses $ 11,021     $ 13,964  
Convertible, other debt, SAFE agreements and accrued interest $ 13,557     $ 20,360  
Total liabilities $ 28,220     $ 37,366  
Temporary redeemable preferred stock $     $ 106,952  
Stockholders’ deficit $ (14,688 )   $ (130,471 )
Total Liabilities, Temporary Redeemable Preferred Stock, and Stockholders’ Deficit $ 13,532     $ 13,847  
           



Clearside Biomedical Announces Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update

– Successful End-of-Phase 2 Meeting with FDA Results in Alignment on Phase 3 Plans for CLS-AX in Wet AMD –

– Asia-Pacific Partner’s New Drug Application for ARCATUS
®
(XIPERE
®
) for Uveitic Macular Edema Accepted for Regulatory Review in China –

– Multiple Medical Meeting Presentations Highlight Potential Advantages and Key Differentiators of Suprachoroidal Drug Delivery Utilizing Clearside’s SCS Microinjector

®


– Management to Host Webcast and Conference Call Today at 4:30 P.M. ET –

ALPHARETTA, Ga., March 27, 2025 (GLOBE NEWSWIRE) — Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), today announced financial results for the fourth quarter and year ended December 31, 2024, and provided a corporate update.

“We are redefining the delivery of therapeutics to the retina through the suprachoroidal space with the proven reliability and broad applicability of our innovative SCS Microinjector®,” said George Lasezkay, PharmD, JD, President and Chief Executive Officer. “Over the past six months, we announced positive Phase 2b data, conducted a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), designed the CLS-AX (axitinib injectable suspension) Phase 3 program to maximize commercial potential in wet AMD, and supported several of our SCS Microinjector partners as they advance their suprachoroidal drug candidates into Phase 3 clinical trials.”

“Clearside has developed a differentiated platform of early and later stage SCS assets, has entered into multiple validating SCS collaborations, and has the potential for pipeline expansion opportunities in geographic atrophy, diabetic retinopathy, and diabetic macular edema,” concluded Dr. Lasezkay.

Key Recent Highlights

  • Completion of an End-of-Phase 2 meeting with the FDA and alignment on Phase 3 plans for suprachoroidal CLS-AX in wet AMD. The meeting and formal minutes confirmed key elements of the proposed pivotal Phase 3 program, including agreement on the protocol design of two non-inferiority trials, patient population, primary and secondary endpoints, and use of sham injections.
  • CLS-AX Phase 3 plans are based on positive results from the ODYSSEY Phase 2b clinical trial that achieved its primary and secondary endpoints, demonstrated extended duration, stable vision and anatomic measures and a well-tolerated safety profile.
  • Clearside’s Asia-Pacific partner, Arctic Vision, announced that its New Drug Application (NDA) for ARCATUS® (known as XIPERE® in the U.S.) for the treatment of uveitic macular edema (UME) was formally accepted for review by the Center for Drug Evaluation of China National Medical Products Administration.
  • Arctic Vision’s NDAs for ARCATUS were approved by the Therapeutic Goods Administration of Australia and the Health Sciences Authority in Singapore for the treatment of UME.
  • Arctic Vision signed a new commercial collaboration with Santen Pharmaceutical Co., Ltd. for commercial rights in China to ARVN001 (ARCATUS) in the treatment of UME and certain other ophthalmic indications under development.
  • Clearside’s gene therapy partner, REGENXBIO, in collaboration with AbbVie, announced in January 2025 that they will plan a Phase 3 clinical program for sura-vec (ABBV-RGX-314) using suprachoroidal delivery for the treatment of diabetic retinopathy. Their Phase 2 ALTITUDE® trial is enrolling a cohort of patients with center-involved diabetic macular edema (DME). Their Phase 2 AAVIATE® trial continues enrolling a new cohort to evaluate sura-vec at dose level 4 with a short course of prophylactic steroid eye drops.
  • Clearside’s ocular oncology partner, Aura Biosciences, is enrolling patients in its global Phase 3 CoMpass trial evaluating belzupacap sarotalocan (bel-sar) for the first-line treatment of adult patients with small choroidal melanoma or indeterminate lesions.
  • Clearside’s partner, BioCryst Pharmaceuticals, highlighted plans to initiate clinical testing in 2025 of avoralstat, its plasma kallikrein inhibitor, for the potential treatment of DME.
  • Multiple medical meeting presentations were delivered on transforming retinal disease treatments using suprachoroidal delivery, including Hawaiian Eye & Retina 2025, 3rd Annual Ophthalmic Drug Delivery Summit, Angiogenesis, Exudation, and Degeneration 2025, Macula Society 48th Annual Meeting, Asia-Pacific Vitreo-Retina Society (APVRS), and the Academy of Ophthalmology (AAO).
  • The Royal College of Ophthalmologists, Eye and Nature.com, published a summary of critical insights into drug development and regulatory processes based on a presentation at the prestigious annual Edridge Green Lecture by Clearside’s Chief Medical Officer and Executive Vice President, Head of Research and Development, Dr. Victor Chong. The article provides a comprehensive overview of the intricate processes involved in clinical trial design and regulatory pathways for drug development, with a special focus on retinal diseases.
  • Tony Gibney was appointed Chair of Clearside’s Board of Directors, effective November 1, 2024, succeeding Clay Thorp, who continues serving as a member of the Board. Mr. Gibney joined Clearside’s Board as an independent director in April 2024 and is an experienced biotechnology executive and former investment banker, most recently serving as Executive Vice President, Chief Business & Strategy Officer, of Iveric Bio, Inc. until the company’s acquisition by Astellas Pharma Inc. in July 2023.

Fourth Quarter 2024 Financial Results

  • License and other revenue for the fourth quarter of 2024 was $0.3 million, compared to $6.3 million for the fourth quarter of 2023. The decrease was primarily attributable to the receipt of license fees and milestone payments from partners in the fourth quarter of 2023.
  • Research and development (R&D) expenses for the fourth quarter of 2024 were $4.2 million, compared to $6.3 million for the fourth quarter of 2023. The decrease was primarily due to lower clinical trial costs following completion of the ODYSSEY Phase 2b trial.
  • General and administrative (G&A) expenses for the fourth quarter of 2024 were $3.1 million, compared to $2.9 million for the fourth quarter of 2023. The increase was primarily due to higher patent-related expenses and consulting fees.
  • Net loss for the fourth quarter of 2024 was $7.3 million, or $0.10 per share of common stock, compared to net loss of $4.8 million, or $0.08 per share of common stock, for the fourth quarter of 2023. The increase in net loss was primarily attributable to the receipt of license fees and milestone payments from partners in the fourth quarter of 2023.
  • As of December 31, 2024, Clearside’s cash and cash equivalents totaled $20.0 million. The Company believes it will have sufficient resources to fund its planned operations into the fourth quarter of 2025.

Full Year 2024 Financial Results

  • License and other revenue for the year ended December 31, 2024 was $1.7 million, compared to $8.2 million for the year ended December 31, 2023. The $6.6 million decrease was primarily attributable to the receipt of license fees and milestone payments from partners in the fourth quarter of 2023.
  • R&D expenses for the year ended December 31, 2024 were $18.6 million, compared to $20.8 million for the year ended December 31, 2023. The decrease was primarily due to lower clinical trial costs following completion of the ODYSSEY Phase 2b trial.
  • G&A expenses for the year ended December 31, 2024 were $11.8 million, compared to $11.9 million for the year ended December 31, 2023.
  • Net loss for the year ended December 31, 2024 was $34.4 million, or $0.47 per share of common stock, compared to net loss of $32.5 million, or $0.53 per share of common stock, for the year ended December 31, 2023.

Conference Call & Webcast Details

Clearside’s management will host a webcast and conference call today at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update. The live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. The live call can be accessed by dialing 888-506-0062 (domestic) or 973-528-0011 (international) and entering conference code: 733956. The Company suggests participants join 15 minutes in advance of the event.

About Clearside Biomedical, Inc.

Clearside Biomedical, Inc. is a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®) to improve patient outcomes. Clearside’s SCS injection platform, utilizing the Company’s patented SCS Microinjector®, enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to the macula, retina, or choroid to potentially preserve and improve vision in patients with sight-threatening eye diseases. Clearside is developing its own pipeline of small molecule product candidates for administration via its SCS Microinjector. The Company’s lead program, CLS-AX (axitinib injectable suspension), is in development for the treatment of neovascular age-related macular degeneration (wet AMD). Planning for a Phase 3 program is underway. In addition, Clearside is evaluating various small molecules for the potential long-acting treatment of geographic atrophy (GA). Clearside developed and gained approval for its first product, XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, which is available in the U.S. through a commercial partner. Clearside also strategically partners its SCS injection platform with companies utilizing other ophthalmic therapeutic innovations. For more information, please visit clearsidebio.com or follow us on LinkedIn and X.

Cautionary Note Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include statements regarding the clinical development of CLS-AX, including the planned Phase 3 trial design, CLS-AX’s potential impact on the wet AMD market, the potential benefits of CLS-AX, Clearside’s suprachoroidal delivery technology and Clearside’s SCS Microinjector®, pipeline expansion opportunities, and Clearside’s ability to fund its operations into the fourth quarter of 2025. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside’s reliance on third parties over which it may not always have full control, Clearside’s ability to raise additional capital, and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission (SEC) on March 27, 2025 and Clearside’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

*Reference

  • XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use is being commercialized by Bausch + Lomb who has the exclusive license for the commercialization and development of XIPERE in the United States and Canada. Arctic Vision has the exclusive license for the commercialization and development of XIPERE, in Greater China, South Korea, Australia, New Zealand, India and the ASEAN Countries. XIPERE is approved by the U.S. Food and Drug Administration and is commercially available in the U.S. A link to the full prescribing information is available at https://www.xipere.com/hcp/#isi.

Investor and Media Contacts:

Jenny Kobin
Remy Bernarda
[email protected]

-Financial Tables Follow-

CLEARSIDE BIOMEDICAL, INC.

Selected Financial Data

(in thousands, except share and per share data)
(unaudited)

Statements of Operations Data   Three Months Ended

December 31,
    Year Ended

December 31,
 
    2024     2023     2024     2023  
License and other revenue   $ 306     $ 6,345     $ 1,664     $ 8,226  
Operating expenses:                                
Cost of goods sold     149             149       355  
Research and development     4,244       6,313       18,590       20,846  
General and administrative     3,062       2,947       11,807       11,869  
Total operating expenses     7,455       9,260       30,546       33,070  
Loss from operations     (7,149 )     (2,915 )     (28,882 )     (24,844 )
Interest income     358       360       1,462       1,719  
Other income, net     2,064             2,847        
Non-cash interest expense on liability related to
the sales of future royalties
    (2,579 )     (2,277 )     (9,779 )     (9,360 )
Net loss   $ (7,306 )   $ (4,832 )   $ (34,352 )   $ (32,485 )
Net loss per share of common stock — basic
and diluted
  $ (0.10 )   $ (0.08 )   $ (0.47 )   $ (0.53 )
Weighted average shares outstanding — basic
and diluted
    75,850,759       62,404,329       73,803,348       61,806,959  

Balance Sheet Data December 31,     December 31,  
  2024     2023  
               
Cash and cash equivalents $ 20,020     $ 28,920  
Total assets   25,126       34,018  
Liabilities related to the sales of future royalties, net   51,767       41,988  
Warrant liabilities   6,692        
Total liabilities   63,981       49,930  
Total stockholders’ deficit   (38,855 )     (15,912 )
               

Source: Clearside Biomedical, Inc.



Alpine Income Property Trust Announces First Quarter 2025 Earnings Release and Conference Call Information

WINTER PARK, Fla., March 27, 2025 (GLOBE NEWSWIRE) — Alpine Income Property Trust, Inc. (NYSE: PINE) (the “Company”) announced today that it will report its financial and operating results for the first quarter of 2025 after the market closes on Thursday, April 24, 2025. A conference call to discuss its financial and operating results is scheduled for Friday, April 25, 2025 at 9:00 AM ET.

A live webcast of the call will be available on the Investor Relations page of the Company’s website at www.alpinereit.com or at the link provided in the event details below. To access the call by phone, please go to the link provided in the event details below and you will be provided with dial-in details.

Event Details:  
Webcast: https://edge.media-server.com/mmc/p/2z8mw8kf
Registration: https://register-conf.media-server.com/register/BIa4784cf846494047b82c5db2965501de
   

We encourage participants to register and dial into the conference call at least fifteen minutes ahead of the scheduled start time. A replay of the earnings call will be archived and available online through the Investor Relations section of the Company’s website at www.alpinereit.com.


About Alpine Income Property Trust, Inc.

Alpine Income Property Trust, Inc. (NYSE: PINE) is a publicly traded real estate investment trust that seeks to deliver attractive risk-adjusted returns and dependable cash dividends by investing in, owning and operating a portfolio of single tenant net leased commercial income properties that are predominately leased to high-quality publicly traded and credit-rated tenants.

We encourage you to review our most recent investor presentation which is available on our website at http://www.alpinereit.com.

Contact: Philip R. Mays
  Senior Vice President, Chief Financial Officer and Treasurer
  (407) 904-3324
  [email protected]



CAMP4 Reports Full Year 2024 Financial Results and Provides Corporate Update

– Phase 1 clinical trial of CMP-CPS-001 in Urea Cycle Disorders (UCDs) ongoing, with dosing completed in two of four multiple ascending dose (MAD) cohorts; safety, pharmacokinetic, and pharmacodynamic data anticipated in Q4 2025

– Initiation of expansion into Phase 1b clinical trial in female OTC heterozygotes expected in Q2 2025

– Nomination of development candidate CMP-SYNGAP-01 to address SYNGAP1-related disorders; GLP toxicology studies expected to be initiated in 2025

CAMBRIDGE, Mass., March 27, 2025 (GLOBE NEWSWIRE) — CAMP4 Therapeutics Corporation (“CAMP4”) (Nasdaq: CAMP), a clinical-stage biopharmaceutical company developing a pipeline of regulatory RNA-targeting therapeutics designed to upregulate gene expression with the goal of restoring healthy protein levels to treat a broad range of genetic diseases, today announced financial results for the full year ended December 31, 2024, and provided a corporate update.

“We are off to a strong start in 2025, building on the momentum of a successful 2024, which included advancing our Phase 1 clinical program in UCDs, establishing key research collaborations, securing important regulatory designations, and completing our initial public offering,” said Josh Mandel-Brehm, Chief Executive Officer of CAMP4. “We remain focused on the ongoing healthy volunteer Phase 1 clinical trial of CMP-CPS-001 in UCDs, as well as our planned expansion into a Phase 1b clinical trial in Australia in female OTC heterozygotes – a potential additional addressable patient population of UCDs that has previously been underserved. In addition, we intend to submit a Clinical Trial Application (CTA) in Europe and to open an additional clinical trial site, pending regulatory clearance. This expansion reflects both the growing body of evidence supporting our approach and our commitment to addressing critical gaps in genetic disease care.”

Mr. Mandel-Brehm continued, “We are also pleased to announce the selection of a development candidate, CMP-SYNGAP-01, for our SYNGAP1-related disorders program based on compelling data across our preclinical studies, including recent non-human primate studies. The discovery and selection of a novel regRNA-targeting antisense oligonucleotide (ASO) that increases SYNGAP1 protein levels underscores the transformative potential of our platform to identify and advance this novel class of therapeutic candidates for SYNGAP1-related disorders, a group of neurodevelopmental conditions with no approved therapies that we believe impacts approximately 10,000 individuals in the U.S.”

Ornithine transcarbamylase (OTC) deficiency is a rare genetic disorder that leads to the buildup of ammonia in the blood, which can cause brain damage, coma, or death if left untreated. It is estimated to affect approximately 1 in 56,500 births in the United States and is the only genetic subtype of Urea Cycle Disorders that is X-linked. While males with OTC deficiency almost always experience symptoms, the severity and presence of symptoms in female heterozygotes can vary. CAMP4 estimates that over 1,200 heterozygous female carriers of a mutation in the OTC gene in the United States experience potentially treatable UCD symptoms.

“OTC deficiency has long been seen as a disorder that primarily affects males, with females assumed to be less affected by the disease, and hence this important potential patient population has been overlooked and underserved. Recent research shows that many of these women face chronic, underrecognized symptoms and serious health risks, including the danger of hyperammonemic crises triggered by stress, illness, pregnancy or surgery,” said Dr. Yuri Maricich, Chief Medical Officer of CAMP4. “CAMP4’s Phase1b clinical trial represents a crucial step forward in redefining care for female OTC heterozygotes – moving from passive observation to proactive monitoring and treatment. We are excited to expand our study of CMP-CPS-001, which appeared to be well-tolerated in a Single-Ascending Dose (SAD) study in normal healthy volunteers, as a potential therapy to help manage ammonia levels and improve patient outcomes.”

Recent Corporate Highlights:

  • Completed planned interim analysis of all four SAD cohorts of the Phase 1 clinical trial of CMP-CPS-001 in 48 healthy volunteer participants. Safety results were favorable and consistent with the safety profile of approved liver-targeted ASOs, with all treatment emergent adverse events (TEAEs) being Grade 1 (mild) or Grade 2 (moderate). The two most common TEAEs across all cohorts were headache (six participants) and nausea (four participants). No safety trends of concern were observed, and CMP-CPS-001 appeared to be well-tolerated.
  • Completed dosing in the first two MAD cohorts and dosing has been initiated in MAD Cohort 3.
  • Nominated a development candidate, CMP-SYNGAP-01, for the treatment of SYNGAP-1 related disorders based on preclinical data, including recent results from non-human primate studies.
  • Initiated a discovery program for the treatment of GBA1-related Parkinson’s Disease. Using CAMP4’s RAP Platform™, ASOs have been identified that enhance the expression of GBA1 in vitro. Preclinical studies are ongoing to enable the company to select a development candidate.
  • Appointed Doug E. Williams, Ph.D., and Murray Stewart, DM FRCP, to the Board of Directors, bringing decades of experience in pharmaceutical development and extensive expertise in genetic medicine.

Expected Milestones in 2025

  • Initiation of expansion into Phase 1b clinical trial of CMP-CPS-001 in female OTC heterozygotes in Australia expected in Q2 2025, with Europe to follow pending CTA clearance.
  • Data from the SAD and MAD portions of the trial evaluating CMP-CPS-001 in 96 healthy volunteer participants, including safety, pharmacokinetic, and pharmacodynamic biomarker data, are expected in Q4 2025.
  • GLP toxicity studies of CMP-SYNGAP-01 for the treatment of neurodevelopmental disorders caused by SYNGAP1 mutations to be initiated this year.
  • Advance a new discovery program targeting a GBA1 regRNA to increase gene expression for the treatment of Parkinson’s disease (PD) caused by mutations in GBA1, with potential for application in sporadic PD.
  • Company continues to focus on expanding its strategic partnerships to continue maximizing the value of its RAP Platform.

Full Year 2024 Financial Results

R&D Expenses: Research and development expenses for the year ended December 31, 2024 were $38.8 million, compared to $40.6 million for the year ended December 31, 2023. The decrease was primarily due to decreases in clinical and preclinical expenses and personnel-related expenses.

G&A Expenses: General and administrative expenses for the year ended December 31, 2024, were $14.9 million, as compared to $11.6 million for the year ended December 31, 2023. The increase was primarily due to an increase in personnel-related expenses.

Net Loss: The net loss was $51.8 million for the year ended December 31, 2024, compared to $49.3 million for the year ended December 31, 2023.

Cash Position: As of December 31, 2024, cash and cash equivalents totaled approximately $64.0 million. The Company believes that its current cash and cash equivalents will be sufficient to fund its planned activities into Q2 2026.

About CAMP4 Therapeutics

CAMP4 is developing disease-modifying treatments for a broad range of genetic diseases where amplifying healthy protein may offer therapeutic benefits. Our approach amplifies mRNA by harnessing a fundamental mechanism of how genes are controlled. To amplify mRNA, our therapeutic ASO drug candidates target regulatory RNAs (regRNAs), which act locally on transcription factors and are the master regulators of gene expression. CAMP4’s proprietary RAP Platform™ enables the mapping of regRNAs and generation of therapeutic candidates designed to target the regRNAs associated with genes underlying haploinsufficient and recessive partial loss-of-function disorders, of which there are more than 1,200, in which a modest increase in protein expression may have the potential to be clinically meaningful. For more information, visit camp4tx.com.

Forward-Looking Statements

This press release contains forward-looking statements which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning CAMP4’s plans and expectations regarding its ongoing Phase 1 clinical trial of CMP-CPS-001 and its intention to initiate the expansion into a Phase 1b clinical trial of CMP-CPS-001; the anticipated timing and results of the company’s ongoing and future clinical trials, including expectations regarding the timing of reporting data from the CMP-CPS-001 clinical trials; the expected timing for the company’s initiation of GLP toxicity studies relating to CAMP4’s SYNGAP1 program; the therapeutic potential of CAMP4’s product candidates; estimates regarding the size of patient populations; and cash runway guidance. The forward-looking statements in this press release speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company’s actual results to differ materially from those anticipated in the forward-looking statements, including, but not limited to: the Company’s limited operating history, incurrence of substantial losses since the Company’s inception and anticipation of incurring substantial and increasing losses for the foreseeable future; the Company’s need for substantial additional financing to achieve the Company’s goals; the uncertainty of clinical development, which is lengthy and expensive, and characterized by uncertain outcomes, and risks related to additional costs or delays in completing, or failing to complete, the development and commercialization of the Company’s current product candidates or any future product candidates; delays or difficulties in the enrollment and dosing of patients in clinical trials; the impact of any significant adverse events or undesirable side effects caused by the Company’s product candidates; potential competition, including from large and specialty pharmaceutical and biotechnology companies; the Company’s ability to realize the benefits of the Company’s current or future collaborations or licensing arrangements and ability to successfully consummate future partnerships; the Company’s ability to obtain regulatory approval to commercialize any product candidate in the United States or any other jurisdiction, and the risk that any such approval may be for a more narrow indication than the Company seeks; the Company’s dependence on the services of the Company’s senior management and other clinical and scientific personnel, and the Company’s ability to retain these individuals or recruit additional management or clinical and scientific personnel; the Company’s ability to grow the Company’s organization, and manage the Company’s growth and expansion of the Company’s operations; risks related to the manufacturing of the Company’s product candidates, which is complex, and the risk that the Company’s third-party manufacturers may encounter difficulties in production; the Company’s ability to obtain and maintain sufficient intellectual property protection for the Company’s product candidates or any future product candidates the Company may develop; the Company’s reliance on third parties to conduct the Company’s preclinical studies and clinical trials; the Company’s compliance with the Company’s obligations under the licenses granted to the Company by others, for the rights to develop and commercialize the Company’s product candidates; risks related to the operations of the Company’s suppliers; and other risks and uncertainties described in the section “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as well as other information the Company files with the Securities and Exchange Commission. The forward-looking statements in this press release are inherently uncertain and are not guarantees of future events. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond the Company’s control, you should not unduly rely on these forward-looking statements. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Except as required by applicable law, the Company does not undertake to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Contacts

Investor Relations:

Dan Ferry (US)
LifeSci Advisors
[email protected]

Sandya von der Weid (Europe)
LifeSci Advisors
[email protected]

Media:

Jason Braco, Ph.D.
LifeSci Communications
[email protected]

CAMP4 Therapeutics Corporation
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except for share and per share data)
       
Year ended December 31,
  2024       2023  
Revenue  
Research and collaboration revenue $ 652     $ 350  
Operating expenses      
Research and development   38,817       40,616  
General and administrative   14,923       11,613  
Total operating expenses   53,740       52,229  
Loss from operations   (53,088 )     (51,879 )
Other income, net:      
Interest income   1,330       2,808  
Other expense   (33 )     (220 )
Total other income, net   1,297       2,588  
Net loss attributable to common stockholders and comprehensive loss $ (51,791 )   $ (49,291 )
Net loss per share attributable to common stockholders, basic and diluted $ (11.04 )   $ (124.80 )
Weighted average shares of common stock outstanding, basic and diluted   4,690,094       394,976  

Unaudited Condensed Balance Sheet Data:   December 31,   December 31,
(in thousands)     2024       2023  
Cash and cash equivalents   $ 64,039     $ 38,380  
Working capital(1)     56,785       32,206  
Total assets     78,307       54,946  
Total liabilities     15,163       16,529  
Convertible preferred stock           162,147  
Accumulated deficit     (211,753 )     (159,962 )
Total stockholders’ equity (deficit)     63,144       (123,730 )

(1) Working capital is defined as total current assets less total current liabilities. See our consolidated financial statements and the related notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2024, for further details regarding our current assets and current liabilities.



BioRestorative Therapies Reports 2024 Financial Results and Provides Business Update

MELVILLE, N.Y., March 27, 2025 (GLOBE NEWSWIRE) — BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a regenerative medicine innovator focused on stem cell-based therapies and products, today reported financial results for the year ended December 31, 2024 and provided an update on its business.

“2024 was a transformative year for BioRestorative, highlighted by significantly improved financial performance and meaningful clinical program advancement,” said Lance Alstodt, BioRestorative’s Chief Executive Officer. “Looking ahead, we remain focused on aggressively executing our growth strategy, and very much look forward to updating investors as we progress.”

Recent Highlights

DEVELOPMENT

  • In November, BioRestorative received a provisional license from the New York State Department of Health (“NYSDOH”) for the processing of allogeneic (non-autologous) donor tissue material for the isolation, expansion and cryopreservation of various cell types, including stem cells, for medical research. Previously, the Company was licensed by the NYSDOH to act as a tissue bank for the processing of mesenchymal stem cells derived from autologous donors only.

Disc/Spine Program

  • In a podium presentation at the 2025 Orthopaedic Research Society (“ORS”) Annual Meeting in February, the Company’s Vice President of Research and Development, Francisco Silva, presented 26–52 week blinded data from the first 15 patients with chronic lumbar disc disease (“cLDD”) enrolled in the ongoing Phase 2 clinical trial of BRTX-100. No serious adverse events (SAEs) were reported, and there was no dose (40X106 cells) limiting toxicity at 26-52 weeks. Preliminary blinded Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) data collected at weeks 26 and 52 post-injection demonstrated an exceptionally positive trend compared to baseline. Furthermore, 52 week comparison of MRI images to baseline appear to demonstrate morphological changes, such as an increase in T2 signal (hydration), a decrease in protrusion size, as well as resolutions of annular tears, potentially demonstrating disc microenvironment remodeling as a result of cLDD treatment with BRTX-100.
    • On the heels of the ORS presentation, BioRestorative announced that the U.S. Food and Drug Administration (“FDA”) granted Fast Track designation to the BRTX-100 program for the treatment of cLDD. Fast Track designation reflects the positive preliminary Phase 2 safety and efficacy data reported to date. The Company hopes that such designation will lead to Priority Review and Accelerated Biologics License Application (BLA) Approval for BRTX-100.
    • Also in February, the FDA cleared the Company’s Investigational New Drug (“IND”) application for BRTX-100 for the treatment of chronic cervical discogenic pain (cCDP), expanding BioRestorative’s advanced clinical pipeline for BRTX-100 to include the treatment of both chronic lower back and neck pain.

Metabolic Program

  • The Company’s previously reported substantive discussions with an undisclosed commercial stage regenerative medicine company with regard to a potential license of BioRestorative’s ThermoStem® metabolic intellectual property are continuing; however, no assurances can be given that a license agreement will be entered into whether on commercially reasonable terms or otherwise.
  • BioRestorative also continues to explore a first-in-human clinical trial for its ThermoStem® metabolic platform technology.

COMMERCIAL

BioCosmeceuticals

  • The Company derived $300,000 in revenue from BioCosmeceuticals in 2024.

Summary 2024 Results

Total revenue for the year ended December 31, 2024 was $401,000, a 175% increase over $146,000 for 2023.

The Company’s 2024 loss from operations was $11.6 million, a 24% improvement from a loss of operations of $15.2 million for 2023.

The Company’s 2024 net loss was $9.0 million, or $1.16 per share, a 14% improvement from a net loss of $10.4 million, or $2.47 per share, for 2023.

Cash used in operating activities in 2024 was $8.2 million.

The Company ended the year in a strong financial position, with cash, cash equivalents, and investments held in marketable securities of $10.7 million, with no outstanding debt.

For complete financial results, please see BioRestorative’s filings at www.sec.gov, and on the Company’s website at www.biorestorative.com under “SEC Filing” in the Investors and Media section.

Conference Call Details

BioRestorative management will host a webcasted conference call with an associated slide presentation today at 4:30pm EDT to review its 2024 financial results and provide a business update. To join the conference call via telephone and participate in the live Q&A session, please dial 888-506-0062 (United States) or 973-528-0011 (International), participant access code 726526. The call will also be webcast live and archived on the investor section of the Company’s website at www.biorestorative.com under “Events”’ in the Investors and Media section.

About BioRestorative Therapies, Inc.

BioRestorative (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. As described below, our two core clinical development programs relate to the treatment of disc/spine disease and metabolic disorders, and we have also recently begun offering BioCosmeceutical products:

• Disc/Spine Program (brtxDISC): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patient’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient’s damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have commenced a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease. We have also obtained U.S. Food and Drug Administration (“FDA”) Investigational New Drug (“IND”) clearance to evaluate BRTX-100 in the treatment of chronic cervical discogenic pain.

• Metabolic Program (ThermoStem®): We are developing cell-based therapy candidates to target obesity and metabolic disorders using brown adipose (fat) derived stem cells (“BADSC”) to generate brown adipose tissue (“BAT”), as well as exosomes secreted by BADSC. BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes. BADSC secreted exosomes may also impact weight loss.

• BioCosmeceuticals: We operate a commercial BioCosmeceutical platform. Our current commercial product, formulated and manufactured as a third party contract manufacturer, using our cGMP ISO-7 certified clean room, is a cell-based secretome containing exosomes, proteins and growth factors. This proprietary biologic serum has been specifically engineered by us to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness. Moving forward, we also intend to explore the potential of expanding our commercial offering to include a broader family of cell-based biologic aesthetic products and therapeutics via IND-enabling studies, with the aim of pioneering FDA approvals in the emerging BioCosmeceuticals space.

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, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company’s latest Form 10-K, as amended, filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:

Stephen Kilmer
Investor Relations
Direct: (646) 274-3580
Email: [email protected]



CTO Realty Growth Announces First Quarter 2025 Earnings Release and Conference Call Information

WINTER PARK, Fla., March 27, 2025 (GLOBE NEWSWIRE) — CTO Realty Growth (NYSE: CTO) (the “Company”) announced today that it will report its financial and operating results for the first quarter of 2025 after the market closes on Thursday, May 1, 2025. A conference call to discuss its financial and operating results is scheduled for Friday, May 2, 2025 at 9:00 AM ET.

A live webcast of the call will be available on the Investor Relations page of the Company’s website at www.ctoreit.com or at the link provided in the event details below. To access the call by phone, please go to the registration link provided in the event details below and you will be provided with dial-in details.

Event Details:
Webcast: https://edge.media-server.com/mmc/p/4tgu64bi
Registration: https://register-conf.media-server.com/register/BI4aedbe642bf743c8bf83e1370af52278
   

We encourage participants to register and dial into the conference call at least fifteen minutes ahead of the scheduled start time. A replay of the earnings call will be archived and available online through the Investor Relations section of the Company’s website at www.ctoreit.com.


About CTO Realty Growth, Inc.

CTO Realty Growth, Inc. owns and operates high-quality, open-air shopping centers located in the higher growth Southeast and Southwest markets of the United States. CTO also externally manages and owns a meaningful interest in Alpine Income Property Trust, Inc. (NYSE: PINE).

We encourage you to review our most recent investor presentation and supplemental financial information, which is available on our website at www.ctoreit.com.

Contact:

Investor Relations
[email protected]