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Release – Gyre Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update

Posted on May 9, 2025May 9, 2025 by aweinsoff@channelchek.com

May 9, 2025

Net Income of $3.7 million; reaffirms Full-Year Revenue Guidance of $118–$128 million

Q1 2025 revenue of $22.1 million; GAAP basic EPS: $0.03
Completed data collection and achieved database lock for the pivotal Phase 3 trial of Hydronidone in Chronic Hepatitis B (“CHB”)-associated liver fibrosis; currently reviewing data and on track to report topline results in Q2 2025
Received IND approval from China’s National Medical Products Administration (“NMPA”) for a new indication of pirfenidone to treat radiation-induced lung injury (“RILI”), with or without immune-related pneumonitis (“CIP”), marking Gyre’s first entry into oncology supportive care space
Initiated commercialization of avatrombopag in China in March 2025, building a strategic presence with liver disease specialists
Nintedanib remains on track for commercialization in May 2025, expanding IPF treatment options across our physician network
$51.3 million in cash, cash equivalents, and short and long-term deposits as of March 31, 2025

SAN DIEGO, May 09, 2025 (GLOBE NEWSWIRE) — Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced financial results for the first quarter ended March 31, 2025 and provided a business update.

“This quarter marked a meaningful step forward in expanding our market presence, particularly in the liver space,” said Han Ying, Ph.D., CEO of Gyre Therapeutics. “The successful launch of avatrombopag and our growing commercial footprint with hepatology and hematology specialists provide a strong foundation for our future growth. In addition, the recent NMPA approval to initiate a clinical trial of pirfenidone in radiation-induced lung injury, including with or without immune-related pneumonitis, supports our ability to enter the oncology supportive care space with a novel, lung-protective therapy. We plan to initiate an adaptive Phase 2/3 trial in the second half of 2025 to advance this program through development.”

First Quarter 2025 Business Highlights and Upcoming Milestones

Commercial Portfolio Expansion

ETUARY^® (pirfenidone): Delivered $21.7 million in Q1 sales. While sales declined year-over-year due to relatively high sales in the first quarter of 2024, ETUARY remains the market leader for idiopathic pulmonary fibrosis (IPF) in the PRC.

Nintedanib: Gyre remains on track to commercially launch nintedanib in May 2025, targeting multiple forms of fibrosing interstitial lung disease (“ILD”), including IPF, systemic sclerosis-associated ILD, and progressive fibrosing ILD. This is expected to expand Gyre’s share of the pulmonary fibrosis treatment landscape and support second-half 2025 revenue growth.

Avatrombopag: Commercialization of avatrombopag was initiated in March 2025, expanding Gyre’s footprint in hepatology and hematology. Approved for thrombocytopenia in adults with chronic liver disease and immune thrombocytopenic purpura, the launch aligns with Gyre’s strategy to deepen clinical engagement with liver disease specialists and diversify the market of available products.

Indication Expansion: Oncology Supportive Care

Pirfenidone New Indication: In March 2025, Gyre received NMPA approval to initiate a clinical trial of pirfenidone for RILI, including cases complicated by CIP. This development positions pirfenidone for potential entry into oncology supportive care, with plans to begin an adaptive Phase 2/3 trial in the second half of 2025 across top oncology centers in China.

Pipeline Development Updates

F573:

F573 is a caspase inhibitor and potential Category 1 new drug for the treatment of acute/acute on-chronic liver failure (“ALF/ACLF”). Completion of the Phase 2 clinical trial of F573 for ALF/ACLF is expected by the end of 2026.

F230:

F230, a selective endothelin receptor agonist for the treatment of pulmonary arterial hypertension (“PAH”), is expected to begin a Phase 1 trial in Q2 2025.

F528:

F528, a novel anti-inflammation agent with the potential to modify the progression of chronic obstructive pulmonary disease (“COPD”), is undergoing preclinical studies as a potential first-line therapy for the treatment of COPD. Gyre Pharmaceuticals plans to submit an IND application in 2026.

Corporate Updates

In March 2025, Gyre appointed Ping Zhang as Executive Chairman of the Company’s Board of Directors; he remains a member of the Nominating and Corporate Governance Committee.

Financial Results

Cash Position

As of March 31, 2025, Gyre Therapeutics held $15.0 million in cash and cash equivalents, $14.8 million in short-term bank deposits, and $21.4 million in long-term certificates of deposit, totaling $51.3 million.

Gyre believes that its existing cash resources, combined with anticipated cash flow from commercial operations, will be sufficient to fund its operating and capital requirements for the next 12 months.

Financial Results for the Three Months Ended March 31, 2025

Revenues: Revenues for the three months ended March 31, 2025, were $22.1 million, compared to $27.2 million in the same period last year. The $5.1 million decrease was primarily due to a $5.2 million decline in ETUARY^® sales. This was anticipated, as early 2024 revenues were elevated by a one-time marketing campaign focused on rural expansion, which we did not repeat in 2025. The shift in marketing resources was deliberate, with funds reallocated to support the upcoming launches of Nintedanib and avatrombopag. Additionally, weaker economic conditions in China and increased competition in the IPF treatment market also contributed to the decline. Revenues from generic products decreased by $0.2 million, partially offset by $0.3 million in initial revenue from the March 2025 launch of avatrombopag.

Gyre anticipates revenue growth over the remainder of the year, driven by the planned commercial launch of Nintedanib in May 2025 and the continued expansion of avatrombopag. Based on current performance and market outlook, the company is reaffirming its full-year 2025 revenue guidance of $118 to $128 million¹, compared to $105.8 million in 2024.

Cost of Revenues: For the three months ended March 31, 2025, cost of revenues was $0.9 million, compared to $1.0 million for the same period in 2024. The $0.1 million decrease was in line with the corresponding decline in sales.
Selling & Marketing Expense: For the three months ended March 31, 2025, selling and marketing expense was $10.8 million, compared to $12.5 million for the same period in 2024. The $1.7 million decrease was primarily driven by a reduction in commission costs due to the decrease of sales.
Research & Development Expense: For the three months ended March 31, 2025, research and development expense was $3.1 million, compared to $2.2 million for the same period in 2024. The increase was primarily attributable to Gyre Pharmaceuticals and was driven by a $1.3 million increase in clinical research expenses, primarily related to data analysis costs for F351. This increase was partially offset by a $0.2 million decrease in materials and utilities and a $0.1 million reduction in staff costs, primarily due to reduction of headcounts. The overall increase was further offset by a $0.1 million decrease from Gyre Therapeutics, due to the reduction in contract services.

[1] 2025 revenue guidance assumes a constant foreign currency exchange rate and no significant economic disruption or downturn.

General & Administrative Expense: For the three months ended March 31, 2025, general and administrative expense was $5.0 million, compared to $3.4 million for the same period in 2024. The increase was primarily driven by a $0.6 million increase in functional and administrative department’s personnel and stock compensation costs, a $0.8 million increase in miscellaneous expense, mainly due to the increase in the annual meeting expense.
Income from operations: For the three months ended March 31, 2025, income from operations was $2.3 million, compared to $8.1 million for the same period in 2024. The decrease was primarily due to a reduction in revenue.
Net Income: For the three months ended March 31, 2025, net income was $3.7 million, compared to $9.9 million in net income for the same period in 2024. The decrease was primarily attributable to lower income from operations and unfavorable change in fair value of warrant liabilities.
Non-GAAP Adjusted Net Income: For the three months ended March 31, 2025, non-GAAP adjusted net income was $2.9 million, compared to $8.2 million non-GAAP adjusted net income for the same period in 2024. The decrease was primarily driven by the decline in revenue of $5.1 million and increase in operating expenses of $0.2 million.

Use of Non-GAAP Financial Measures by Gyre Therapeutics, Inc.

Gyre reports financial results in accordance with accounting principles generally accepted in the United States (“GAAP”). This release presents the financial measure “adjusted net income,” which is not calculated in accordance with GAAP. The most directly comparable GAAP measure for this non-GAAP financial measure is “net income.” Adjusted net income presents Gyre’s results of operations after excluding gain from change in fair value of warrants, stock-based compensation, and provision for income taxes. This is meant to supplement, and not substitute, Gyre’s financial information presented in accordance with GAAP. Adjusted net income as defined by Gyre may not be comparable to similar non-GAAP measures presented by other companies. Management believes that presenting adjusted net income provides investors with additional useful information in evaluating the Gyre’s performance and valuation. See the reconciliation of adjusted net income to net income in the section titled “Reconciliation of GAAP to Non-GAAP Financial Measures” below.

About F351 (Hydronidone)

F351 is a structural analogue of the approved anti-fibrotic IPF drug pirfenidone and has been shown to inhibit in vitro both p38γ kinase activity and TGF-β1-induced excessive collagen synthesis in hepatic stellate cells (“HSCs”), which are recognized as critical event in the development and progression of fibrosis in the liver. This is further supported by its anti-proliferative effects on the HSCs in the liver. In vitro anti-fibrotic effects of F351 were also confirmed in several established in vivo models of liver fibrosis such as CCI4-induced liver fibrosis mouse model, DMN-induced liver fibrosis rat model, and HSA-induced liver rat model, as well as mouse model of MASH fibrosis (CCI4+Western High Fat Diet).

About Gyre Pharmaceuticals

Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY^® (pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2024 net sales of $105.8 million). In addition, Gyre Pharmaceuticals is evaluating F351 in a Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC, which is expected to report topline data by Q2 2025. F351 received Breakthrough Therapy designation by the NMPA Center for Drug Evaluation in March 2021. Gyre Pharmaceuticals is also developing treatments for PD, DKD, RILI with or without immune-related pneumonitis, COPD, PAH and ALF/ACLF. In October 2023, Gyre Therapeutics acquired an indirect majority interest in Gyre Pharmaceuticals (also known as Beijing Continent Pharmaceuticals Co., Ltd.).

About Gyre Therapeutics

Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, with a primary focus on the development and commercialization of F351 (Hydronidone) for the treatment of MASH-associated fibrosis in the U.S. Gyre’s development strategy for F351 in MASH is based on the company’s experience in MASH rodent model mechanistic studies and CHB-induced liver fibrosis clinical studies. Gyre is also advancing a diverse pipeline in the PRC through its indirect controlling interest in Gyre Pharmaceuticals, including ETUARY therapeutic expansions, F573, F528, and F230.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the expectations regarding Gyre’s research and development efforts, timing of expected clinical readouts, including topline results of the Phase 3 trial of Hydronidone in CHB-associated liver fibrosis, timing of initiation of Gyre’s Phase 2 trial in the U.S. for F351 for the treatment of MASH-associated liver fibrosis, initiation of Gyre Pharmaceuticals’ clinical trial evaluating pirfenidone capsules in oncology-related pulmonary complications, timing of completion of Gyre’s Phase 2 clinical trial in the PRC of F573 for ALF/ACLF, initiation of Phase 1 trial of F230 for the treatment of PAH and IND submission of F528 in COPD, the expectations regarding commercial launch of nintedanib, interactions with regulators, expectations regarding future product sales, and Gyre’s financial position and cash resources. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings with the Securities and Exchange Commission.

Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

For Investors:

Stephen Jasper

stephen@gilmartinir.com

View full release here.

Release – SelectQuote Responds to Allegations in Department of Justice Complaint

Posted on May 9, 2025May 9, 2025 by aweinsoff@channelchek.com

Research News and Market Data on SLQT

05/09/2025

For over 40 years, SelectQuote has helped millions of Americans find the right insurance coverage to meet their healthcare needs. Our steadfast commitment to integrity, compliance and customer service is foundational to our business.

OVERLAND PARK, Kan.–(BUSINESS WIRE)– SelectQuote, Inc. (NYSE: SLQT), a leading distributor of Medicare insurance policies and owner of a rapidly-growing healthcare services platform, strongly disagrees with the allegations made by the Department of Justice (DoJ) complaint filed against multiple participants in the Medicare Advantage industry last week. SelectQuote believes the allegations are incorrect and lack a clear understanding of the overall industry and SelectQuote’s business model.

As we have previously disclosed, we have cooperated with the DoJ’s inquiries since 2022. We firmly reject these allegations and will defend our reputation as a compliant and fair-dealing standard bearer in the Medicare Advantage industry.

SelectQuote’s mission remains as it always has been: to connect our customers to the best insurance plans to meet their unique needs. We look forward to continuing our 40-year legacy as customer-focused, value-enhancing broker in the Medicare Advantage sector.

Over the past four decades, we have served over 8 million Americans, helping them find the right insurance coverage for their needs. We are particularly proud of our Senior health work, which helps some of the most underserved communities in every corner of our country, including many seniors in small towns, rural areas, and urban areas.

The beneficiary population we serve also skews toward seniors who are both lower income and less healthy than the U.S. average. The percent of our customers who qualify for dual special needs plans based upon their income level is more than twice the national average. Our policy sales also represent a much higher portion of individuals with severe and chronic diseases than the national average.

Throughout our history, we have worked hard to build a culture based on values of integrity and compliance, and we require and prioritize adherence to all applicable laws, rules and regulations.

SelectQuote will defend itself against the allegations in the DoJ’s complaint, and we are confident that once the facts are presented, there will be a positive resolution to this matter.

About SelectQuote:

Founded in 1985, SelectQuote (NYSE: SLQT) pioneered the model of providing unbiased comparisons from multiple, highly-rated insurance companies, allowing consumers to choose the policy and terms that best meet their unique needs. Two foundational pillars underpin SelectQuote’s success: a strong force of highly-trained and skilled agents who provide a consultative needs analysis for every consumer, and proprietary technology that sources and routes high-quality leads. Today, the Company operates an ecosystem offering high touchpoints for consumers across insurance, pharmacy, and virtual care.

With an ecosystem offering engagement points for consumers across insurance, Medicare, pharmacy, and value-based care, the company now has three core business lines: SelectQuote Senior, SelectQuote Healthcare Services, and SelectQuote Life. SelectQuote Senior serves the needs of a demographic that sees around 10,000 people turn 65 each day with a range of Medicare Advantage and Medicare Supplement plans. SelectQuote Healthcare Services is comprised of the SelectRx Pharmacy, a Patient-Centered Pharmacy Home™ (PCPH) accredited pharmacy, SelectPatient Management, a provider of chronic care management services, and Healthcare Select which proactively connects consumers with a wide breadth of healthcare services supporting their needs.

Investor Relations:
Sloan Bohlen
877-678-4083
investorrelations@selectquote.com

Media:
Matt Gunter
913-286-4931
matt.gunter@selectquote.com

Source: SelectQuote, Inc.

Release – Ocugen Provides Business Update with First Quarter 2025 Financial Results

Posted on May 9, 2025May 9, 2025 by aweinsoff@channelchek.com

Research News and Market Data on OCGN

May 9, 2025

PDF Version

Conference Call and Webcast Today at 8:30 a.m. ET

OCU400 Phase 3 clinical trial for retinitis pigmentosa (RP) is progressing well and on target for potential BLA/MAA filings by mid-2026
Anticipate initiating OCU410ST Phase 2/3 pivotal confirmatory clinical trial for Stargardt disease mid- 2025

MALVERN, Pa., May 09, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today reported first quarter 2025 financial results along with a general business update.

“All three of our novel modifier gene therapies are advancing through the clinic and we are on track to meet our goal of three Biologics License Application (BLA)/Marketing Authorization Application (MAA) filings in the next three years,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “We remain steadfast in our mission to provide a one-time therapy for life to address considerable unmet medical needs that exist for millions of patients facing the terrifying prospect of losing their vison.”

In January, the Company announced positive two-year long-term safety and efficacy data from the Phase 1/2 clinical trial of OCU400 for RP that demonstrated a durable, clinically meaningful, and statistically significant (p=0.005) improvement in visual function (LLVA) in all evaluable treated subjects at two years when compared to untreated eyes. Additionally, 100% (10/10) of treated evaluable subjects demonstrated improvement or preservation in visual function compared to untreated eyes. This data further supports the gene-agnostic mechanism of action of OCU400, a broad RP treatment not restricted to specific mutations, with durability.

The OCU400 Phase 3 liMeliGhT clinical trial is open to all eligible RP patients—early to advanced stage RP including pediatric subjects age 5+—regardless of gene mutation (syndromic and non-syndromic forms of RP). OCU400 has the potential to treat all 300,000 RP patients in the U.S. and EU.

Alignment was reached with the FDA to move forward with a Phase 2/3 pivotal confirmatory trial for OCU410ST for Stargardt disease, which includes an adaptive design with a masked interim analysis at 8 months. Stargardt disease affects 100,000 people in the U.S. and EU. The Phase 2/3 clinical trial will randomize 51 subjects, 34 of whom will receive a single, subretinal, injection of OCU410ST (200 μL at a concentration of 1.5 × 10¹¹ vector genomes/mL) in the eye with worse visual acuity, and 17 of whom will serve as untreated controls. The primary endpoint in the clinical trial is change in atrophic lesion size. Key secondary endpoints include visual acuity as measured by best corrected visual acuity (BCVA) and LLVA compared to untreated controls. One-year data will be utilized for the BLA filing. The latest data from the OCU410ST Phase 1 clinical trial demonstrates atrophic lesions grew slower by 54% at six months in evaluable treated eyes when compared to untreated eyes. In BCVA, treated eyes demonstrated statistically significant (p=0.02) improvement in visual function when compared to untreated fellow eyes. Ocugen plans to initiate the Phase 2/3 study by mid-year with a target BLA filing in 2027.

In February, dosing was complete in the Phase 2 portion of the OCU410 Phase 1/2 ArMaDa clinical trial for geographic atrophy (GA), an advanced stage of dry age-related macular degeneration (dAMD). In evaluable subjects, OCU410 12-month data demonstrates a 4-line (23-letter) gain in visual acuity and 41% slower GA lesion growth in treated eyes versus untreated fellow eyes after a single injection. The unique mechanism of action of OCU410 targets multiple pathways associated with dAMD pathogenesis, in contrast to products currently approved or under development that treat only one cause of GA, require multiple injections per year, and have safety considerations. Approximately 2-3 million patients in the U.S. & EU and 8 million globally suffer from GA.

All of Ocugen’s modifier gene therapies—OCU400 for RP, OCU410ST for Stargardt disease, and OCU410 for GA were granted Advanced Therapy Medicinal Product (ATMP) classification from the European Medicines Agency’s (EMA) Committee for Advanced Therapies. ATMP classification is granted to medicines that can offer groundbreaking opportunities for the treatment of disease and accelerates the regulatory review timeline of this potential one-time gene therapy for life. Additionally, this classification allows the Company to interact with the EMA more frequently for scientific advice and protocol assistance.

Relevant to Ocugen’s recent ATMP classifications, Dr. Musunuri participated in a panel addressing the journey of successfully commercializing ATMPs, which focused on the challenges and strategies in achieving commercial success while also ensuring access for the patients who need them, during the 2025 Cell & Gene Meeting on the Mediterranean, hosted by the Alliance for Regenerative Medicine. The Meeting on the Med provided an excellent forum to reach a wide audience about the importance of changing the treatment paradigm by bringing potentially transformative modifier gene therapies to market.

Also in the first quarter of 2025, the first patient was dosed in the Phase 1 clinical trial for OCU200, the Company’s biologic product candidate for diabetic macular edema. Currently, patients are being dosed in the second cohort and Ocugen is planning to complete the Phase 1 clinical trial in the second half of this year. The Company intends to initiate the Phase 3 trial for NeoCart® contingent on adequate availability of funding and/or based on the potential of a future partnership. Finally, the Investigational New Drug application is in effect for OCU500, and the National Institute of Allergy and Infectious Diseases intends to initiate a Phase 1 clinical trial in the second quarter of 2025. Ocugen is continuing discussions with relevant government agencies as well as strategic partners regarding developmental funding for its vaccines technology for flu.

“We have had a strong start to 2025 and are approaching considerable milestones in the next few months,” said Dr. Musunuri. “I am enthusiastic about where we are as a Company, with a clear and precise business strategy to operate efficiently in service of our patients and shareholders.”

Modifier Gene Therapy Platform—a Novel First-in-Class Platform

OCU400 for RP – The EMA provided a positive opinion for ATMP classification for OCU400 and granted eligibility to submit the OCU400 MAA via the centralized procedure as an ATMP based on the current study design and statistical analysis plan. Actively recruiting patients in the U.S. and Canada in the Phase 3 liMeliGhT clinical trial and on track to meet BLA/MAA filing targets in mid-2026.
OCU410ST for Stargardt Disease – Received FDA alignment to move forward with Phase 2/3 pivotal confirmatory clinical trial, which can be the basis of a BLA submission. ATMP classification granted by the EMA.
OCU410 for GA – Announced that dosing was complete, ahead of schedule, in the Phase 2 portion of the Phase 1/2 ArMaDa clinical trial for OCU410. Received ATMP classification from the EMA.

First Quarter 2025 Financial Results

The Company’s cash and restricted cash totaled $38.1 million as of March 31, 2025, compared to $58.8 million as of December 31, 2024. The Company had 292.0 million shares of common stock outstanding as of March 31, 2025. The Company expects its cash and restricted cash runway into the first quarter of 2026.
Total operating expenses for the three months ended March 31, 2025 were $16.0 million and included research and development expenses of $9.5 million and general and administrative expenses of $6.5 million. This compares to total operating expenses for the three months ended March 31, 2024 of $13.2 million that included research and development expenses of $6.8 million and general and administrative expenses of $6.4 million.
Ocugen reported a $0.05 net loss per common share for the three months ended March 31, 2025 compared to a $0.05 net loss per common share for the three months ended March 31, 2024.

Conference Call and Webcast Details

Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks.

Attendees are invited to participate on the call or webcast using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 1773288
Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.

About Ocugen, Inc.
Ocugen, Inc. is a pioneering biotechnology leader in gene therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late stage dry age-related macular degeneration. Discover more at www.ocugen.com and follow us X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, the ability to initiate new clinical programs; Ocugen’s expected cash runway, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our annual and periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Communications
IR@ocugen.com

View full release here.

Release – Zomedica to Report First Quarter 2025 Financial Results with a Business Update on Thursday, May 15, 2025 at 4:30 pm ET

Posted on May 9, 2025May 9, 2025 by aweinsoff@channelchek.com

Research News and Market Data on ZOMDF

ANN ARBOR, MI / ACCESS Newswire / May 9, 2025 / Zomedica Corp. (OTCQB:ZOMDF) (“Zomedica” or the “Company”), a veterinary health company offering point-of-care diagnostic and therapeutic products for equine and companion animals, will host a conference call and audio-only webcast on Thursday, May 15, 2025, at 4:30 p.m. ET to discuss the Company’s operational and financial highlights for its first quarter ended March 31, 2025. A question-and-answer session will follow management’s prepared remarks.

Event: Zomedica First Quarter 2025 Earnings Call

Date: Thursday, May 15, 2025

Time: 4:30 p.m. Eastern Time

Live Call: +1-800-717-1738 (U.S. Toll-Free) or +1-646-307-1865 (International)

Webcast: LINK

For interested individuals unable to join the conference call, a dial-in replay of the call will be available until Thursday, May 29, 2025 at 11:59 PM ET and can be accessed by dialing +1-844-512-2921 (U.S. Toll-Free) or +1-412-317-6671 (International) and entering replay pin number: 1148151.

About Zomedica

Zomedica is a leading equine and companion animal healthcare company dedicated to improving animal health by providing veterinarians innovative therapeutic and diagnostic solutions. Our gold standard PulseVet^® shock wave system, which accelerates healing in musculoskeletal conditions, has transformed veterinary therapeutics. Our suite of products also includes the Assisi^® Loop line of therapeutic devices, along with the TRUFORMA^® diagnostic platform, TRUVIEW^® digital cytology system, VETGuardian^® no-touch monitoring system, and VETIGEL^® hemostatic gel, all designed to empower veterinarians to provide top-tier care. In the aggregate, their total addressable market in the U.S. exceeds $2 billion. Headquartered in Michigan, Zomedica employs approximately 150 people and manufactures and distributes its products from its world-class facilities in Georgia and Minnesota. Zomedica grew revenue 8% in 2024 to $27 million and maintains a strong balance sheet with approximately $71 million in liquidity as of December 31, 2024. Zomedica is advancing its product offerings, leveraging strategic acquisitions, and expanding internationally as we work to enhance the quality of care for pets, increase pet parent satisfaction, and improve the workflow, cash flow and profitability of veterinary practices. For more information visit www.zomedica.com.

Follow Zomedica

Email Alerts: http://investors.zomedica.com
LinkedIn: https://www.linkedin.com/company/zomedica
Facebook: https://m.facebook.com/zomedica
X (formerly Twitter): https://twitter.com/zomedica
Instagram: https://www.instagram.com/zomedica_inc

Investor Relations Contact:

Zomedica Investor Relations
investors@zomedica.com
1-734-369-2555

SOURCE: Zomedica Corp.

View the original press release on ACCESS Newswire

Cadrenal Therapeutics (CVKD) – Cadrenal Reports Tecarfarin Updates With 1Q25 Report

Posted on May 9, 2025May 9, 2025 by cpereira@noblefcm.com

Friday, May 09, 2025

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

First Quarter Was Highlighted By The Collaboration With Abbott. Cadrenal Therapeutics reported a 1Q25 loss of $3.8 million or $(2.09) per share. An important development during the quarter was an agreement with Abbott to develop tecarfarin in LVADs (Left Ventricular Assist Devices). As planned, the company held a meeting with the FDA to discuss the next steps for clinical development of tecarfarin, its anticoagulant. Cash on March 31, 2025 was $7.3 million.

Meeting For Clinical Development Guidance Held With FDA. Cadrenal and the FDA held a meeting to discuss plans to conduct clinical trials to support an application for tecarfarin approval. The FDA gave guidance on the design and data requirements. Cadrenal plans to use the information to plan the final study design then submit it to the FDA for review and feedback.

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Information Services Group (III) – First Look 1Q25

Posted on May 9, 2025May 9, 2025 by cpereira@noblefcm.com

Friday, May 09, 2025

ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 700 clients, including more than 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including automation, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs more than 1,300 digital-ready professionals operating in more than 20 countries—a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For additional information, visit www.ISG-One.com

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

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Q1 Results. Reported Q1 revenue of $59.6 million, slightly over the top end of management’s issued guidance and our estimate of $59.0 million. Net income totaled $1.5 million, or $0.03 per diluted share, an improvement from a loss of $3.4 million, or $0.07 per share, last year. We estimated a net income of $0.78 million or $0.02 per share. Adjusted EBITDA was $7.4 million, near the high end of management’s issued guidance and above our estimate of $6.5 million. Adjusted EPS for Q1 came in at $0.07 per share, up from $0.01 per share last year, and above our estimate of $0.05 per share.

Favorable Developments. Notably, adj. EBITDA increased 68%, and adj. EBITDA margin increased by more than 550 basis points compared to the prior year period. The favorable growth in adj. EBITDA and adj. EBITDA margin are reflective of the Company’s disciplined operating approach and improved business mix. Additionally, we believe the Company is well-positioned to benefit from the uncertain economic environment as more companies look to optimize costs with investments in technology.

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Kelly Services (KELYA) – First Look 1Q25

Posted on May 9, 2025May 9, 2025 by cpereira@noblefcm.com

Friday, May 09, 2025

Kelly (Nasdaq: KELYA, KELYB) connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. We’re always thinking about what’s next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ nearly 350,000 people around the world and connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice. Revenue in 2021 was $4.9 billion. Visit kellyservices.com and let us help with what’s next for you.

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Q1 Results. The Company recorded revenue of $1.16 billion, up 11.5% year over year, in line with our estimate of $1.16 billion. Adj. EBITDA came in at $34.9 million, up 4.8% over the prior year period and modestly lower than our estimate of $36.5 million. Adj. EBITDA margin decreased 20 basis points to 3.0%. Furthermore, Kelly reported net income of $0.16/sh. On an adjusted basis, EPS was $0.39/sh compared to $0.56/sh last year and our estimate of $0.60/sh.

Solid Results. The y-o-y revenue growth of 11.5% was largely driven by the Company’s May 2024 acquisition of Motion Recruitment Partners (MRP). On an organic basis, total revenue was only up 0.2%, which includes a 0.8% decrease in revenue from U.S. federal contractors and a 6.3% increase in Education segment revenue.

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1-800-Flowers.com (FLWS) – Recent Quarter Highlights Significant Challenges

Posted on May 9, 2025May 9, 2025 by cpereira@noblefcm.com

Friday, May 09, 2025

For more than 45 years, 1-800-Flowers.com has offered truly original floral arrangements, plants and unique gifts to celebrate birthdays, anniversaries, everyday occasions, and seasonal holidays, and to deliver comfort during times of grief. Backed by a caring team obsessed with service, 1-800-Flowers.com provides customers thoughtful ways to express themselves and connect with the most important people in their lives. 1-800-Flowers.com is part of the 1-800-FLOWERS.COM, Inc. family of brands. Shares in 1-800-FLOWERS.COM, Inc. are traded on the NASDAQ Global Select Market, ticker symbol: FLWS.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Fiscal Q3 disappoints. Fiscal Q3 revenues of $311.5 million was well below our $367.8 million estimate. Adj. EBITDA loss of $38.6 million was below our seasonal loss estimate of $12.4 million. In spite of a good Valentine’s Day, fiscal third quarter results were adversely affected by weakened consumer confidence and macro economic forces.

Pulls guidance. In lieu of recent trade policies and a weakened consumer, management pulled fiscal full year 2025 guidance. We estimate that fiscal Q4 revenues will decline roughly 6.3% (including the benefit of Easter) and that the company will report an adj. EBITDA loss of $20.5 million. Fiscal full year 2025 revenue and adj. EBIDA are revised to $1.687 billion and $29.2 million, respectively.

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DLH Holdings (DLHC) – Post Call Commentary and Updated Models

Posted on May 9, 2025May 9, 2025 by cpereira@noblefcm.com

Friday, May 09, 2025

DLH delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,300 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit www.DLHcorp.com.

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Moving Forward. While the path forward has been more challenging than we had anticipated, we believe DLH remains on the right path to strong operating results. We believe the Company’s core competencies are well aligned with the Federal government’s goals.

New Business. Management expects some $1 billion of business to be awarded by the end of the fiscal year, providing a substantial opportunity for DLH to win its fair share and drive organic growth in 2026. Yesterday, the Company announced it had been awarded a five year task order valued at up to $37.7 million to continue delivering scientific research and development, modeling & simulation, artificial intelligence, machine learning, robotic process automation, biomedical engineering, and cloud-enabled big data analytic solutions for the Telemedicine and Advanced Technology Research Center.

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InPlay Oil (IPOOF) – Revising Estimates Based on Updated Corporate Guidance

Posted on May 9, 2025May 9, 2025 by cpereira@noblefcm.com

Friday, May 09, 2025

InPlay Oil is a junior oil and gas exploration and production company with operations in Alberta focused on light oil production. The company operates long-lived, low-decline properties with drilling development and enhanced oil recovery potential as well as undeveloped lands with exploration possibilities. The common shares of InPlay trade on the Toronto Stock Exchange under the symbol IPO and the OTCQX Exchange under the symbol IPOOF.

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

Hans Baldau, Associate Analyst, Noble Capital Markets, Inc.

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First quarter financial results. InPlay Oil reported a first quarter net loss of C$2.9 million or C$0.18 per share compared to net income of C$1.7 million or C$0.02 per share during the prior year period. This was below our net income estimate of C$4.2 million or C$0.15 per share, primarily due to an unrealized loss on derivative contracts of C$4.6 million and higher-than-expected expenses. Moreover, commodity prices declined slightly during the first quarter, leading to lower revenues of C$38.4 million compared to our estimate of C$40.4 million.

Corporate 2025 guidance. The company generated quarterly production of 9,076 barrels of oil equivalent per day (boe/d), a 5% increase year-over-year and above our expectations of 8,800 boe/d. The company is raising its estimated field production expectations to 21,500 boe/d, a marked increase from 18,750 boe/d, and expects 2025 full year production to be in the range of 16,000 to 16,800 boe/d. Revenue guidance has been adjusted downward to C$46.75 to C$51.75 boe/d from C$56.50 to C$61.50 boe/d. Adjusted funds flow is expected to be between C$124 million and C$133 million, down from $204 million.

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Townsquare Media (TSQ) – Showing The Rest How Its Done

Posted on May 9, 2025May 9, 2025 by cpereira@noblefcm.com

Friday, May 09, 2025

Townsquare is a community-focused digital media and digital marketing solutions company with market leading local radio stations, principally focused outside the top 50 markets in the U.S. Our assets include a subscription digital marketing services business, Townsquare Interactive, providing website design, creation and hosting, search engine optimization, social media and online reputation management as well as other digital monthly services for approximately 26,800 SMBs; a robust digital advertising division, Townsquare IGNITE, a powerful combination of a) an owned and operated portfolio of more than 330 local news and entertainment websites and mobile apps along with a network of leading national music and entertainment brands, collecting valuable first party data, and b) a proprietary digital programmatic advertising technology stack with an in-house demand and data management platform; and a portfolio of 321 local terrestrial radio stations in 67 U.S. markets strategically situated outside the Top 50 markets in the United States. Our portfolio includes local media brands such as WYRK.com, WJON.com, and NJ101.5.com and premier national music brands such as XXLmag.com, TasteofCountry.com, UltimateClassicRock.com and Loudwire.com.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Solid first quarter results. Total company revenues were down a modest 1% to $98.7 million, in line with our $98.5 million estimate. Digital revenues increased 6.4%, nearly completely offsetting the weakness in legacy broadcast. Notably, Digital revenue in the quarter represented 57% of total revenue, but, more importantly, 62% of total company adj. EBITDA. Q1 adj. EBITDA of $18.1 million was better than our $17.0 million estimate.

Ignite continues to be on fire. Ignite, the company’s programmatic/advertising solutions business, increased revenues an attractive 7.6% in the quarter. Management indicated that the growth of Ignite will be enhanced by its white label initiative, which is expected to account for $10 million in revenue in 2025 and is expected to grow to $50 million in the next 3 to 5 years and with a 20% operating margin.

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Saga Communications (SGA) – Unique Digital Strategy Gains Traction

Posted on May 9, 2025May 9, 2025 by cpereira@noblefcm.com

Friday, May 09, 2025

Saga Communications, Inc. is a broadcast company whose business is primarily devoted to acquiring, developing and operating radio stations. Saga currently owns or operates broadcast properties in 27 markets, including 79 FM and 33 AM radio stations. Saga’s strategy is to operate top billing radio stations in mid sized markets, defined as markets ranked (by market revenues) from 20 to 200. Saga’s radio stations employ a myriad of programming formats, including Active Rock, Adult Album Alternative, Adult Contemporary, Country, Classic Country, Classic Hits, Classic Rock, Contemporary Hits Radio, News/Talk, Oldies and Urban Contemporary. In operating its stations, Saga concentrates on the development of strong decentralized local management, which is responsible for the day-to-day operations of the stations in their market area and is compensated based on their financial performance as well as other performance factors that are deemed to effect the long-term ability of the stations to achieve financial objectives. Saga began operations in 1986 and became a publicly traded company in December 1992. The stock trades on NASDAQ under the ticker symbol “SGA”.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Q1 Results. The company reported Q1 revenue of $24.2 million and an adj. EBITDA loss of $0.5 million, both of which declined over the prior year period, but were modestly better than our estimates of $23.0 million and a loss of $1.1 million, respectively, as illustrated in Figure #1 Q1 Results. Notably, the company is focused on its blended digital growth strategy and improving profitability. We believe the company’s strategic actions are a step in the right direction for returning toward revenue and adj. EBITDA growth.

Digital growth strategy. The company’s blended growth strategy combines radio and digital advertising to provide a consistent message to customers on both mediums and to drive radio listeners to digital platforms. Notably, year to date, the company has generated digital revenue of $5.3 million, surpassing the company’s $5.0 million generated for full year 2024.

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The ONE Group Hospitality (STKS) – A Solid Start to 2025

Posted on May 9, 2025May 9, 2025 by cpereira@noblefcm.com

Friday, May 09, 2025

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

A Solid Start. ONE Group reported results modestly above our expectations for 1Q25. The accomplishments were driven by another quarter of sequential improvement in comparable sales trends, positive comparable sales at the Benihana restaurants, and strong positive transaction growth of 4.1% at the flagship STK brand.

1Q25 Results. ONE Group reported revenue of $211.1 million, up nearly 150% y-o-y, driven by the May 2024 Benihana acquisition. Same Store Sales declined 3.2%, compared to guidance of a negative 3-4%. Adjusted EBITDA was $25.2 million, up from $7.6 million. Adjusted EPS came in at $0.14, compared to an adjusted loss of $0.02/sh last year.

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