Mersana Therapeutics Announces Additional FDA Fast Track Designation Granted to Emiltatug Ledadotin (XMT-1660)

Conference call to discuss positive initial Phase 1 clinical data today at 8:30 a.m. ET

CAMBRIDGE, Mass., Jan. 10, 2025 (GLOBE NEWSWIRE) — Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today announced the U.S. Food and Drug Administration (FDA) recently granted an additional Fast Track designation to XMT-1660. The company also announced that the World Health Organization has approved emiltatug ledadotin (abbreviated as Emi-Le) as XMT-1660’s international nonproprietary name (INN).

The new Fast Track designation is for the treatment of advanced or metastatic breast cancer in patients with human epidermal growth factor receptor 2 (HER2) low (IHC 1+ or IHC 2+/ISH–) or HER2-negative (IHC 0) disease, including triple-negative breast cancer (TNBC), who have received a prior topoisomerase-1 inhibitor ADC. Additionally, hormone-receptor positive patients should also have received or be ineligible for endocrine therapy. The FDA previously granted Fast Track designation to Emi-Le for the treatment of adult patients with advanced or metastatic recurrent TNBC.

“Topoisomerase-1 inhibitor ADCs are rapidly becoming the standard of care for metastatic TNBC and hormone-receptor positive breast cancer, and an increasing amount of research shows that these patients are exceedingly difficult to treat thereafter,” said Martin Huber, M.D., President and Chief Executive Officer of Mersana Therapeutics. “This growing population is a primary focus for us as we advance the development of Emi-Le. We are excited to announce this additional Fast Track designation and the initial clinical data from our ongoing Phase 1 clinical trial that were press released separately this morning.”

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fill an unmet medical need. A product candidate granted Fast Track designation may be eligible for several benefits, including more frequent meetings and communications with the FDA and, if certain criteria are met, the potential for Accelerated Approval, Priority Review or Rolling Review of a Biologics License Application (BLA) by the FDA.


Conference Call Information


Mersana will host a conference call today at 8:30 a.m. ET to discuss the initial clinical data from its Phase 1 clinical trial of Emi-Le. To access the call, please dial 833-255-2826 (domestic) or 412-317-0689 (international). A live webcast that includes the data presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com, and a replay of the webcast will be available in the same location following the conference call for approximately 90 days.


About Mersana Therapeutics


Mersana Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel antibody-drug conjugates (ADCs) and driven by the knowledge that patients are waiting for new treatment options. The company has developed proprietary cytotoxic (Dolasynthen) and immunostimulatory (Immunosynthen) ADC platforms that are generating a pipeline of wholly-owned and partnered product candidates with the potential to treat a range of cancers. Its pipeline includes Emi-Le (emiltatug ledadotin; XMT-1660), a Dolasynthen ADC targeting B7-H4, and XMT-2056, an Immunosynthen ADC targeting a novel epitope of human epidermal growth factor receptor 2 (HER2). Mersana routinely posts information that may be useful to investors on the “Investors & Media” section of its website at www.mersana.com.


Forward-Looking Statements


This press release contains “forward-looking” statements and information within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, those concerning Mersana’s areas of focus; the continued development and therapeutic potential of Mersana’s product candidates, including Emi-Le (XMT-1660); Mersana’s anticipated disclosure of initial clinical trial data from its Phase 1 clinical trial of Emi-Le; and the potential advantages of Fast Track Designation. Mersana may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including, among other things, uncertainties inherent in research and development and clinical development of Mersana’s product candidates, including Emi-Le; whether the outcomes of preclinical studies will be predictive of clinical trial results; the risk that the receipt of Fast Track designation for Emi-Le may not result in a faster development or regulatory review or approval process compared to products considered for approval under conventional FDA procedures the risk that the FDA may later decide that Emi-Le no longer meets the conditions for Fast Track designation or decide that the time period for FDA review or approval will not be shortened; the risk that Mersana may not realize the intended benefits of its platforms, technology and collaborations; and other important factors, any of which could cause Mersana’s actual results to differ from those contained in the forward-looking statements, that are described in greater detail in the section entitled “Risk Factors” in Mersana’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (“SEC”) on November 13, 2024, as well as in other filings Mersana may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Mersana expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

Contact:

Jason Fredette
617-498-0020
[email protected]



Mersana Therapeutics Announces Positive Initial Clinical Data from Phase 1 Clinical Trial of Emiltatug Ledadotin (XMT-1660); Initiation of Expansion in Triple Negative Breast Cancer

– Emiltatug ledadotin observed to be generally well tolerated with differentiated safety and tolerability profile

– Promising clinical activity observed in patients with triple-negative breast cancer (TNBC) previously treated with topoisomerase-1 inhibitor (topo-1) ADCs; confirmed responses observed across all enrolled tumor types

– First expansion cohort initiated in patients with TNBC previously treated with at least one topo-1 ADC; dose exploration efforts ongoing

– Company announces expected 2025 milestones and areas of focus

– Conference call today at 8:30 a.m. ET

CAMBRIDGE, Mass., Jan. 10, 2025 (GLOBE NEWSWIRE) — Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today announced positive initial clinical data from the Phase 1 dose escalation and backfill cohorts for emiltatug ledadotin (Emi-Le; XMT-1660), Mersana’s lead Dolasynthen ADC candidate targeting B7-H4.

“We believe the initial safety, tolerability and efficacy data for Emi-Le demonstrate a profile that is exciting and differentiated within both the B7-H4 field and the broader ADC landscape,” said Martin Huber, M.D., President and Chief Executive Officer of Mersana Therapeutics. “We have observed clinical activity across tumors, including in heavily pre-treated patients with TNBC. These clinical data have led us to initiate expansion in patients with TNBC who have previously been treated with at least one topo-1 ADC, a population with very high unmet need.”

As of a December 13, 2024 data cutoff, the dose escalation portion of the Emi-Le Phase 1 clinical trial enrolled a total of 130 patients with advanced/metastatic TNBC; hormone-receptor-positive, human epidermal growth factor receptor 2 negative breast cancer; ovarian cancer; endometrial cancer and adenoid cystic carcinoma type 1. The enrolled patient population was heavily pretreated, with patients receiving up to 15 and a median of 4.5 prior lines of therapy, and approximately 92% of enrolled patients with TNBC had been previously treated with at least one topo-1 ADC. Among the 103 patients with known B7-H4 tumor expression, approximately 44% had a tumor proportion score of 70% or higher, which Mersana has preliminarily characterized as “B7-H4 high.”

Emi-Le was observed to be generally well tolerated, with no Grade 4 or 5 treatment-related adverse events (TRAEs) reported. The most common TRAEs of any grade across the entire patient population were transient aspartate aminotransferase (AST) increase (38% of patients), generally asymptomatic and reversible proteinuria (31%), generally low-grade nausea (29%) and low-grade fatigue (28%). The only Grade 3 TRAEs in ≥5% or more of all patients were AST increase (14%) and proteinuria (9%). Across the entire enrolled patient population, TRAEs leading to discontinuation, dose reduction and dose delay were observed in 2.3%, 9.2% and 12.3% of patients, respectively. No dose-limiting treatment-related neutropenia, neuropathy, ocular toxicity, interstitial lung disease or thrombocytopenia were reported, which the company believes differentiates Emi-Le from many other approved and clinical-stage ADCs.

At intermediate doses in the trial (38.1 mg/m2 to 67.4 mg/m2), the confirmed objective response rate (ORR) among evaluable patients (those with measurable disease at baseline and at least one post-baseline scan) was 23% (6 of 26 patients) across all B7-H4 high tumors and 23% (3 of 13 patients) with B7-H4 high TNBC, all of whom had previously been treated with at least one topo-1 ADC.

In the ASCENT Phase 3 clinical trial of sacituzumab govitecan, a topo-1 ADC, the ORR with standard-of-care single-agent chemotherapy in relapsed/refractory TNBC was approximately 5% with progression free survival of approximately seven weeks. Based on these encouraging Emi-Le data at intermediate doses, Mersana has advanced a dose of 67.4 mg/m2 every four weeks (Q4W) into an expansion cohort in patients with TNBC who have received one to four prior treatment lines, including at least one prior topo-1 ADC.

“In terms of both tolerability and clinical activity, these Emi-Le data are encouraging,” Erika Hamilton, M.D., Director Breast Cancer Research, Sarah Cannon Research Institute in Nashville, Tennessee, said. “It is notable that all the TNBC patients who responded to Emi-Le had previously been treated with at least one topo-1 ADC. The results indicate that Emi-Le may help address an already substantial and growing need among topo-1 experienced breast cancer patients for new treatments.”

At high doses above 76 mg/m2, the confirmed ORR among evaluable patients was 22% (2 of 9 patients) across all B7-H4 high tumors. Additionally, 78% (7 of 9 patients) had ≥30% tumor reduction in target lesions. At these high dose levels, objective responses in multiple evaluable patients with B7-H4 high tumors were not confirmed after protocol-mandated dose delays for proteinuria. Mersana is implementing proteinuria mitigation efforts and continues to explore higher doses in dose escalation and backfill cohorts to identify a second dose for the expansion portion of the trial.


Mersana’s Expected 2025 Milestones and Areas of Focus

Emi-Le

  • 1H2025: Continue enrollment in expansion at a dose of 67.4 mg/m2 Q4W in patients with TNBC who have previously received at least one prior topo-1 ADC
  • 2025: Initiate enrollment in expansion at a second dose in patients with TNBC who have previously received at least one prior topo-1 ADC
  • 2025: Present additional Phase 1 clinical data from dose escalation and backfill cohorts

XMT-2056, Mersana’s lead Immunosynthen ADC targeting a novel HER2 epitope

  • 2025: Present initial clinical pharmacodynamic STING activation data

Pipeline

  • Continue to support internal pipeline and existing collaborations with Johnson & Johnson and Merck KGaA, Darmstadt, Germany


Conference Call Information


Mersana will host a conference call today at 8:30 a.m. ET to discuss the initial clinical data from its Phase 1 clinical trial of Emi-Le. To access the call, please dial 833-255-2826 (domestic) or 412-317-0689 (international). A live webcast that includes the data presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com, and a replay of the webcast will be available in the same location following the conference call for approximately 90 days.


About Mersana Therapeutics


Mersana Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel antibody-drug conjugates (ADCs) and driven by the knowledge that patients are waiting for new treatment options. The company has developed proprietary cytotoxic (Dolasynthen) and immunostimulatory (Immunosynthen) ADC platforms that are generating a pipeline of wholly-owned and partnered product candidates with the potential to treat a range of cancers. Its pipeline includes Emi-Le (emiltatug ledadotin; XMT-1660), a Dolasynthen ADC targeting B7-H4, and XMT-2056, an Immunosynthen ADC targeting a novel epitope of human epidermal growth factor receptor 2 (HER2). Mersana routinely posts information that may be useful to investors on the “Investors & Media” section of its website at www.mersana.com.


Forward-Looking Statements


This press release contains “forward-looking” statements and information within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements concerning Mersana’s plans regarding the clinical development of Emi-Le and XMT-2056, including with respect to the progress and design of the clinical trials of these product candidates; the potential clinical benefits of Emi-Le; Mersana’s efforts to identify an additional dose for investigation in the expansion portion of its Phase 1 clinical trial of Emi-Le; Mersana’s planned data presentations, including with respect to its Phase 1 clinical trial of Emi-Le and to clinical pharmacodynamic STING activation data related to XMT-2056; Mersana’s collaborations with third parties; and the development and potential of Mersana’s product candidates, platforms, technology and pipeline of ADC candidates. Mersana may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including, among other things, uncertainties inherent in research and development, in the advancement, progression and completion of clinical trials and in the clinical development of Mersana’s product candidates, including Emi-Le and XMT-2056; the risk that Mersana may face delays in patient enrollment in its Phase 1 clinical trials of Emi-Le and XMT-2056; the risk that outcomes of preclinical studies may not be predictive of clinical trial results; the risk that initial or interim results from a clinical trial may not be predictive of the final results of the trial or the results of future trials; the risk that clinical trial data may not support regulatory applications or approvals; the risk that Mersana may not realize the intended benefits of its platforms, technology and collaborations; and other important factors, any of which could cause Mersana’s actual results to differ from those contained in the forward-looking statements, that are described in greater detail in the section entitled “Risk Factors” in Mersana’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (“SEC”) on November 13, 2024, as well as in other filings Mersana may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Mersana expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

Contact:

Jason Fredette
617-498-0020
[email protected]



Armada Hoffler Announces Morningstar Upgrades Outlook to Stable and Confirms BBB Credit Rating

VIRGINIA BEACH, Va., Jan. 10, 2025 (GLOBE NEWSWIRE) — Armada Hoffler (NYSE: AHH) announced that Morningstar has upgraded its outlook to stable and confirmed its BBB credit rating.

“We are pleased that Morningstar has upgraded our outlook to stable and reiterated our BBB credit rating,” said Shawn Tibbetts, Chief Executive Officer and President of Armada Hoffler. “This reflects the quality, stability and strategic execution that define Armada Hoffler’s operations. Furthermore, it demonstrates the dedication of our team and our commitment to delivering value to our shareholders.”

In its analysis of the Company, Morningstar, a globally recognized credit rating agency, cited several factors supporting the rating confirmation. According to Morningstar, “the Stable trend reflects the [company’s] improving leverage profile and the more diversified real estate portfolio following the completion and delivery of Allied, leading to an improvement in the Diversification business risk assessment factor. Allied is a mixed-use, 312-unit multifamily, retail, and parking garage asset under development in Baltimore, scheduled to be completed in Q1 2025 and stabilized by Q3 2026. Upon stabilization, the asset is expected to be a top asset in the portfolio by net operating income (NOI) contribution and increase geographical and asset type diversification. The enhanced business risk assessment factor allows greater financial flexibility within the respective credit rating category. The improving leverage profile is largely the result of a $103.5 million net proceed equity raise in September 2024 with funds used to repay debt.”

More information regarding Armada Hoffler’s credit rating assignment can be found in the Morningstar press release dated January 9, 2025.

About Armada Hoffler

Armada Hoffler (NYSE: AHH) is a vertically integrated, self-managed real estate investment trust (“REIT”) with over four decades of experience developing, building, acquiring, and managing high-quality office, retail, and multifamily properties located primarily in the Mid-Atlantic and Southeastern United States. We also provide general construction and development services to third-party clients, in addition to developing and building properties to be placed in our stabilized portfolio. Founded in 1979 by Daniel A. Hoffler, Armada Hoffler has elected to be taxed as a REIT for U.S. federal income tax purposes. For more information visit ArmadaHoffler.com.

Contact:

Chelsea Forrest

Armada Hoffler

Vice President of Corporate Communications and Investor Relations

Email: [email protected]

Phone: (757) 612-4248



Biodesix Announces Preliminary Fourth Quarter and Full-Year 2024 Results (Unaudited)

Grew full-year revenue to an estimated $71.3 million, an increase of 45%

LOUISVILLE, Colo., Jan. 10, 2025 (GLOBE NEWSWIRE) — Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions company, today announced its preliminary financial results for the fourth quarter and year ended December 31, 2024 (fiscal 2024). The financial results included in this release pertaining to the fourth quarter and fiscal 2024 are preliminary, unaudited, and subject to final review and adjustment.

Preliminary Unaudited Fourth Quarter and Full-Year 2024 Financial Highlights

  • Total revenue is estimated to be $20.4 million and $71.3 million for the fourth quarter and fiscal 2024, respectively, an increase of 39% and 45% over the respective prior year comparable periods;
    • Lung Diagnostics revenue is estimated to be $17.2 million and $64.7 million for the fourth quarter and fiscal 2024, respectively, an increase of 34% and 43% over the respective prior year comparable periods;
    • Biopharma Services and other revenue is estimated to be $3.2 million and $6.6 million for the fourth quarter and fiscal 2024, respectively, an increase of 68% and 69% over the respective prior year comparable periods; entering 2025 with $12.2 million under contract but not yet recognized as revenue, a 54% increase over the prior year comparable period;
  • Lung Diagnostic test volumes of 14,600 and 54,300 for the fourth quarter and fiscal 2024, respectively, an increase of 34% and 40% over the respective prior periods;
  • Cash and cash equivalents of $26.2 million as of December 31, 2024.

“Biodesix capped off a strong fourth quarter and 2024, successfully delivering on our three key initiatives. We grew revenue for both our Lung Diagnostics tests and our Biopharma Services, implemented operational efficiencies, and made progress on our path to profitability through our cost-disciplined approach,” said Scott Hutton, Chief Executive Officer. “In 2024, we delivered an estimated $71.3 million in total revenue, exceeding the mid-point of our increased guidance range. We expanded and capitalized on our commercial, clinical, and R&D strengths, growing our Lung Diagnostics revenues by 43% and our Biopharma Services revenues by 69%, year-over-year. We also continued to present new clinical data supporting our tests, increased reimbursement coverage, and launched new research partnerships. I am exceptionally proud of the Biodesix team and our accomplishments in 2024, setting us up for another year of success in 2025.”

The financial information above is preliminary and subject to Biodesix’s normal quarter and year-end accounting procedures and external audit by the company’s independent registered public accounting firm. In addition, these preliminary unaudited results are not a comprehensive statement of the company’s financial results for the year ended December 31, 2024, should not be viewed as a substitute for full, audited financial statements prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the company’s results for any future period.

About Biodesix

Biodesix is a leading diagnostic solutions company with five Medicare-covered tests available for pulmonology patients. The Nodify Lung® Nodule Risk Assessment evaluates the risk of malignancy in pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The IQLung™ test portfolio for lung cancer patients supports treatment decisions across all stages of lung cancer and expedites personalized treatment. In addition, Biodesix collaborates with the world’s leading biopharmaceutical companies to provide biomarker discovery, diagnostic test development, and clinical trial support services. For more information, visit biodesix.com.

Trademarks: Biodesix, Biodesix Logo, Nodify Lung, and IQLung are trademarks or registered trademarks of Biodesix, Inc.

Note Regarding Forward-Looking Statements

This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,” “opportunity,” “goals,” or “should,” and similar expressions are intended to identify forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. Biodesix has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions. Forward-looking statements may include information concerning the impact of backlog and the timing and assumptions regarding collection of revenues on projections, availability of funds and future capital including under the term loan facility, the anticipated impact and benefits of new clinical data, reimbursement coverage and research partnerships, and the impact of a pandemic, epidemic, or outbreak, including the COVID-19 pandemic, on Biodesix and its operations and financial performance. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. The Company’s ability to continue as a going concern could cause actual results to differ materially from those contemplated in this press release and additionally, other factors that could cause actual results to differ materially from those contemplated in this press release can be found in the Risk Factors section of Biodesix most recent annual report on Form 10-K, filed March 1, 2024 or subsequent quarterly reports on Form 10-Q during 2024, if applicable. Biodesix undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.

Media:

Natalie St. Denis



[email protected]



(720) 925-9285

Investors:

Chris Brinzey



[email protected]



(339) 970-2843



Modivcare Raises $105 Million in Incremental Financing Backed by Stakeholders Across the Capital Structure and Takes Strategic Steps to Position Business for the Future

Modivcare Raises $105 Million in Incremental Financing Backed by Stakeholders Across the Capital Structure and Takes Strategic Steps to Position Business for the Future

$75 Million in Incremental Term Loan and $30 Million in New Second Lien Notes to Support Operational Improvements, Strategic Priorities and Covenant Relief

Will Pursue Strategic Review of Assets with Key Company Advisors to Maximize Value

Chief Transformation Officer and Board Additions Bolster Company Leadership

Company Withdraws Previously Stated Revenue and Adjusted EBITDA Growth Guidance

DENVER–(BUSINESS WIRE)–
Modivcare Inc. (the “Company” or “Modivcare”) (Nasdaq: MODV), a technology-enabled healthcare services company providing a platform of integrated supportive care solutions focused on improving health outcomes, today announced key initiatives to support future growth. The Company has secured $75 million in incremental financing, backed by stakeholders across the capital structure, and appointed Chad Shandler as its Chief Transformation Officer. An existing investor, Coliseum Capital Management, has also committed $30 million to purchase new second lien senior notes due 2029, subject to a stockholder vote. As part of the financing agreement, revolving lenders have agreed to amend the Company’s existing credit agreement in order to, among other things, provide covenant relief. The Company will also bolster its board of directors (the “Board”) with the addition of three new independent directors to be appointed in the coming months. These initiatives, along with a strategic review of its assets that the Company is pursuing with its advisors, are intended to strengthen the Company’s financial foundation, enhance operational performance and best position Modivcare for a future of sustainable growth.

“This financing highlights broad-based support from stakeholders across the capital structure and provides the Company with additional resources to focus on long-term strategic priorities,” said Heath Sampson, Chief Executive Officer and President of Modivcare. “As we turn to the future, we are also excited to welcome Chad Shandler as Chief Transformation Officer. He brings a wealth of experience supporting large-scale transformations across the healthcare industry. I’m looking forward to working with him, the Board and our financial partners to advance Modivcare’s strategic goals.”

“The steps Modivcare is taking now to transform its business will ensure the Company is well positioned to connect people with the care they need, now and in the future,” said Leslie Norwalk, Interim Chair of the Board. “We and the leadership team have worked diligently to strengthen the Company’s financial foundation and remain focused on improving the Company’s operational performance with a view toward long-term growth.”

“We are pleased to be able to provide this incremental financing to Modivcare, which will bolster its balance sheet and position the Company to achieve its long-term strategic priorities and deliver value to its stakeholders,” said a representative of the supporting lenders. “Modivcare plays a critical role in the country’s healthcare network with an important mission to connect people to care, wherever they are. As we continue to work with Modivcare’s leadership team and the Board, our goals are aligned in ensuring the Company is well positioned to continue to support its members nationwide.”

Transaction Details

Modivcare has raised $105 million in additional financing from stakeholders across its capital structure as a $75 million incremental term loan under its existing credit agreement and, subject to a stockholder vote, $30 million of new Second Lien Senior Secured PIK Toggle Notes due 2029 (the “Second Lien Notes”). The financing will provide Modivcare with additional liquidity to support its strategic initiatives. It will bolster the Company’s financial position, allowing the Company to continue operating to its same high level of service for members, while positioning the Company to meet its long-term strategic goals and maximize shareholder value.

The incremental term loan was priced at SOFR + 750 bps, with 1.00% SOFR Floor (no CSA) with a maturity of January 10, 2026 (the “Maturity Date”) and OID of 2 points. The Company has the option to prepay the incremental term loan, in whole or in part, at any time prior to its maturity, subject to a prepayment fee equal to the present value of all scheduled interest payments on the fully committed amount that would accrue through the Maturity Date calculated based on a discount rate equal to the treasury rate plus 50 basis points. The Company’s existing credit agreement was also amended in connection with such financing with consenting lenders receiving a customary consent fee, payable-in-kind.

The Company’s existing credit agreement was amended to, among other things, replace the pricing grid in respect of revolving loans with pricing set at SOFR + 425 bps, with a 1.00% SOFR Floor, change the 2% default rate so that it applies on all obligations upon an event of default, amend the term loan maturity date to spring to July 2, 2029 if the Second Lien Notes remain outstanding as of such date, include enhanced reporting requirements and eliminate or reduce certain baskets for a period of time, including eliminating reinvestment rights with respect to certain asset sales and reduction of the de minimis exception for certain asset sale prepayments to $5,000,000.

The Company’s existing lenders have agreed to provide financial covenant relief in the form of (i) a covenant holiday with respect to the maximum net leverage ratio and interest coverage ratio from Q4 2024 through and including Q2 2025, (ii) resetting the maximum total net leverage ratio covenant to 6.75:1.00 for the third fiscal quarter of 2025 and the fourth fiscal quarter of 2025 and (iii) resetting the minimum interest coverage ratio to 1.65:1.00 for the third fiscal quarter of 2025 and the fourth fiscal quarter of 2025. The Company’s lenders have also agreed to reduce the minimum liquidity covenant from $75 million to $25 million, which will be tested each week through the week ending April 11, 2025, each month through the month ending June 30, 2025 and, thereafter, each fiscal quarter. In addition, the Company will be subject to a cash variance compliance test with respect to aggregate disbursements and aggregate receipts, subject to customary cures.

Pursuant to the amended credit agreement, upon the receipt of requisite consents to make certain amendments to the indenture governing the Company’s 5.000% Senior Notes due 2029 (the “Senior Notes”), the Company will exchange $251 million in aggregate principal amount of Senior Notes held by certain lenders party to the Company’s amended credit agreement for $251 million in aggregate principal amount of Second Lien Notes, pursuant to the terms and subject to the conditions set forth in an exchange agreement, entered into between the Company and participating lenders. Interest on the Second Lien Notes will be, at the Company’s option, 5% per annum if paid in cash and 10% per annum if paid-in-kind, provided if the Company’s liquidity is greater than a to-be-determined threshold, the Company will be required to pay interest in cash.

In addition, the Company entered into a purchase and exchange agreement with clients of Coliseum Capital Management pursuant to which Coliseum has agreed to purchase $30 million in aggregate principal amount of Second Lien Notes at a purchase price equal to 100% of the principal amount thereof plus any accrued and unpaid interest thereto from, and including, October 1, 2024 to, but excluding, the date of issuance of such Second Lien Notes and to exchange approximately $20 million in aggregate principal amount of Senior Notes for a like amount of Second Lien Notes. The transaction with Coliseum is subject to approval of 66-2/3% of the Company’s stockholders other than Coliseum under Delaware General Corporation Law Section 203 because Coliseum owns more than 15% of the Company’s common stock. The Company intends to seek such stockholder approval at a special stockholder meeting to be held in the first quarter of 2025.

Modivcare was advised in the transaction by Kirkland & Ellis LLP, Moelis & Company, and FTI Consulting.

Transformation

As part of Modivcare’s efforts to drive strategic and operational excellence, Chad Shandler, Senior Managing Director and Co-Leader of the Corporate Finance Healthcare practice at FTI Consulting, has been appointed as Chief Transformation Officer. This newly created role will focus on strengthening Modivcare in the near and long term and supporting the transformation of the Company via strategic divestitures or other potential initiatives. Mr. Shandler has more than 30 years of experience in executing on strategic and financial plans and has previously served in executive and advisory roles on behalf of a number of companies across the healthcare space. He will focus on advancing key strategic priorities and enhancing operational efficiencies for Modivcare.

Modivcare has also engaged advisors to conduct a strategic review of its assets to maximize shareholder value, which may include the potential sale of assets of the Company. There is no assurance that this review will result in a transaction, nor can the Company provide certainty on timing or outcomes.

Guidance

The Company has withdrawn its previously stated revenue and adjusted EBITDA guidance for fiscal year 2024 and adjusted EBITDA growth for fiscal year 2025 and related forward-looking statements due to changes in the business and overall environment.

About Modivcare

Modivcare Inc. is a technology-enabled healthcare services company that provides a suite of integrated supportive care solutions for public and private payors and their members. Our value-based solutions address the social determinants of health (SDoH) by connecting members to essential care services. By doing so, Modivcare helps health plans manage risks, reduce costs, and improve health outcomes. Modivcare is a provider of non-emergency medical transportation (NEMT), personal care services (PCS), and remote patient monitoring solutions (RPM). The Company also holds a minority equity investment in CCHN Holdings (d/b/a Matrix Medical Network), an independent, at scale provider of comprehensive in-home health assessments in the U.S. To learn more about Modivcare, please visit www.modivcare.com.

Important Information for Investors and Shareholders

This press release does not constitute an offer to sell or the solicitation of an offer to buy or exchange any securities or a solicitation of any vote or approval in any jurisdiction.

In connection with the proposed transaction between the Company and Coliseum Capital Management, the Company intends to file relevant materials with the Securities and Exchange Commission (the “SEC”), including, among other filings, a definitive proxy statement, which will be mailed to stockholders of the Company. INVESTORS AND SECURITY HOLDERS OF THE COMPANY ARE URGED TO READ THE PROXY STATEMENT AND OTHER DOCUMENTS THAT WILL BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Investors and security holders will be able to obtain free copies of the proxy statement (when available) and other documents filed with the SEC by the Company through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by the Company will be available free of charge on the Company’s website at investors.modivcare.com under the tab “SEC Filings” and under the heading “Financials.”

Certain Information Regarding Participants

The Company and its directors and executive officers may be considered participants in the solicitation of proxies from the shareholders of the Company in connection with the Company’s proposed transaction with Coliseum Capital Management. Information about the directors and executive officers of the Company is set forth in its Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on February 26, 2024, its proxy statement for its 2024 annual meeting, which was filed with the SEC on April 29, 2024, and its Current Reports on Form 8-K, which were filed with the SEC on May 10, 2024, May 22, 2024, December 13, 2024 and December 26, 2024. To the extent holdings of the Company’s securities by its directors or executive officers have changed since the amounts set forth in such filings, such changes have been or will be reflected on Initial Statements of Beneficial Ownership on Form 3 or Statements of Beneficial Ownership on Form 4 filed with the SEC. Information about the directors and executive officers of the Company and other information regarding the potential participants in the proxy solicitations and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement and other relevant materials to be filed with the SEC regarding the proposed transaction. You may obtain these documents (when they become available) free of charge through the website maintained by the SEC at http://www.sec.gov and from the Company’s website as described above.

Cautionary Note Regarding Forward-Looking Statements

Statements contained in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are predictive in nature and are identified generally by the use of the terms “intended”, “expected”, “estimates”, “will”, and “anticipates”, and similar words or expressions indicating possible future expectations, events or actions. The Company’s expectation about reaching a mutually agreeable long-term amendment to the Credit Agreement is a forward-looking statement. Forward-looking statements are based on current expectations, assumptions, estimates and projections about the Company’s business and its industry, and are not guarantees of future performance. These statements are subject to a number of known and unknown risks, uncertainties and other factors, many of which are beyond the Company’s ability to control or predict, which may cause actual events to be materially different from those expressed or implied herein. The Company has provided additional information about the risks facing its business and the Company in its most recent annual report on Form 10-K, and in its subsequent periodic and current reports on Forms 10-Q and 8-K, filed by it with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date the statements were made and are expressly qualified in their entirety by the cautionary statements set forth herein and in the periodic and current reports filed with the Securities and Exchange Commission identified above, which you should read in their entirety before making an investment decision with respect to the Company’s securities. The Company undertakes no obligation to update or revise any forward-looking statements contained in this report, whether as a result of new information, future events or otherwise, except as required by applicable law.

Media and Investor Contact

Rachel Chesley / Kyla MacLennan / Victoria Zaharoff

[email protected]

KEYWORDS: Colorado United States North America

INDUSTRY KEYWORDS: General Health Health Technology Health

MEDIA:

Logo
Logo

Li-Cycle Provides Preliminary Commercial and Operational Highlights for 2024

Li-Cycle Provides Preliminary Commercial and Operational Highlights for 2024

Company’s largest source of battery feedstock during 2024 was a U.S.-headquartered, vertically integrated electric vehicle (“EV”) and battery manufacturer with a substantial global EV market share

Continued focus on securing a full financing package for the Rochester Hub and optimizing Spoke performance

TORONTO–(BUSINESS WIRE)–Li-Cycle Holdings Corp. (NYSE: LICY) (“Li-Cycle” or the “Company”), a leading global lithium-ion battery resource recovery company, is pleased to report preliminary commercial and operational highlights for full-year 2024.

Commercial Highlights

Li-Cycle continued to gain commercial traction in 2024, bolstering its position as a preferred lithium-ion battery recycling partner. Its largest customers comprise leading global battery supply chain companies, including EV OEMs, battery manufacturers, miners, and raw material buyers.

In 2024, the largest source of the Company’s battery feedstock was a U.S.-headquartered, vertically integrated EV and battery manufacturer with a substantial global EV market share. Throughout 2024, Li-Cycle supported approximately 13 prominent EV manufacturers and approximately 15 key battery cell and material producers with the Company’s sustainable recycling services.

“We are pleased to be able to widen our commercial footprint for battery feedstock for our Spoke network in the United States and Germany. Our top source of battery feedstock during the past year was a leading U.S. EV and battery manufacturer and is indicative of our position as a preferred recycling partner for the largest blue-chip companies in the global battery supply chain,” said Ajay Kochhar, Li-Cycle President and CEO. “Our sustainable, battery-agnostic recycling technology — which can process full-pack batteries regardless of form factor and without the need to dismantle or discharge — continues to provide value for our global customers.”

Rochester Hub and Spoke Operations Highlights

Li-Cycle is continuing to prioritize securing a full financing package to support the construction restart of the Rochester Hub project and to satisfy requirements for first advance under the $475 million loan facility from the U.S. Department of Energy (DOE).

Li-Cycle produced approximately 5,370 tonnes of black mass and equivalents1 (“BM&E”) in full-year 2024, and approximately 1,200 tonnes of BM&E in Q4 2024.

The Company is continuing to focus on its Spoke optimization initiatives to establish a financially accretive and self-sufficient Spoke business.

“Our two main goals for the Company are clear: we are focused on securing a full financing package to underpin the restart of construction of the Rochester Hub and starting to draw on the DOE loan, alongside implementing initiatives to enhance Spoke performance and improve cash flow to establish a self-sufficient Spoke business.”

Balance Sheet Position

As of December 31, 2024, Li-Cycle had cash and cash equivalents of $22.6 million, compared to $32.2 million as of September 30, 2024.

Between August 12, 2024, and December 31, 2024, Li-Cycle raised $16.3 million of net proceeds by issuing an aggregate of 7,403,621 of the Company’s common shares under its at-the-market program at a weighted average price of $2.25 per share. The number of issued and outstanding common shares as of December 31, 2024, was 30,427,796.

The Company expects to release its full-year 2024 financial and operational results in the first half of March 2025.

About Li-Cycle Holdings Corp.

Li-Cycle (NYSE: LICY) is a leading global lithium-ion battery resource recovery company. Established in 2016, and with major customers and partners around the world, Li-Cycle’s mission is to recover critical battery-grade materials to create a domestic closed-loop battery supply chain for a clean energy future. The Company leverages its innovative, sustainable and patent-protected Spoke & Hub Technologies™ to recycle all different types of lithium-ion batteries. At our Spokes, or pre-processing facilities, we recycle battery manufacturing scrap and end-of-life batteries to produce black mass, a powder-like substance which contains a number of valuable metals, including lithium, nickel and cobalt. At our future Hubs, or post-processing facilities, we plan to process black mass to produce critical battery-grade materials, including lithium carbonate, for the lithium-ion battery supply chain. For more information, visit https://li-cycle.com/.

Forward-Looking Statements

Certain statements contained in this press release may be considered “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the U.S. Securities Act of 1933, as amended, Section 21 of the U.S. Securities Exchange Act of 1934, as amended, and applicable Canadian securities laws. Forward-looking statements may generally be identified by the use of words such as “believe”, “may”, “will”, “continue”, “anticipate”, “intend”, “expect”, “should”, “would”, “could”, “plan”, “potential”, “future”, “target” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, although not all forward-looking statements contain such identifying words. Forward-looking statements in this press release include but are not limited to statements about: the continued value provided by the Company to its global customers; the work on securing a full financing package to support the construction restart of the Rochester Hub project and to satisfy requirements for first advance of a loan facility from the DOE; the continued focus on the Company’s Spoke optimization initiatives; and the timeline for the release of the Company’s full-year 2024 financial and operational results.

These statements are based on various assumptions, whether or not identified in this press release, including but not limited to assumptions regarding the timing, scope and cost of Li-Cycle’s projects, including paused and curtailed projects; the processing capacity and production of Li-Cycle’s facilities; Li-Cycle’s ability to source feedstock and manage supply chain risk; Li-Cycle’s ability to increase recycling capacity and efficiency; Li-Cycle’s ability to obtain financing on acceptable terms or at all; the success of Li-Cycle’s cash preservation plan; the outcome of the go-forward strategy of the Rochester Hub; Li-Cycle’s ability to retain and hire key personnel and maintain relationships with customers, suppliers and other business partners; expectations related to the outcome of future litigation; general economic conditions; currency exchange and interest rates; compensation costs; and inflation. There can be no assurance that such estimates or assumptions will prove to be correct and, as a result, actual results or events may differ materially from expectations expressed in or implied by the forward-looking statements.

These forward-looking statements are provided for the purpose of assisting readers in understanding certain key elements of Li-Cycle’s current objectives, goals, targets, strategic priorities, expectations and plans, and in obtaining a better understanding of Li-Cycle’s business and anticipated operating environment. Readers are cautioned that such information may not be appropriate for other purposes and is not intended to serve as, and must not be relied on, by any investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability.

Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and many of which are beyond the control of Li-Cycle and are not guarantees of future performance. Li-Cycle believes that these risks and uncertainties include, but are not limited to, the following: Li-Cycle’s inability to fund the anticipated costs of, and realize the anticipated benefits from, its Spoke optimization plan; Li-Cycle’s inability to satisfy the drawdown conditions and access funding under a loan facility with the DOE; Li-Cycle’s inability to develop the Rochester Hub as anticipated or at all, and other future projects including its Spoke network expansion projects in a timely manner or on budget or that those projects will not meet expectations with respect to their productivity or the specifications of their end products; risk and uncertainties related to Li-Cycle’s ability to continue as a going concern; Li-Cycle’s insurance may not cover all liabilities and damages; Li-Cycle’s reliance on a limited number of commercial partners to generate revenue; Li-Cycle’s failure to effectively remediate the material weaknesses in its internal control over financial reporting that it has identified or its failure to develop and maintain a proper and effective internal control over financial reporting; and risks of litigation or regulatory proceedings that could materially and adversely impact Li-Cycle’s financial results. These and other risks and uncertainties related to Li-Cycle’s business are described in greater detail in the sections titled “Item 1A. Risk Factors” and “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operation—Key Factors Affecting Li-Cycle’s Performance” in its Annual Report on Form 10-K and the sections titled “Part II. Other Information—Item 1A. Risk Factors” and “Part I. Financial Information—Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operation—Key Factors Affecting Li-Cycle’s Performance” in its Quarterly Reports on Form 10-Q, in each case filed with the U.S. Securities and Exchange Commission and the Ontario Securities Commission in Canada. Because of these risks, uncertainties and assumptions, readers should not place undue reliance on these forward-looking statements. Actual results could differ materially from those contained in any forward-looking statement.

Li-Cycle assumes no obligation to update or revise any forward-looking statements, except as required by applicable laws. These forward-looking statements should not be relied upon as representing Li-Cycle’s assessments as of any date subsequent to the date of this press release.

_____________________

1“Black mass and equivalents is black mass and products analogous to black mass that have similar metal content.

Investor Relations & Media

Louie Diaz

Sheldon D’souza

Investor Relations: [email protected]

Media: [email protected]

KEYWORDS: North America Canada

INDUSTRY KEYWORDS: Automotive Manufacturing Alternative Energy Energy Green Technology Manufacturing Alternative Vehicles/Fuels Technology Batteries Other Natural Resources Environment Mining/Minerals General Automotive Natural Resources Automotive Other Energy

MEDIA:

Logo
Logo

Insulet to Announce Fourth Quarter and Full Year 2024 Financial Results on February 20, 2025

Insulet to Announce Fourth Quarter and Full Year 2024 Financial Results on February 20, 2025

ACTON, Mass.–(BUSINESS WIRE)–
Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced plans to release its financial results for the fourth quarter and full year of 2024 on February 20, 2025, after the close of the financial markets. In connection with the release, management will host a conference call that day at 4:30 p.m. (Eastern Time).

The link to the live call will be available on the Investor Relations section of the Company’s website at investors.insulet.com, “Events and Presentations,” and will be archived for future replay. You may also access the live call by dialing (888) 770-7129 for domestic callers, or (929) 203-2109 for international callers, passcode is 5904836.

About Insulet Corporation:

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, visit Insulet.com or omnipod.com.

©2025 Insulet Corporation. Omnipod is a registered trademark of Insulet Corporation. All rights reserved.

Source: Insulet Corporation

Investor Relations:

June Lazaroff

Sr. Director, Investor Relations

(978) 600-7718

[email protected]

Media:

Angela Geryak Wiczek

Senior Director, Corporate Communications

(978) 932-0611

[email protected]

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: Biotechnology Diabetes Medical Devices Health Pharmaceutical

MEDIA:

Logo
Logo

SemiLEDs Reports First Quarter Fiscal Year 2025 Financial Results

SemiLEDs Reports First Quarter Fiscal Year 2025 Financial Results

HSINCHU, Taiwan–(BUSINESS WIRE)–
SemiLEDs Corporation (NASDAQ: LEDS), “SemiLEDs” or the “Company,” a developer and manufacturer of LED chips and LED components, today announced its financial results for the first quarter of fiscal year 2025, ended November 30, 2024.

Revenue for the first quarter of fiscal 2025 was $1.3 million, compared to $1.3 million in the fourth quarter of fiscal 2024. GAAP net loss attributable to SemiLEDs stockholders for the first quarter of fiscal 2025 decreased to $547 thousand, or $(0.08) per diluted share, compared to a net loss of $560 thousand, or $(0.08) per diluted share, in the fourth quarter of fiscal 2024.

GAAP gross margin for the first quarter of fiscal 2025 increased to 21%, compared to 12% for the fourth quarter of fiscal 2024. Operating margin for the first quarter of fiscal 2025 was negative 52%, compared with negative 62% for the fourth quarter of fiscal 2024. The Company’s cash and cash equivalents were $1.2 million at November 30, 2024, compared to $1.7 million at the end of the fourth quarter of fiscal 2024.

About SemiLEDs

SemiLEDs develops and manufactures LED chips and LED components for general lighting applications, including street lights and commercial, industrial, system and residential lighting, along with specialty industrial applications such as ultraviolet (UV) curing, medical/cosmetic, counterfeit detection, horticulture, architectural lighting and entertainment lighting. SemiLEDs sells blue, white, green and UV LED chips.

Forward Looking Statements

This press release contains statements that may constitute “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 as defined in the U.S. Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact could be deemed forward-looking, including, but not limited to, revenue expectations for the second quarter ending February 28, 2025, the expedited timing of the recognition of revenue relating to the buy-sell purchase orders and estimated costs of revenue related thereto, any statements about historical results that may suggest trends for SemiLEDs’ business; any statements of the plans, strategies and objectives of management for future operations; any statements of expectation or belief regarding recovery of the LED industry, market opportunities and other future events or technology developments; any statements regarding SemiLEDs’ position to capitalize on any market opportunities; and any statements of assumptions underlying any of the foregoing. These forward-looking statements are based on current expectations, estimates, forecasts and projections of future SemiLEDs’ or industry performance based on management’s judgment, beliefs, current trends and market conditions and involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. SemiLEDs’ Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) and other SemiLEDs filings with the SEC (which you may obtain for free at the SEC’s website at http://www.sec.gov) discuss some of the important risks and other factors that may affect SemiLEDs’ business, results of operations and financial condition. SemiLEDs undertakes no intent or obligation to publicly update or revise any of these forward looking statements, whether as a result of new information, future events or otherwise, except as required by law.

SEMILEDS CORPORATION AND SUBSIDIARIES

Unaudited Condensed Consolidated Balance Sheets

(In thousands of U.S. dollars)

 

 

November 30,

August 31,

 

2024

2024

ASSETS

CURRENT ASSETS:

Cash and cash equivalents

$

1,248

 

$

1,671

 

Restricted cash and cash equivalents

 

77

 

 

78

 

Accounts receivable (including related parties), net

 

261

 

 

416

 

Inventories, net

 

3,722

 

 

3,574

 

Prepaid expenses and other current assets

 

185

 

 

223

 

Total current assets

 

5,493

 

 

5,962

 

Property, plant and equipment, net

 

2,609

 

 

2,798

 

Operating lease right of use assets

 

1,041

 

 

1,091

 

Intangible assets, net

 

85

 

 

90

 

Investments in unconsolidated entities

 

949

 

 

969

 

Other assets

 

223

 

 

228

 

TOTAL ASSETS

$

10,400

 

$

11,138

 

LIABILITIES AND EQUITY

CURRENT LIABILITIES:

Current installments of long-term debt

$

2,847

 

$

2,854

 

Accounts payable

 

340

 

 

137

 

Accrued expenses and other current liabilities

 

2,799

 

 

2,936

 

Other payable to related parties

 

1,049

 

 

1,001

 

Operating lease liabilities, current portion

 

76

 

 

94

 

Total current liabilities

 

7,111

 

 

7,022

 

Long-term debt, excluding current installments

 

744

 

 

870

 

Operating lease liabilities, less current portion

 

965

 

 

997

 

Total liabilities

 

8,820

 

 

8,889

 

Commitments and contingencies

EQUITY:

SemiLEDs stockholders’ equity

Common stock

 

 

 

 

Additional paid-in capital

 

187,277

 

 

187,337

 

Accumulated other comprehensive income

 

3,531

 

 

3,545

 

Accumulated deficit

 

(189,228

)

 

(188,681

)

Total SemiLEDs stockholders’ equity

 

1,580

 

 

2,201

 

Noncontrolling interests

 

 

 

48

 

Total equity

 

1,580

 

 

2,249

 

TOTAL LIABILITIES AND EQUITY

$

10,400

 

$

11,138

 

 

SEMILEDS CORPORATION AND SUBSIDIARIES

Unaudited Condensed Consolidated Statements of Operations

(In thousands of U.S. dollars and shares, except per share data)

 

 

Three Months Ended

 

November 30, 2024

August 31, 2024

Revenues, net

$

1,261

 

$

1,324

 

Cost of revenues

 

1,001

 

 

1,171

 

Gross profit

 

260

 

 

153

 

Operating expenses:

Research and development

 

221

 

 

217

 

Selling, general and administrative

 

696

 

 

760

 

Gain on disposals of long-lived assets

 

 

 

1

 

Total operating expenses

 

917

 

 

978

 

Loss from operations

 

(657

)

 

(825

)

Other income (expenses):

Investment loss from unconsolidated entities

 

(3

)

 

(3

)

Interest expenses, net

 

(67

)

 

(36

)

Other income, net

 

282

 

 

268

 

Foreign currency transaction (loss) gain , net

 

(102

)

 

34

 

Total other income, net

 

110

 

 

263

 

Loss before income taxes

 

(547

)

 

(562

)

Income tax expense

 

 

Net loss

 

(547

)

 

(562

)

Less: Net income (loss) attributable to noncontrolling interests

 

 

 

(2

)

Net loss attributable to SemiLEDs stockholders

$

(547

)

$

(560

)

Net loss per share attributable to SemiLEDs stockholders:

Basic and diluted

$

(0.08

)

$

(0.08

)

Shares used in computing net loss per share attributable

to SemiLEDs stockholders:

Basic and diluted

 

7,212

 

 

7,203

 

 

Christopher Lee

Chief Financial Officer

SemiLEDs Corporation

+886-37-586788

[email protected]

KEYWORDS: Taiwan Asia Pacific

INDUSTRY KEYWORDS: Semiconductor Consumer Electronics Security Technology Nanotechnology Other Technology Telecommunications

MEDIA:

Logo
Logo

QIAGEN Increases QIAcuity Digital PCR High-Order Multiplexing Capabilities to Gain Deeper Insights From Biological Samples

QIAGEN Increases QIAcuity Digital PCR High-Order Multiplexing Capabilities to Gain Deeper Insights From Biological Samples

  • QIAcuity digital PCR now offers ability for simultaneous detection of up to 12 targets from one biological sample, a more than two-fold increase from prior capability for up to five targets

     
  • No instrument hardware changes required for upgraded capability thanks to new QIAcuity Software 3.1 update and launch of QIAcuity High Multiplex Probe PCR Kit

     
  • New QIAcuity digital PCR capabilities helps make lab work more productive and cost-efficient through savings on time, reagents consumption and use of precious sample materials

VENLO, Netherlands–(BUSINESS WIRE)–
QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced a significant increase in the powerful capabilities of its QIAcuity Digital PCR (dPCR) system with a more than two-fold increase in the number of targets that can be simultaneously analyzed from a single biological sample.

The new capabilities overcome the assay design challenges of currently available quantitative multiplex PCR methods, making QIAcuity digital PCR ideal for applications such as translational research, microbiome analysis, pathogen detection and the development of cell and gene therapies.

Through a software upgrade and the launch of the new QIAcuity High Multiplex Probe PCR Kit, customers can now analyze up to 12 targets simultaneously compared to the earlier version offering up to five targets, using their existing instruments without any hardware changes.

This upgrade provides QIAcuity customers with a powerful technology that amplifies and detects multiple targets within a single reaction. By combining multiple PCR assays, researchers can now maximize sample use while simultaneously reducing time and reagent consumption that accelerates the process to obtain deep biological insights.

“Analyzing more targets simultaneously from a single biological sample is an important step in making QIAcuity even more the top choice for groundbreaking dPCR applications,” said Nitin Sood, Senior Vice President and Head of the Life Sciences Business Area at QIAGEN. “We are exploring ways to further increase the capabilities of QIAcuity to help researchers gain a deeper biological understanding of any sample type in a cost-efficient way without tedious optimization or fear of inaccurate quantification.”

The adoption of QIAcuity digital PCR research instrument is strong, with more than 2,700 cumulative placements at the end of 2024 and citations in over 550 publications. Key customers include pharmaceutical and biotechnology companies, academic and research organizations and forensic laboratories. In the fall of 2024, QIAGEN expanded its dPCR portfolio into clinical testing with the launch of QIAcuityDx, which is designed to address clinical customer segments and applications and to further strengthen the QIAcuity family.

The QIAcuity High Multiplex Probe PCR Kit contains a ready-to-use master mix optimized for microfluidic use in the QIAcuity Nanoplates and lets users conveniently perform high-order multiplexing on existing QIAcuity instruments. The kit enhances the specificity and efficiency of probe-based digital PCR to provide accurate singleplex, or up to 12-plex analysis.

As a prerequisite to use the QIAcuity High Multiplex Probe PCR Kit, the QIAcuity Software 3.1 introduces essential features for high-order multiplexing such as crosstalk compensation which corrects signal overlap between targets. This enables researchers to confidently analyze more targets in parallel from one undivided sample.

QIAcuity dPCR catalog and custom assays for copy number variation (CNV) analysis and microbial detection have been re-designed to support up to 12-plex reactions. These assays are available through QIAGEN’s GeneGlobe platform.

The combination of sophisticated software and innovative chemistry make QIAcuity dPCR a superior solution for high-order multiplexing. It enhances workflows by offering greater target capacity and improved data reliability while QIAcuity remains the dPCR system with the highest throughput and is highly automation-friendly.

QIAGEN’s QIAcuity digital PCR platform utilizes nanoplates to disperse a sample into thousands of tiny partitions and then reads the reaction in each one simultaneously to quantify even the faintest signals from DNA and RNA. The platform integrates partitioning, thermocycling, and imaging into a streamlined multiplex workflow, reducing processing times from six hours to just two. Available in one-, four-, and eight-plate versions, the platform meets the needs of a wide range of laboratory sizes and throughput requirements.

For more information about QIAcuity’s new multiplexing capabilities, please visit: https://www.qiagen.com/applications/digital-pcr/beginners/dpcr-multiplexing

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of September 30, 2024, QIAGEN employed more than 5,800 people in over 35 locations worldwide. Further information can be found at https://www.qiagen.com.

Forward-Looking Statement

Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN’s products, timing for launch and development, marketing and/or regulatory approvals, financial and operational outlook, growth and expansion, collaborations, markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN’s products (including fluctuations due to general economic conditions, the level and timing of customers’ funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN’s products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors’ products; market acceptance of QIAGEN’s new products and the integration of acquired technologies and businesses; actions of governments, global or regional economic developments, weather or transportation delays, natural disasters, political or public health crises, and its impact on the demand for our products and other aspects of our business, or other force majeure events; as well as the possibility that expected benefits related to recent or pending acquisitions may not materialize as expected; and the other factors discussed under the heading “Risk Factors in our most recent Annual Report on Form 20-F. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission.

Source: QIAGEN N.V.

Category: Corporate

QIAGEN:

Investor Relations

John Gilardi +49 2103 29 11711

Domenica Martorana +49 2103 29 11244

e-mail: [email protected]

Public Relations

Thomas Theuringer +49 2103 29 11826

Lisa Specht +49 2103 29 14181

e-mail: [email protected]

KEYWORDS: New York Netherlands North America United States Europe Germany

INDUSTRY KEYWORDS: Software Research Professional Services Pharmaceutical Technology Genetics Data Analytics Clinical Trials Science Nanotechnology Biotechnology Stem Cells Health

MEDIA:

Logo
Logo

Innate Pharma Announces Transformative Strategy to Accelerate Growth

 Innate Pharma Announces Transformative Strategy to Accelerate Growth

  •  Strategy anchored on early clinical development of proprietary assets with single-agent potential:

    • Drive innovation with first-in-class ANKET® NK-cell engager Platform
    • Accelerate development of differentiated Antibody-Drug Conjugates
    • Advance current late-stage assets through partnerships

MARSEILLE, France–(BUSINESS WIRE)–
Regulatory News:

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced its updated strategy for company growth. This comprehensive plan is anchored in three key pillars designed to drive sustainable growth, foster innovation, and deliver transformative therapies to patients worldwide.

Our updated strategy underscores Innate Pharma’s unwavering dedication to innovation, collaboration, and delivering transformative therapies for patients worldwide,” said Jonathan Dickinson, Chief Executive Officer of Innate Pharma. “With a focus on our ANKET® platform and ADC programs, we are poised to redefine the landscape of immunotherapy, addressing unmet needs in oncology and autoimmune diseases. This roadmap reflects our steadfast commitment to advancing science, strengthening partnerships, and maximizing value for patients and shareholders alike as we look toward a brighter future in immuno-oncology.

 

Jonathan Dickinson will represent the Company in a session at the 43rd Annual J.P. Morgan Healthcare Conference scheduled Tuesday, January 14, 2025 from 11:15 – 11:55 am PST.

 

A live webcast of the session will be available at the following link:

https://jpmorgan.metameetings.net/events/healthcare25/sessions/58707-innate-pharma/webcast?gpu_only=true&kiosk=true

 

Three Pillars of Growth

  • Drive innovation with first-in-class ANKET® Platform: A new era in NK cell therapeutics is at the heart of Innate Pharma’s strategy, based around its validated, proprietary Antibody-based NK Cell Engager Therapeutics (ANKET®) platform. This cutting-edge technology with anticipated applications in hematologic malignancies, solid tumors, and autoimmune diseases leverages the advantages of harnessing NK cell effector functions and can create proliferation of NK cells. By advancing its clinical pipeline, Innate aims to exploit therapeutic possibilities in oncology and autoimmune diseases. IPH6501, Innate’s proprietary ANKET® is currently being investigated in a Phase 1/2 study in patients with CD20-expressing non-Hodgkin’s Lymphoma.
  • Accelerate development of differentiated Antibody-Drug Conjugates (ADCs): Innate Pharma is advancing its ADC programs to develop differentiated and highly targeted treatments that combine the specificity of monoclonal antibodies with the potency of cytotoxic drugs. IPH4502, Innate’s lead ADC, a novel and differentiated topoisomerase I inhibitor ADC conjugated to exatecan targeting Nectin-4, is being investigated in a Phase 1 trial in patients with advanced solid tumors.
  • Advance current late-stage assets through partnerships: Partnerships will continue to play a critical role in the Company’s strategy, for broader impact with Innate’s established antibody assets, including lacutamab and monalizumab. Innate is actively seeking a partner to progress lacutamab for patients with advanced forms of T cell lymphomas. Monalizumab, currently in a Phase 3 trial PACIFIC-9 led by AstraZeneca in non-small cell lung cancer, will see readouts by end of 2026. By entrusting these promising therapies to strategic partners, Innate ensures their ongoing development and potential commercialization, maximizing their therapeutic potential and reach.

With this multi-faceted strategy, Innate Pharma believes it is positioned to accelerate its growth trajectory and reinforce its leadership in the immuno-oncology space. The Company’s robust scientific expertise, strategic collaborations, and focus on patient outcomes create a strong foundation for success.

About Innate Pharma

Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through three therapeutic approaches: multi-specific NK Cell Engagers via its ANKET® (Antibody-based NK cell Engager Therapeutics) proprietary platform and Antibody Drug Conjugates (ADC) and monoclonal antibodies (mAbs).

Innate’s portfolio includes several ANKET® drug candidates to address multiple tumor types as well as IPH4502 a differentiated ADC in development in solid tumors. In addition, anti-KIR3DL2 mAb lacutamab is developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, and anti-NKG2A mAb monalizumab is developed with AstraZeneca in non-small cell lung cancer.

Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients.

Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.

Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X.

Information about Innate Pharma shares

ISIN code

Ticker code

LEI

FR0010331421

Euronext: IPH Nasdaq: IPHA

9695002Y8420ZB8HJE29

Disclaimer on forward-looking information and risk factors

This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. The use of certain words, including “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “may,” “might,” “potential,” “expect” “should,” “will,” or the negative of these and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s reliance on third parties to manufacture its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties, which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2023, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company’s website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release.

In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

For additional information, please contact:

Investors

Innate Pharma

Henry Wheeler

Tel.: +33 (0)4 84 90 32 88

[email protected]

Media Relations


NewCap

Arthur Rouillé

Tel.: +33 (0)1 44 71 00 15

[email protected]

KEYWORDS: Europe United States North America France California

INDUSTRY KEYWORDS: Oncology Health Clinical Trials General Health Pharmaceutical Biotechnology

MEDIA:

Logo
Logo