Trailhead Biosystems Expands iPSC-Derived Portfolio with TrailBio® Hematopoietic Progenitor Cells
TrailBio ® Hematopoietic Progenitor Cells express key hematopoietic markers including CD34, CD43 and CD90. Functional characterization confirms their ability to form myeloid and erythroid colonies in colony-forming unit (CFU) assays, differentiate into multiple hematopoietic lineages and demonstrate hematopoietic commitment through transcriptomic profiling.
Designed for applications such as hematopoietic disease modeling, drug screening and hematotoxicity studies, TrailBio ® Hematopoietic Progenitor Cells enable a reliable human model system that eliminates donor variability and supports reproducible results.
"TrailBio ® Hematopoietic Progenitor Cells strengthen our portfolio by providing researchers with high-quality, human-relevant cellular models," said David Llewellyn, Chief Executive Officer of Trailhead Biosystems. "Their consistency and multipotency enable scientists to advance research in hematopoietic biology and therapeutic development."
"These Hematopoietic Progenitor Cells deliver a dependable combination of purity, potency and versatility," said Angelica Gomes Ueltschy, Scientific Director at Trailhead Biosystems. "Their robust marker expression and multilineage differentiation capacity make them well suited for modeling blood disorders and evaluating therapeutic candidates."
Cell characterization information and additional data can be found at TrailBio.com.
About Trailhead Biosystems
Trailhead Biosystems, Inc. is pioneering an informatics-based approach in regenerative medicine and drug discovery. Founded in 2015 as a spinout from the Cleveland Clinic and Case Western Reserve University, Trailhead emerged from the research of CSO/CTO and founder Dr. Jan Jensen. Trailhead creates optimized human cells at scale with its proprietary High-Dimensional Design-of-Experiments (HD-DoE ®) platform, integrating advanced mathematical modeling with high-throughput robotic manufacturing. This innovative system allows Trailhead to develop specialized, high-quality iPSC-derived human cells for drug discovery and cell-based therapies. TrailBio ® Hematopoietic Progenitor Cells join a growing portfolio of iPSC-derived human cell types designed to bridge the gap between discovery and clinical translation.
Learn more about Trailhead Biosystems, TrailBio® Hematopoietic Progenitor Cells and HD-DoE® at www.TrailBio.com.
For more information, please contact:
Tim Mauk, Corporate Communications
Trailhead Biosystems
Email: [email protected]
SOURCE Trailhead Biosystems Inc
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Cision Canada
a day ago
- Cision Canada
Oncolytics Biotech® Reports Second Quarter Financial Results and Details Clinical Program Plans for Pelareorep
Key opinion leader event and pancreatic cancer clinical data validate decision to engage with regulators on plans for a registration-enabling study New members of the management team bring expertise in progressing clinical programs and executing successful biotech transactions Translational data further elucidate pelareorep's mechanism of action and ability to prime the tumor microenvironment for treatment Commitment to limiting dilution evidenced by termination of At-the-Market and Equity Line of Credit facilities SAN DIEGO, Aug. 8, 2025 /CNW/ -- Oncolytics Biotech ® Inc. (NASDAQ: ONCY) (TSX: ONC) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, today reported financial results and recent highlights for the second quarter of 2025. All dollar amounts are expressed in Canadian currency unless otherwise noted. "We have turned the corner from proof-of-concept studies and will be sprinting toward regulatory clarity for the remainder of the year," said Jared Kelly, Chief Executive Officer of Oncolytics. "As we shore up our intellectual property, get a clear registration path for pelareorep, and allow our GOBLET data to mature, we will establish our position as the only platform immunotherapy in gastrointestinal tumors." Poster presentation at the American Society of Clinical Oncology Annual Meeting features translational data further demonstrating pelareorep's mechanism of action. Additional analyses of the combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab in first-line ("1L") metastatic pancreatic ductal adenocarcinoma ("mPDAC") patients enhance the understanding of pelareorep's ability to stimulate the immune system and enable treatment regimens to be effective in a traditionally hostile tumor microenvironment (click here for the PR, click here for the poster). Pelareorep expands reovirus-specific T cells, increases cytokines and chemokines, and increases tumor-infiltrating lymphocytes ("TILs") in the blood. New Chief Executive Officer Jared Kelly and Chief Business Officer Andrew Aromando hired to optimize pelareorep's development path. Both are experienced biotech executives with decades of experience advising companies, advancing clinical programs, and navigating successful transactions. They were both instrumental in guiding the sale of Ambrx Biopharma to Johnson & Johnson. Analyses of clinical data show pelareorep's ability to improve survival, and translational data confirming how the intended benefits are achieved. Recently highlighted survival data in mPDAC and breast cancer point to meaningful survival benefits for patients treated with pelareorep-based regimens compared to either control arms or historical data (click here for the PR). In 1L mPDAC, a review of landmark studies shows a historical benchmark of 9.2% two-year survival for chemotherapy regimens, in contrast to the 21.9% two-year survival rate recorded for 100 patients receiving pelareorep and chemotherapy. Translational data from multiple studies and tumor types provide evidence as to how these impressive results have been achieved (click here for the PR). In the GOBLET and AWARE-1 studies, pelareorep converted immunologically "cold" tumors to "hot" ones as a result of the upregulation of interferons, CXCL9/10/11, and PD-L1 in addition to the expansion and mobilization of TILs in the blood, which is correlated with a reduction in tumor size. Key Opinion Leader ("KOL") webinar discussion solidifies pelareorep's opportunity in mPDAC and other gastrointestinal cancers. Presentations from KOLs and a roundtable discussion of pelareorep's clinical data in mPDAC and gastrointestinal cancers point to a potentially significant opportunity for an immunotherapeutic drug candidate that already has shown the ability to extend survival for patients (click here for the PR). Specifically, 1L mPDAC would be ideal for pelareorep as there are no immunotherapies approved for that line of treatment, multiple 1L studies have already demonstrated pelareorep's ability to improve survival in that patient population, and it is backed up by translational data showing the ability to activate the immune system and alter the tumor microenvironment so it is more amenable to therapeutic intervention. Strategic decision to pursue registration-enabling pivotal study for pelareorep in 1L mPDAC. Discussions with regulators are underway to finalize the approval pathway for pelareorep in 1L mPDAC (click here for the PR). This includes decisions on which treatment regimens will be involved, whether to collaborate with a third party on the study, and formalizing overall survival as the primary endpoint. The prioritization of the pancreatic cancer program is based on the compelling survival and translational data from previous studies involving over 100 patients, and the particularly high unmet medical need in this indication. Pelareorep has already received Fast Track and Orphan Drug designation from the U.S. Food and Drug Administration (the "FDA") for mPDAC. If discussions with regulators proceed as expected and the feedback is positive, start-up activities for the study are expected to commence as early as Q4 2025. Commitment to limiting dilutive financing and maximizing shareholder value. Oncolytics intends to terminate its At-the-Market financing facility with Cantor Fitzgerald and Equity Line of Credit with Alumni Capital. The Company believes it has sufficient capital to reach critical regulatory and clinical milestones this fall and pursue strategic opportunities that demonstrate pelareorep's potential without the need for near-term dilutive financings at this time. Additionally, as separately announced, the Company has given formal notice to delist from the Toronto Stock Exchange (the "TSX"). Once delisted from the TSX, the Company's common shares will continue to trade under the symbol "ONCY" on the Nasdaq. Financial Highlights As of June 30, 2025, the Company reported $14.6 million in cash and cash equivalents, projecting a cash runway through key milestones and into the first quarter of 2026. The net loss for the second quarter of 2025 was $6.2 million, compared to a net loss of $7.3 million for the second quarter of 2024. The basic and diluted loss per share was $0.07 in the second quarter of 2025, compared to a basic and diluted loss per share of $0.10 in the second quarter of 2024. Research and development ("R&D") expenses for the second quarter of 2025 were $2.8 million, compared to $4.6 million for the second quarter of 2024. The decrease was primarily attributable to lower clinical trial expenses as the Company focused its R&D efforts on Cohort 5 of the GOBLET study, which is supported by the Pancreatic Cancer Action Network ("PanCAN") Therapeutic Accelerator Award. General and administrative expenses for the second quarter of 2025 were $2.9 million, compared to $3.4 million for the second quarter of 2024. The decrease was primarily due to lower public company-related expenses, and partially offset by higher personnel-related expenses associated with changes to the management team. Net cash used in operating activities for the six months ended June 30, 2025, was $12.0 million, compared to $14.3 million for the six months ended June 30, 2024. The decrease reflected lower operating activities in 2025, partially offset by higher non-cash working capital changes. Anticipated Milestones Q3 2025: Provide an updated clinical timeline for the registration-enabling pivotal study for pelareorep in 1L mPDAC. As early as Q4 2025: Initiate start-up activities for the registration-enabling study for pelareorep in 1L mPDAC. End of 2025: Updated clinical data regarding safety and efficacy in Cohort 4 of the GOBLET study investigating pelareorep combined with atezolizumab in anal carcinoma. Q4 2025: Initial responses from the U.S. Patent and Trademark Office ("PTO") regarding the company's application to extend patent protection for pelareorep. Annual General Meeting and Conference Call Change Management is hosting the Annual General Meeting later today at 10:00 a.m. ET, August 8, 2025. Oncolytics' Chief Executive Officer, Jared Kelly, will provide a brief update after the formal portion of the meeting. To access the meeting as a guest (i.e., a non-voting shareholder): Visit the webcast site: Click the button "I am a Guest" and complete the form If necessary, provide the case-sensitive password: onc2025 Information on how to vote your shares by proxy and attend the meeting as a shareholder is available in the Company's most recent Management Information Circular (the "Circular") dated June 18, 2025. The Circular is available on the Reports page of the investor relations section of the Company's website at and in Canadian and American securities filings. Going forward, Oncolytics will continue to announce quarterly financial results via press releases and in securities filings, but will no longer host quarterly conference calls with the management team. As at June 30, 2025 December 31, 2024 Assets Current assets Cash and cash equivalents $ 14,626 $ 15,942 Other receivables 72 68 Prepaid expenses 3,174 1,885 Warrant derivative 1,024 980 Total current assets 18,896 18,875 Property and equipment 351 411 Right-of-use assets 727 901 Total assets $ 19,974 $ 20,187 Liabilities and Shareholders' Equity Current liabilities Accounts payable and accrued liabilities $ 5,285 $ 4,792 Other liabilities 982 1,618 Lease liabilities 291 277 Total current liabilities 6,558 6,687 Contract liability 6,730 6,730 Lease liabilities 597 787 Total liabilities 13,885 14,204 Commitments Shareholders' equity Share capital Authorized: unlimited Issued: June 30, 2025 – 97,407,903 December 31, 2024 – 80,020,131 451,142 438,193 Contributed surplus 44,792 44,542 Accumulated other comprehensive income 720 961 Accumulated deficit (490,565) (477,713) Total shareholders' equity 6,089 5,983 Total liabilities and shareholders' equity $ 19,974 $ 20,187 ONCOLYTICS BIOTECH INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY (unaudited) (in thousands of Canadian dollars) Share Capital Contributed Surplus Accumulated Other Comprehensive Income Accumulated Deficit Total As at December 31, 2023 $ 430,906 $ 42,116 $ 544 $ (446,003) $ 27,563 Net loss and other comprehensive income — — 178 (14,150) (13,972) Issued pursuant to incentive share award plan 3 (3) — — — Issued pursuant to "At the Market" Agreement 3,840 — — — 3,840 Share issue costs (202) — — — (202) Share-based compensation expense — 1,082 — — 1,082 As at June 30, 2024 $ 434,547 $ 43,195 $ 722 $ (460,153) $ 18,311 As at December 31, 2024 $ 438,193 $ 44,542 $ 961 $ (477,713) $ 5,983 Net loss and other comprehensive loss — — (241) (12,852) (13,093) Issued pursuant to incentive share award plan 1,481 (1,481) — — — Issued pursuant to "At the Market" Agreement 8,714 — — — 8,714 Issued pursuant to share purchase agreement 3,841 — — — 3,841 Share issue costs (1,087) — — — (1,087) Share-based compensation expense — 1,731 — — 1,731 As at June 30, 2025 $ 451,142 $ 44,792 $ 720 $ (490,565) $ 6,089 Six Months Ended June 30, 2025 2024 Operating Activities Net loss for the period $ (12,852) $ (14,150) Depreciation - property and equipment 51 56 Depreciation - right-of-use-assets 140 165 Share-based compensation expense 1,731 1,082 Interest expense on lease liabilities 74 57 Unrealized foreign exchange loss (gain) 1 (576) Change in fair value of warrant derivative (44) (1,104) Net change in non-cash working capital (1,070) 182 Cash used in operating activities (11,969) (14,288) Investing Activities Acquisition of property and equipment — (201) Cash used in investing activities — (201) Financing Activities Proceeds from "At the Market" equity distribution agreement, net 8,386 3,638 Proceeds from share purchase agreement, net 3,082 — Payment of lease liabilities (205) (168) Cash provided by financing activities 11,263 3,470 Decrease in cash and cash equivalents (706) (11,019) Cash and cash equivalents, beginning of period 15,942 34,912 Impact of foreign exchange on cash and cash equivalents (610) 957 Cash and cash equivalents, end of period $ 14,626 $ 24,850 About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer and early-phase studies in anal and colorectal cancer. It induces anti-cancer immune responses by converting immunologically "cold" tumors "hot" through the activation of innate and adaptive immune responses. The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic pancreatic and breast cancers, both of which have received Fast Track designation from the FDA, and other gastrointestinal tumors. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: or follow the Company on social media on LinkedIn and on X @ oncolytics. Forward-looking statements This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; its upcoming milestones; its belief that we will establish our position as the only platform immunotherapy in gastrointestinal tumors; its plans for a potential registration-enabling pivotal study in 1L mPDAC; the anticipated potential timing of commencement of start-up activities and enrollment in a study; the focus of its discussions with the FDA in respect of the study; the anticipated trial design; its plan to delist from the Toronto Stock Exchange; its plans with respect to shareholder communications; and its plan to continue actively pursuing strategic partnerships; its goals, strategies and objectives; its belief in the clinical promise of pelareorep in mPDAC and other gastrointestinal cancers; financial projections and the sufficiency of capital to reach critical milestones and pursue strategic opportunities and its need for near-term dilutive financing. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics' public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law. Company Contact Jon Patton Director of IR & Communication [email protected] Investor Relations for Oncolytics Mike Moyer LifeSci Advisors +1-617-308-4306 [email protected]
Cision Canada
a day ago
- Cision Canada
Tim Hortons®, The PWHL and Barbie® Team Up on New Hockey Dolls in Collaboration with Superstars Sarah Nurse and Marie-Philip Poulin Français
Barbie ® Tim Hortons ® PWHL™ Dolls will be available starting Aug. 11 at participating Tim Hortons restaurants in Canada and are available now at and (Canada) and (US). $5 from every doll sold at Tims restaurants and or at the online PWHL Shops will be donated to Grindstone Award Foundation. In celebration of the launch of Barbie ® Tim Hortons ® PWHL™ Dolls, the Tim Hortons restaurant located at 3157 Dundas St. W. in Toronto has been transformed, with its iconic Tims red replaced with Barbie pink and PWHL purple. The restaurant makeover will be available for guests to see until Aug. 13. TORONTO, Aug. 8, 2025 /CNW/ - She shoots, she scores, she supports! Tim Hortons, the PWHL and Mattel, Inc. announced today the launch of new Barbie ® Tim Hortons ® PWHL™ Dolls, which will be available starting Aug. 11 at participating Tim Hortons restaurants across Canada and online now at and PWHL Shops. As part of a shared commitment to increasing access for girls in hockey, Tim Hortons will donate $5 to the Grindstone Foundation for every Barbie ® Tim Hortons ® PWHL™ Doll sold in participating restaurants and and the PWHL will match this with a $5 donation for each doll bought through its online store. As the most diverse doll line on the market, Barbie is continuing to empower young children to unlock their limitless potential. Studies show that girls who are involved in team sports are more likely to believe they are smart enough for their dream career, have high opinions on their abilities and competencies, increased leadership aspirations and enjoy higher levels of self-confidence. 1 The two Barbie ® Tim Hortons ® PWHL ™ Dolls are inspired by members of Team Barbie and PWHL superstars Sarah Nurse and Marie-Philip Poulin, who were recognized as Barbie role models in 2020 for being trailblazers on the ice and breaking down barriers for women in hockey. Each Barbie doll comes with a Tim Hortons PWHL hockey jersey, hockey stick, helmet and skates and can be purchased for $34.99. There are more ways for fans to celebrate the launch of the Barbie ® Tim Hortons ® PWHL ™ Dolls, including: Tims Rewards members who purchase a Barbie ® Tim Hortons ® PWHL ™ Doll from a Tims restaurant will also be entered for a chance to win an exclusive PWHL game day experience. For more details and contest information, visit Starting Aug. 11, the Barbie PWHL Donut — a yeast ring donut dipped in white icing and topped with pink sprinkles — and Barbie Pineapple Dragon Fruit Quenchers will also be available at participating Tims restaurants. The Tims Barbie ® Hoodie is available at ____________________________ 1 According to the NAACP + The Girls' Index QUOTES "Tim Hortons is incredibly proud of our hockey leadership in Canada including how our local restaurant owners collectively support 100,000 youth players in communities across the country every year through Timbits Hockey. We're thrilled to be partnering with Barbie, Sarah Nurse, Marie-Philip Poulin and the PWHL on the new Barbie Tim Hortons PWHL Dolls and we're proud that each doll sold at a Tims restaurant and at the PWHL Shop will result in a donation to the Grindstone Award Foundation to help break down financial barriers for girls who want to play the sport." Hope Bagozzi, Chief Marketing Officer for Tim Hortons "Our goal is to inspire the next generation of hockey players by bringing these Barbie dolls to life in partnership with Tim Hortons and the PWHL. Barbie has a long-standing partnership with Tim Hortons, built on a shared commitment of inspiring young hockey players. Now, with Barbie as an official partner of the PWHL in Canada since its inaugural season, it was a natural next step to bring together brands with a common goal. These Barbie dolls reflect our commitment to championing the belief that a girl can be anything she wants to be — including a hockey player — in and outside of the playroom." Tara George, General Manager at Mattel Canada "We've heard from fans across the league that they're eager to see Barbie Tim Hortons PWHL Dolls, making this collaboration with Tim Hortons and Barbie an ideal fit. We're especially proud that this initiative also makes a meaningful impact, as the Grindstone Foundation continues to transform the lives of girls across Canada by helping to remove barriers and create more opportunities for the next generation of players." Amy Scheer, Executive Vice President of Business Operations at the PWHL "We're incredibly grateful to Tim Hortons and the PWHL for their generous support, and for teaming up with Mattel to champion the growth of girls' hockey across Canada. As a national charity, we're proud to partner with organizations that not only support gender equality in sport, but understand that when girls are given the chance to play hockey, they gain confidence, build resilience, and grow into future leaders. This collaboration will help more girls access the game and discover all that Grindstone has to offer." Danielle Bell, President of the Grindstone Award Foundation Rules apply. No purchase necessary. Open to 13+ (14+ in Quebec) residents of Canada only. Full rules and entry details at © Tim Hortons, 2025. ABOUT TIM HORTONS In 1964, the first Tim Hortons ® restaurant in Hamilton, Ontario opened its doors and Canadians have been ordering Tim Hortons iconic Original Blend coffee, Double-Double™ coffees, Donuts and Timbits ® in the years since. For more than 60 years, Tim Hortons has captured the hearts and taste buds of Canadians and has become synonymous with serving Canada's favourite coffee. Tim Hortons is Canada's largest restaurant chain operating in the quick service industry with nearly 4,000 restaurants across the country. More than a coffee and bake shop, Tim Hortons is part of the Canadian fabric and guests can enjoy hot and cold specialty beverages – including lattes, cappuccinos and espressos, teas and our famous Iced Capps ® – alongside delicious breakfast, sandwiches, wraps, soups and more. Tim Hortons has more than 6,000 restaurants in Canada, the United States and around the world. For more information on Tim Hortons visit ABOUT MATTEL Mattel is a leading global toy and family entertainment company and owner of one of the most iconic brand portfolios in the world. We engage consumers and fans through our franchise brands, including Barbie ®, Hot Wheels ®, Fisher-Price ®, American Girl ®, Thomas & Friends ™, UNO ®, Masters of the Universe ®, Matchbox ®, Monster High ®, Polly Pocket ®, and Barney ®, as well as other popular properties that we own or license in partnership with global entertainment companies. Our offerings include toys, content, consumer products, digital and live experiences. Our products are sold in collaboration with the world's leading retail and ecommerce companies. Since its founding in 1945, Mattel is proud to be a trusted partner in empowering generations to explore the wonder of childhood and reach their full potential. Visit us at ABOUT THE PROFESSIONAL WOMEN'S HOCKEY LEAGUE (PWHL) The Professional Women's Hockey League (PWHL) is a professional ice hockey league in North America that features the best women's players in the world. It is comprised of eight teams: Boston, Minnesota, Montréal, New York, Ottawa, Seattle, Toronto and Vancouver. Launched on Jan. 1, 2024, the PWHL has broken multiple attendance records and holds the worldwide all-time record for a women's hockey game. In 2024, the PWHL was recognized by Sports Business Journal as the Sports Breakthrough of the Year and received the top position in the first-ever Canadian edition of the Harris Poll, which ranks companies' reputations. Visit to purchase tickets and merchandise and subscribe to the PWHL e-newsletter to receive the latest league updates. Follow the league on all social media platforms @thepwhlofficial. PWHL, the PWHL Logo, and PWHL team names and logos are trademarks of the PWHL. © PWHL 2025. All Rights Reserved. ABOUT GRINDSTONE AWARD FOUNDATION The Grindstone Award Foundation is a registered Canadian charity that provides financial assistance to female hockey players under the age of 19 who want to play hockey but are unable to due to financial barriers. Founded in 2014 in Kelowna, British Columbia, Grindstone awarded its first grant in 2015, and has since gone on to provide over $140,000 in financial assistance towards registration fees to female players all across Canada. Funded entirely through generous donations from the public, Grindstone believes that all girls should have equal opportunity when it comes to playing the game they love. Their mandate is to help grow the game of hockey by supporting diverse Canadian families from coast to coast to ensure the sport is accessible for all female players. For more information on Grindstone or to make a donation, please visit and follow Grindstone on social media - @GrindstoneAward. SOURCE Tim Hortons
Cision Canada
2 days ago
- Cision Canada
Cipher Pharmaceuticals Reports Second Quarter 2025 Results, Including Record Revenue
(All figures are presented in U.S. Dollars) Highest single-quarter revenue in the Company's history with total revenue of $13.4 million in Q2 2025 Adjusted EBITDA 1 in Q2 2025 was $7.6 million, an increase of 148% over Q2 2024 Epuris sales volumes grew 14% in the quarter compared to Q2 2024 Natroba TM sales were $7.8 million during the quarter, a sequential increase of 16% over Q1 2025 Strong cash generation with $6.0 million cash from operations in Q2 2025 $15.0 million debt repayment and share repurchases of $2.1 million during Q2 2025 $7.0 million debt repayment subsequent to Q2 2025 MISSISSAUGA, ON, Aug. 7, 2025 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: CPH) (OTCQX: CPHRF) (" Cipher" or the " Company") today announced its financial and operating results for the three and six months ended June 30, 2025. First Quarter 2025 Financial Highlights (All figures in U.S. dollars, compared to Q2 2024, unless otherwise noted) Total revenue was $13.4 million in Q2 2025, an increase of 152% Canadian product portfolio revenue increased by 12% to $4.1 million in Q2 2025, compared to $3.7 million in Q2 2024 Natroba TM provided $7.8 million of incremental product revenue in Q2 2025 Licensing revenue was $1.5 million in Q2 2025, compared to $1.6 million in Q2 2024 Total gross profit from operations increased by 159% to $10.9 million in Q2 2025 Adjusted EBITDA 1 increased 148% to $7.6 million in Q2 2025 Cash balance of $11.3 million at the end of Q2 2025 Management Commentary Craig Mull, Interim CEO, commented:"Cipher has continued its growth during the second quarter of 2025, with quarterly revenue achieving a historical record for the Company, largely contributed to by our U.S. business. The U.S. business, led by Natroba™, continues to exceed our expectations from when we acquired the business almost one year ago, in July 2024. The U.S. business has contributed to a more than doubling of Cipher's total revenue and Adjusted EBITDA 1 compared to the prior year, for both the second quarter and the year-to-date. We look forward to providing further updates on the impact our strategy and activities surrounding the business have on the performance of Natroba™ for the remainder of 2025. Cipher's base business in Canada continues to experience year-over-year growth from Epuris®, with the product realizing revenue growth of 25% for the year-to-date 2025 compared to the same period in 2024, which largely offsets the decline in revenue derived from our licensing portfolio as a result of the competitive pressures faced by our commercial partners for these out-licensed products in the U.S. market." Ryan Mailling, CFO, commented: "In Q2 2025, we had another quarter of strong cash generation, with $6.0 million of cash generated from operations during the quarter. Cash generated in the second quarter, combined with previous cash accumulation, was allocated during the quarter to a $15.0 million repayment on our revolving credit facility, de-levering the business, as well as repurchases of our common shares through our normal course issuer bid ("NCIB"), which returned $2.1 million to our shareholders. After this effective use of available capital, at the end of the second quarter $11.3 million of cash remained on our balance sheet. Accordingly, subsequent to the end of the quarter we further allocated $7.0 million to an additional repayment on our revolving credit facility, resulting in $47.0 million of financing remaining available through the facility, plus a $25.0 million accordion option, which in total is $72.0 million of total potential financing available. We continue to be in an excellent position to execute on growth opportunities." Corporate Highlights On April 29, 2025, Cipher announced its product Natroba TM received preferred step-through status on Medicaid in the state of Illinois, whereby its main product competitor Permethrin 5% was downgraded to non-preferred on the state's preferred drug listing. This move by Illinois Medicaid will require all prescriptions for Permethrin 5% to first 'step-though' Natroba TM representing the treatment of choice in the state. On May 1, 2025, Cipher announced that the Toronto Stock Exchange (the "TSX") had approved the Company's Notice of Intention to Make a Normal Course Issuer Bid under which the Company may purchase for cancellation, from time to time up to May 4, 2026, up to an aggregate of 1,485,260 of its issued and outstanding common shares, being 10% of its public float of 14,852,604 common shares as of April 22, 2025. In accordance with TSX rules, any daily repurchases on the TSX under the NCIB are limited to a maximum of 10,427 common shares, which represents 25% of the average daily trading volume on the TSX of 41,708 for the six months ended March 31, 2025. To facilitate larger repurchases, the Company is entitled to make one weekly block purchase on the TSX that may exceed the daily repurchase restrictions. On May 8, 2025, the Company repaid $15.0 million of the outstanding balance on its revolving credit facility. On August 6, 2025, the Company repaid $7.0 million of the remaining outstanding balance on its revolving credit facility. As a result of the repayment, the outstanding balance on the Company's revolving credit facility has been reduced to $18.0 million. Due to the revolving nature of the credit facility, an additional $47.0 million remains available to the Company to draw upon, should financing be required. Q2 2025 Financial Review (All figures in U.S. dollars, compared to Q2 2024, unless otherwise noted) Total revenue was $13.4 million in Q2 2025, compared to $5.3 million in Q2 2024, an increase of 152% Product revenue from the Canadian product portfolio was $4.1 million in Q2 2025, an increase of 12% from $3.7 million in Q2 2024 Product revenue from Natroba TM in the U.S. was $7.8 million, up sequentially from $6.7 million in Q1 2025 Licensing revenue decreased 9% to $1.5 million in Q2 2025 compared to $1.6 million in Q2 2024, impacted by lower net sales realized by Cipher's partners on which the Company earns a royalty and contractual royalty rate reductions, partially offset by higher product shipments to licensing partners Total gross profit was $10.9 million in Q2 2025, compared to $4.2 million in Q2 2024, an increase of 159% Gross margin as a percentage of product revenue increased by 9% to 79% in Q2 2025 from 70% in Q2 2024, driven by the addition of Natroba™, which was acquired on July 29, 2024 Total gross margin increased by 2% to 81% in Q2 2025 from 79% in Q2 2024 due to the addition of Natroba™, partially offset by reduced licensing revenue Net income and earnings per common share were $5.9 million and $0.23, respectively, in Q2 2025, compared to $3.0 million and $0.12, respectively, in Q2 2024, with the increase primarily attributable to the additional operating income generated from Natroba™ in Q2 2025 EBITDA 1 in Q2 2025 was $8.6 million, compared to $2.2 million in Q2 2024, an increase of 290% Adjusted EBITDA 1 in Q2 2025 was $7.6 million, compared to $3.1 million in Q2 2024, an increase of $4.5 million or 148% Adjusted EBITDA 1 per share in Q2 2025 was $0.29 compared to $0.13 in Q2 2024, an increase of $0.16 per share or 123% Under the Company's NCIB, 230,278 common shares were repurchased and cancelled at an average share price of CDN$12.74 Business Strategy & Outlook Cipher expects to continue to execute on its business strategy, remains focused on profitability and delivering shareholder value. Key areas of focus include: Driving market share growth of Natroba™ in the anti-parasitic market in the U.S. where market leader "Permethrin" is no longer an effective treatment but still holds 75% 2 market share. Obtaining Health Canada regulatory approval for Natroba™ and commercializing the product directly in the Canadian market by leveraging Cipher's existing infrastructure in Canada. Out-licensing Natroba™ globally where there is high unmet need, such as warm climate regions. Acquiring complementary dermatology products to add to our North American platform to enhance the profitability, size and scale of the business. Financial Statements and MD&A Cipher's financial statements for the three and six months ended June 30, 2025, and Management's Discussion and Analysis (the "MD&A") for the three and six months ended June 30, 2025, are available on the Company's website at in the "Investors" section under "Financial Reports" and on SEDAR+ at Notice of Conference Call Cipher will hold a conference call on August 8, 2025 at 8:30 a.m. (ET) to discuss its financial results and other corporate developments. To access the conference call by telephone, dial (416) 945-7677 or (888) 699-1199 A live audio webcast will be available at An archived replay of the webcast will be available until August 15, 2025 and can be accessed by dialing (289) 819-1450 or (888) 660-6345 and entering conference replay code 36094# About Cipher Pharmaceuticals Inc. Cipher Pharmaceuticals (TSX: CPH) (OTCQX: CPHRF) is a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early to late-stage products, mainly in dermatology. Cipher acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and currently markets those products in Canada, the U.S., and South America. For more information, visit Forward-Looking Statements and Non-IFRS Measures This document includes forward-looking statements within the meaning of applicable securities laws. These forward-looking statements include, among others, expectations for future growth, objectives and goals and strategies to achieve those objectives and goals, the potential purchases to be made under the NCIB, as well as statements with respect to our beliefs, plans, expectations, anticipations, estimates and intentions. The words "may", "will", "could", "should", "would", "suspect", "outlook", "believe", "plan", "anticipate", "estimate", "expect", "intend", "forecast", "objective", "hope" and "continue" (or the negative thereof), and words and expressions of similar import, are intended to identify forward-looking statements. By their nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, which give rise to the possibility that predictions, forecasts, projections and other forward-looking statements will not be achieved. Certain material factors or assumptions are applied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements. We caution readers not to place undue reliance on these statements as a number of important factors, many of which are beyond our control, could cause our actual results to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates and intentions expressed in such forward-looking statements. These factors include, but are not limited to, our ability to enter into development, manufacturing and marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect; our dependency on a limited number of products; our dependency on protection from patents that will expire; the extent and impact of health pandemic outbreaks on our business; integration difficulties and other risks if we acquire or in-license technologies or product candidates; reliance on third parties for the marketing of certain products; the product approval process by regulators which can be highly unpredictable; the timing of completion of clinical trials, regulatory submissions and regulatory approvals; reliance on third parties to manufacture our products and events outside of our control that could adversely impact the ability of our manufacturing partners to supply products to meet our demands; we may be subject to future product liability claims; unexpected product safety or efficacy concerns may arise; we generate license revenue from a limited number of distribution and supply agreements; the Company's performance depends, in part, on the performance of its distributors and suppliers; the pharmaceutical industry is highly competitive with new competing product entrants; requirements for additional capital to fund future operations; products may be subject to pricing regulation; dependence on key managerial personnel and external collaborators; the ability to receive regulatory approvals for products in development or future products; certain of our products are subject to regulation as controlled substances; limitations on reimbursement in the healthcare industry; the ability to convince public payors and hospitals to include our products on the approved formulary lists; ability to receive timely payment from certain customers; application of various laws pertaining to health care fraud and abuse; the Company's reliance on the success of strategic investments and partnerships; the publication of negative results of clinical trials; unpredictable development goals and projected time frames; rising insurance costs; ability to enforce covenants not to compete; risks associated with the healthcare industry generally; we may be unsuccessful in evaluating material risks involved in completed and future acquisitions; we may be unable to identify, acquire or integrate acquisition targets successfully; success in applying tax loss carry forwards; inability to meet covenants under our long-term debt arrangement; compliance with privacy and security regulation; our policies regarding product returns, allowances and chargebacks may reduce revenues; additional regulatory burden and controls over financial reporting; application of regulations that could restrict our activities and abilities to generate revenues as planned; reliance on third parties to perform distribution, logistics, invoicing, regulatory and sales services; general commercial litigation, class actions, other litigation claims and regulatory actions; the difficulty for shareholders to realize in the United States upon judgments of U.S. courts predicated upon civil liability of the Company and its directors and officers who are not residents of the United States; increases in tariffs, trade restrictions or taxes on our products; the potential violation of intellectual property rights of third parties; our efforts to obtain, protect or enforce our patents and other intellectual property rights related to our products; changes in U.S., Canadian or foreign patent laws; inability to protect our trademarks from infringement; shareholders may be further diluted if we issue securities to raise capital; volatility of our share price; the fact that we have a significant shareholder; our operating results may fluctuate significantly; and our debt obligations will have priority over the common shares of the Company in the event of a liquidation, dissolution or winding up. We caution that the foregoing list of important factors that may affect future results is not exhaustive. When reviewing our forward-looking statements, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. Additional information about factors that may cause actual results to differ materially from expectations, and about material factors or assumptions applied in making forward-looking statements, may be found in the "Risk Factors" section of our MD&A for the year ended December 31, 2024 and the Company's Annual Information Form, and elsewhere in our filings with Canadian securities regulators. Except as required by Canadian securities law, we do not undertake to update any forward-looking statements, whether written or oral, that may be made from time to time by us or on our behalf; such statements speak only as of the date made. The forward-looking statements included herein are expressly qualified in their entirety by this cautionary language. 1) EBITDA and adjusted EBITDA are non-IFRS financial measures. These non-IFRS measures are not recognized measures under IFRS and do not have a standardized meaning prescribed by IFRS and are unlikely to be comparable to similar measures presented by other companies. Management uses non-IFRS measures such as Earnings Before Interest, Taxes, Depreciation and Amortization ("EBITDA") and Adjusted EBITDA to provide investors with supplemental measures of the Company's operating performance and thus highlight trends in the Company's core business that may not otherwise be apparent when relying solely on IFRS financial measures. The Company defines Adjusted EBITDA as earnings before interest expense, income taxes, depreciation of property and equipment, amortization of intangible assets, non-cash share-based compensation, changes in fair value of derivative financial instruments, costs and provisions for legal matters, loss on disposal of assets and loss on extinguishment of lease, impairment of intangible assets, acquisition costs, restructuring costs, fair value adjustments to acquired inventory and unrealized foreign exchange gains and losses. 2) IQVIA market data as at June 30, 2025. The following is a summary of how EBITDA and Adjusted EBITDA are calculated: (IN THOUSANDS OF U.S. DOLLARS, Three months ended June 30, 2025 Three months ended June 30, 2024 Six months ended June 30, 2025 Six months ended June 30, 2024 except for per share amounts) $ $ $ $ Net income and comprehensive income 5,893 2,995 8,517 7,918 Add back: Depreciation and amortization 1,807 292 3,629 581 Interest expense (income) 345 (611) 815 (1,166) Income tax expense (recovery) 512 (480) (225) (2,435) EBITDA 8,557 2,196 12,736 4,898 Unrealized foreign exchange (gain) loss (1,759) 401 (1,770) 1,043 Acquisition, restructuring and other costs — 284 128 284 Fair value adjustments to acquired inventory 131 — 777 — Costs and provisions for legal matter 221 — 1,221 — Share-based compensation 436 183 680 407 Adjusted EBITDA 7,586 3,064 13,772 6,632 Adjusted EBITDA per share – basic 0.29 0.13 0.54 0.28 Adjusted EBITDA per share – dilutive 0.29 0.12 0.52 0.27 Consolidated statements of income and comprehensive income Three months ended June 30, Six months ended June 30, (IN THOUSANDS OF U.S. DOLLARS, 2025 2024 2025 2024 except for per share amounts) $ $ $ $ Revenue Licensing revenue 1,478 1,618 2,213 4,218 Product revenue 11,903 3,686 23,187 6,953 Net revenue 13,381 5,304 25,400 11,171 Operating expenses Cost of products sold 2,498 1,106 5,377 2,161 Research and development — — 21 — Depreciation and amortization 1,807 292 3,629 581 Selling, general and administrative 4,085 1,601 9,036 3,069 Total operating expenses 8,390 2,999 18,063 5,811 Other (income) expenses Interest expense (income) 345 (611) 815 (1,166) Unrealized foreign exchange (gain) loss (1,759) 401 (1,770) 1,043 Total other (income) expenses (1,414) (210) (955) (123) Income before income taxes 6,405 2,515 8,292 5,483 Current income tax expense — — — — Deferred income tax expense (recovery) 512 (480) (225) (2,435) Total income tax expense (recovery) 512 (480) (225) (2,435) Net income and comprehensive income for the period 5,893 2,995 8,517 7,918 Income per share Basic 0.23 0.12 0.33 0.33 Diluted 0.22 0.12 0.32 0.32 Consolidated statements of financial position As at June 30, As at December 31, 2025 2024 (IN THOUSANDS OF U.S. DOLLARS) $ $ Assets Current assets Cash and cash equivalents 11,339 17,837 Accounts receivable 11,868 13,860 Inventory 5,576 5,792 Prepaid expenses and other assets 1,766 995 Total current assets 30,549 38,484 Property and equipment 522 680 Intangible assets 75,287 78,754 Deferred financing costs 311 386 Goodwill 17,447 17,447 Deferred tax assets 28,278 26,761 Total assets 152,394 162,512 Liabilities and shareholders' equity Current liabilities Accounts payable and accrued liabilities 4,846 5,873 Income taxes payable 9 54 Interest payable 82 358 Contract liabilities 12,564 13,306 Current portion of lease obligation 262 283 Total current liabilities 17,763 19,874 Lease obligation 193 295 Long-term debt 25,000 40,000 Total liabilities 42,956 60,169 Shareholders' equity Share capital 27,556 27,680 Contributed surplus 7,149 6,525 Accumulated other comprehensive loss (9,514) (9,514) Retained earnings 84,247 77,652 Total shareholders' equity 109,438 102,343 Total liabilities and shareholders' equity 152,394 162,512 SOURCE Cipher Pharmaceuticals Inc.
