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6 days ago
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Lyell Immunopharma Reports Business Highlights and Financial Results for the Second Quarter 2025
Presented positive new clinical data demonstrating high rates of durable complete responses from the Phase 1/2 trial of LYL314 for the treatment of aggressive large B-cell lymphoma Initiated the PiNACLE pivotal trial of LYL314 in patients with large B-cell lymphoma receiving treatment in the third‑ or later-line (3L+) setting; remain on track to initiate a pivotal trial in the second-line (2L) setting by early 2026 Entered into a securities purchase agreement for a private placement for gross proceeds of up to approximately $100 million Pro-forma cash of approximately $347 million inclusive of the initial proceeds from the private placement to support advancing pipeline into mid-2027 through key clinical milestones SOUTH SAN FRANCISCO, Calif., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing next-generation CAR T-cell therapies for patients with cancer, today reported financial results and business highlights for the second quarter ended June 30, 2025. Lyell's lead clinical program, LYL314, is a next-generation autologous dual-targeting CD19/CD20 CAR T-cell product candidate under evaluation in PiNACLE, a single-arm pivotal trial enrolling patients with relapsed and/or refractory (R/R) large B-cell lymphoma (LBCL) in the 3L+ setting and in a Phase 1/2 study in the 2L setting. 'Based on the high rate of durable complete responses achieved by LYL314 in patients with aggressive LBCL presented at the International Conference on Malignant Lymphoma in Lugano, Switzerland, in June, we believe that our CD19/CD20 CAR T-cell therapy will disrupt the therapeutic landscape by delivering meaningfully increased complete response rates and improved durability over the currently approved CD19 CAR T-cell therapies,' said Lynn Seely, M.D., President and CEO of Lyell. 'Our recent private placement with well-respected investors significantly derisks our business, extends our cash runway into mid-2027 and enables us to focus on rapidly advancing the clinical development of LYL314. We have initiated the PiNACLE single-arm pivotal trial for patients with LBCL receiving treatment in the third- or later-line setting and are on track to begin a second pivotal trial of LYL314 for patients with LBCL in the second-line setting by early 2026.' Second Quarter Updates and Recent Business Highlights Lyell is advancing a pipeline of next-generation CAR T-cell product candidates targeting cancers with large unmet need and substantial patient populations. Its lead program, LYL314, is in pivotal development for patients with R/R LBCL and its preclinical programs target solid tumor is an autologous CAR T-cell product candidate with a true 'OR' logic gate to target B cells that express either CD19 or CD20 with full potency and that is manufactured with a process that enriches for CD62L-positive cells to generate more naïve and central memory CAR T cells with enhanced stemlike features and antitumor activity. Following a successful End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA), LYL314 is currently being evaluated in the pivotal PiNACLE trial, which is a seamless expansion of the 3L+ cohort of the Phase 1/2 trial of patients with R/R LBCL. The Phase 1/2 trial continues to enroll CAR T-cell therapy naïve patients receiving treatment in the 2L setting and a pivotal trial for these 2L patients is expected be initiated by early 2026. The FDA has granted LYL314 Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for the treatment of R/R diffuse LBCL in the 3L+ setting. RMAT provides all the benefits of the Fast Track and Breakthrough Therapy designation programs and enables increased frequency of communications with the FDA on the development of LYL314. PiNACLE is a single-arm pivotal trial evaluating LYL314 at a dose of 100 x 106 CAR T cells in patients with LBCL receiving treatment in the 3L+ setting. The trial is expected to enroll approximately 120 patients with R/R diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, transformed follicular lymphoma or Grade 3B follicular lymphoma who have not previously received CAR T-cell therapy. Patients may be treated with LYL314 in either the inpatient or outpatient setting and there is no upper age limit for eligibility. The primary endpoint of the trial is the overall response rate, including an evaluation of duration of response. New clinical data from the Phase 1/2 multi-center clinical trial of LYL314 in patients with R/R LBCL were presented at the 18th International Conference on Malignant Lymphoma in June and included more mature data from patients treated in the 3L+ setting and initial data from patients treated in the 2L setting. The data were presented in an oral presentation titled 'LYL314, a CD19/CD20 CAR T‑cell candidate enriched for CD62L+ stem-like cells, achieves high rates of durable complete responses in relapsed and/or refractory large B-cell lymphoma'. Highlights include: Fifty-one CAR T-naive patients with R/R LBCL received LYL314 as of April 15, 2025 (the data cutoff date for the presentation). The efficacy evaluable population consisted of 36 patients with Day 84 assessments or prior disease progression or death. Patient demographics and baseline disease characteristics were consistent with high-risk patient populations: median ages of 65 and 69 years in the 3L+ and 2L, respectively, 41% of 3L+ and 65% of 2L patients had Stage IV disease at trial entry, and 47% of 3L+ and 82% of 2L patients had primary refractory disease. In efficacy-evaluable 3L+ patients, with a median follow-up of 9 months (N = 25): The overall response rate was 88% (22/25 patients), with 72% (18/25) of patients achieving a complete response. 71% (10/14) of patients with complete response remained in complete response at ≥ 6 months. In initial data from efficacy-evaluable 2L patients, with a median follow-up of 5 months (N = 11): The overall response rate was 91% (10/11 patients), with 64% (7/11) achieving a complete response. 100% (7/7) of patients with complete response were in complete response at their last assessment, including 3/3 patients at ≥ 6 months. In patients with primary refractory disease, a difficult to treat population, 70% (7/10) achieved a complete response. In 51 patients, including patients from both the 3L+ and the 2L cohorts, a manageable safety profile appropriate for outpatient administration was observed. No Grade ≥ 3 and low rates of Grade 1 (22%) or Grade 2 (35%) cytokine release syndrome (CRS) were reported. Immune effector cell-associated neurotoxicity syndrome (ICANS) was reported in 6% (Grade 1), 2% (Grade 2), and 14% (Grade ≥ 3) of patients. The median time to complete resolution of all reports of ICANS was 5 days, with rapid improvement (median of 2 days) to Grade 2 or lower with standard therapy. No deaths were related to LYL314 administration. LYL314 demonstrated robust expansion with a time to peak of 10 days. The final drug product contained the desired CD62L-positive naïve T-cell phenotype (median, 95%). Rapid and durable depletion of B cells was demonstrated through month 6 and up to the month 12 assessment. An update on the progress of the PiNACLE trial is planned for late 2025. Data from this trial is expected to form the basis of a Biologics License Application submission to the FDA in 2027 for patients with R/R LBCL receiving treatment in the 3L+ setting. More mature data from the ongoing Phase 1/2 trial in the 2L setting are expected to be presented in late 2025. A Phase 3 randomized controlled trial of LYL314 is expected to be initiated by early 2026 in patients receiving treatment in the 2L setting with R/R LBCL. Preclinical Pipeline, Technologies and Manufacturing Protocols Lyell is advancing next-generation fully-armed CAR T-cell product candidates, each including multiple technologies, designed to overcome T-cell exhaustion and lack of durable stemness, as well as immune suppression within the hostile tumor microenvironment. The first IND for a fully-armed CAR T-cell product candidate with an undisclosed target for solid tumors is expected in 2026. Corporate Updates In July, Lyell entered into a securities purchase agreement for a private placement with certain institutional and other accredited investors, for gross proceeds of up to approximately $100 million. The initial closing of approximately $50 million of common stock at a price of $13.32 per share occurred on July 25, 2025. After deducting offering expenses, Lyell expects to use net proceeds from the private placement, together with its existing cash, cash equivalents, and marketable securities, to advance two pivotal-stage clinical trials of LYL314 as well as working capital for other general corporate purposes. Second Quarter 2025 Financial Results Lyell reported a net loss of $42.7 million for the second quarter ended June 30, 2025, compared to a net loss of $45.8 million for the same period in 2024. The $3.1 million decrease in net loss was primarily due to a decrease of $3.3 million in stock-based compensation expense resulting from lower headcount and the reduced value of new equity awards. Non‑GAAP net loss, which excludes stock-based compensation, non-cash expenses related to the change in the estimated fair value of success payment liabilities and certain non-cash investment gains and charges, decreased to $37.8 million for the second quarter ended June 30, 2025, compared to $39.1 million for the same period in 2024, primarily due to lower interest income primarily driven by decreased interest rates in 2025 coupled with lower cash equivalent and marketable securities balances. GAAP and Non-GAAP Operating Expenses Research and development (R&D) expenses were $34.9 million for the second quarter ended June 30, 2025, compared to $40.3 million for the same period in 2024. The decrease in second quarter 2025 R&D expenses of $5.4 million was primarily due to a $2.9 million reduction in research activities, collaborations and outside services due primarily to a reduction in costs associated with research and laboratory supplies and collaboration agreements and a $2.4 million decrease in personnel‑related expenses primarily due to reduced stock-based compensation expense resulting from lower headcount and the reduced value of new equity awards. Non‑GAAP R&D expenses, which exclude non-cash stock-based compensation and non-cash expenses related to the change in the estimated fair value of success payment liabilities for the second quarter ended June 30, 2025 were $32.6 million, compared to $37.2 million for the same period in 2024. General and administrative (G&A) expenses were $9.8 million for the second quarter ended June 30, 2025, compared to $12.3 million for the same period in 2024. The decrease in second quarter 2025 G&A expenses of $2.5 million was primarily due to a $1.7 million decrease in stock-based compensation expense primarily related to a decrease in the value of new awards granted and a $0.8 million decrease in outside services primarily due to a reduction in legal expenses. Non‑GAAP G&A expenses, which exclude non-cash stock‑based compensation, for the second quarter ended June 30, 2025 were $7.1 million, compared to $7.8 million for the same period in 2024. A discussion of non-GAAP financial measures, including reconciliations of the most comparable GAAP measures to non‑GAAP financial measures, is presented below under 'Non-GAAP Financial Measures.' Cash, cash equivalents and marketable securities Cash, cash equivalents and marketable securities as of June 30, 2025 were approximately $297 million, compared to approximately $384 million as of December 31, 2024. Lyell believes that its cash, cash equivalents and marketable securities balances totaling approximately $347 million inclusive of the initial $50 million of proceeds from its recent private placement, will be sufficient to meet working capital and capital expenditure needs into mid-2027. About Lyell Immunopharma, Inc. Lyell is a late-stage clinical company advancing a pipeline of next-generation CAR T-cell therapies for patients with hematologic malignancies and solid tumors. To realize the potential of cell therapy for cancer, Lyell utilizes a suite of technologies to endow CAR T cells with attributes needed to drive durable tumor cytotoxicity and high rates of long‑lasting clinical responses, including the ability to resist exhaustion, maintain qualities of durable stemness and function in the hostile tumor microenvironment. The Lyell LyFE Manufacturing Center™ has commercial launch capability and can manufacture more than 1,200 CAR T-cell doses at full capacity. To learn more, please visit Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: Lyell's initiation by early 2026 of a pivotal trial for LYL314 for patients with LBCL in the 2L setting; expectations around the potential for CD19/CD20 CAR T-cell therapies to disrupt the therapeutic landscape; the anticipated benefits of RMAT and Fast Track designations for LYL314; Lyell's expectations around the progress of the PiNACLE trial, including expectations around enrollment and timing of progress update in late 2025, and using data from the trial to form the basis of a Biologics License Application submission to the FDA in 2027 for patients with relapsed and/or refractory LBCL receiving treatment in the 3L+ setting; Lyell's expectations around continued enrollment for and timing of more mature clinical data from its ongoing Phase 1/2 trial for LYL314 in the 2L setting in late 2025; the advancement of Lyell's technology platform; Lyell's advancement of its pipeline and its research, development and clinical capabilities; Lyell's submission of an IND in 2026 for a CAR T-cell product candidate with an undisclosed target for solid tumors; Lyell's plans for using the net proceeds from the private placement and its existing cash, cash equivalents and marketable securities, and its expectation that its financial position and cash runway will support advancement of its pipeline into mid-2027 through key clinical milestones; the sufficiency of the capacity of LyFE to manufacture drug supply for Lyell's ongoing and planned pivotal trials and through potential commercial launch; Lyell's anticipated progress, business plans, business strategy and clinical trials; the potential clinical benefits and therapeutic potential of Lyell's product candidates, including meaningful increased complete response rates and prolonged duration of response; and other statements that are not historical fact. These statements are based on Lyell's current plans, objectives, estimates, expectations and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: Lyell's ability to submit planned INDs or initiate or progress clinical trials on the anticipated timelines, if at all; Lyell's limited experience as a company in enrolling and conducting clinical trials, and lack of experience in completing clinical trials; the complexity of manufacturing cellular therapies, which subjects us to a multitude of manufacturing risks, any of which could substantially increase our costs, delay our programs or limit supply of our product candidates; the nonclinical profiles of Lyell's product candidates or technology not translating in clinical trials; the potential for results from clinical trials to differ from nonclinical, early clinical, preliminary or expected results; significant adverse events, toxicities or other undesirable side effects associated with Lyell's product candidates; the significant uncertainty associated with Lyell's product candidates ever receiving any regulatory approvals; RMAT and Fast Track designations may not actually lead to faster development, regulatory review or approval process, and does not assure ultimate FDA approval; Lyell's ability to obtain, maintain or protect intellectual property rights related to its product candidates; implementation of Lyell's strategic plans for its business and product candidates; the sufficiency of Lyell's capital resources and need for additional capital to achieve its goals; the effects of macroeconomic conditions, including the effects of disruption between the U.S. and its trading partners due to tariffs or other policies, and any geopolitical instability; potential changes to U.S. drug pricing, including the potential for 'most-favored nations' pricing limitations; and other risks, including those described under the heading 'Risk Factors' in Lyell's Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, being filed with the SEC today. Forward-looking statements contained in this press release are made as of this date, and Lyell undertakes no duty to update such information except as required under applicable law. Lyell Immunopharma, Inc. Unaudited Selected Consolidated Financial Data (in thousands) Statement of Operations Data: Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Revenue $ 8 $ 13 $ 15 $ 16 Operating expenses: Research and development(1) 34,857 40,261 78,304 83,435 General and administrative 9,786 12,256 23,832 25,750 Other operating loss (income), net 1,062 (976 ) 943 (2,066 ) Impairment of long-lived assets 1,443 — 1,443 — Total operating expenses 47,148 51,541 104,522 107,119 Loss from operations (47,140 ) (51,528 ) (104,507 ) (107,103 ) Interest income, net 3,276 6,364 7,138 13,183 Other income (expense), net(1) 1,180 (645 ) 2,490 445 Impairment of other investments — — — (13,001 ) Total other income, net 4,456 5,719 9,628 627 Net loss $ (42,684 ) $ (45,809 ) $ (94,879 ) $ (106,476 ) (1) As of October 1, 2024, the Company's success payment liability was recognized at fair value as Stanford had provided the requisite service obligation to earn the potential success payment consideration. The change in the estimated fair value of Stanford success payment liabilities in the first half of 2025 was recognized within other income (expense), net in the Condensed Consolidated Statements of Operations and Comprehensive Loss. The change in the estimated fair value of Stanford success payment liabilities in the first half of 2024 was recognized within research and development expenses in the Condensed Consolidated Statements of Operations and Comprehensive Loss. Balance Sheet Data: As of June 30, As of December 31, 2025 2024 Cash, cash equivalents and marketable securities $ 296,849 $ 383,541 Property and equipment, net $ 39,115 $ 48,200 Total assets $ 385,453 $ 490,859 Total stockholders' equity $ 298,923 $ 382,824 Non-GAAP Financial Measures To supplement our financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), we present non-GAAP net loss, non-GAAP R&D expenses and non-GAAP G&A expenses. Non‑GAAP net loss and non-GAAP R&D expenses exclude non-cash stock-based compensation expense and non-cash expenses related to the change in the estimated fair value of success payment liabilities from GAAP net loss and GAAP R&D expenses, respectively. Non-GAAP net loss is further adjusted by non‑cash investment gains and charges, as applicable. Non‑GAAP G&A expenses exclude non-cash stock-based compensation expense from GAAP G&A expenses. We believe that these non‑GAAP financial measures, when considered together with our financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare our results from period to period, and to identify operating trends in our business. We have excluded stock-based compensation expense, changes in the estimated fair value of success payment liabilities, and non-cash investment gains and charges from our non‑GAAP financial measures because they are non-cash gains and charges that may vary significantly from period to period as a result of changes not directly or immediately related to the operational performance for the periods presented. We also regularly use these non‑GAAP financial measures internally to understand, manage and evaluate our business and to make operating decisions. These non-GAAP financial measures are in addition to, and not a substitute for or superior to, measures of financial performance prepared in accordance with GAAP. In addition, these non‑GAAP financial measures have no standardized meaning prescribed by GAAP and are not prepared under any comprehensive set of accounting rules or principles and, therefore, have limits in their usefulness to investors. We encourage investors to carefully consider our results under GAAP, as well as our supplemental non-GAAP financial information, to more fully understand our business. Lyell Immunopharma, Inc. Unaudited Reconciliation of GAAP to Non-GAAP Net Loss (in thousands) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Net loss - GAAP $ (42,684 ) $ (45,809 ) $ (94,879 ) $ (106,476 ) Adjustments: Stock-based compensation expense 5,004 8,284 11,028 17,439 Change in the estimated fair value of success payment liabilities (115 ) (1,534 ) (240 ) (566 ) Impairment of other investments — — — 13,001 Net loss - Non-GAAP(1) $ (37,795 ) $ (39,059 ) $ (84,091 ) $ (76,602 ) (1) There was no income tax effect related to the adjustments made to calculate non-GAAP net loss because of the full valuation allowance on our net deferred tax assets for all periods presented. Lyell Immunopharma, Inc. Unaudited Reconciliation of GAAP to Non-GAAP Research and Development Expenses (in thousands) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Research and development - GAAP $ 34,857 $ 40,261 $ 78,304 $ 83,435 Adjustments: Stock-based compensation expense (2,295 ) (3,865 ) (4,683 ) (7,657 ) Change in the estimated fair value of success payment liabilities(1) — 793 — 268 Research and development - Non-GAAP $ 32,562 $ 37,189 $ 73,621 $ 76,046 (1) As of October 1, 2024, the Company's success payment liability was recognized at fair value as Stanford had provided the requisite service obligation to earn the potential success payment consideration. The change in the estimated fair value of Stanford success payment liabilities in the first half of 2025 was recognized within other income (expense), net in the Condensed Consolidated Statements of Operations and Comprehensive Loss. The change in the estimated fair value of Stanford success payment liabilities in the first half of 2024 was recognized within research and development expenses in the Condensed Consolidated Statements of Operations and Comprehensive Loss. Lyell Immunopharma, Inc. Unaudited Reconciliation of GAAP to Non-GAAP General and Administrative Expenses (in thousands) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 General and administrative - GAAP $ 9,786 $ 12,256 $ 23,832 $ 25,750 Adjustments: Stock-based compensation expense (2,709 ) (4,419 ) (6,345 ) (9,782 ) General and administrative - Non-GAAP $ 7,077 $ 7,837 $ 17,487 $ 15,968 Contact: Ellen Rose Senior Vice President, Communications and Investor Relations erose@
Time of India
11-08-2025
- Business
- Time of India
Cotton Market Skywalk Deadline Extended To October
1 2 Nagpur: MahaMetro has extended its deadline for completing the Rs10 crore Cotton Market Metro station skywalk, pushing the project's opening from August to October this year. The delay means two more months of chaotic traffic conditions at one of the city's busiest squares. The 120-meter-long foot over bridge (FOB), designed to cut directly through the centre of Cotton Market Square, is intended to give the station a long-overdue second entry and exit point. At present, the station operates with only one gate, a situation flagged by the Comptroller and Auditor General (CAG) for failing to meet accessibility and safety norms. Construction began in August 2024 with a one-year completion target; however, MahaMetro says additional time is required. "The primary deadline for completing the Cotton Market skywalk was August. However, ongoing works under the railway line at Cotton Market Square meant we had to adjust our construction plan to ensure traffic flow was not completely disrupted. This required us to work in phases rather than all at once. Additionally, heavy rains in June and July caused slight delays. Taking these factors into account, the completion target has been moved to October, which will be the final deadline," said a senior MahaMetro official. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Europe Travel Hack That Saves You Hundreds on Trips! Undo The station, located on the Aqua Line between Sitabuldi Interchange and Railway Station, serves thousands of commuters daily, including traders and buyers at the city's wholesale vegetable and orange markets. The new skywalk will connect the station to Metro-owned land near Lohapul, equipped with a staircase and two lifts for universal access. In the meantime, traffic congestion in the square has worsened. Barricades for construction work have reduced visibility for motorists and narrowed road space. The road coming from Railway Station towards Cotton Market has become particularly difficult to navigate, with bottlenecks forming near construction pillars. Many commuters fear the extended two-month delay will prolong what they describe as a daily "traffic gamble" in the area, as the RUB at the cotton market railway is also in process, adding to the chaos. Cotton Market Metro itself opened almost a year later than other Phase 1 stations in September 2023 due to land acquisition delays. The FOB was planned as a key upgrade to ease access and manage the heavy pedestrian flow. Now, with the revised October deadline, both traders and daily passengers are waiting to see if this vital connection — already a year in the making — will finally become a reality without further slippage. Stay updated with the latest local news from your city on Times of India (TOI). Check upcoming bank holidays , public holidays , and current gold rates and silver prices in your area.
Hindustan Times
08-08-2025
- Entertainment
- Hindustan Times
Bengaluru isn't just a tech city: Is this the musical that proves that?
Joseph and the Amazing Technicolour Dreamcoat, 'India's first all-male musical', has been making waves in Bengaluru's musical theatre scene with its recent production featuring over 100 boys and men from the city's schools, churches, and communities. It is directed and choreographed by Kevin Oliver and produced by Phase 1 World with music by Andrew Lloyd Webber and lyrics by Tim Rice. Also read | Lights, Camera, Broadway: Hollywood hits hit Broadway as musicals Joseph and the Amazing Technicolour Dreamcoat is based on the Biblical story of Joseph from the Book of Genesi. (Pic courtesy: Nikos Narkissos) The musical not only brings a fresh perspective to the classic story, but also puts Bengaluru in the spotlight, showcasing the city's thriving creative scene and talent pool. Highlights included a shimmering creation – a 21-kg technicolour coat crafted using over 30 fabrics – by Dubai-based fashion designer Michael Cinco, who has dressed several Indian celebrities in his exquisite designs, including Aishwarya Rai. In an interview with HT Lifestyle, Kevin as well as Oum Pradutt, founder and managing director of Phase 1 World, spoke about how a live nine-part narrator format, and a choir-style score with fresh arrangements gave the production emotional depth and global flair. Here are the excerpts. What inspired you to stage this particular production, and how did you approach bringing the story to life? Kevin Oliver: I had first directed Joseph in a school musical at Frank Anthony Public School early in my career. It has always been a show with a strong emotional pull, and the themes of family, resilience, and reconciliation still resonate. When Oum reached out about Phase 1 turning 30, it felt like the right time to return to this story, but with a professional lens. Our approach was to treat it as a full-fledged musical production while retaining the soul and heart of its message. Oum Pradutt: This was a very personal project for me. I grew up watching Kevin's musicals, and some of my earliest experiences on stage were under his direction. For our 30-year milestone at Phase 1, we didn't want a large-scale event just for the sake of scale. We wanted something meaningful. Joseph allowed us to bring together storytelling, music, community, and talent from across Bengaluru in a way that felt both celebratory and grounded. Can you describe your creative process when working with actors, designers, and other crew members? Kevin Oliver: We began by assembling the cast through a mix of school networks, church choirs, and community music circles. The casting was intentional — we wanted range in voice, age, and stage experience. Once the cast was locked in, we workshopped the material extensively. We built vocal harmony first, then layered movement and stagecraft. Design conversations were always integrated. I believe a show works best when the designers and the cast are growing the world together. Everyone on the floor was briefed on the emotional tone and musical rhythm of each scene before technical execution began. Oum Pradutt: We ran this like a professional production while still building in flexibility for younger performers. On the production side, timelines were mapped across departments from the beginning. Whether it was fittings with the designers or stage layout conversations, we structured everything for collaboration. Kevin and I were in constant dialogue with the costume and lighting teams to ensure every element served the story. How do you balance your vision for the show with the input and ideas of your collaborators? How do you work with actors to develop their characters and bring depth to their performances? Kevin Oliver: My role is to give structure, not to impose. With young performers, especially, it's important to create space where they can bring something of themselves to the role. I provide musical and emotional context, guide pacing, and anchor transitions. But I also ask them to think about the character's motivations and relationships. Over time, you see them stop acting and start reacting. That's when the performance starts to feel lived-in. Oum Pradutt: It was important to trust the team. We had senior professionals designing costumes and lighting, alongside a young and enthusiastic cast. Kevin kept the emotional map of the show consistent while giving space for design inputs and character suggestions to come through organically. What was your vision for the set and lighting design, and how did you work with your designers to achieve it? Oum Pradutt: We wanted the stage to feel immersive without being overbuilt. The lighting had to serve the music and transitions without overwhelming them. The challenge was to balance scale with mobility, as we were working within the constraints of an existing auditorium. Kevin Oliver: We worked with our lighting designer to use tone shifts to reflect Joseph's journey, cool tones during moments of exile, warm builds for emotional resolution. The set was designed to be flexible, allowing fluid movement of the cast. It wasn't elaborate by Broadway standards, but it worked in tandem with our choreography and vocals to tell the story. How do you use blocking and movement to enhance the storytelling and emotional impact of the show? Kevin Oliver: This musical is sung-through, so there's a constant rhythm. Movement can't be decorative — it has to serve the story. We mapped character relationships with their movement arcs. Joseph's physical distance from his brothers early in the show narrows as the story progresses. In ensemble scenes, we created symmetry and imbalance deliberately. I worked closely with the narrators to ensure their movement mirrored the tonal shifts in each number. Can you talk about any specific challenges you faced in staging certain scenes or sequences? Kevin Oliver: Potiphar's scene was tricky. It had to be menacing, theatrical, but still appropriate for a family audience. We used costume design, especially Potiphar's wife's gown, to bring in drama without being over the top. Another challenge was Pharaoh's number — it's a rock-and-roll sequence, but we didn't want it to feel like a caricature. We sculpted his look to feel like pop royalty and kept the choreography tight and punchy. What themes or messages do you hope audiences take away from the show, and how did you incorporate those into the production? Oum Pradutt: The idea of redemption is at the core of Joseph. That someone who's betrayed and left behind can still rise and forgive. It's also a story about dreams and resilience. We made sure the emotional beats in the musical were clear and well-placed, so the audience could experience the arc of hope without needing to be told what to feel. Kevin Oliver: We also wanted to showcase what young performers are capable of when given the right platform. Many in our cast had never performed at this level. Yet they owned that stage. The audience doesn't just see a story—they witness growth. How do you think the show's themes and messages resonate with contemporary audiences? What do you hope audiences will take away from the show emotionally or intellectually? Kevin Oliver: The story may be old, but the themes are timeless. We live in a time where family structures, identity, and purpose are constantly evolving. Joseph's journey speaks to anyone trying to find meaning through chaos. Musically, we stayed true to the original composition but let the local voices guide how it landed emotionally. Oum Pradutt: People walked out of the show saying they saw themselves on stage. That was the goal. It wasn't about spectacle. It was about finding emotional clarity in a story that has lasted for generations. Are there any specific social or cultural issues that you aimed to address through the production? Oum Pradutt: Not directly. But by design, this show became a platform for celebrating male vocalists and school-level performers in a city that rarely gives them centre stage in theatre. We had boys from six schools and the Bangalore Men's Choir, all performing live. That sends a strong message — that musical theatre is for everyone and that local talent deserves national attention. What was the most challenging aspect of bringing this production to life, and how did you overcome those challenges? Oum Pradutt: Logistics were a challenge. Balancing rehearsals across school schedules, coordinating fittings with designers like Michael Cinco and Furne One Amato, managing stage tech—it needed tight planning. We treated it like any large-scale experiential event we've produced at Phase 1, with calendars, fixed milestones, and buffer windows built in. Kevin Oliver: The emotional stamina needed from the boys was significant. We were asking 13 to 18-year-olds to perform live across 16 songs, hold character, and deliver in front of 700 people. It took a lot of encouragement and hands-on mentoring to build that consistency. Can you describe a particularly memorable or pivotal moment during rehearsals or performances? Kevin Oliver: One evening during tech rehearsals, the boys were exhausted. But when we ran Any Dream Will Do, something shifted. Their voices blended in a way that hadn't happened before. No one spoke after the last note. That was the moment I knew the show had found its centre. Oum Pradutt: There's a point in the show where Joseph is reunited with his family. Watching the cast perform it, you could feel the room soften. Teachers and parents in the audience were moved to tears. That emotional connection—that's what theatre is about. How do you manage the logistics of a large-scale production, including scheduling, budgeting, and communication? Oum Pradutt: We run this just like we would any high-stakes corporate campaign. There's a master production calendar, weekly check-ins, and dedicated leads for every department. Budgeting included line items for costume production, venue rentals, technical setup, and hospitality. We also had an extended team handling content, PR, and audience experience. Everyone knew what they were responsible for, and we had a daily wrap to track progress in the final two weeks.
National Post
07-08-2025
- Business
- National Post
AbCellera Reports Q2 2025 Business Results & First Participants Dosed in a Phase 1 Clinical Trial of ABCL635 for Vasomotor Symptoms
Article content VANCOUVER, British Columbia — AbCellera (Nasdaq: ABCL) today announced financial results for the second quarter of 2025 and that dosing has begun in a Phase 1 clinical trial of ABCL635 for the potential treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause. All financial information in this press release is reported in U.S. dollars, unless otherwise indicated. Article content 'In the second quarter we hit two critical milestones, receiving authorization to initiate Phase 1 studies for both ABCL635 and ABCL575. I am pleased to announce today that we have successfully begun dosing the first participants in the Phase 1 study of ABCL635. This is a landmark achievement for AbCellera, one that completes our transition to a clinical-stage biotechnology company,' said Carl Hansen, Ph.D., founder and CEO of AbCellera. 'Today we also announced that a third program, ABCL688, has advanced into IND-enabling studies. With over $750 million in available liquidity, we are well-positioned to continue to execute our strategy.' Article content Q2 2025 Business Summary Article content Generated a net loss of $34.7 million, compared to a net loss of $36.9 million in 2024. Received authorization from Health Canada to initiate Phase 1 clinical trials for ABCL635 and ABCL575, bringing the cumulative total of molecules to reach the clinic to 18. Advanced ABCL688, an ion channel- or GPCR-targeted antibody development candidate (autoimmunity), into IND/CTA-enabling studies. Presented preclinical data for ABCL575 at the Society for Investigative Dermatology. Reached a cumulative total of 102 partner-initiated program starts with downstreams. Article content Recent Developments Article content ABCL635 (Endocrinology/Women's Health): AbCellera has initiated dosing of participants in a Phase 1 clinical trial of ABCL635, a potential non-hormonal, long-acting treatment for moderate-to-severe VMS, commonly known as hot flashes, associated with menopause. This is a randomized, placebo-controlled, double-blind Phase 1 study in healthy men and postmenopausal women with or without VMS. Its purpose is to evaluate safety, pharmacokinetics, pharmacodynamics, as well as frequency and severity of VMS with subcutaneous doses of ABCL635. The initial safety and efficacy data from this study is expected to be presented in mid 2026. ABCL575 (Immunology and Inflammation): AbCellera has initiated a Phase 1 clinical trial of ABCL575, which is being developed for the treatment of moderate-to-severe atopic dermatitis. This is a randomized, placebo-controlled, double-blind study to assess safety and tolerability in healthy participants following subcutaneous doses of ABCL575. ABCL575 is an OX40-ligand-targeting antibody engineered to support a dosing interval of once every 6 months. Article content AbCellera started discovery on an additional five partner-initiated programs with downstreams to reach a cumulative total of 102 partner-initiated program starts with downstreams in Q2 2025 (up from 93 on June 30, 2024). AbCellera and its partners have advanced a cumulative total of 18 molecules into the clinic (up from 14 on June 30, 2024). Article content Discussion of Q2 2025 Financial Results Article content Revenue – Total revenue was $17.1 million, compared to $7.3 million in Q2 2024. Research & Development (R&D) Expenses – R&D expenses were $39.2 million, compared to $40.9 million in Q2 2024. A greater proportion of R&D expenses are used on internal programs reflecting the increased emphasis on building the internal pipeline. Sales & Marketing (S&M) Expenses – S&M expenses were $3.0 million, compared to $3.1 million in Q2 2024. General & Administrative (G&A) Expenses – G&A expenses were $19.0 million, compared to $20.2 million in Q2 2024. Net Loss – Net loss of $34.7 million, or $(0.12) per share on a basic and diluted basis, compared to net loss of $36.9 million, or $(0.13) per share on a basic and diluted basis, in Q2 2024. Liquidity – $580 million of total cash, cash equivalents, and marketable securities and approximately $173 million in available non-dilutive government funding, bringing total available liquidity to approximately $753 million to execute on AbCellera's strategy. Article content Conference Call and Webcast Article content AbCellera will host a conference call and live webcast to discuss these results today at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time). Article content The live webcast of the earnings conference call can be accessed on the Events and Presentations section of AbCellera's Investor Relations website. A replay of the webcast will be available through the same link following the conference call. Article content About AbCellera Biologics Inc Article content . Article content AbCellera (Nasdaq: ABCL) is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women's health, immunology, and oncology. For more information, please visit Article content Definition of Key Business Metrics Article content We regularly review the following key business metrics to evaluate our business, measure our performance, identify trends affecting our business, formulate financial projections, and make strategic decisions. We believe that the following metrics are important to understand our current business. These metrics may change or may be substituted for additional or different metrics as our business develops. Article content Partner-initiated program starts with downstreams Article content represent the number of unique partner-initiated programs where we stand to participate financially in downstream success for which we have commenced the discovery effort. The discovery effort commences on the later of (i) the day on which we receive sufficient reagents to start discovery of antibodies against a target and (ii) the day on which the kick-off meeting for the program is held. We view this metric as an indication of the selection and initiation of projects by our partners and the resulting potential for near-term payments. Cumulatively, partner-initiated program starts with downstream participation indicate our total opportunities to earn downstream revenue from milestone fees and royalties (or royalty equivalents) in the mid- to long-term. Article content Molecules in the clinic Article content represent the count of unique molecules for which an Investigational New Drug, or IND, New Animal Drug, or equivalent under other regulatory regimes, application has reached 'open' status or has otherwise been approved based on an antibody that was discovered either by us or by a partner using licensed AbCellera technology. Where the date of such application approval is not known to us, the date of the first public announcement of a clinical trial will be used for the purpose of this metric. We view this metric as an indication of our near- and mid-term potential revenue from milestone fees and potential royalty payments in the long term. Article content AbCellera Forward-Looking Statements Article content This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. Article content In some cases, you can identify forward-looking statements by the words 'may,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'intend,' 'plan,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'continue,' 'ongoing' or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under 'Risk Factors,' 'Management's Discussion and Analysis of Financial Condition and Results of Operations' and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law. Article content Three months ended June 30, Six months ended June 30, 2024 2025 2024 2025 Revenue: Research fees $ 5,453 $ 6,639 $ 15,227 $ 10,707 Licensing revenue 370 10,445 550 10,613 Milestone payments 1,500 – 1,500 – Total revenue 7,323 17,084 17,277 21,320 Operating expenses: Research and development (1) 40,927 39,213 80,214 81,711 Sales and marketing (1) 3,136 3,009 6,501 5,851 General and administrative (1) 20,192 18,977 37,544 35,203 Depreciation, amortization, and impairment 36,522 5,470 41,366 10,801 Total operating expenses 100,777 66,669 165,625 133,566 Loss from operations (93,454 ) (49,585 ) (148,348 ) (112,246 ) Other (income) expense: Interest income (9,801 ) (7,592 ) (20,202 ) (15,643 ) Grants and incentives (3,310 ) (3,692 ) (6,585 ) (7,845 ) Other (32,156 ) (1,957 ) (30,627 ) 570 Total other income (45,267 ) (13,241 ) (57,414 ) (22,918 ) Net loss before income tax (48,187 ) (36,344 ) (90,934 ) (89,328 ) Income tax recovery (11,257 ) (1,617 ) (13,394 ) (8,980 ) Net loss $ (36,930 ) (34,727 ) $ (77,540 ) $ (80,348 ) Foreign currency translation adjustment (257 ) 4,341 (353 ) 1,721 Comprehensive loss $ (37,187 ) $ (30,386 ) $ (77,893 ) $ (78,627 ) Net loss per share Basic $ (0.13 ) $ (0.12 ) $ (0.26 ) $ (0.27 ) Diluted $ (0.13 ) $ (0.12 ) $ (0.26 ) $ (0.27 ) Weighted-average common shares outstanding Article content Article content Article content Article content Article content Contacts Article content Inquiries Article content Media: Tiffany Chiu; Article content media@ Article content , +1(236)521-6774 Article content Article content Partnering: Murray McCutcheon, Ph.D.; Article content Article content Article content
Yahoo
07-08-2025
- Business
- Yahoo
Strand Therapeutics Raises $153 Million Series B Financing to Further Advance Programmable mRNA Therapeutic Pipeline
Funding will advance Strand's pipeline and mission to bring targeted, next-generation mRNA therapies to patients First-in-human solid tumor Phase 1 data from lead program, STX-001, was recently presented at 2025 ASCO Annual Meeting BOSTON, August 07, 2025--(BUSINESS WIRE)--Strand Therapeutics, a leader in next-generation mRNA-based therapeutics, today announced $153M Series B funding led by Kinnevik, with new investors Regeneron Ventures, ICONIQ, Amgen Ventures, Alderline Group (the family office of Alex Gorsky), JIC-VGI, LG Technology Ventures, and Gradiant Corporation, with continued participation from existing investors including FPV Ventures, Playground Global, Eli Lilly and Company, ANRI, and Potentum. To date, Strand has raised over $250M. As part of the financing, Ala Alenazi, Ph.D., of Kinnevik, will join the company's Board of Directors. The funding will advance Strand's pipeline, led by STX-001, a programmable mRNA therapy that expresses the cytokine interleukin-12 (IL-12) directly from the tumor microenvironment. The company recently announced promising initial Phase 1 clinical data for patients with advanced solid tumors at the 2025 ASCO annual meeting, noting multiple RECIST responses (including cases of complete response and complete metabolic response), multiple cases of prolonged disease stabilization, and a favorable safety profile in treatment-resistant patients. Earlier this year, Strand also presented preclinical data for STX-003, a world-first systemically administrable mRNA therapy with tumor targeting that is programmed to avoid off-target payload delivery (including liver avoidance), showing the first glimpse into the massive potential of their programmable mRNA genetic circuits. Data presented at the 2025 AACR and ASGCT annual meetings demonstrated the candidate's potential to target expression of IL-12 to tumors following systemic administration of the LNP-mRNA drug, creating an effective anti-tumor therapy that was well tolerated. IL-12 is a potent pro-inflammatory cytokine primarily produced by antigen-presenting cells such as macrophages and dendritic cells. IL-12 holds significant promise in cancer immunotherapy due to its robust immunostimulatory effects. STX-001 encodes IL-12 which Strand has designed so that it can reprogram the tumor microenvironment and stimulate a systemic anti-tumor immune response. Unlike traditional mRNA therapies, Strand's approach uses self-replicating mRNA, ensuring localized and durable therapeutic activity. "We believe programmable RNA is the next frontier in therapeutics, and Strand has built the leading platform to unlock it," said Christian Scherrer, Senior Investment Director and Head of Health and Bio at Kinnevik. "Their early clinical data is outstanding, and the systemic delivery capability has the potential to reshape how we treat disease, starting with cancer, with more disease targets on the horizon. We look forward to partnering with founders Jake and Tasuku and the entire team as they move into this next phase of growth." "With support from our investors, we're advancing our vision of developing safe, effective, and accessible therapies through programmable genetic medicines, especially for those patients with few treatment options," said Jake Becraft, PhD, CEO and Co-founder of Strand Therapeutics. "Our initial STX-001 Phase 1 data provides early and strong clinical validation of our platform's capabilities. We have observed systemic immune activation and anti-tumor responses, including responses in non-injected lesions, across multiple tumor types. Now is an exciting period of expansion for our existing clinical work, as well as the exciting breakthrough assets in our pipeline, all with the potential to transform the treatment of cancer and other serious diseases." Strand's proprietary platform for programmable and potent mRNA therapeutics is the first of its kind. Its therapies combine best-in-class engineered next-generation mRNA modalities, such as self-replicating mRNA and circular RNA, with genetically programmed logic circuits, allowing for precise, controlled therapeutic payload delivery directly into the cells/tissues themselves. The novel approach brings the potential to effectively treat cancer and other deadly chronic diseases through its targeted therapies that are scalable, accessible, and expand the treatment landscape for patients desperately in need. About STX-001 STX-001 is an investigational multi-mechanistic, synthetic self-replicating mRNA technology that expresses an IL-12 cytokine for an extended period of time, directly administered to tumors in order to promote immune modulation and antitumor activity. The company received IND clearance from the U.S. Food and Drug Administration (FDA) in December 2023 to initiate a Phase 1/2 clinical trial for STX-001, announced its first patient dosed just before the 2024 ASCO Annual Meeting, and presented the first data of the trial at the 2025 ASCO Annual Meeting. Additional details can be found at using identifier: NCT06249048. About Strand Therapeutics Strand Therapeutics is leading the next generation of programmable mRNA therapies: where synthetic biology meets programmable biology to unlock the full potential of gene regulation and delivery inside the body. Unlike traditional mRNA technologies, Strand's platform programs RNA to think, enabling logic-controlled expression, precision delivery, and unprecedented control over therapeutic outcomes. Born out of MIT and led by world-class synthetic biologists, Strand is building the infrastructure to create medicines that respond to disease signals in real-time. With its computationally-driven design engine, self-amplifying/circular RNA modalities, and mRNA-only genetic circuits, the company is pioneering a new therapeutic modality poised to disrupt immuno-oncology, cell therapy, autoimmune diseases, and beyond. Strand's lead pipeline program, STX-001, is already in the clinic showing unprecedented response rates in late stage "salvage" cancer patients, with multiple patients showing RECIST responses. Strand's modular platform opens a broad horizon of partnership and licensing opportunities. Strand isn't just another mRNA company: it's the operating system for the programmable medicines of tomorrow. Follow us on LinkedIn and on X at @strandtx. View source version on Contacts Media contacts:Karen Sharmaksharma@ Shannia Coleyscoley@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
