Pfizer Canada ULC

Omicron KP.2 variant adapted vaccine COMIRNATY is now authorized in Canada for individuals 6 months of age and older. It is expected to be available in Canada in the coming weeks. The updated COVID-19 vaccine is tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage. KIRKLAND, QC , Sept. 24, 2024 /CNW/ - Pfizer Canada ULC and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that Health Canada has authorized the KP.2 variant adapted COMIRNATY ® COVID-19 vaccine for ages 6 months and older. The updated COMIRNATY ® vaccine targets the Omicron KP.2 variant, one of the most recently circulating SARS-CoV-2 lineages. The adapted COVID-19 vaccine will be available in Canada as a single dose for individuals 5 years of age and older, regardless of prior COVID-19 vaccination history. For children 6 months through 4 years of age, COMIRNATY ® is authorized for administration as a three-dose series in those without a history of completion of a COVID-19 primary vaccination course, or as a single dose for those with a history of completion of a COVID-19 primary vaccination course. The newly formulated vaccine will be available in pharmacies and vaccination centers across the country in the fall. Each province and territory will have its own pathway for accessing the vaccine, and individuals are encouraged to refer to their provincial/territorial authorities for more information. The COVID-19 Vaccines (COMIRNATY ® ) by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for COMIRNATY and its adapted vaccines in the United States , the European Union, the United Kingdom , Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. About Pfizer Canada Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world’s leading biopharmaceutical companies. At Pfizer, we apply science and our global resources to bring therapies to people that help extend and improve their lives. We strive to set the standard for quality, safety, and value in the discovery, development, and manufacture of health care products. Every day, Pfizer colleagues work to advance wellness, prevention, treatments, and cures that challenge the most feared diseases of our time. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on LinkedIn , Facebook , X , Instagram or YouTube . About BioNTech Biopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor (CAR) T cells, several protein-based therapeutics, including bispecific immune checkpoint modulators, targeted cancer antibodies and antibody-drug conjugate (ADC) therapeutics, as well as small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global and specialized pharmaceutical collaborators, including Biotheus, DualityBio, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron. For more information, please visit . SOURCE Pfizer Canada

VANCOUVER, British Columbia--( BUSINESS WIRE )--Life Sciences BC (LSBC) is pleased to announce new and returning members to the Board of Directors following its Annual General Meeting (AGM) held on September 18, 2024. The Board of Directors is comprised of life sciences leaders aligned with LSBC’s vision of a thriving sector within the province. AGM & Board Meeting Announcements Anne Stevens, VP of Business Development at AbCellera was elected as Chair, Ali Ardakani, Founder and Managing Director of Novateur Ventures Inc. was elected as Past Chair, and Rajveer Hundal, Partner at PWC Canada was re-elected as Treasurer. “Ali Ardakani has been a phenomenal leader for LSBC during his term as Board Chair over the past two years. I would like to thank him for everything he has done not only for LSBC but for the entire sector,” said Wendy Hurlburt, LSBC President & CEO. “Ali will continue his work with LSBC as Past Chair and we are excited to welcome Anne Stevens as our incoming Board Chair.” LSBC welcomes Sherry Aulin, CFO of Xenon Pharmaceuticals and Tom Frohlich, Former COO of Chinook Therapeutics as new Board Directors, who were each elected to three-year terms. LSBC would like to thank Board Directors continuing their terms: Max Blouw, Kevin Chaplin, Suzanne Gill, David Helliwell, Wendy Hurlburt, Bev Holmes, Dr. Lana Janes, Dr. David Llewellyn, Michael R. Martin, Scott Phillips, David Poon, and Dr. Peter Zandstra. At the Board Meeting following the AGM, Joseph Garcia, Hector MacKay-Dunn, KC, and Roger Kuypers received renewed one-year appointments as Board Observers. To see the full list of Life Sciences BC’s Board of Directors, please visit: https://lifesciencesbc.ca/about-us/board-directors/ LSBC Board Directors – Executive Committee Chair: Anne Stevens, VP Business Development, AbCellera Past Chair: Ali Ardakani, Founder and Managing Director, Novateur Ventures Inc. Treasurer: Rajveer Hundal, Partner, PWC Canada LSBC Board Directors Sherry Aulin, CFO, Xenon Pharmaceuticals Max Blouw, Past President, Research Universities Council of British Columbia Kevin Chaplin, CEO, Kardium Tom Frohlich, Life Sciences Executive Leader & Former COO, Chinook Therapeutics Suzanne Gill, President & CEO, Genome British Columbia David Helliwell, Co-Founder and Executive Board Chair, Thrive Health Bev Holmes, President & CEO, Michael Smith Health Research BC Wendy Hurlburt, President & CEO, Life Sciences BC Dr. Lana Janes, Co-Founder & COO, Abdera Dr. David Llewellyn, PhD, MBA, Chief Strategy Officer, STEMCELL Technologies Michael R. Martin, Life Sciences Executive Leader, Founder & Former COO / Business Officer, Aurinia Pharmaceuticals Scott Phillips, Founder & President, Starfish Medical David Poon, Life Sciences Business Executive Dr. Peter Zandstra, Director, UBC School of Biomedical Engineering & Michael Smith Labs LSBC Board Observers Joseph Garcia, Partner, Blake, Cassels & Graydon LLP Roger Kuypers, Partner, Fasken, Martineau, Dumoulin LLP Hector MacKay-Dunn, KC, Senior Partner, Farris, Vaughan, Wills & Murphy LLP Past Board Members LSBC would like to thank our outgoing Board Directors for their service and leadership over the past years. Jennifer Cudlipp, President & CEO, BACAS Family Wines Bob Dawson, National Director, Access and Government Relations, Pfizer Canada Peter Simpson, Proprietor, Third Quarter Consulting About Life Sciences BC Life Sciences BC is a not-for-profit, non-government industry association that supports and represents British Columbia’s life sciences community through numerous local, national, and international initiatives. We nurture economic development in the province through leadership, facilitation of investment and partnering, advocacy, and promotion of our world-class life sciences sector. Throughout the year, Life Sciences BC initiates a range of programs and projects designed to bolster the life sciences sector. These initiatives encompass activities such as advocating for public policies, fostering connections between our local organizations and the global industry, enhancing our sector's international visibility, and facilitating investments and global partnerships.

SUMMIT, PEAK and APEX registration-directed clinical trial enrollment remains on track; topline results expected from all three studies in 2025 Ended 2Q 2024 with $390 million, sufficient to fund operations into 2027 WALTHAM, Mass. and BOULDER, Colo., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported financial results for the second quarter ended June 30, 2024. “Cogent has made tremendous progress in the first half of 2024 and we look forward to continuing to execute on our key priorities across the portfolio,” said Andrew Robbins, the Company’s President and Chief Executive Officer. “All three of our bezuclastinib registration-directed trials remain on track and we expect to complete enrollment in our PEAK global Phase 3 trial this quarter, with topline data expected from all three trials in 2025. In parallel, our Research team continues to make excellent progress as we develop next-generation programs to build out our pipeline.” Recent Business Highlights Announced alignment with the U.S. Food and Drug Administration (FDA) on the Company’s novel patient reported outcome measure, Mastocytosis Symptom Severity Daily Diary (MS2D2), for use in Part 2 of the registration-directed SUMMIT trial evaluating bezuclastinib in Nonadvanced Systemic Mastocytosis (NonAdvSM) patients.Announced additional clinical data from SUMMIT Part 1 at the 2024 European Hematology Association (EHA) Congress. As of the cutoff date, December 18, 2023, patients in Part 1 treated at the recommended dose of 100 mg bezuclastinib demonstrated >90% reductions across all markers of mast cell burden. Additional data also showed meaningful reduction in symptom severity and objective measures of disease, including: Substantial reduction in mast cell reactions (>50%) and patients’ most severe symptoms as measured by MS2D2.Clinically meaningful reduction in all individual MS2D2 TSS symptoms and domains, as well as additional symptoms including dizziness, diarrhea severity, and brain fog. Clinically meaningful improvement in skin symptoms as well as objective reduction in skin lesions. Consistent with results previously reported, the recommended dose of 100 mg demonstrates a favorable safety and tolerability profile. Presented positive lead-in data from the ongoing Phase 3 PEAK trial at the 2024 ASCO annual meeting. As of the cutoff date, April 1, 2024, 42 patients in Part 1 had been on study for a median of 15.3 months. The median progression-free survival (mPFS) during treatment with bezuclastinib and sunitinib was 10.2 months in all patients. In a subset of patients with second-line gastrointestinal stromal tumors (GIST) with only prior imatinib, which most closely resembles patients currently enrolling in Part 2 of PEAK, the data demonstrate a mPFS of 19.4 months. In addition, the objective response rate (ORR) in all patients treated with bezuclastinib and sunitinib was 27.5% and in the subset of second-line patients the ORR was 33.3%, per investigator assessment. Combination treatment resulted in a disease control rate of 80% in all patients and 100% in patients with prior imatinib only.The combination of bezuclastinib and sunitinib does not appear to add to the severity of adverse events known to be associated with sunitinib monotherapy and is well-tolerated. The majority of treatment-emergent adverse events (“TEAEs”) were low-grade and reversible and discontinuations due to TEAEs remain limited. Announced a new Phase 2 clinical trial of bezuclastinib plus sunitinib in later line GIST patients, sponsored by the Sarcoma Alliance for Research through Collaboration (SARC) and in collaboration with The Life Raft Group and Dana-Farber Cancer Institute. The open label, single-arm Phase 2 trial sponsored by SARC and in collaboration with The Life Raft Group and Dana-Farber Cancer Institute is designed to evaluate the mPFS as well as the safety and tolerability of bezuclastinib plus sunitinib in 40 patients with GIST who have previously progressed on sunitinib. Appointed Cole Pinnow Chief Commercial Officer. Mr. Pinnow joined Cogent from Pfizer, where he held increasing roles of responsibility, including President and Managing Director of Pfizer Canada and most recently as Global Franchise Lead, Genitourinary and Breast Cancer Business where he led a global commercial team accountable for the growth of a $5B innovative cancer portfolio in prostate, kidney, bladder and breast therapies. Prior to Pfizer, he held several leadership roles with Hospira and founded the company’s commercial development organization. Mr. Pinnow began his pharmaceutical career as a scientist at Abbott Laboratories. Initiated IND-enabling studies for the potent, selective CNS-penetrant ErbB2 program following presentation of new preclinical data at the American Association for Cancer Research (AACR) 2024 Annual Meeting. The poster described CGT4255’s exceptional stability in human whole blood and liver cytosol fractions and high oral bioavailability and low clearance across preclinical species.In addition, CGT4255 demonstrated 80% brain penetrance in mice and was well-tolerated at 10 fold maximally efficacious concentration, resulting in mouse tumor regression, suggesting potential best-in class performance. Anticipated Upcoming Milestones Complete enrollment in the global, Phase 3 PEAK trial in patients with GIST in Q3 2024.Provide additional safety, tolerability, and patient-reported outcomes data from the open label extension portion of SUMMIT Part 1 by the end of 2024.Complete enrollment in the registration-directed APEX Phase 2 trial in patients with Advanced Systemic Mastocytosis (AdvSM) by the end of 2024 and report top-line results by mid-2025.Complete enrollment in SUMMIT Part 2 in the second quarter of 2025 and deliver top-line results by the end of 2025.Initiate a Phase 1 trial of the first Cogent-discovered pipeline program, designed as a potent, selective, reversible FGFR2 inhibitor with best-in-class potential in the second half of 2024.Select lead candidate and initiate IND-enabling studies from ongoing PI3Kα program, designed to potently and selectively target the H1047R driver mutation, which affects >30,000 cancer patients each year. Second Quarter 2024 Financial Results Cash Position: As of June 30, 2024, cash, cash equivalents and marketable securities were $389.9 million, as compared to $435.7 million as of March 31, 2024. The company expects its existing cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements into 2027 and through clinical readouts from ongoing SUMMIT, PEAK, and APEX registration-directed trials. R&D Expenses: Research and development expenses were $54.3 million for the second quarter of 2024 as compared to $38.9 million for the second quarter of 2023. The increase was primarily due to costs associated with accelerating enrollment in both SUMMIT and PEAK clinical trials, on-going APEX costs and costs related to development of the research pipeline. R&D expenses include non-cash stock compensation expense of $4.7 million for the second quarter of 2024 as compared to $3.5 million for the second quarter of 2023. In the quarter, an additional $4.5 million was incurred to support sunitinib clinical supply for the PEAK trial due to faster than expected enrollment. G&A Expenses: General and administrative expenses were $10.1 million for the second quarter of 2024 as compared to $8.2 million for the second quarter of 2023. The increase was primarily due to the growth of the organization. G&A expenses include non-cash stock compensation expense of $5.3 million for the second quarter of 2024 as compared to $3.6 million for the second quarter of 2023. Net Loss: Net loss was $59.0 million for the second quarter of 2024 as compared to a net loss of $44.1 million for the same period of 2023. About Cogent Biosciences, Inc. Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. In addition to bezuclastinib, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases initially targeting mutations in FGFR2, ErbB2 and PI3Kα. Cogent Biosciences is based in Waltham, MA and Boulder, CO. Visit our website for more information at www.cogentbio.com. Follow Cogent Biosciences on social media: X (formerly known as Twitter) and LinkedIn. Information that may be important to investors will be routinely posted on our website and X. Forward Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: the company’s anticipated cash runway into 2027, the expectation to complete enrollment in the global Phase 3 PEAK trial in the third quarter of 2024 and to report top-line results by the end of 2025, the expectation to complete enrollment in the SUMMIT Part 2 trial in the second quarter of 2025 and to report top-line results by the end of 2025, the expectation to complete enrollment in the registration-directed APEX Phase 2 trial by the end of 2024 and to report top-line results mid-2025, the expectation to provide additional safety, tolerability and patient-reported outcomes data from the open label extension portion of SUMMIT Part 1 by the end of 2024, the expectation to initiate a Phase 1 trial of the company’s FGFR2 inhibitor with best-in-class potential in the second half of 2024, the expectation to select a lead candidate and initiate IND-enabling studies from the company’s ongoing PI3Kα program. The use of words such as, but not limited to, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results, the rate of enrollment in our clinical trials and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts or milestones disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Cogent's most recent Quarterly Report on Form 10-Q filed with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof. COGENT BIOSCIENCES, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except share and per share amounts)(unaudited) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Operating expenses: Research and development$54,294 $38,871 $106,999 $74,909 General and administrative 10,093 8,214 19,792 15,413 Total operating expenses 64,387 47,085 126,791 90,322 Loss from operations (64,387) (47,085) (126,791) (90,322)Other income: Interest income 5,393 2,741 9,450 5,009 Other income, net 44 268 43 950 Change in fair value of CVR liability — — — 1,700 Total other income, net 5,437 3,009 9,493 7,659 Net loss$(58,950) $(44,076) $(117,298) $(82,663)Net loss per share attributable to common stockholders, basic and diluted$(0.59) $(0.59) $(1.21) $(1.14)Weighted average common shares outstanding, basic and diluted 99,240,030 74,753,269 $97,022,345 72,755,210 COGENT BIOSCIENCES, INC.SELECTED CONDENSED CONSOLIDATED BALANCE SHEET DATA(in thousands)(unaudited) June 30, December 31, 2024 2023 Cash, cash equivalents and marketable securities $389,904 $273,170 Working capital $329,968 $232,603 Total assets $429,935 $313,437 Total liabilities $56,712 $55,635 Total stockholders’ equity $373,223 $257,802 Contact:Christi WaarichSr. Director, Investor Relationschristi.waarich@cogentbio.com617-830-1653