BOSTON and LONDON, April 23, 2024 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (NASDAQ:CNTA), a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients, today announced that it has commenced an underwritten public offering of $100 million of American Depositary Shares ("ADSs"), each representing one ordinary share. All of the ADSs are being offered by Centessa. In addition, Centessa intends to grant the underwriters a 30-day option to purc ...

BOSTON and LONDON, April 22, 2024 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (NASDAQ:CNTA), a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) to initiate a Phase 1 first-in-human, clinical trial of ORX750 for the treatment of narcolepsy. ORX750 is an investigational, orally administered, highly potent and s ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-40445 CENTESSA PHARMACEUTICALS PLC (Exact name of registrant as specified in its charter) England and Wales 98-1612 ...

[Business and Program Updates](index=1&type=section&id=Business%20and%20Program%20Updates) Centessa Pharmaceuticals advanced SerpinPC, ORX750, and LB101 programs, anticipating key milestones in 2024 - CEO emphasizes a laser focus on executing the PRESent registrational studies for SerpinPC and advancing the orexin receptor 2 (OX2R) agonist development program into the clinic for narcolepsy[2](index=2&type=chunk)[3](index=3&type=chunk) - The company continues to evaluate its proprietary LockBody technology platform in a first-in-human clinical study of LB101 for solid tumors, designed to selectively drive CD47 into the tumor microenvironment[4](index=4&type=chunk) [Recent Highlights](index=2&type=section&id=Recent%20Highlights) Recent highlights include positive SerpinPC Phase 2a data, registrational study initiation, and promising ORX750 preclinical data - SerpinPC Phase 2a study showed a continued favorable safety and tolerability profile and sustained long-term efficacy, with a **96% reduction in median all-bleed annualized bleeding rate (ABR)** over an additional 52 weeks of continuous treatment[4](index=4&type=chunk)[17](index=17&type=chunk) - Dosing was initiated in July 2023 for the registrational PRESent-2 study (hemophilia B without inhibitors) and in October 2023 for the PRESent-3 study (hemophilia B with inhibitors) of SerpinPC[19](index=19&type=chunk) - Preclinical data for the investigational OX2R agonist, ORX750, announced in October 2023, supports its potential best-in-class profile for narcolepsy and other sleep-wake disorders[5](index=5&type=chunk)[18](index=18&type=chunk) [Anticipated Upcoming Program Milestones](index=3&type=section&id=Anticipated%20Upcoming%20Program%20Milestones) Key upcoming milestones include SerpinPC PRESent-2 interim analysis, ORX750 clinical proof-of-concept, and preclinical program updates - For the PRESent-2 study of SerpinPC, an interim analysis is planned in 2024 to confirm a dose and advance to Part 2, with Part 1 data expected to be shared in late 2024 or early 2025[2](index=2&type=chunk)[6](index=6&type=chunk) - Upon Investigational New Drug (IND) clearance, ORX750 is planned to rapidly advance into clinical development with the goal of sharing clinical proof-of-concept data in sleep-deprived healthy volunteers in 2024[16](index=16&type=chunk)[21](index=21&type=chunk) - Updates on preclinical programs, including follow-up orexin agonists and LB206 (PD-L1xCD3 LockBody), will be provided as they advance toward clinical studies[22](index=22&type=chunk) [Fourth Quarter and Full-Year 2023 Financial Results](index=3&type=section&id=Fourth%20Quarter%20and%20Full-Year%202023%20Financial%20Results) Centessa reported reduced net loss and operating expenses for Q4 and FY2023, maintaining a strong cash position into 2026 - Cash, cash equivalents and short-term investments totaled **$256.5 million** as of December 31, 2023, which includes approximately **$6.2 million** in net proceeds from ATM sales in Q4 2023 and an additional **$9.7 million** in January 2024[23](index=23&type=chunk) - The company expects its current cash, cash equivalents and short-term investments will fund operations into 2026, without drawing on the remaining available tranches under the Oberland credit facility[23](index=23&type=chunk) [Financial Highlights](index=3&type=section&id=Financial%20Highlights) The company saw decreased net loss and operating expenses for Q4 and FY2023, while maintaining a robust cash runway Key Financial Highlights (Q4 and Full-Year 2023 vs. 2022) | Metric | Q4 2023 ($M) | Q4 2022 ($M) | FY 2023 ($M) | FY 2022 ($M) | | :----------------------------------- | :----------- | :----------- | :----------- | :----------- | | Research & Development Expenses | 29.7 | 27.8 | 124.4 | 155.1 | | General & Administrative Expenses | 12.3 | 13.8 | 53.7 | 55.2 | | Net Loss Attributable to Shareholders| 36.8 | 43.2 | 151.1 | 216.2 | [Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Consolidated operations show a net loss of $36.8M for Q4 2023 and $151.1M for FY2023, improved by reduced operating expenses Consolidated Statements of Operations and Comprehensive Loss (Amounts in thousands) | Metric | Q4 2023 (Thousands) | Q4 2022 (Thousands) | FY 2023 (Thousands) | FY 2022 (Thousands) | | :------------------------------------------- | :------------------ | :------------------ | :------------------ | :------------------ | | License and other revenue | $6,853 | $— | $6,853 | $— | | Research and development | 29,716 | 27,835 | 124,405 | 155,083 | | General and administrative | 12,315 | 13,768 | 53,731 | 55,200 | | Loss from operations | (35,178) | (41,603) | (171,283) | (212,263) | | Net loss | (36,837) | (43,173) | (151,085) | (216,207) | | Net loss per ordinary share - basic and diluted | $(0.38) | $(0.45) | $(1.57) | $(2.31) | | Weighted average ordinary shares outstanding | 97,923,585 | 94,603,860 | 96,177,578 | 93,400,513 | [Condensed Consolidated Balance Sheets](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $360.2M from $444.3M in 2022 due to reduced cash, while total liabilities increased to $124.0M Condensed Consolidated Balance Sheets (Amounts in thousands) | Metric | Dec 31, 2023 (Thousands) | Dec 31, 2022 (Thousands) | | :----------------------------------- | :----------------------- | :----------------------- | | Cash and cash equivalents | $128,030 | $393,644 | | Short-term investments | 128,519 | — | | Other assets | 103,697 | 50,663 | | **Total assets** | **$360,246** | **$444,307** | | Other liabilities | $48,302 | $38,338 | | Long term debt | 75,700 | 69,800 | | **Total liabilities** | **$124,002** | **$108,138** | | Total shareholders' equity | 236,244 | 336,169 | | **Total liabilities and shareholders' equity** | **$360,246** | **$444,307** | [About Centessa Pharmaceuticals and Product Candidates](index=4&type=section&id=About%20Centessa%20Pharmaceuticals%20and%20Product%20Candidates) Centessa is a clinical-stage company developing transformational medicines across hemophilia, narcolepsy, and immuno-oncology platforms - Centessa Pharmaceuticals plc is a clinical-stage pharmaceutical company that aims to discover and develop medicines transformational for patients[32](index=32&type=chunk) - The most advanced programs include a hemophilia program, an orexin agonist program for narcolepsy and other sleep-wake disorders, and an immuno-oncology program focused on the LockBody® technology platform[32](index=32&type=chunk) [About Centessa Pharmaceuticals](index=4&type=section&id=About%20Centessa%20Pharmaceuticals) Centessa is a clinical-stage company dedicated to developing innovative medicines, focusing on hemophilia, narcolepsy, and immuno-oncology - The company operates with the conviction that each of its programs has the potential to change the current treatment paradigm and establish a new standard of care[32](index=32&type=chunk) [About SerpinPC (Hemophilia Program)](index=4&type=section&id=About%20SerpinPC) SerpinPC is an investigational, subcutaneously administered APC inhibitor for hemophilia, with Fast Track designation from the FDA - SerpinPC is an investigational subcutaneously administered novel inhibitor of APC being developed as a potential treatment for hemophilia, regardless of severity or inhibitor status[11](index=11&type=chunk)[25](index=25&type=chunk) - The registrational program for SerpinPC in hemophilia B includes PRESent-2 (moderately severe to severe hemophilia B without inhibitors) and PRESent-3 (hemophilia B with inhibitors), along with an observational feeder study PRESent-5[11](index=11&type=chunk) - The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SerpinPC for the treatment of hemophilia B, with or without inhibitors[11](index=11&type=chunk) [About ORX750 (Orexin Agonist Program)](index=4&type=section&id=About%20ORX750) ORX750 is an investigational, orally administered, highly potent and selective OX2R agonist for narcolepsy and sleep-wake disorders - ORX750 is an investigational, orally administered, highly potent and selective orexin receptor 2 (OX2R) agonist[3](index=3&type=chunk)[26](index=26&type=chunk)[33](index=33&type=chunk) - It is designed to directly target the underlying pathophysiology of orexin neuron loss in narcolepsy type 1 (NT1)[26](index=26&type=chunk) - Preclinical studies showed ORX750 potently activates the OX2R with an in vitro EC50 of **0.11 nM** and **9,800-fold selectivity** over the human orexin receptor (hOX1R)[26](index=26&type=chunk) [About the LockBody Technology Platform and LB101](index=4&type=section&id=About%20the%20LockBody%20Technology%20Platform%20and%20LB101) LockBody platform redefines immuno-oncology by selectively activating effector functions in the TME; LB101 is the lead candidate - Centessa's proprietary LockBody technology platform aims to redefine immuno-oncology treatment for patients with cancer by selectively driving potent effector function activity, such as CD47 or CD3, to the tumor micro-environment (TME) while avoiding systemic toxicity[12](index=12&type=chunk)[34](index=34&type=chunk) - The first LockBody candidate is LB101, a conditionally tetravalent PD-L1xCD47 bispecific monoclonal antibody[27](index=27&type=chunk)[34](index=34&type=chunk) - LB101's CD47 cell-killing mechanism is designed to be blocked by the PD-L1 tumor targeting domain until IgG-derived hinges are naturally degraded in the TME, unlocking and activating the CD47 effector function activity in the tumor[27](index=27&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward%20Looking%20Statements) This section outlines risks and uncertainties related to product development, clinical trials, financing, and regulatory approvals - Forward-looking statements are based on current expectations, estimates, assumptions, and projections and are subject to risks and uncertainties that could cause actual results to differ materially and adversely[13](index=13&type=chunk)[35](index=35&type=chunk) - Risks include those related to the safety and tolerability profile of product candidates, ability to recruit subjects for clinical trials, timely execution of IND-enabling activities, intellectual property protection, adequate financing, regulatory clearances, and broader economic and geopolitical risks[28](index=28&type=chunk)[35](index=35&type=chunk) - The company explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law[28](index=28&type=chunk) [Contact Information](index=6&type=section&id=Contact) Provides contact details for investor relations inquiries - For investor relations inquiries, contact Kristen K. Sheppard, Esq., SVP of Investor Relations, at investors@centessa.com[14](index=14&type=chunk)[28](index=28&type=chunk)

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akinbostanciCentessa Pharmaceuticals (NASDAQ:CNTA) has become an interesting player in the biopharmaceutical field, characterized by an innovative business model and a unique portfolio. Unlike other companies, the unique structure of Centessa combines the flexibility of innovation of small-scale biotechs and the robust support of a large corporation that can give it an advantage in the turbulent world of drug development. Such a framework enables the company to concentrate on the development of its pipe ...

Financial Position - Centessa Pharmaceuticals has cash, cash equivalents, and short-term investments of $281.3 million as of September 30, 2023, expected to fund operations into 2026[406]. - As of September 30, 2023, the company had cash, cash equivalents, and short-term investments totaling $281.3 million[445]. - The company has filed a shelf registration statement covering the offering of up to $350.0 million in various securities, including ordinary shares and debt securities[449]. Revenue and Profitability - The company has not generated any revenue and relies on successful development and commercialization of product candidates for future profitability[408]. - The company expects to incur significant expenses and operating losses as it advances its clinical and preclinical programs[406]. - The company recorded a net loss of $38.6 million for the three months ended September 30, 2023, compared to a net loss of $53.9 million for the same period in 2022, reflecting a 28.4% improvement[422]. Research and Development - SerpinPC, a treatment for hemophilia, has shown favorable safety and efficacy in ongoing Phase 2a studies, with plans to present new data in December 2023[386][393]. - The registrational program for SerpinPC includes global studies, with the first subjects dosed in July and October 2023 for different hemophilia types[393]. - ORX750, an orally administered OX2 receptor agonist for narcolepsy, has demonstrated significant activity in preclinical models, with clinical development expected to begin in 2024[399]. - LB101, the first LockBody product candidate, is undergoing a Phase 1/2a study for advanced solid tumors, with the first subject dosed in March 2023[395]. - LB206, a second LockBody candidate for solid tumors, was announced in August 2023, showing promising preclinical data[389]. - The company has deprioritized several programs, including CBS001 and CBS004, while continuing to evaluate strategic partnerships for their development[405]. - The company expects to incur significant expenses related to ongoing development activities and anticipates a long-term increase in expenses as it continues research and development efforts[457]. Expenses - Research and development expenses for the three months ended September 30, 2023, were $28.2 million, a decrease of 23.2% from $36.7 million in the same period of 2022[433]. - Research and development expenses for the nine months ended September 30, 2023, totaled $94.7 million, a decrease of 25.6% from $127.2 million for the same period in 2022[437]. - The company incurred $13.0 million in research and development expenses for the SerpinPC program during the three months ended September 30, 2023, compared to $5.6 million in the same period of 2022, reflecting a 132.5% increase[426]. - General and administrative expenses for the three months ended September 30, 2023, were $12.0 million, slightly down from $12.3 million in the same period of 2022[428]. - General and administrative expenses for the nine months ended September 30, 2023, were $41.4 million, unchanged from the same period in 2022, with personnel expenses increasing by $2.6 million due to higher share-based compensation[440]. Income and Tax - Interest income increased to $3.0 million for the three months ended September 30, 2023, compared to $0.1 million in the same period of 2022[429]. - Interest income for the nine months ended September 30, 2023, was $7.5 million, up from $0.2 million in the same period of 2022, reflecting interest earned from cash and cash equivalents and short-term marketable securities[441]. - Interest expense for the three months ended September 30, 2023, was $2.5 million, an increase of 30.4% from $1.9 million in the same period of 2022[429]. - Interest expense increased to $7.3 million for the first nine months of 2023, up $2.3 million from the same period in 2022, due to a higher average interest rate on the Note Purchase Agreement[442]. - The company recorded an income tax benefit of $2.8 million for the three months ended September 30, 2023, compared to a benefit of $0.1 million in the same period of 2022[431]. - The income tax benefit for the nine months ended September 30, 2023, was $26.2 million, significantly higher than the $83 thousand benefit recorded in the same period of 2022[444]. Cash Flow - Net cash used in operating activities for the nine months ended September 30, 2023, was $129.3 million, an improvement from $149.0 million in the same period of 2022[452]. - Net cash used in investing activities was $108.7 million for the nine months ended September 30, 2023, primarily due to investments in U.S. Treasury securities[454]. Company Classification - The company is classified as an emerging growth company under the JOBS Act, allowing it to delay the adoption of new accounting standards until they apply to private companies[480]. - The company will remain an emerging growth company until it reaches total annual gross revenues of $1.235 billion or more or meets other specified criteria[480]. Other - The company has provided a full valuation allowance for its U.K. deferred tax assets due to a history of cumulative net losses, while it released a previously recorded valuation allowance for its U.S. deferred tax assets in Q2 2023[478]. - As of September 30, 2023, the company reported no material contractual obligations or commitments beyond those disclosed in Note 6[479].

The Company's unaudited interim consolidated financial statements include the accounts of Centessa Pharmaceuticals plc, and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Emerging Growth Company and Smaller Reporting Company We are an "emerging growth company," as defined in the Jumpstart Our Business Startups Act ("JOBS Act") enacted in April 2012. For so long as we remain an emerging growth company, we are permitted and intend to rely on ce ...

Table of Contents (Exact name of registrant as specified in its charter) England and Wales 98-1612294 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-04321 CENTESSA PHARMACEUTICALS PLC (Exact name of registrant as specified in its charter) England and Wales 98-1612294 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 3rd Floor 1 Ashley Road Altrin ...