On March 18, 2024 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, reported that the first clinical candidate in its TCB agreement with Astellas has entered into GLP toxicology studies which triggers a $5 million payment to CytomX (Press release, CytomX Therapeutics, MAR 18, 2024, View Source [SID1234641231]). The clinical candidate is the first PROBODY TCB molecule under this alliance to progress into a GLP toxicology study. CytomX and Astellas are also collaborating on additional conditionally activated TCB programs with CytomX eligible to receive future preclinical, clinical and commercial milestones. CytomX retains a cost share and co-commercialization option on a select number of targets.

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"We are excited by the continued momentum towards a potential future IND for the first PROBODY TCB clinical candidate in our collaboration with Astellas, and we continue to partner with Astellas on multiple preclinical programs. The progress with this collaboration highlights the benefits of our strategy to create value through both wholly-owned and partnered programs, as well as the potential of our expanding pipeline of PROBODY T-cell engagers which are designed to localize T-cell activity to the tumor microenvironment," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX Therapeutics.

On March 18, 2024 Bristol Myers Squibb (NYSE: BMY) reported that it has successfully completed its acquisition of Karuna Therapeutics, Inc. ("Karuna") (Press release, Bristol-Myers Squibb, MAR 18, 2024, View Source [SID1234641230]). With the acquisition’s completion, Karuna shares have ceased trading on the Nasdaq Global Select Market and Karuna is now a wholly owned subsidiary of Bristol Myers Squibb ("BMS").

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"We are excited to expand our neuroscience portfolio as we welcome Karuna to Bristol Myers Squibb," said Chris Boerner, Ph.D., Chief Executive Officer, Bristol Myers Squibb. "Importantly, this transaction aligns with our commitment to strengthening BMS’s growth profile in the latter half of the decade and beyond. We look forward to working with Karuna’s talented team to bring KarXT to patients with schizophrenia later this year."

Through this transaction, BMS has added KarXT (xanomeline-trospium), an antipsychotic with a novel mechanism of action and a differentiated efficacy and safety profile, and Karuna’s early-stage and pre-clinical pipeline. KarXT has a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024 for the treatment of schizophrenia in adults. KarXT is also in registrational trials both for adjunctive therapy to existing standard of care agents in schizophrenia and for the treatment of psychosis in patients with Alzheimer’s disease, with potential to expand to additional indications, including Bipolar I disorder and Alzheimer’s disease agitation.

As previously disclosed, the transaction is expected to be dilutive to Bristol Myers Squibb’s non-GAAP diluted earnings per share by approximately $0.30 in 2024 from the financing cost of the transaction, which is primarily from a recently completed new debt issuance. Bristol Myers Squibb expects to offset the operational expenses of the transaction through continued disciplined resource allocation, cost efficiencies and portfolio prioritization. Bristol Myers Squibb’s cash flows and strong financial profile enable continued commitment to strong investment-grade credit ratings and investment for growth through business development opportunities and distributions to shareholders through ongoing dividends and share repurchases.

The transaction will be accounted for as an asset acquisition resulting in an approximately $12 billion one-time, non-deductible Acquired In-Process Research and Development (Acquired IPR&D) charge impacting both 2024 first quarter and full-year GAAP and non-GAAP EPS by approximately $5.93.

Consistent with past practice, Bristol Myers Squibb generally provides updates to its financial outlook once each quarter. When considering Bristol Myers Squibb’s financial outlook issued on February 2, 2024, investors and analysts should take into account the impacts outlined above. Bristol Myers Squibb will provide an update to its financial outlook when it reports first quarter 2024 results on April 25, 2024.

Advisors

Gordon Dyal & Co. and Citi are serving as financial advisors to Bristol Myers Squibb, and Covington & Burling LLP is serving as legal counsel. Goldman Sachs & Co. LLC is serving as exclusive financial advisor to Karuna, and Simpson Thacher & Bartlett LLP is serving as legal counsel.

On March 18, 2024 bluebird bio, Inc. (NASDAQ: BLUE) ("bluebird bio" or the "Company") reported that it has entered into a $175 million five-year, term loan facility with Hercules Capital, Inc. (NYSE: HTGC) ("Hercules") (Press release, bluebird bio, MAR 18, 2024, View Source [SID1234641229]). The transaction strengthens the Company’s balance sheet as it executes on the commercial launches for its three FDA approved gene therapies – LYFGENIA for sickle cell disease, ZYNTEGLO for beta-thalassemia and SKYSONA for cerebral adrenoleukodystrophy.

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The term loan facility provides for up to $175 million of term loans in aggregate, available in four tranches. Upon closing of the transaction, the first tranche of $75 million was drawn. Under the terms of the agreement, bluebird will be eligible to draw two additional tranches of $25 million each, subject to the achievement of commercial milestones. Based on launch trajectory and current business plans, and assuming three tranches totaling $125 million are executed, the transaction is expected to extend bluebird’s cash runway through the first quarter of 2026. A fourth tranche of up to $50 million may be available at the sole discretion of Hercules. During the first three years of the five-year term, the Company will be responsible for paying only the interest on any amounts borrowed; any outstanding balance as of April 1, 2027 will be amortized over the remaining life of the loan.

"Since establishing bluebird as an independent gene therapy company in 2021, we have been focused on diligently deploying our capital and strengthening our balance sheet to further our mission," said Chris Krawtschuk, chief financial officer, bluebird bio. "This financing underscores the value bluebird offers as a standalone gene therapy leader and meaningfully extends our runway, bolstering our ability to bring transformative treatments to patients and their families."

"Hercules is excited to partner with bluebird as they launch LYFGENIA and bring this transformational therapy to patients living with sickle cell disease," said Michael Dutra, Managing Director and Senior Investment Officer at Hercules Capital. "We are proud to support bluebird’s mission of developing and commercializing treatments for severe genetic diseases. This financing should help support the availability of their novel gene therapies for patients," added John Miotti, Principal at Hercules Capital.

Additional details of the loan agreement will be filed with the Securities and Exchange Commission on a Current Report on Form 8-K.

J. Wood Capital Advisors acted as sole financial advisor to the Company. Latham & Watkins LLP served as legal counsel to bluebird and DLA Piper served as legal counsel to Hercules.

On March 18, 2024 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, reported full year 2023 financial results and company highlights for the fourth quarter ended December 31, 2023 (Press release, Alpine Immune Sciences, MAR 18, 2024, View Source [SID1234641228]).

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"2023 was a transformational year for Alpine, with initial IgA nephropathy (IgAN) data presented at the American Society of Nephrology Kidney Week 2023 suggesting a best-in-class profile for povetacicept, our next-generation dual BAFF/APRIL inhibitor. With our encouraging data set in IgAN, convenient once monthly dosing regimen, and strong balance sheet, we are rapidly advancing development of povetacicept as a potentially meaningful new therapeutic option for patients living with IgAN, systemic lupus erythematosus (SLE), and multiple other autoantibody-related diseases," said Mitchell H. Gold, MD, Executive Chairman and Chief Executive Officer of Alpine.

Dr. Gold continued, "Looking ahead, Alpine is well positioned for a year of meaningful catalysts, with multiple updates for povetacicept in IgAN and other indications, and the planned initiation of RAINIER, a pivotal phase 3 study of povetacicept in IgAN, and DENALI, a phase 2 study of povetacicept in SLE. In addition to updates on our clinical studies, we look forward to sharing translational data that further supports the best-in-class potential of povetacicept in multiple inflammatory diseases."
Fourth Quarter 2023 Corporate Updates
Povetacicept (ALPN-303)
•First clinical data in IgAN demonstrate that povetacicept 80 mg administered once every four-weeks (Q4W) reduced proteinuria (as assessed by urine protein to creatinine ratio, UPCR) by greater than 50% and was associated with stable renal function (as assessed by estimated glomerular filtration rate, eGFR) at six months. In addition, povetacicept was well tolerated during subcutaneous administration, with no instances of IgG < 3 g/L, and no severe infections (2023 American Society of Nephrology Kidney Week).
•In a model of murine experimental autoimmune myasthenia gravis, povetacicept improved disease activity, with clinical scores superior to treatment with either the FcRn inhibitor efgartigimod or an anti-CD20 depleting antibody (2023 American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting).
•New translational data from povetacicept in systemic lupus erythematosus demonstrate that povetacicept, as compared to single BAFF or APRIL pathway inhibitors, more potently downregulates genes associated with activation in B cells and significantly reduces multiple disease parameters in a mouse model of lupus, more effectively than WT TACI-Fc or conventional B cell depletion (2023 American College of Rheumatology Convergence).
•Throughout 2023, the Company presented multiple oral and poster presentations on povetacicept at scientific conferences.
Corporate Updates
•The Company plans to present additional data on povetacicept in IgA nephropathy, including follow up data from the 80 mg Q4W and initial data from the IgAN 240 mg Q4W dose cohorts, during a Late Breaking Abstract session at the World Congress of Nephrology 2024 on Monday, April 15th at 4:45 PM ET.
•The Company plans to present new preclinical data on povetacicept, demonstrating its greater distribution to disease-related end organs compared with WT TACI-Ig, at the 14th European Lupus Meeting. These findings correlate with povetacicept’s improved efficacy in multiple preclinical disease models.

•The Company intends to initiate RAINIER, a pivotal phase 3 study of povetacicept in IgA nephropathy and DENALI, a phase 2 study of povetacicept in systemic lupus erythematosus in the second half of 2024, pending regulatory agreement.
•The Company plans to share initial data from RUBY-4 in autoimmune cytopenias in the first half of 2024 at a relevant scientific congress.
•The Company amended its option and license agreement on acazicolcept with AbbVie, stopping enrollment in the phase 2 study in systemic lupus erythematosus (Synergy), and facilitating early assessment of data.
•The Company ended the year with $368.2 million in cash and investments as of December 31, 2023, which the Company anticipates should be sufficient to fund its planned operations into 2026.
2023 Financial Results
Cash Position and Runway: As of December 31, 2023, Alpine’s cash and investments totaled $368.2 million compared to $273.4 million as of December 31, 2022. The Company anticipates its current cash and investments are sufficient to fund planned operations into 2026.
Collaboration Revenue: For the year ended December 31, 2023, collaboration revenue was $58.9 million compared to $30.1 million for the same period in 2022. The increase in collaboration revenue relates primarily to a $24.9 million increase in AbbVie revenue, of which $20.4 million relates to a cumulative catch-up adjustment resulting from the completion of enrollment in Synergy per the amendment with AbbVie, and a $4.5 million increase in Amgen revenue, driven primarily by the expiration of Amgen’s option to select a third Research Program. These increases were partially offset by a $0.6 million decrease in Adaptimmune revenue as we completed our final deliverables under the agreement in June 2023.
Research and Development Expense: For the year ended December 31, 2023, research and development expense, inclusive of non-cash expenses, were $80.9 million compared to $70.2 million for the same period in 2022. The increase of $10.7 million was driven by an $8.2 million increase in povetacicept costs, primarily related to higher clinical trial costs, process development, and manufacturing, a $1.3 million increase in acazicolcept costs, due primarily to process development and manufacturing costs, and a $7.7 million increase in personnel costs.
General and Administrative Expenses: For the year ended December 31, 2023, general and administrative expenses, inclusive of non-cash expenses, were $22.2 million compared to $18.0 million for the same period in 2022. The increase of $4.3 million was primarily attributable to increases in personnel costs and professional services.
Net Loss: Net loss for the year ended December 31, 2023, was $32.2 million compared to $57.8 million for the same period in 2022.

On March 17, 2024 Infinitopes reported the company collaborating with the leading mass spectrometry technology company Bruker to develop a world leading immunopeptidomic based antigen discovery platform (Press release, Infinitopes, MAR 17, 2024, View Source [SID1234648454]). In a recent poster, Infinitopes showcase their state-of-the-art sample preparation capabilities in synergy with the latest high-sensitivity mass spectrometry technology from Bruker. Building on Inifinitopes’ proprietary antigen purification strategy Bruker optimise the performance of their new timsTOF Ultra mass spectrometer providing a highly sensitive platform for antigen discovery. Bruker fine-tuned their instrument parameters to enable identification of thousands of peptide antigens from just 1 million melanoma cells. This development paves the way for cancer antigen discovery directly from patient biopsies, overcoming a critical unmet need for target discovery in the field of immuno-oncology. Dr. Rob Parker, Lead Scientist Discovery Immunomics of Infinitopes, commented:

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"We are excited to see our R&D capabilities drastically expanded through our unique collaboration with Bruker. Bruker’s commitment toward ultra-sensitive discovery immunopeptidomics will accelerate Infinitopes growth and provide unique benefit to our existing and future and partners, with our enhanced R&D output positioning Infinitopes as a leading force in cancer antigen discovery".