On April 28, 2022 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX System powered by Nano-Pulse Stimulation (NPS) technology, reported it will report financial results for the first quarter of 2022 after market close on Wednesday, May 11, 2022 (Press release, Pulse Biosciences, APR 28, 2022, View Source [SID1234613166]). Company management will host a corresponding conference call beginning at 1:30pm PT.

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Investors interested in listening to the conference call may do so by dialing 1-877-704-4453 for domestic callers or 1-201-389-0920 for international callers. A live and recorded webcast of the event will be available at View Source

On April 28, 2022 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a clinical-stage precision oncology company developing next-generation therapies that target genetic drivers of cancer, and Zai Lab (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, reported topline data for repotrectinib within the China region from the previously disclosed Phase 1/2 TRIDENT-1 study dataset (Press release, Turning Point Therapeutics, APR 28, 2022, View Source [SID1234613165]).

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"We are incredibly pleased with our collaboration with Zai Lab given their strong enrollment into the global TRIDENT-1 study and are happy to share these initial results," said Mohammad Hirmand, M.D., Chief Medical Officer of Turning Point Therapeutics. "We look forward to discussing our global TRIDENT-1 data with the FDA prior to the end of this quarter and presenting detailed study results from the global dataset at a medical conference in the second half of the year."

"With over 800,000 newly diagnosed lung cancer patients every year in China, NSCLC accounts for approximately 85% of the cases, and ROS1 rearrangements occur in 2-3% of patients with advanced NSCLC. The majority of these patients are diagnosed at advanced stages, representing significant unmet medical need," said Alan Sandler, M.D., President and Head of Global Development, Oncology, at Zai Lab. "It is encouraging to see the similar results of the efficacy analyses comparing data from sites in China and globally for repotrectinib, a potential best-in-class drug candidate for patients with ROS1-positive advanced NSCLC. We will continue to work closely with Turning Point to advance this program to help support NSCLC patients in China and around the world."

The primary objective of the TRIDENT-1 study is to determine the cORR based on BICR as assessed by RECIST 1.1. DOR is a key secondary objective of the study. The dataset utilizes a February 11, 2022 data cutoff date. The global safety analysis included 380 treated patients from the pooled Phase 1 and Phase 2 portions of TRIDENT-1 across all cohorts. The global efficacy analyses included pooled patients from Phase 1 across all dose levels with an identified ROS1 fusion by next generation sequencing at baseline and Phase 2 patients. All patients received at least one dose of repotrectinib with at least four months of follow-up, and the majority of responders had at least six months of DOR follow-up.

Topline Efficacy Analyses by BICR

In TKI-naïve patients (EXP-1), in 71 total patients, there was a cORR of 79% across the global trial. Ten of 11 patients responded within China for a cORR of 91% (95% CI: 59,100) and DOR ranged from 3.6+ to 7.5+ months with a median duration of follow-up of 3.7 months.

In patients previously treated with 1 TKI and platinum-based chemotherapy (EXP-2), in 26 total patients, there was a cORR of 42% across the global trial. Two of 3 patients responded within China for a cORR of 67% (95% CI:9,99) and DOR ranged from 3.6+ to 3.7+ months with a median duration of follow-up of 3.7 months.

In patients previously treated with two TKIs without prior chemotherapy (EXP-3), in 18 total patients, there was a cORR of 28% across the global trial. Two of 4 patients responded within China for a cORR of 50% (95% CI: 7,93) and DOR ranged from 1.9+ to 3.4+ months with a median duration of follow-up of 2.6 months.

In patients previously treated with 1 TKI without prior chemotherapy (EXP-4), in 56 total patients, there was a cORR of 36% across the global trial. Four of 11 patients responded within China for a cORR of 36% (95% CI: 11,69) and DOR ranged from 2.0+ to 3.7+ months with a median duration of follow-up of 3.1 months.
Global TRIDENT-1 Topline Safety Analyses

Repotrectinib was generally well tolerated in a total of 380 patients treated globally with a safety and tolerability profile that was consistent with previously reported findings. The most commonly reported treatment emergent adverse event remained dizziness (61% all grade), of which 76% of patients who reported dizziness had a maximum severity of grade 1. The safety profile was comparable among the 287 patients who were treated at the Phase 2 dose.

The TRIDENT-1 study continues to enroll patients globally across the study. As previously guided, Turning Point Therapeutics anticipates discussing the topline BICR data for the ROS1-positive advanced NSCLC cohorts with the U.S. Food and Drug Administration (FDA) at a pre-NDA meeting this quarter. Turning Point Therapeutics plans to present detailed study results, including intracranial activity, from the ROS1-positive advanced NSCLC cohorts of the TRIDENT-1 study, at a medical conference in the second half of 2022.

Zai Lab plans to complete enrollment in the phase 1/2 registrational TRIDENT-1 study and discuss the regulatory pathway with the National Medical Products Administration (NMPA) at a pre-NDA meeting in the fourth quarter of 2022.

On April 28, 2022 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, reported results for the quarter ended March 31, 2022, and provided a corporate update (Press release, AC Bioscience, APR 28, 2022, View Source [SID1234613164]).

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Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "We continue to make strong progress in pursuit of our mission to enable the earlier diagnosis, treatment, and ultimately prevention, of neurodegenerative diseases. Our recent AD/PDTM presentations exemplified the breadth and innovative excellence of our approaches, including ACI-12589 generating the first live images of alpha-synuclein in human brains. This critical breakthrough lays the groundwork for precision medicine, including a pathway for biomarker-based development for NeuroOrphan indications."

Prof. Pfeifer continued: "Throughout the remainder of 2022, we expect to report five additional clinical data readouts from vaccine, antibody, and diagnostic programs targeting Abeta and Tau, including top line results from the landmark Alzheimer’s prevention trial of anti-Abeta antibody crenezumab expected in the coming months. Each of the anticipated milestones represents an important opportunity for value creation and an affirmation of AC Immune’s position as a global leader in addressing neurodegenerative diseases. We look forward to executing on our plan in the year ahead and are pleased to be well financed through at least Q1 2024."

Q1 2022 and Subsequent Highlights

Reported the first live images of alpha-synuclein in the human brain with ACI-12589, AC Immune’s wholly-owned alpha-synuclein (a-syn) positron emission tomography (PET) tracer, at the AD/PDTM 2022 Conference. Clinical PET image analyses showed enhanced contrast and a-syn target specificity in patients with multiple system atrophy (MSA), as well as increased tracer retention in brain areas affected by MSA disease processes. Together with preclinical data also presented at AD/PDTM 2022, these analyses demonstrate ACI-12589’s potential to be the first non-invasive diagnostic for alpha-synucleinopathies (e.g. MSA).

Hosted a key opinion leader webinar on a-syn as a target in neurodegenerative diseases featuring Oskar Hansson, MD, PhD, of Skåne University Hospital and Lund University. To view the presentation and a replay of the webinar, click here.

Announced interim Phase 1b/2a trial data confirming the consistent safety and potent immunogenicity of ACI-35.030, a first-in-class phosphorylated-Tau (pTau) vaccine candidate. Data from the high-dose cohort showed the strong induction of antibodies selective for pTau and its aggregated form, enriched paired helical filaments (ePHF). The data also support ACI-35.030’s favorable safety profile and plans for its continued late-stage development.

Published new data on the optimized formulation of ACI-24 in the peer-reviewed journal Brain Communications, showing that the anti-Abeta vaccine was well tolerated in preclinical models and generated a broad polyclonal anti-Abeta response with high titers of antibodies against neurotoxic pyroglutamate Abeta (pyroGlu-Abeta), a major component of Abeta plaques. Optimized ACI-24 was also shown to have enhanced and sustained immunogenicity against another key pathological Abeta species, oligomeric Abeta, in preclinical studies presented at AD/PDTM 2022.

Expanded leadership with the appointment of Howard Donovan as Chief HR Officer and member to the Executive Committee. Mr. Donovan is an internationally experienced, commercially focused leader. He joins from the World Economic Forum, where he led People Services since 2015.

Joerg Hornstein, Chief Financial Officer, will leave in the second half of 2022 to pursue a new opportunity. AC Immune is well positioned with two members of the company’s proven Finance Leadership Team who will transition to new roles. Christopher Roberts is appointed Vice President, Finance and interim CFO. Julian Snow is appointed Vice President, U.S. Finance & Corporate Development.

Achieved and Anticipated 2022 Clinical Milestones

ACI-12589
a-syn-PET tracer Reported results from first-in-human study at AD/PD 2022 conference
ACI-35.030
anti-pTau vaccine Reported Phase 1b/2a interim analysis from highest dose group in Q1; Expect to disclose future late-stage development plans in H2 2022
ACI-24 (optimized)
anti-Abeta vaccine ACI-24 (optimized vaccine formulation) Phase 1b/2a first-patient-in (AD) in H1 2022
Phase 1b in AD readout and decision to move into DS expected in H2 2022
Crenezumab
anti-Abeta antibody Top line Phase 2 results from AD prevention trial in patients with autosomal dominant AD expected in H1 2022
Semorinemab
anti-Tau antibody Additional fluid biomarker data from the Phase 2 Lauriet study in mild-to-moderate AD expected in H2 2022
PI-2620
Tau-PET tracer Phase 2 and Phase 1 results in AD and progressive supranuclear palsy (PSP) respectively, expected in H2 2022
ACI-7104
anti-a-syn vaccine Initiation of Phase 2 trial in early PD expected in H2 2022

Analysis of Financial Statements for the Quarter Ended March 31, 2022

Cash Position: The Company had a total cash balance of CHF 173.8 million, composed of CHF 57.8 million in cash and cash equivalents and CHF 116.0 million in short-term financial assets. This compares to a total cash balance of CHF 198.2 million as of December 31, 2021. The Company’s cash balance provides enough capital resources to progress through at least Q1 2024 without consideration of potential incoming milestone payments.

R&D Expenditures: R&D expenses increased by CHF 1.8 million for the three months ended March 31, 2022, to CHF 15.1 million.
Discovery and preclinical expenses (- CHF 0.6 million): The Company decreased expenditures across a variety of its discovery and preclinical programs, led by ACI-24 for DS as this program advances into clinical development.

Clinical expenses (+ CHF 0.9 million): The Company increased expenditures across multiple clinical programs, predominantly for ACI-24 for DS and ACI-7104 as the program prepares to enter Phase 2 testing in early PD patients in H2 2022.

Other non-allocated (+ CHF 1.5 million): The Company’s other non-allocated R&D expenditure increased by CHF 0.9 million related to the reallocation of certain IT and facilities costs and IT related investments as well as CHF 0.6 million across various other cost centers.

G&A Expenditures: For the three months ended March 31, 2022, G&A decreased by CHF 0.2 million to CHF 4.2 million. This decrease is predominantly related to a CHF 0.7 million reallocation of certain IT and facilities expenditures made in Q1 2022 that were not reclassified in the prior period.

Other Operating Income: The Company recognized CHF 0.5 million in grant income for R&D activities performed under our Michael J. Fox Foundation for Parkinson’s Research (MJFF) and Target ALS grants, an increase of less than CHF 0.1 million compared to the prior period.

IFRS Loss for the Period: The Company reported a net loss after taxes of CHF 18.8 million for the three months ended March 31, 2022, compared with a net loss of CHF 16.7 million for the comparable period in 2021.
2022 Financial Guidance

For the full year 2022, the Company expects its total cash burn to be in the range, CHF 75 million to CHF 80 million. The Company defines cash burn as operating expenditures adjusted to include capital expenditures and offset by significant non-cash items (including share-based compensation and depreciation expense).

On April 28, 2022 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the first-quarter 2022 and updated full-year 2022 financial guidance (Press release, West Pharmaceutical Services, APR 28, 2022, View Source [SID1234613163]).

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First-Quarter 2022 Summary (comparisons to prior-year period)

Net sales of $720.0 million grew 7.4%; organic sales growth was 11.0%.
Reported-diluted EPS of $2.29 increased 15.1%.
Adjusted-diluted EPS of $2.30 increased 12.2%.
The Company is reaffirming full-year 2022 financial guidance of net sales in a range of $3.050 billion to $3.075 billion. The Company is raising full-year 2022 financial guidance of adjusted-diluted EPS to a new range of $9.30 to $9.45, compared to a prior range of $9.20 to $9.35.
The Company also announced that its Board of Directors has approved a third-quarter 2022 dividend of $0.18 per share. The dividend will be paid on August 3, 2022, to shareholders of record as of July 20, 2022.
"Adjusted-diluted EPS" and "organic sales growth" are Non-U.S. GAAP measurements. See discussion under the heading "Non-U.S. GAAP Financial Measures" in this release.

"We delivered a solid first-quarter 2022 and remain on track to increase capacity throughout the year to satisfy the growing demand for our high-value products (HVP)," said Eric M. Green, President and Chief Executive Officer. "Our team members across the globe continue to demonstrate their passion to improve patient lives as they remain focused on executing our strategic initiatives despite macroeconomic challenges. Even with these challenges, and headwinds related to changes in foreign currency exchange rates, we remain well positioned for continued net sales growth and margin expansion. We are reaffirming our full-year 2022 net sales guidance, raising our full-year organic sales growth guidance, and raising our full-year 2022 adjusted-diluted EPS guidance."

Proprietary Products Segment
Net sales grew by 10.6% to $601.3 million. Organic sales growth was 14.4% with currency translation negatively impacting sales growth by 380 basis points. High-value products (components and devices) represented more than 70% of segment sales and generated double-digit organic sales growth, led by customer demand for NovaPure and Westar components.

The Biologics market unit had double-digit organic sales growth. The Pharma and Generics market units had high-single digit and mid-single digit organic sales growth, respectively.

Contract-Manufactured Products Segment
Net sales declined by 6.6% to $118.7 million. Organic sales decline was 3.8% with currency translation negatively impacting sales growth by 280 basis points. Segment performance was impacted by a decline of sales of components for diagnostic devices.

Financial Highlights
Operating cash flow was $151.2 million, an increase of 70.5%. Capital expenditures in the quarter were $65.8 million. Free cash flow (operating cash flow minus capital expenditures) was $85.4 million, an increase of 151.2%.

During the quarter, the Company repurchased 390,000 shares for $147.1 million at an average share price of $377.23 under its share repurchase program.

Full-Year 2022 Financial Guidance

The Company is reaffirming full-year 2022 net sales guidance to be in a range of $3.050 billion to $3.075 billion.
Organic sales growth is expected to be in a range of 11% to 12%, compared to prior guidance of approximately 10%.
Net sales guidance, based on current foreign exchange rates, includes an estimated full-year 2022 headwind of $115 million, compared to prior guidance of a $70 million headwind.
The Company is raising full-year 2022 adjusted-diluted EPS to be in a range of $9.30 to $9.45, compared to a prior range of $9.20 to $9.35.
Full-year reported-diluted EPS guidance range, based on current foreign currency exchange rates, includes an estimated headwind of $0.38, compared to prior guidance of a $0.21 headwind.
The revised guidance includes a $0.12 EPS positive impact from first-quarter tax benefits from stock-based compensation.
For the remaining quarters of the year, our EPS guidance range assumes a tax rate of 23% and does not include potential tax benefits from stock-based compensation. Any tax benefits associated with stock-based compensation beyond those recorded in the first-quarter 2022 would provide a positive adjustment to our full-year adjusted-diluted EPS guidance
Full-year 2022 capital spending is expected to be $380 million. This includes incremental capital spending to support capacity expansions at existing HVP facilities.
First-Quarter 2022 Conference Call
The Company will host a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time today. To participate on the call please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 6690124.

A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the "Investors" section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

An online archive of the broadcast will be available at the website three hours after the live call and will be available through Thursday, May 5, 2022, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International) and entering conference ID 6690124.

On April 28, 2022 Merck & Co reported its first quarter 2022 results (Presentation, Merck & Co, APR 28, 2022, View Source [SID1234613162]).

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