On July 28, 2022 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that Chief Scientific Officer and Co-Founder, Dr Julian Kenyon, MD, MB, ChB, reflects on the unique anti-cancer effects of PRP discovered as a result of the significant and diligent research invested by the Company and its joint research team over the past decade (Press release, Propanc, JUL 28, 2022, View Source [SID1234617103]). PRP is a proenzyme therapy for the treatment and prevention of metastatic cancer from solid tumors. This unique approach could become an effective tool in the fight against metastatic cancer, which is the main cause of patient death for sufferers. PRP is considered unique because rather than kill cancer cells like most standard therapies, proenzymes induce cancer cells to differentiate so they are no longer malignant and die off naturally, "thus preventing these dangerous cells to spread and metastasize," according to Dr Kenyon.

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Since 2013, Dr Kenyon and his joint research team have published five scientific papers highlighting the effects of proenzymes against a range of solid tumors, by inducing cell differentiation (reversing cancerous cells so they are no longer malignant), impairing angiogenesis (blood vessel formation) of solid tumors, and inhibiting cancer stem cell (CSC) formation by blocking the epithelial to mesenchymal (EMT) process. The EMT is a normal biological process normally associated with embryogenesis and wound healing. When CSCs undergo the EMT process, they become motile and invasive, with an ability to spread into surrounding tissues. Furthermore, they become immortal and are resistant to standard treatment approaches, which can often cause a patient to relapse post treatment.

"Since our first peer reviewed scientific publication in 2013, which highlights how proenzymes suppresses the EMT program and promotes cell differentiation, I continue to be amazed at the compelling results achieved by our research team which demonstrates that we have a unique approach to treat and prevent metastatic cancer by targeting and eradicating cancer stem cells, whilst leaving healthy cells alone. This confirms what I observed clinically, when I first treated 46 late-stage cancer patients in a compassionate use study, which extended the survival of a number of patients, free from the serious side effects normally associated with standard treatment approaches. Since then, we have achieved proof of concept, in vivo (in a living organism), and completed translational development activities so that we can reproduce these scientific results in a randomized and controlled clinical study in advanced cancer patients."

The joint scientific papers have been published in journals such as Cellular Oncology, Scientific Reports (an online Nature journal) and Expert Opinion on Biological Therapy. One paper, which explores in vivo pharmacokinetic (activity of drugs in an organism over time) studies and the anti-tumour efficacy of PRP against orthotopic (grafted) pancreatic and ovarian cancer tumours, as well as clinical observations from the compassionate use study conducted by Dr Kenyon, achieved over 2,000 reads, thus indicating strong interest among the scientific community.

Further research is in progress with the Company’s joint research partners focusing on the effects of PRP on the tumor microenvironment. Results shows that PRP causes reversal of the malignant tumor phenotype (observable characteristics) towards a normal, or benign state, which was, "most unexpected, very exciting and powerfully conclusive," according to Ms. Belen Toledo MSc, from the laboratory of Professor Macarena Perán PhD, University of Jaén, Spain.

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include kidney, ovarian, breast, brain, prostate, colorectal, lung, liver, uterine and skin cancers.

On July 28, 2022 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported that management will participate virtually in the following investor conferences during August 2022 (Press release, Sapience Therapeutics, JUL 28, 2022, View Source [SID1234617102]):

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2022 BTIG Biotechnology Conference, August 8-9, 2022

Sapience management will participate virtually in one-on-one meetings with investors on August 9.
2022 Wedbush PacGrow Healthcare Conference, August 9-10, 2022

Sapience management will participate virtually in a fireside chat with Robert Driscoll, Research Analyst at Wedbush, on August 10 at 8:35 am ET. Company management will also participate in virtual one-on-one meetings with investors on the same day.

On July 28, 2022 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, reported results for the quarter ended June 30, 2022, and provided a corporate update (Press release, AC Immune, JUL 28, 2022, View Source [SID1234617101]).

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Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: "With world-class collaborators, including three major pharma companies, and cash for operations until Q1 2024, we believe we are well positioned to execute on multiple value-creating milestones. Our experienced team is working to deliver in H2 2022 four further clinical readouts from our precision medicine pipeline, adding to the three already reported.

"We continue to make real progress towards our goal of earlier diagnosis and prevention," Dr. Pfeifer continued, "We recently treated the first prodromal Alzheimer’s disease patient in our innovative adaptive design Phase 1b/2 trial of ACI-24.060, a highly differentiated best-in-class vaccine-candidate that has demonstrated strong immunogenicity against the two most toxic forms of Abeta, pyroGlu-Abeta and oligomeric Abeta. We expect interim data later this year from the Phase 1b, enabling us to advance into Phase 2 in individuals with Down syndrome, virtually all of whom develop Alzheimer’s."

Q2 2022 and Subsequent Highlights

Dosed the first patient in the placebo-controlled, Phase 1b/2 ABATE study evaluating the anti-Abeta vaccine ACI-24.060 in patients with prodromal Alzheimer’s disease (AD) and individuals with Down syndrome (DS). An interim data readout from the Phase 1b portion of the trial in AD is expected in H2 2022.
Announced a peer-reviewed publication in JAMA Neurology1 featuring data showing that ACI-24, the predecessor of ACI-24.060, was safe and elicited an immune response in a Phase 1b clinical trial in adults with DS. This was the first-ever anti-Abeta vaccine study conducted in people living with DS and the paper also highlighted data providing evidence of target engagement in the trial.
Announced topline results from the Phase 2 Alzheimer’s Prevention Initiative (API) study evaluating the anti-Abeta monoclonal antibody crenezumab in autosomal dominant Alzheimer’s disease (ADAD). Results showed that both co-primary endpoints of the study were not statistically significant but numerical differences favoring crenezumab were observed across the majority of primary, secondary and exploratory endpoints. More detailed results will be presented at the Alzheimer’s Association International Conference (AAIC) on August 2, 2022 by AC Immune’s partner Genentech, a member of the Roche group and the Banner Alzheimer’s Institute.
Announced that AC Immune Co-Founder and CEO Dr. Andrea Pfeifer received the prestigious Aenne Burda Award for Creative Leadership in recognition of her work.
Expanded leadership by appointing Howard Donovan as Chief Human Resources Officer and member of 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 (CFO), will leave AC Immune 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 has been appointed Vice President, Finance and interim CFO. Julian Snow has been appointed Vice President, U.S. Finance & Corporate Development.
Achieved and Anticipated 2022 Clinical Milestones

ACI-12589
a-syn-PET tracer Reported breakthrough 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; Expect to disclose late-stage development plans in H2 2022
ACI-24.060
anti-Abeta vaccine Dosed first patient in Phase 1b/2 trial of ACI-24.060 in patients with AD and individuals with DS
Phase 1b in AD readout and decision to move into DS expected in H2 2022
Crenezumab
anti-Abeta antibody Reported top line Phase 2 results from API study in autosomal dominant AD .
Semorinemab
anti-Tau antibody Additional biomarker data from the Phase 2 Lauriet study in mild-to-moderate AD expected in H2 2022
PI-2620
Tau-PET tracer Phase 2 results in AD to be unveiled at AAIC in San Diego, California (United States) and online, July 31 – August 4, 2022.
Clinical PET study readout in orphan indication 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 June 30, 2022

Cash Position: The Company had a total cash balance of CHF 154.1 million, composed of CHF 63.1 million in cash and cash equivalents and CHF 91.0 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 2.0 million for the three months ended June 30, 2022, to CHF 15.7 million.

Discovery and preclinical expenses (- CHF 0.5 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 0.4 million): The Company increased expenditures across multiple clinical programs, predominantly for ACI-24 for DS and ACI-7104.

Other non-allocated (+ CHF 1.2 million): The Company’s other non-allocated R&D expenditure increased by CHF 0.9 million mostly related to the reallocation of certain IT and facilities costs, IT investments, as well as CHF 0.3 million across various other cost centers.

G&A Expenditures: For the three months ended June 30, 2022, G&A decreased by CHF 0.9 million to CHF 4.4 million. This decrease is mostly related to the reallocation of certain IT and facilities expenditures made in Q2 2022 that were not reclassified in the prior period.

Other Operating Income: The Company recognized CHF 0.2 million in grant income for R&D activities performed under our Michael J. Fox Foundation for Parkinson’s Research (MJFF) and Target ALS grants, a decrease 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 19.6 million for the three months ended June 30, 2022, compared with a net loss of CHF 19.1 million for the comparable period in 2021.
References

Rafii MS et al, Safety, Tolerability, and Immunogenicity of the ACI-24 Vaccine in Adults With Down Syndrome, A Phase 1b Randomized Clinical Trial, JAMA Neurology, 2022 May 9:79(5).

On July 28, 2022 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the second-quarter 2022 and updated full-year 2022 financial guidance (Press release, West Pharmaceutical Services, JUL 28, 2022, View Source;utm_medium=Email&utm_campaign=Investors_Email&utm_content=28_July_2022&utm_source=West+Pharmaceutical+Services%2C+Inc.&utm_campaign=f7424fcbb0-EMAIL_CAMPAIGN_2022_03_31_10_50_COPY_01&utm_medium=email&utm_term=0_4b4b77d239-f7424fcbb0-584006100&ct=t(EMAIL_CAMPAIGN_5_12_2022_16_15_COPY_01)#west-announces-second-quarter-2022-results [SID1234617100]).

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

Net sales of $771.3 million grew 6.6%; organic net sales growth was 13.1%.
Reported-diluted EPS of $2.48, compared to $2.47 in the same period last year.
Adjusted-diluted EPS of $2.47, compared to $2.46 in the same period last year.
The Company is updating full-year 2022 net sales guidance to a range of $2.950 billion to $2.975 billion, compared to a prior range of $3.050 billion to $3.075 billion, to reflect changes in foreign currency rates and a decline in expected COVID-19 related net sales.
The Company is updating full-year 2022 adjusted-diluted EPS guidance to a new range of $9.00 to $9.15, compared to a prior range of $9.30 to $9.45.
"We delivered excellent second-quarter results with Proprietary Products organic net sales growth in the high-teens, led by demand for our high-value products (HVPs)," said Eric M. Green, President, Chief Executive Officer and Chair of the Board. "Our base business continues to be strong, reflecting our team’s successful execution of strategic initiatives and dedication to improving patient lives. In the quarter, COVID-19 related net sales slightly declined. While we expect further declines in COVID-19 related demand over the next two quarters, we also anticipate a more robust base business. We remain on track to expand our global HVP manufacturing capacity to support increased demand across our Biologics, Generics and Pharma market units."

Proprietary Products Segment
Net sales grew by 11.3% to $653.7 million. Organic net sales growth was 18.3%, with currency translation decreasing sales growth by 700 basis points. HVP sales represented over 70% of segment sales and generated double-digit organic sales growth, led by customer demand for NovaPure, Envision and Daikyo Crystal Zenith components and for self-injection devices.

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

Contract-Manufactured Products Segment
Net sales declined by 13.6% to $117.8 million. Organic net sales declined by 8.9% with currency translation decreasing sales growth by 470 basis points. Segment sales declined primarily due to a decrease in sales of components for diagnostic devices.

Financial Highlights (first six months of 2022)
Operating cash flow was $324.3 million, an increase of 39.1%. Capital expenditures were $131.9 million, an increase of 18.2% over the same period last year. Free cash flow (operating cash flow minus capital expenditures) was $192.4 million, an increase of 58.4%.

During the first-half 2022, the Company repurchased 476,667 shares for $175.7 million at an average share price of $368.54 under its share repurchase program.

Full-Year 2022 Financial Guidance

Full-year 2022 net sales are expected to be in the range of $2.950 billion to $2.975 billion, compared to a prior guidance range of $3.050 billion to $3.075 billion.
Organic sales growth is expected to be approximately 11%, compared to a prior guidance range of 11% to 12%.
The Company expects a full-year decline in COVID-19 related sales of approximately 20%, or $85 million less than 2021 sales, compared to prior expectation of year-over-year growth. Higher base business sales are expected to partially offset the decline in COVID-19 related sales.
Net sales guidance, based on current foreign currency exchange rates, includes an estimated full-year 2022 headwind of $190 million, compared to prior guidance of a $115 million headwind.
Full-year 2022 adjusted-diluted EPS is expected to be in the range of $9.00 to $9.15, compared to a prior guidance range of $9.30 to $9.45.
The full-year adjusted-diluted EPS guidance range, based on current foreign currency exchange rates, includes an estimated headwind of $0.55, compared to a prior guidance of a $0.38 headwind.
The revised guidance includes a $0.13 EPS positive impact from first-half 2022 tax benefits from stock-based compensation.
For second-half 2022, 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 first-half 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, unchanged from prior guidance. This includes incremental capital spending to support capacity expansions at existing HVP facilities.
Second-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. The live audio-only webcast will be made available via the Company’s Investor Relations website at https://bit.ly/3cgSM9S.

To participate and ask questions during the conference call, you must register in advance at https://bit.ly/3z4iU0g. Upon registration, all telephone participants will receive the dial-in number along with a unique PIN number that will be used to access the call.

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.

A replay of the conference call and webcast will be available on the Company’s website for 30 days.

On July 28, 2022 Celyad Oncology SA (Euronext & Nasdaq: CYAD) (Brussels:CYAD) (Paris:CYAD) (NASDAQ:CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, reported that the Company will report first half 2022 financial and operating results on the morning of Friday, August 5, 2022 (Press release, Celyad, JUL 28, 2022, View Source [SID1234617099]).

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Following the press release, Celyad Oncology management will host a conference call that day Friday, August 5 at 2 p.m. CEST / 8 a.m. EDT to discuss first half 2022 results and provide an update on the Company’s recent progress and upcoming milestones.

Participants may access the conference call by dialing +1 201 493 6779 (International), +: 1 877 407 9716 (United States) or +32 (0) 800 73 904 (Belgium) and ask to be joined into the Celyad Oncology SA call.

To access the live webcast and archived recording, visit the "Events" section of the Celyad Oncology website.