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Prescient Therapeutics (ASX:PTX) logs timely progress across anti-cancer programs in Q3

On October 28, 2021 Prescient Therapeutics (PTX) reported it is poised to reach value-adding milestones across its anti-cancer programs after wrapping up the September quarter with $14.8 million in cash (Press release, Prescient Therapeutics, OCT 28, 2021, View Source;utm_medium=rss&utm_campaign=prescient-therapeutics-asxptx-logs-timely-progress-across-anti-cancer-programs-in-q3 [SID1234592116]).

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Based in Melbourne, Prescient is a clinical-stage oncology company developing personalised medical approaches to cancer, including targeted and cellular therapies.

Finances
The health stock reported quarterly costs, including investments in clinical studies of its PTX-100 and PTX-200 targeted therapies; pre-clinical development of its OmniCAR platform; and the Cell Therapy Enhancement Program.

Net cash outflows for the quarter clocked in at $1.47 million, with around $782,000 invested in research and development across Australia and the United States.

Notably, PTX said it had retained a strong cash position and was headed towards value-creating milestones on the back of timely progress made across its anti-cancer programs.

OmniCAR update
Prescient continued to work on its OmniCAR technology during the September period.

OmniCAR is a universal immune receptor platform that enables controllable T-cell activity and multi-antigen targeting with a single cell product.

PTX said it had received positive in-silico results from immunogenicity testing of the platform’s key binding components, SpyTag and SpyCatcher, which was designed to test the immune response against the therapy and its overall safety profile.

The results reportedly showed low immunogenicity — equal to circulating human antibodies.

The company said the results de-risked the platform ahead of future in-house and external collaborations.

Cell Therapy Enhancement program
Meanwhile, Prescient’s Cell Therapy Enhancement program progressed towards a number of important pre-clinical milestones under the guidance of the research team at Melbourne’s Peter MacCallum Cancer Centre.

While the particulars of this work remain undisclosed for competitive reasons, PTX said the nature and outcomes of the research held significant possibilities for cancer treatments.

Further updates
Notably, Prescient also reported "successful" results from Phase 1b of its PTX-100 basket trial, in which it said the therapy showed an excellent safety profile.

PTX-100 will now progress to an expansion cohort study focused on T cell lymphomas, with potential for a subsequent registration study.

Lastly, the company welcomed brain cancer expert Professor Donald M. O’Rourke to its Scientific Advisory Board.

Despite the update, shares in Prescient Therapeutics were down 1.85 per cent to 26.5 cents each at 2:30 pm AEDT.

PASCAL BIOSCIENCES ANNOUNCES FINANCING

On October 28, 2021 Pascal Biosciences Inc. ("Pascal" or the "Company") (TSXV: PAS) (OTC: PSCBF) (FSE: 6PB-FF) reported the following actions to continue the development of the Company’s PAS-403 and PAS-393 patented molecules for development of cancer therapeutics prior to commencing clinical trials and for general working capital to support this direction (Press release, Pascal Biosciences, OCT 28, 2021, View Source [SID1234592115]).

The Company announces a non-brokered private placement financing of up to 9,000,000 units (each a "Unit") of securities at a price of $0.10 per Unit for aggregate gross proceeds of up to $900,000.00 (the "Offering"). Each Unit will be comprised of one (1) common share and one (1) non-transferable common share purchase warrant, with each whole warrant entitling the holder to purchase one additional common share at a price of $0.15 for two years from the closing date of the private placement. The exercise term of the warrant will be accelerated in the event the closing price of the Shares is above $0.20 for ten consecutive days and will be exercisable for a period of 15 days from the date of receipt by investors of a Notice of Acceleration. Finder’s fees of up to 10% may be paid.

All securities issued will be subject to a four month holding period which will expire on the date that is four months and one day from the date of issue.

Pan Cancer T Extends Seed Financing Round with Additional Funding from Existing Shareholders and New Investor Thuja Capital

On October 28, 2021 Pan Cancer T B.V., a biotech spin-off from the Erasmus MC dedicated to the discovery and development of novel TCR-T therapies against solid tumors, reported the closing of an extended seed investment round (Press release, Pan Cancer T, OCT 28, 2021, https://pancancer-t.com/2021/10/28/pan-cancer-t-extends-seed-financing-round-with-additional-funding-from-existing-shareholders-and-new-investor-thuja-capital/ [SID1234592114]). All current shareholders participated in the round, with Thuja Capital joining as a new investor. The undisclosed proceeds add to the initial seed capital financing announced earlier this year. The Company’s syndicate of experienced life science venture capital investors now includes Van Herk Ventures, Swanbridge Capital, and Thuja Capital as well as founding shareholder Erasmus MC.

Katrien Reynders-Frederix, CEO of Pan Cancer T, said: "Despite certain successes of adoptive cell therapies like the Chimeric Antigen Receptor (CAR) T cell therapy, the vast majority of solid cancers remains refractory to such treatments. TCR-T cell therapy is a novel, promising option that has demonstrated significant clinical benefits in patients with various solid tumors. Thanks to the extended seed round and the continuous support of our investors we will be able to further advance our lead program and strengthen our pre-clinical assets. Next, we will be preparing to raise a Series A financing round to advance our lead program into the clinic."

Michel Briejer, Investment Manager at Thuja Capital added: "Since we identified Pan Cancer T as an investment opportunity, we have been deeply impressed by the quality of the science, the team and its advisers. We are thrilled to join the shareholder base and take a seat on the Supervisory Board to help and support Pan Cancer T towards the success it is bound for."

Dharminder Chahal, Investment Manager at Van Herk and Swanbridge Capital, said: "I am pleased to see that Pan Cancer T made such a progress within only one year after its foundation. I am convinced that the company will continue this high pace of development through this additional investment."

Prof. Chris Bangma, Professor of the Department of Urology at Erasmus University Medical Centre in Rotterdam, stated: "Erasmus MC valorizes the development of novel therapeutic treatment options for its patients. The results of immune therapy in various tumors are beyond expectations. Many patients may benefit from the carefully designed new immunologic approaches and evaluation in the clinic. Hence, Erasmus MC is pleased to support Pan Cancer T on this journey."

OPKO Health Reports 2021 Third Quarter Business Highlights and Financial Results

On October 28, 2021 OPKO Health, Inc. (NASDAQ: OPK) reported that business highlights and financial results for the three months ended September 30, 2021 (Press release, Opko Health, OCT 28, 2021, View Source [SID1234592113]).

Business Highlights

Health Canada approved NGENLA (somatrogon) injection for pediatric growth hormone deficiency. NGENLA is a once-weekly, long-acting recombinant human growth hormone, for the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone (growth hormone deficiency, or GHD). Please click here to view Pfizer Canada’s news release issued earlier today. Global regulatory applications for somatrogon continue to advance with action dates in the U.S., Europe and Japan expected during the first half of 2022.

BioReference Laboratories (BRL) processed approximately 2.2 million COVID-19 PCR tests in the third quarter of 2021. In addition, during the quarter BRL performed approximately 158,100 COVID-19 serology tests to measure SARS-CoV-2 antibody levels and currently has significant additional capacity. In August 2021 Rite Aid, the U.S. Department of Health and Human Services, and BRL announced a "Back to School" COVID-19 testing program offering students at New York State public schools the opportunity for free COVID-19 testing prior to or at the start of the 2021-2022 school year. Students will be tested using highly accurate RT-PCR laboratory-based COVID-19 tests.

BRL acquired the U.S. Ariosa centralized laboratory prenatal testing business from Roche. Ariosa’s noninvasive prenatal screening (NIPS) test, the Harmony Prenatal Test, is one of the most widely studied tests utilized in prenatal screening. This test has been performed in more than 1.5 million patients. The acquisition of Ariosa will complement the current NIPS offering at GenPath, BRL’s specialty health division.

Completed enrollment in Phase 2 trial evaluating RAYALDEE as a treatment for symptomatic COVID-19 outpatients. The U.S. trial, "A Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of RAYALDEE (calcifediol) Extended-release Capsules to Treat Symptomatic Patients Infected with SARS-CoV-2," completed final enrollment with 171 subjects, including some with stage 3 or 4 chronic kidney disease who are at higher risk for developing more severe illness. Topline data are expected later this year.

Formed a joint venture with LeaderMed Group to develop, manufacture and commercialize oxyntomodulin and Factor VIIa-CTP in China and other Asian territories. Under the terms of the agreements, OPKO granted the joint venture exclusive rights to develop, manufacture and commercialize OPK88003, an oxyntomodulin analog being developed for the treatment of obesity and diabetes, and Factor VIIa-CTP, a novel long-acting coagulation factor being developed to treat hemophilia, in exchange for a 47% ownership interest in the joint venture. LeaderMed will be responsible for funding the joint venture’s operations, development and commercialization efforts. OPKO retains full rights to oxyntomodulin and Factor VIIa-CTP in all other geographies.

Executed exclusive worldwide agreement with CAMP4 Therapeutics Corporation (CAMP4) for the development, manufacture and commercialization of therapeutics utilizing the AntagoNAT technology. This technology is an oligonucleotide platform developed under OPKO CURNA. CAMP4 has prioritized OPKO’s lead AntagoNAT compound to progress into clinical trials for the treatment of Dravet syndrome. Under the terms of the agreement, OPKO received an upfront payment and shares of privately held CAMP4. In addition, OPKO will be eligible to receive up to $93.5 million and additional shares upon the achievement of certain development and sales milestones for products developed from this technology and associated intellectual property. CAMP4 will also pay OPKO double-digit royalties on product sales.
Third Quarter Financial Results

Consolidated: Consolidated total revenues for the third quarter of 2021 were $385.8 million compared with $428.1 million for the comparable period of 2020. Operating income for the third quarter of 2021 increased 72% to $37.8 million compared with $21.9 million, for the comparable period of 2020. Net income for the third quarter of 2021 was $28.7 million, or $0.04 per diluted share, compared with $23.7 million, or $0.04 per diluted share, for the comparable period of 2020.

Diagnostics: Revenue from services in the third quarter of 2021 decreased to $340.1 million from $382.5 million in the prior-year period, primarily due to a decrease in COVID-19 testing volume, which was partially offset by an improvement in COVID-19 test reimbursement and an increase in clinical and genomic test revenue. Total costs and expenses were $320.5 million in the third quarter of 2021 compared with $346.4 million in the third quarter of 2020, resulting in operating income of $19.7 million compared with $46.2 million in the 2020 period. The decrease in operating income is primarily due to a decline in COVID-19 test volume and an increased level of investment in our commercial organization for our base business and digital health activities resulting in increased professional fees and personnel expenses. During the third quarter of 2020, BioReference received a $10.0 million non-recurring grant under the CARES Act.

Pharmaceuticals: Revenue from products in the third quarter of 2021 increased almost 29% to $36.9 million compared with $28.7 million in the third quarter of 2020, with the increase primarily attributable to accelerating growth within OPKO’s international pharmaceutical businesses. Total prescriptions for RAYALDEE in the third quarter of 2021 decreased to approximately 11,500 from approximately 16,700 in the third quarter of 2020. Revenue from sales of RAYALDEE in the third quarter of 2021 was $8.5 million compared with $8.1 million in the prior-year period, with the increase reflecting a higher net realized price as a result of lower Medicare Part D rebates. Revenue from the transfer of intellectual property was $8.8 million in the third quarter of 2021 compared with $6.8 million for the 2020 period. The increase reflects the CAMP4 and LeaderMed agreements partially offset by a decrease in revenue related to the Pfizer transaction. Total costs and expenses were $17.0 million in the third quarter of 2021 compared with $49.9 million in the prior-year period, primarily due to a $31.5 million gain on the sale of assets to Horizon Therapeutics plc for OPKO’s sterile-fill-finish manufacturing facility in Ireland. Operating income was $28.6 million in the third quarter of 2021 compared with an operating loss of $14.4 million in the third quarter of 2020.

Cash and equivalents: Cash, cash equivalents and marketable securities were $148.6 million as of September 30, 2021. In addition, the Company has $64.3 million availability under its line of credit with JP Morgan.
CONFERENCE CALL & WEBCAST INFORMATION

OPKO’s senior management will provide a business update, discuss third quarter financial results and answer questions during a conference call and live audio webcast today beginning at 4:30 p.m. Eastern time. Participants are requested to pre-register for the conference call using the link here. Upon pre-registering, participants will receive dial-in numbers, an event passcode and a unique registrant ID to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to and after the start of the call. Alternatively, please dial (888) 869-1189 or (706) 643-5902 and use conference ID 6958207

To access the live call via webcast, please click on the link OPKO 3Q21 Results Conference Call. Individual investors and investment community professionals who do not plan to ask a question during the call’s Q&A session are encouraged to listen to the call via the webcast.

For those unable to listen to the live conference call, a replay can be accessed for a period of time on OPKO’s website at OPKO 3Q21 Results Conference Call. A telephone replay will be available beginning approximately two hours after the completion of the conference call. To access the replay, please dial (855) 859-2056 or (404) 537-3406, and use conference ID 6958207.

Interim Management Statement Q3 2021 of Molecular Partners: Advancement of COVID-19 Clinical Program and Continued Immuno-Oncology Momentum

On October 28, 2021 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported its interim management statement for the quarter ending September 30, 2021 (Press release, Molecular Partners, OCT 28, 2021, View Source [SID1234592112]).

"COVID-19 continues to be a major concern globally, and a main focus of our efforts at Molecular Partners. As new variants emerge and novel therapeutic modalities are being developed to fight the disease alongside vaccines, the need to develop efficacious and robust therapeutics is clearer than ever. Our COVID-19 program has significantly advanced in the last quarter. Having now enrolled over 700 patients across two global late stage studies, we have accomplished much and are approaching two significant milestones. In the coming weeks and months we are preparing for futility assessment in the NIH-sponsored hospitalized study and data from our phase 2b-3 EMPATHY study in outpatients," said Patrick Amstutz, Ph.D., Molecular Partners’ CEO. "In addition, we have maintained momentum across our two immuno-oncology clinical programs, and advanced our preclinical AML program, a truly differentiated CD3 engaging molecule with a unique mechanism of action which is beyond the feasibility of most traditional therapies."

Research & development highlights:

Ensovibep COVID-19 antiviral program: Two global studies ongoing
In October 2021, the Phase 2b portion of the EMPATHY (ambulatory) study reached its target recruitment of 400 patients; Topline data from Phase 2b are expected in early 2022
Also in October 2021, the ACTIV-3 (hospitalized) study reached its initial target recruitment of 300 patients. A futility analysis of the study will be conducted at the next data and safety monitoring board (DSMB) assembly, in the coming weeks. Should ensovibep pass the futility analysis, the study will advance to full enrollment. Topline data are expected in 2022
Assessment of a subcutaneous formulation of ensovibep is ongoing in healthy volunteers and will provide the rationale to initiate patient studies in the coming months
Ensovibep continues to maintain full potency in vitro against all known variants of concern, including Delta variants

AMG 506 / MP0310 (FAP x 4-1BB)
Ongoing Phase 1 trials with weekly dosing
Expecting data late in 2021 or early 2022, for Amgen and Molecular Partners’ evaluation

MP0317 (FAP x CD40):
The second immuno-oncology DARPin candidate is expected to enter the clinic in Q4 2021
Strong preclinical data supports MP0317’s potential to deliver tumor-localized immune activation while avoiding systemic toxicity seen with other CD40-targeting agents

MP0533 (CD33 x CD70 x CD123 x CD3)
Molecular Partners’ lead AML targeting candidate selected, formally termed MP0533
Preclinical data to be presented at the ASH (Free ASH Whitepaper) conference, December 2021
Expected to enter clinical trials in 2022

Abicipar:
Molecular Partners regained global rights to abicipar, the Company’s registrational-stage ophthalmology therapeutic candidate for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME)
Molecular Partners is evaluating the program and will determine the appropriate next steps
Operational and financial highlights:

Strong financial position with CHF 154.3 million in cash (incl. short term deposits) as of September 30, 2021
Operating loss of CHF 47.6 million and net loss of CHF 45.9 million for the 9 months ended September 30, 2021
Company funded into H2 2023, excluding any potential payments from R&D partnerships
The Q3 2021 Financial Statements are available on the company’s website
COVID-19 program rapidly advancing in two global registrational trials with Novartis and the NIH

Molecular Partners’ lead infectious disease therapeutic candidate, ensovibep, is currently being evaluated in EMPATHY, a global Phase 2b-3 study designed to explore the use of ensovibep for the treatment of COVID-19 in patients who are in the early stages of infection to prevent worsening symptoms and hospitalization. Molecular Partners’ collaboration partner, Novartis, is conducting the clinical trial for ensovibep, with Molecular Partners as a sponsor. The phase 2b portion of EMPATHY enrolled patients across six countries. Topline data for the first 400 patients are expected in early 2022, allowing for potential EUA submission and full data in 2022.

Ensovibep is additionally being evaluated in ACTIV-3 for the treatment of hospitalized COVID-19 patients as part of the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program, which is evaluating multiple therapies for COVID-19 in hospital setting. The Phase 3 study is presently enrolling hospitalized patients globally. The study has surpassed the target enrollment of approximately 300 patients required for the pre-planned interim futility analysis.The futility analysis will be conducted in November 2021 by the Data and Safety Monitoring Board (DSMB) to determine if enrollment in the ensovibep arm of ACTIV-3 may continue to its full enrollment. Topline data are expected in 2022.

In addition to its clinical development, ensovibep continues to be regularly tested in the laboratory for its inhibition of infectivity in newly discovered variants of the virus. As presented at the ISIRV-WHO conference in October 2021, all in vitro data to-date show that ensovibep retains full potency and viral inhibition against all known SARS-CoV-2 variants of concern, including the key Delta variants.

Immuno-oncology: Phase 1 trial of MP0317 (FAP x CD40); ongoing studies of AMG 506 (MP0310); Progress in AML program

MP0317 trial enrollment is expected to take place in the Netherlands and France. Up to 30 patients are expected to be enrolled across six dosing cohorts and up to 15 patients are then expected to be enrolled in a dose expansion cohort. In addition to evaluating monotherapy dynamics, the study will gather a wide variety of biomarker data to support the establishment of combination therapies with MP0317 in specific indications.

Clinical studies of AMG 506 (MP0310) as a treatment for solid tumors are ongoing in collaboration with Amgen with weekly administration to identify a dosing regimen to obtain sustained 4-1BB activation.

MP0533, Molecular Partners’ novel AML candidate, is a DARPin designed to engage CD3 on T cells and target AML cells by the tumor associated antigens CD33, CD70 and CD123, with an addition for half-life extension. The candidate binds to cells by an avidity dependent mechanism, preferentially targeting AML cells, which express two or more of these antigens. These malignant cells are then marked for termination by CD3 T-cell activation. Additional data from MP0533 will be presented at the Company’s R&D day in December 2021 and presenters will include leading AML researchers from the University of Bern. Preclinical data from the new candidate will be presented at the ASH (Free ASH Whitepaper) conference in December 2021, with clinical development expected to be initiated in 2022.

Balance sheet: Strong cash and equity positions as of September 2021

In June 2021, Molecular Partners successfully completed an initial public offering of American Depositary Shares ("ADSs") on the Nasdaq, raising $63.8 million (CHF 58.8 million) in gross proceeds.
Ongoing strong financial position with CHF 154.3 million in cash and short-term deposits as of September 30, 2021
Net cash outflow from operating activities of CHF 71.6 million in the first nine months of 2021
Financial outlook 2021

For the full year 2021, at constant exchange rates, the Company expects total expenses of CHF 70 – 75 million, of which approximately CHF 7 million will be non-cash effective costs.

In terms of cash outflow, the Company expects a gross cash utilization of approximately CHF 90 million for the full year 2021, which includes a total of CHF 20 million payable to Novartis for the manufacturing of commercial supply (of which CHF 14.5 million occurred in the first nine months of 2021). This cash flow guidance does not include any potential receipts from R&D partnerships.

With CHF 154.3 million cash and short-term time deposits and no debt as of September 30, 2021, the Company expects to be funded into H2 2023, excluding any potential receipts from R&D partners.

Financial Calendar

December 15, 2021 R&D Day
March 15, 2022 Expected Publication of FY 2021 Annual report and audited 2021 results
April 13, 2022 Annual General Meeting
About DARPin therapeutics

DARPin therapeutics are a new class of custom-built protein therapeutics based on natural binding proteins that open a new dimension of multi-functionality and multi-target specificity in drug design. A single DARPin candidate can engage more than five targets, and its flexible architecture and small size offer benefits over conventional monoclonal antibodies or other currently available protein therapeutics. DARPin therapeutics have been clinically validated through to registration via the development of abicipar, Molecular Partners’ most advanced DARPin drug candidate. The DARPin platform is a fast and cost-effective drug discovery engine, producing drug candidates with optimized properties for development and very high production yields.