On March 16, 2022 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (NASDAQ: IPA) (TSX VENTURE: IPA), a leader in full-service therapeutic antibody discovery and development, reported financial results for third quarter fiscal year 2022, which ended January 31, 2022 (Press release, ImmunoPrecise Antibodies, MAR 16, 2022, View Source [SID1234610170]).

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Third Quarter Fiscal Year 2022 Financial Summary*
(All comparisons are to the period ended January 31, 2022)

• The Company achieved Project revenue of $4.1 million, an increase of $0.7 million or 22.6% as compared to Project revenue of $3.3 million from the same year ago period.
• The Company’s total revenue of $4.8 million was an increase of $0.3 million or 6.6% as compared to total revenue of $4.5 million from the same year ago period.
• The Company, primarily through its subsidiary Talem Therapeutics LLC, invested $1.8 million in strategic research and development costs as compared to an investment of nil in the same year ago-period.
• The Company recorded a net loss of $3.8 million, as compared to net loss of $1.3 million as compared to the same year-ago period.
• As of January 31, 2022, the Company held cash of $33.0 million.

*Expressed in Canadian dollars, unless otherwise indicated.

Dr. Jennifer Bath, CEO of ImmunoPrecise, stated, "We are pleased with both the progress and continued execution of IPA’s strategic operating plan this quarter. In filling key roles within the organization’s sales and marketing teams, we believe we have provided the critical infrastructure to ramp growth of the commercial business. Consequently, project revenues in the CRO business increased a healthy 22.6% in the period, and we remain optimistic in our ability to grow revenues organically through existing clients and through new business wins alike. Additionally, we are moving the development of Polytope (TATX-03), Talem’s lead pipeline asset, forward on multiple fronts both in-house and through external partnering."

"TATX-03, currently in pre-IND phase — is tracking well against development timelines. As such, we expect to submit an investigational new drug application (IND) with the FDA by the third quarter of the calendar year. A highlight of this development program has been the absence of any significant regulatory hurdles to date, as we believe IPA’s conservative development and working in lockstep with the FDA inquiry process has paid off. This is against the backdrop of a rapidly evolving regulatory framework required to address the shifting future landscape around the fight against COVID-19. In tandem to the Company’s independent development efforts, we have also recently announced a partnering agreement with Elektrofi, to participate in a U.S. Defense Health Agency (DHA) funded program that will leverage funds from Elektrofi’s contract with the DHA Small Business Innovation Research program with the U.S. Department of Defense (DoD)," concluded Dr. Bath.

Recent Third Quarter Fiscal 2022 Operational Highlights

• IPA was selected to work with Elektrofi on COVID-19 therapeutic delivery and future pandemic preparation under SBIR contract from Defense Health Agency (DHA) within the US Department of Defense
• Polytope TATX-03 aggregate program update:

o No pharmacokinetic aberrations in in vivo animal model study.
o Injection with TATX-03 is well tolerated – with a significant safety margin and no clinical signs of toxicity.
o Maximum tolerated dose study evaluating up to a 12.5-fold higher amount than the highest dose anticipated for use in humans did not uncover any observable clinical signs of toxicity.
o SARS-CoV-2 PolyTope antibody cocktail retains in vitro binding efficacy against viral variants-of-concern tested to date.
o Initiated assessment of retention of binding to cell-associated Omicron spike protein variant (B.1.1.529).
o Improved protein homogeneity in PolyTope antibody cocktail for production purposes.
o Demonstrated in vitro pseudovirus assays, PolyTope advanced immunotherapeutic TATX-03 prevents infection of cells by SARS-CoV-2 variant-of-concern, Omicron, and all variants of concern tested to date.
o Established manufacturing collaboration with ChemPartner Biologics for PolyTope TATX-03 Antibody Cocktail.

• Talem Therapeutic filed a non-provisional U.S. patent application and concurrent international PCT (Patent Cooperation Treaty) and other national patent applications relating to the discovery of PolyTope TATX-03, its in vitro and in vivo effects, and therapeutic use.
• Leased future new space for laboratory expansion at IPA Europe in a new multi-tenant biotech Center of Excellence at the Pivot Park Campus in Oss, Netherlands.

Financial Results

Revenue
Project revenue of $4.1 million was $0.7 million, or 22.6%, higher than the same period last year. Growth is driven primarily by the Company’s B cell Select platform, with expansion in both the number and size of projects under contract leading to revenue increases.

The Company achieved revenue of $4.8 million during the three months ended January 31, 2022, a 6.6% increase from the three months ended January 31, 2021.

Product sales during the three months ended January 31, 2022, totaled $0.5 million, a decrease of $0.7 million, or 60.9%, compared to the same period last year. The higher product sales during the three months ended January 31, 2021, relates to the Company’s sale of its first internally generated therapeutic antibody asset. The Company achieved an increase in catalog sales of $0.4 million during the three months ended January 31, 2022, as compared to the same period last year. Catalog products include antibodies, enzymes, enzyme activity assays, arthritis animal products, proteins, deiminated proteins, organoid growth factors and hybridoma licensing for research purposes.

Research & Development
Research and development increased to $1.8 million from nil in 2021, due to the strategic investment in research the Company is undertaking, including the Company’s SARS-CoV-2 PolyTope cocktail and other research projects.

Net Loss
The Company recorded a net loss of $3.8 million during the three months ended January 31, 2022, compared to a net loss of $1.3 million for the three months ended January 31, 2021. The $2.5 million increased net loss is primarily due to the Company’s investment in R&D and salaries and benefits to support the Company’s strategic plans and operations.

Financing Activities / Liquidity and Capital Resources
As of January 31, 2022, the Company held cash of $33.0 million (April 30, 2021 – $41.8 million) and had working capital of $33.4 million (April 30, 2021 – $42.8 million).

On October 13, 2021, an at-the-market ("ATM") equity offering facility, was entered into with H.C. Wainwright & Co., LLC, as sole sales agent ("Agent"). The Company will be entitled, at its discretion and from time-to-time during the term of the ATM agreement, to sell through the Agent common shares of the Company having an aggregate gross sales price of up to US $50 million. As of March 15, 2022, US $50 million of the Company’s stock remained available for sale under the ATM facility.

The conference call will be webcast live and available for replay via a link provided in the Investors section of the company’s website at View Source

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Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Toronto Stock Exchange and Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On March 16, 2022 Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT), a company focused on the discovery and development of next-generation synthetically lethal therapies for cancer, reported financial results for the fourth quarter and full year ended December 31, 2021 and provided an update on recent operational highlights (Press release, Cyteir Therapeutics, MAR 16, 2022, View Source [SID1234610169]).

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"In 2021, we made significant progress towards our goal of advancing our lead program CYT-0851 in the clinic with the completion of a dose escalation study and identification of the recommended Phase 2 dose. Our interim analysis demonstrated anti-tumor effects with disease control and responses in heavily pretreated and progressing lymphoma and solid tumor patients, with a safety profile consisting primarily of mild adverse events," said Markus Renschler, MD, President and Chief Executive Officer of Cyteir. "We are now dosing patients in the Phase 2 monotherapy expansion cohorts and have begun Phase 1 combination therapy cohorts. We expect interim safety and efficacy data read-outs from these cohorts this year that may allow us to design one or more potentially registrational trials. We continue to invest in our pipeline and are advancing two new targets from our synthetic lethality DNA damage response platform toward the clinic."

Fourth Quarter and Full Year 2021 Accomplishments

Advanced CYT-0851 Clinical Program

Cyteir completed the dose-escalation portion of the first-in-human Phase 1/2 trial of CYT-0851 up to the maximum feasible daily dose of 1200 mg and determined the maximum tolerated dose of 600 mg per day. The recommended Phase 2 dose was identified as 400 mg per day. An interim analysis of the Phase 1 portion was presented in an oral session at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting. In a heavily pretreated and progressing patient group typical of Phase 1 studies, we demonstrated disease control in 20 of 46 response evaluable patients, including three responses in non-Hodgkin lymphoma and soft tissue sarcoma. No patient at or below the recommended Phase 2 dose discontinued treatment for treatment-related adverse events. The three most common treatment-related adverse events were fatigue (21% of patients), hyperuricemia (11%), and nausea (11%). There was no clinically significant myelosuppression.
We began enrolling patients in six disease-specific Phase 2 expansion cohorts with monotherapy in hematologic malignancies and solid tumors. In January 2022, the first patient was dosed. Completion of stage 1 of this study is expected before the end of 2022.
Simultaneously, we initiated a Phase 1 combination study of CYT-0851 with three standard-of-care regimens: rituximab plus bendamustine, gemcitabine and capecitabine, in both hematologic malignancies and solid tumors. In January 2022, we dosed the first patient in the study, and we are currently enrolling additional patients. Initial safety data from this combination study is expected before the end of 2022.
In total for our CYT-0851 Phase 1/2 trial, we are now actively enrolling nine patient cohorts in both monotherapy and combination therapy with interim safety results expected in 2022.
Advanced DNA Damage Response (DDR) Platform

In 2021, we initiated two additional drug discovery projects focused on identifying inhibitors of DNA damage repair. The first of these undisclosed targets (Target 2) plays a key role in Non-Homologous End Joining (NHEJ) and the second (Target 3) in Microhomology-Mediated End Joining (MMEJ) DNA repair pathways. For both targeted drug discovery projects, we have identified subsets of cancers that, we believe, uniquely depend on the target of interest for their survival and we are working to identify patient selection biomarkers to identify these cancer subsets for use in drug candidate development. Both undisclosed target projects are currently in lead generation, and we anticipate reaching the drug candidate nomination stage in 2023.
We expect to complete IND-enabling studies for CYT-1853 in the first half of 2022 and if the data supports an overall risk-benefit improvement and differentiation from CYT-0851, we plan to file an IND application with the FDA before the end of 2022.
Efficient execution of research and clinical strategy with cash runway into 2024

Ended 2021 with approximately $190 million in cash and cash equivalents with cash runway expected to extend into 2024
Continued investment in our clinical and preclinical portfolio
Progress achieved in key clinical milestones, including advancing CYT-0851 monotherapy to Phase 2 and initiating Phase 1 combination therapy study
Continuing to build management and research teams while maintaining low employee turnover
2022 Key Milestones Completed

Dose first patient in the Phase 1 CYT-0851 combination therapy cohorts
Dose first patient in the Phase 2 CYT-0851 monotherapy expansion cohorts
2022 Expected Key Milestones Completed

Present data from Phase 1 CYT-0851 monotherapy dose escalation study
Announce top line safety data from Phase 1 CYT-0851 combination therapy study
Announce top line interim results from stage 1 of CYT-0851 Phase 2 monotherapy study
Design potential registrational trial for one or more indications with CYT-0851
File IND for CYT-1853
Continue to elucidate CYT-0851’s molecular target and mechanism of action
Lead optimization of NHEJ inhibitor leading to potential target nomination in 2023
Lead optimization of MMEJ inhibitor leading to potential target nomination in 2023
Fourth Quarter and Full Year 2021 Financial Results

Cash and cash equivalents: Cash and cash equivalents as of December 31, 2021 were $189.7 million, which are expected to fund planned operations into 2024.

Research and development (R&D) expenses: R&D expenses were $8.3 million for the fourth quarter of 2021 versus $3.9 million for the same period in 2020 and $31.0 million for the full year 2021 versus $16.8 million for full year 2020. The year-over-year increase in R&D spending in the comparative periods was due primarily to increased research activity, clinical trial expenses and headcount, including initiation of Phase 1 and Phase 2 studies for our product CYT-0851.

General and administrative (G&A) expenses: G&A expenses were $3.6 million for the fourth quarter of 2021 compared to $1.5 million for the same period in 2020 and $11.3 million for the full year 2021 compared to $4.2 million for full year 2020. The year-over-year increase in G&A expenses in the comparative periods was primarily due to employee-related costs, as well as other administrative expenses associated with company growth and operating as a public company.

Net loss: Net loss was $11.8 million, or $0.34 per share, in the fourth quarter of 2021 compared to $5.4 million, or $2.92 per share, for the same period in 2020. For the full year 2021, net loss was $42.1 million, or $2.16 per share compared to $20.8 million, or $13.60 per share for full year 2020.

Fourth Quarter and Full year 2021 Conference Call and Webcast Information

Cyteir will host a conference call to discuss the fourth quarter and full year of 2021 financial and operational results on Wednesday, March 16, 2022, at 4:30 p.m. ET. The conference call will be available by webcast on the Investor Relations page at www.cyteir.com. An audio replay of the call will be available on the website after 9:00 p.m. ET the same day.

On March 16, 2022 Clovis Oncology, Inc. (NASDAQ: CLVS) reported the initiation of a development, manufacturing, and services agreement with Evergreen Theragnostics to develop actinium-225-labeled-FAP-2286 (225Ac-FAP-2286) (Press release, Clovis Oncology, MAR 16, 2022, View Source [SID1234610168]). Under the agreement, Clovis and Evergreen intend to develop radiolabeling chemistry and analytical methods for use in potential future pre-clinical and clinical studies.

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"This agreement with Evergreen Theragnostics represents an important step forward for Clovis in our efforts to optimize our clinical development program for FAP-2286," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We are enthusiastic about exploring the potential of FAP-2286 labeled with actinium-225 in our targeted radiopharmaceuticals program. Actinium-225 represents an emerging radionuclide that is generating significant interest for its potential for therapeutic use."

Actinium-225 (225Ac) is an alpha particle-emitting radionuclide uniquely suited to targeted radiotherapeutic applications based on its half-life of approximately 10 days, balancing the ability to deliver a meaningful dose of radiation to target tumors while allowing central manufacturing and distribution of 225Ac-FAP-2286. The high-energy radioactive decay emitted from tumor-targeted 225Ac delivery causes double-stranded DNA damage and cell death, however, given the limited distance traveled by alpha particles, damage is minimized to cells in the tumor mass and systemic toxicity is potentially limited. i,ii

Under the terms of the agreement, Evergreen will develop 225Ac-FAP-2286 at its facility in Springfield, N.J. The facility was purpose-built to develop and manufacture a variety of therapeutic radiopharmaceuticals, including those based on alpha-emitting isotopes such as 225Ac, from early development to commercial scale manufacturing.

"We are excited to support Clovis and its targeted radionuclide development program with the development of an actinium-225-labeled FAP-2286. Actinium-based radiotherapies offer the potential to play an important role in the fight against cancer," said James Cook, CEO of Evergreen Theragnostics. "We seek to provide a robust and efficient radiopharmaceutical manufacture, testing, and supply process for our partners from early-stage development through commercialization."

FAP-2286 is the first peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP) to enter clinical development. In the Phase 1/2 LuMIERE study (NCT04939610), the investigational therapeutic agent is linked to lutetium-177 labeled FAP-2286 (177Lu-FAP-2286). Lutetium-177 (177Lu) is a beta-particle-emitting radionuclide with established supply and distribution networks ideally suited for clinical development of a PTRT. FAP-2286 labeled with gallium-68 (68Ga-FAP-2286) is being used as an investigational imaging agent to identify patients with FAP-positive tumors appropriate for treatment with the therapeutic agent. FAP-2286 is the lead candidate in Clovis Oncology’s targeted radionuclide therapy (TRT) development program.

For more information about FAP-2286, targeted radionuclide therapy, or Clovis’ TRT development program, please visit targetedradiotherapy.com.

About FAP-2286

FAP-2286 is a clinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use. High FAP expression has been shown in pancreatic ductal adenocarcinoma, cancer of unknown primary, salivary gland, mesothelioma, colon, bladder, sarcoma, squamous non–small cell lung, and squamous head and neck cancers. High FAP expression was detected in both primary and metastatic tumor samples and was independent of tumor stage or grade. Clovis holds US and global rights for FAP-2286 excluding Europe, Russia, Turkey, and Israel.

FAP-2286 is an unlicensed medical product.

About Targeted Radionuclide Therapy

Targeted radionuclide therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing delivery of radiation to normal tissue. Targeted radionuclides are created by linking radioactive isotopes, also known as radionuclides, to targeting molecules (e.g., peptides, antibodies, small molecules) that can bind specifically to tumor cells or other cells in the tumor environment. Based on the radioactive isotope selected, the resulting agent can be used to image and/or treat certain types of cancer. Agents that can be adapted for both therapeutic and imaging use are known as "theranostics." Clovis, together with licensing partner 3B Pharmaceuticals, is developing a pipeline of novel, targeted radiotherapies for cancer treatment and imaging, including its lead candidate, FAP-2286, an investigational peptide-targeted radionuclide therapeutic (PTRT) and imaging agent, as well as three additional discovery-stage compounds.

On March 16, 2022 Catalent, the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, reported the completion of a $30 million (€27 million) project at its facility in Limoges, France, to transform the site into a European center of excellence for biopharmaceutical development, drug product fill/finish services, and packaging (Press release, Catalent, MAR 16, 2022, https://www.catalent.com/catalent-news/catalent-biologics-completes-30-million-project-for-biopharmaceutical-development-and-drug-product-manufacturing-in-limoges-france/ [SID1234610167]). The site will further expand Catalent Biologics’ global network, with early phase integrated clinical development through to clinical supply services and small-scale commercial manufacturing, allowing seamless tech transfer of projects as they progress to late-stage and larger-scale commercial supply from other Catalent manufacturing facilities in Europe and North America.

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The project has seen a complete modernization of the Limoges site, to handle large molecule programs, with additional capacity for small molecule injectable dosage form development. A new small-to-mid-scale flexible filling line has been installed, capable of handling vials, syringes or cartridges under barrier isolator technology, and enhancements have been made to analytical and quality control laboratories, supporting clinical packaging, cold storage, and regulatory capabilities. It is envisaged that the expansion will create up to 80 additional jobs at the site.

"This investment has transformed the Limoges site into a world-class facility to support the development of early phase and small-scale commercial biologic drugs, and offers customers integrated services to accelerate programs towards and through the clinic, and ultimately to market. Even prior to completion, multiple clinical and commercial customers have already signed contracts for programs to be undertaken at the site," commented Mike Riley, Catalent’s President, Biotherapeutics. "Limoges will now work closely with other Catalent facilities in Europe and the U.S. to provide globally integrated solutions for a range of therapies."

With over 40 years of experience and expertise in supplying life-saving injectable medicines, Catalent Biologics’ approximately 56,000 square-foot (5,200 square-meter) Limoges site currently employs over 170 staff.

On March 16, 2022 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported that it will announce its financial results for the full year and fourth quarter 2021 on Wednesday, March 30th, 2022 (Press release, BioNTech, MAR 16, 2022, View Source [SID1234610166]). BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the fourth quarter and full year 2021.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The slide presentation and audio of the webcast will be available via this link.

To participate in the conference call, please dial the following numbers ten minutes prior to the start and provide the Conference ID:

Participants may also access the slides and the webcast of the conference call via the "Events & Presentations" page of the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.