On March 16, 2022 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported financial results and business highlights for the fourth quarter and year ended December 31, 2021 (Press release, Sana Biotechnology, MAR 16, 2022, View Source [SID1234610174]).

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"We are pleased with the progress we are making in our pipeline and in building capabilities to execute our vision of exploiting the potential of engineered cells to treat a number of diseases that don’t have effective treatments today," said Steve Harr, Sana’s President and Chief Executive Officer. "In 2021, we meaningfully strengthened our balance sheet, advanced our pipeline giving us the potential for two investigational new drug applications (INDs) in 2022 and multiple INDs per year going forward, built out our supply chain, including commercial access to gene-editing reagents and pluripotent stem cells, and commenced the build-out of our own manufacturing facility. Most importantly, we successfully attracted talent in key business areas, which, combined with the people already inside of the company, give us the capabilities, insights, focus, and dedication to reach our mission for patients."

Recent Corporate Highlights

Demonstrating forward progress in moving toward clinical trials for Sana’s multiple platforms including Sana’s ex vivo hypoimmune allogeneic CAR T, in vivo fusogen CAR T, and stem cell-derived programs:

Continued progress in building Sana’s hypoimmune ex vivo platform
Presented data in non-human primates showing survival and immune evasion, without immune suppression, of transplanted stem cells with Sana’s hypoimmune gene modifications.
Entered into a non-exclusive license and development agreement with FUJIFILM Cellular Dynamics, Inc. (FCDI) for access to FCDI induced pluripotent stem cells (iPSCs).
Gained access to gene editing capability to enable programs within Sana’s allogeneic CAR T and pluripotent stem cell portfolio through non-exclusive license for commercial rights to Beam Therapeutics Inc.’s (Beam) CRISPR Cas12b.
Progressed Sana’s hypoimmune allogeneic CD19-targeted CAR T program, SC291; IND expected as early as this year
Continue to progress on key steps required to advance to clinical trials, including contract manufacturing agreement for Phase I clinical supply, gene-editing reagent access through Beam license, Good Laboratory Practices (GLP) toxicology studies, and Good Manufacturing Practices (GMP) manufacturing processes and scale-up.
Presented data showing that hypoimmune CAR T cells evade both innate and adaptive immune systems in murine models, even in animals with pre-existing immunity to CAR T cells.
Presented data showing that CD19-targeted hypoimmune CAR T cells effectively kill tumor cells in mice and functionally evade the innate and adaptive immune system in allogeneic mouse recipients with either a murine or humanized immune system.
Progressed Sana’s in vivo CAR T program, SG295, utilizing a CD8-targeted fusosome to deliver a CD19-targeted CAR; IND expected as early as this year
Continue to progress on key steps to advance to clinical trials, including contract manufacturing agreement for Phase I clinical supply, GLP toxicology studies, and GMP manufacturing processes and scale-up.
Presented data highlighting ability of a single intravenous administration of a CD8-targeted fusosome containing a CD20-targeted CAR to deplete CD20+ B cells in NHPs.
Presented data highlighting ability of a single intravenous administration of SG295 to eliminate CD19+ tumor cells in mouse tumor models.
Expanded Sana’s CAR T capability to potentially develop best-in-class, broadly accessible CAR T cell therapies
Entered into an exclusive agreement with the National Institutes of Health (NIH) for worldwide commercial rights to the NIH’s CD22 chimeric antigen receptor with a fully-human binder. This CAR construct has shown efficacy in several clinical studies, including in CD19 CAR T cell therapy failures. Targeting both CD19 and CD22 with an "off-the-shelf" product, whether in combination with Sana’s hypoimmune platform or fusogen platform, offers the potential of higher and more durable complete response rates in earlier-stage patients as well as in patients that have previously failed an autologous CD19 CAR T cell therapy.
Entered into a non-exclusive agreement with IASO Biotherapeutics and Innovent Biologics for commercial rights to a clinically validated fully-human B cell maturation antigen (BCMA) CAR construct, which Sana intends to incorporate into both the company’s ex vivo hypoimmune allogeneic and in vivo fusogen platforms for the treatment of multiple myeloma.
Progressed Sana’s stem cell-derived pancreatic beta cell program, SC451, with potential to treat type 1 diabetes
Presented pre-clinical murine data demonstrating the ability to make stem cell-derived hypoimmune pancreatic islet cells with robust function and hypoimmune pancreatic islet cells that evade immune detection and have the ability to regulate glucose levels.
Established necessary agreements to establish GMP grade cell lines, including FCDI and Beam licenses, and secured contract manufacturing partner for cell bank production.
Remain on track for an IND as early as 2023.
Progressed Sana’s stem cell-derived cardiomyocyte program with the goal of treating heart failure
Presented data that demonstrated four edits in ion channels that alter the electrical properties of pluripotent stem cell-derived cardiomyocytes such that they eliminate engraftment arrythmias in a pig transplant model. These results demonstrate important progress in addressing a key risk associated with transplanting cardiomyocytes into the heart.
Strengthened balance sheet and Board leadership; signed lease to add internal manufacturing capability

Strengthened balance sheet with net proceeds of $626.6 million from the sale of 27 million shares of common stock in the company’s initial public offering.
Expanded Board of Directors with the addition of Joshua Bilenker, M.D., CEO of Treeline Biosciences, Alise Reicin, M.D., CEO of Tectonic Therapeutic, and Michelle Seitz, CFA, Chairman and CEO of Russell Investments.
Announced a lease agreement to develop a manufacturing facility in Fremont, California to support the manufacture of late-stage clinical development and early commercial product candidates across the multiple technologies in the pipeline.
Fourth Quarter 2021 Financial Results

GAAP Results

Cash Position: Cash, cash equivalents, and marketable securities as of December 31, 2021 were $746.9 million compared to $412.0 million as of December 31, 2020, an increase of $334.9 million. The increase was primarily driven by net proceeds of $626.4 million received in Sana’s initial public offering in February 2021, partially offset by cash used in operations of $201.1 million, a one-time upfront cash payment to Beam of $50.0 million to license its genome editing technology, and cash used for the purchase of property and equipment of $29.9 million.

Research and Development Expenses: For the three and twelve months ended December 31, 2021, research and development expenses, inclusive of non-cash expenses, was $108.5 million and $248.6 million, respectively, compared to $36.5 million and $132.9 million, respectively, for the same periods in 2020. The increases of $72.0 million and $115.7 million, respectively, for the three and twelve months ended December 31, 2021 were due to the one-time upfront payment to Beam to license its genome editing technology, an increase in personnel expenses related to increased headcount to expand Sana’s research and development capabilities, costs for laboratory supplies, costs for preclinical studies and external manufacturing, and facility costs. Research and development expenses include non-cash stock-based compensation of $5.3 million and $15.2 million, respectively, for the three and twelve months ended December 31, 2021 and $2.3 million and $4.9 million, respectively, for the same periods in 2020.

Research and Development Related Success Payments and Contingent Consideration: For the three months ended December 31, 2021, we recognized a non-cash gain of $9.9 million, and for the twelve months ended December 31, 2021, we recognized non-cash expense of $57.9 million, in connection with the change in the estimated fair value of the success payment liabilities and contingent consideration in aggregate, compared to expenses of $67.6 million and $124.9 million, respectively, for the same periods in 2020.

General and Administrative Expenses: General and administrative expenses for the three and twelve months ended December 31, 2021, inclusive of non-cash expenses, were $12.7 million and $50.4 million, respectively, compared to $9.2 million and $28.3 million, respectively, for the same periods in 2020. The increases of $3.5 million and $22.1 million, respectively, in the three and twelve months ended December 31, 2021 were primarily due to increased personnel-related expenses attributable to an increase in headcount to build our infrastructure and support our continued research and development activities, legal fees to support our patent portfolio and license arrangements, insurance associated with being a public company, consulting fees, and facility costs. General and administrative expenses include stock-based compensation of $2.0 million and $7.1 million, respectively, for the three and twelve months ended December 31, 2021 and $0.4 million and $0.9 million, respectively, for the same periods in 2020.

Net Loss: Net loss for the three and twelve months ended December 31, 2021 were $110.7 million, or $0.60 per share, and $355.9 million, or $2.14 per share, respectively, compared to $113.2 million, or $7.40 per share, and $285.3 million, or $21.92 per share, respectively, for the same periods in 2020.
Non-GAAP Measures

Non-GAAP Operating Cash Burn: Non-GAAP operating cash burn for the twelve months ended December 31, 2021 was $209.6 million compared to $125.0 million for the same period in 2020. Non-GAAP operating cash burn is the decrease in cash, cash equivalents, and marketable securities, excluding cash inflows from financing activities, cash outflows from business development activities, and the purchase of property and equipment.

Non-GAAP Research and Development Expenses: Non-GAAP research and development expenses for the three and twelve months ended December 31, 2021 were $108.5 million and $248.6 million, respectively, compared to $36.5 million and $123.0 million, respectively, for the same periods in 2020. Non-GAAP research and development expenses excludes certain one-time costs to acquire technology.

Non-GAAP Net Loss: Non-GAAP net loss for the three and twelve months ended December 31, 2021 was $120.6 million, or $0.65 per share, and $298.1 million, or $1.79 per share, respectively, compared to $45.5 million, or $2.98 per share, and $150.4 million, or $11.56 per share, respectively, for the same periods in 2020. Non-GAAP net loss excludes certain one-time costs to acquire technology and non-cash expenses related to the change in the estimated fair value of contingent consideration and success payment liabilities.
A discussion of non-GAAP measures, including a reconciliation of GAAP and non-GAAP measures, is presented below under "Non-GAAP Financial Measures."

On March 16, 2022 Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, reported its financial results for the fiscal year ended December 31, 2021 (Press release, Prelude Therapeutics, MAR 16, 2022, View Source [SID1234610173]).

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"With Prelude’s core competencies in cancer biology and medicinal chemistry, in approximately five years we have successfully created a highly differentiated diverse pipeline that includes five distinct targets and six proprietary small molecule compounds, each with best-in-class potential aimed at addressing clinically validated pathways for cancers with selectable underserved patients," stated Kris Vaddi, Ph.D., Chief Executive Officer of Prelude. "Given the clinical progress we made in 2021, we have made important strategic portfolio prioritization and resource allocation decisions focusing on select molecules and indications where we see the greatest need and most efficient path to establishing proof-of-concept. This includes selecting PRT811 as the lead candidate in our PRMT5 program and prioritizing development of the intravenous formulation of our MCL1 candidate, PRT1419, and rapidly selecting a Phase 2 dose for PRT2527, our CKD9 inhibitor, in selected patients with cancers dependent on CKD9."

"Our discovery team continued to exceed expectations by bringing two new candidates into our pipeline, a differentiated SMARCA2/BRM protein degrader and most recently, PRT3645, a differentiated, selective and highly brain penetrant CDK4/6 inhibitor. We remain on track to file Investigational New Drug applications for each of these molecules in 2022."

Dr. Vaddi added, "Dr. Jane Huang’s appointment as President and Chief Medical Officer strengthens our leadership team. Dr. Huang’s extensive experience in oncology drug development, strong associations within the oncology community and success in building high-performing clinical development and operational teams supports our commitment to discover and deliver safe and effective precision oncology medicines to patients with underserved cancers."

Program Highlights and 2022 Objectives

PRMT5: Prelude is prioritizing PRT811 for continued clinical development focusing on splicing mutated myeloid malignancies and solid tumors, including uveal melanoma, and IDH1 mutated high grade gliomas. Prelude intends to complete the data analyses of the ongoing expansion cohorts for PRT543, including adenoid cystic carcinoma (ACC). Prelude expects to report data for the PRMT5 program in 2H/2022.

MCL1: Prelude is prioritizing development of the intravenous (IV) formulation of PRT1419 which demonstrated a desirable pharmacokinetic, pharmacodynamic and safety profile with potential for differentiation from competitor compounds. Prelude plans to initiate a combination trial with venetoclax by mid-year and report data by year-end 2022.

CKD9: Prelude intends to complete enrollment in the Phase 1 dose escalation study and identify a recommended Phase 2 dose by 2H/2022.

CDK4/6: Prelude intends to file an Investigational New Drug (IND) application mid-year and initiate a Phase 1 trial in 2H/2022.

SMARCA2/BRM: Prelude plans to complete IND-enabling studies and submit an IND application by year-end 2022.

Corporate Update

On March 9, 2022, Prelude announced the appointment of Jane Huang, M.D., to the newly created position of President and Chief Medical Officer. Dr. Huang joins Prelude from BeiGene Ltd., where she served as Chief Medical Officer, Hematology. Currently, Dr. Huang serves as an Adjunct Clinical Assistant Professor in Thoracic Oncology at Stanford University.

Full Year 2021 Financial Results

Cash and Cash Equivalents: Cash and cash equivalents as of December 31, 2021 were $291.2 million. Following Prelude’s recently announced program prioritization initiatives, the Company has extended its cash guidance and anticipates that its existing cash, cash equivalents and marketable securities will fund Prelude’s operations into the second half of 2024.

Research and Development (R&D) Expenses: R&D expenses for the year ended December 31, 2021 increased $38.6 million to $86.8 million compared to $48.2 million for the year ended December 31, 2020. The increase year-over-year was primarily due to increased clinical research costs to support the advancement of Prelude’s clinical programs and related chemistry, manufacturing and other costs for the clinical trials, in addition to an increase in discovery-stage program expenses.

General and Administrative (G&A) Expenses: G&A expenses for the year ended December 31, 2021 increased by $16.4 million to $27.0 million compared to $10.6 million for the year ended December 31, 2020. The increase was primarily due to increased employee headcount and an increase in professional fees as Prelude expanded its operations to support R&D efforts and incurred additional costs associated with operating as a public company.

Net Loss: Net loss for the year ended December 31, 2021 was $111.7 million or $2.43 per share, compared with a net loss of $56.9 million, or $4.56 per share for the year ended December 31, 2020.

On March 16, 2022 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that results from the Phase 3 SIENDO study will be presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper)’s (ESMO) (Free ESMO Whitepaper) Virtual Plenary taking place on Thursday, March 17, 2022 (Press release, Karyopharm, MAR 16, 2022, View Source [SID1234610172]). The data will also be presented in a late-breaking abstract at the Society for Gynecologic Oncology (SGO) 2022 Annual Meeting on Women’s Cancer taking place March 18-21, 2022, in Phoenix, Arizona.

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Details for the presentations are as follows:

ESMO Virtual Plenary:

Title: Prospective double-blind, randomized phase III ENGOT-EN5/GOG-3055/SIENDO study of oral selinexor/placebo as maintenance therapy after first-line chemotherapy for advanced or recurrent endometrial cancer
Presenter: Professor Ignace Vergote, MD, PhD, Leuven University Hospitals, Leuven, Belgium
Date and Time: Thursday, March 17, 2022, 6:00pm-7:00pm CET/1:00pm-2:00pm ET

SGO 2022 Annual Meeting on Women’s Cancer:

Title: Prospective double-blind, randomized phase III ENGOT-EN5/GOG-3055/SIENDO study of oral selinexor/placebo as maintenance therapy after first-line chemotherapy for advanced or recurrent endometrial cancer
Presenter: Professor Ignace Vergote, MD, PhD, Leuven University Hospitals, Leuven, Belgium
Session Type: Oral Presentation
Session: Scientific Plenary IV: Late-Breaking Abstracts
Date and Time: Saturday, March 19, 2022, 5:19pm-5:27pm MT/7:19pm-7:27pm ET

Conference Call Information
Karyopharm will host a conference call Thursday, March 17, 2022, at 4:30 p.m. Eastern Time, to discuss the SIENDO study results. To access the conference call, please dial (888) 349-0102 (local) or (412) 902-4299 (international) at least 10 minutes prior to the start time and ask to be joined into the Karyopharm Therapeutics call. A live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the Company’s website, View Source An archived webcast will be available on the Company’s website approximately two hours after the event.

About the SIENDO Study

The Phase 3 SIENDO study (ENGOT-EN5/GOG-3055) is a multicenter, blinded, placebo-controlled, randomized study evaluating the efficacy and safety of selinexor as a maintenance therapy following chemotherapy in patients with advanced or recurrent endometrial cancer. The study enrolled 263 patients with primary stage IV or recurrent disease who had a partial or complete response after at least 12 weeks of standard taxane-platinum combination chemotherapy. Patients were randomized 2:1 to receive either maintenance therapy of 80mg of selinexor taken once weekly, or placebo, until disease progression. The primary endpoint of the study is statistically significant improvement of progression-free survival compared to placebo. The goal of the study was to demonstrate a hazard ratio of 0.6 or better. In partnership with Karyopharm, the study was initiated by the ENGOT group. In the U.S., the collaboration includes the GOG-F.

About Endometrial Cancer

Endometrial cancer is the most common cancer of the female reproductive organs in the U.S., with approximately 66,000 new cases expected in 2022 leading to nearly 13,000 deaths.1 In 2020, there were approximately 130,000 new cases and 29,000 deaths in Europe from endometrial cancer, while on a global scale there were 417,000 new cases and approximately 97,000 deaths.2 More than 90 percent of uterine body cancers occur in the endometrium, so the actual numbers for endometrial carcinoma cases and deaths are slightly lower than these estimates, which include both endometrial carcinomas and uterine sarcomas. Unlike other cancers that have decreased with preventative measures, endometrial cancer is on the rise.3 Risk factors include obesity, Type 2 diabetes, high-fat diets, use of tamoxifen and oral estrogens, and delayed menopause.4 While the majority of endometrial cancers are diagnosed at early stages, approximately 14,000 patients in the U.S. are diagnosed with advanced disease that cannot be fully removed using surgery.5 These patients, and those with recurrent disease, are treated with chemotherapy. Chemotherapy does not cure patients with endometrial cancer. The use of later lines of chemotherapy are intended to control symptoms rather than cure the disease. There are no approved therapies in the maintenance setting for patients with advanced or recurrent endometrial cancer. The current standard of care is a "watch and wait" approach.6

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor and the first of Karyopharm’s Selective Inhibitor of Nuclear Export (SINE) compounds to be approved for the treatment of cancer. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein XPO1. XPOVIO is approved in the U.S. and marketed by Karyopharm in multiple oncology indications, including: (i) in combination with Velcade (bortezomib) and dexamethasone (XVd) in patients with multiple myeloma after at least one prior therapy; (ii) in combination with dexamethasone in patients with heavily pre-treated multiple myeloma; and (iii) in patients with diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. XPOVIO (also known as NEXPOVIO in certain countries) has received regulatory approvals in a growing number of ex-U.S. territories and countries, including Europe, the United Kingdom, China, South Korea and Israel, and is marketed in those areas by Karyopharm’s global partners. Selinexor is also being investigated in several other mid- and late-stage clinical trials across multiple high unmet need cancer indications, including myelofibrosis. For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at:

Tel: +1 (888) 209-9326
Email: [email protected]

XPOVIO (selinexor) is a prescription medicine approved:

In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (XVd).
In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti–CD38 monoclonal antibody (Xd).
For the treatment of adult patients with relapsed or refractory diffuse large B–cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
SELECT IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Thrombocytopenia: Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care.
Neutropenia: Monitor neutrophil counts throughout treatment. Manage with dose interruption and/or reduction and granulocyte colony–stimulating factors.
Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care.
Hyponatremia: Monitor serum sodium levels throughout treatment. Correct for concurrent hyperglycemia and high serum paraprotein levels. Manage with dose interruption, reduction, or discontinuation, and supportive care.
Serious Infection: Monitor for infection and treat promptly.
Neurological Toxicity: Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves. Optimize hydration status and concomitant medications to avoid dizziness or mental status changes.
Embryo–Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception.
Cataract: Cataracts may develop or progress. Treatment of cataracts usually requires surgical removal of the cataract.
Adverse Reactions

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract and vomiting. Grade 3–4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia. In the BOSTON trial, fatal adverse reactions occurred in 6% of patients within 30 days of last treatment. Serious adverse reactions occurred in 52% of patients. Treatment discontinuation rate due to adverse reactions was 19%.
The most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and upper respiratory tract infection. In the STORM trial, fatal adverse reactions occurred in 9% of patients. Serious adverse reactions occurred in 58% of patients. Treatment discontinuation rate due to adverse reactions was 27%.
The most common adverse reactions (incidence ≥20%) in patients with DLBCL, excluding laboratory abnormalities, are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3–4 laboratory abnormalities (≥15%) are thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. In the SADAL trial, fatal adverse reactions occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal adverse reactions were infection (4.5% of patients). Serious adverse reactions occurred in 46% of patients; the most frequent serious adverse reaction was infection (21% of patients). Discontinuation due to adverse reactions occurred in 17% of patients.

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.

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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.