On February 24, 2022 Emergent BioSolutions Inc. (NYSE: EBS) reported financial results for the fourth quarter and year ended December 31, 2021 (Press release, Emergent BioSolutions, FEB 24, 2022, View Source [SID1234608961]).

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"Emergent’s performance in 2021 is a testament to our strategic focus and highly capable team," said Robert G. Kramer, president and CEO of Emergent BioSolutions. "Looking forward, I am encouraged by the stability and durability of our diversified business lines and exciting R&D portfolio, supported by our improved operational structure that better aligns us with patients and customers, and more effectively positions us for success."

FINANCIAL HIGHLIGHTS (1)

SELECT Q4 2021 AND OTHER RECENT BUSINESS UPDATES

Announced a supply agreement with Sandoz for them to distribute an authorized generic of NARCAN (naloxone HCl) Nasal Spray 4 mg, which is available in the U.S. via retail pharmacies and institutions, including hospitals
Initiated the rolling submission to the U.S. Food and Drug Administration (FDA) of the Biologics License Application (BLA) for AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted), the Company’s investigational anthrax vaccine candidate
Initiated a pivotal Phase 3 safety and immunogenicity study to evaluate CHIKV VLP, the Company’s single-dose chikungunya virus virus-like particle (VLP) vaccine candidate
Initiated a Phase 1 safety, tolerability, and immunogenicity study to evaluate UniFlu, the Company’s universal influenza vaccine candidate comprised of multiple components intended to induce broad and supra-seasonal immunity against influenza A viruses
Announced the Company’s Board of Directors authorization to management to repurchase up to $250 million of the Company’s common stock through November 11, 2022; as of December 31, 2021, the Company repurchased approximately 2.6 million shares for $112.6 million, an average price per share of $42.67
Announced the retirement of the Company’s founder and executive chairman, Fuad El-Hibri, effective April 1, 2022
Q4 2021 FINANCIAL PERFORMANCE (1)

Product Sales, net
Anthrax vaccines
For Q4 2021, revenues from anthrax vaccines increased $22.0 million as compared to Q4 2020. The increase is largely driven by an increase in deliveries of AV7909 to the U.S. government (USG), specifically the Strategic National Stockpile (SNS). The Company received an AV7909 contract modification in September 2021 and began delivering additional doses of AV7909 under that modification, which covers a period of 18 months and is valued at approximately $399 million.

ACAM2000
For Q4 2021, revenues from ACAM2000 (Smallpox (Vaccinia) Vaccine, Live) decreased $3.5 million as compared to Q4 2020. The decrease is largely driven by the timing of deliveries to the USG. The revenues recognized in Q4 2021 reflect delivery of doses into the SNS resulting from the July 2021 exercise by the USG of the second of nine annual contract term extension options pursuant to the Company’s 10-year supply agreement with the USG. This latest option is valued at approximately $182 million.

Nasal naloxone products
For Q4 2021, revenues from nasal naloxone products increased $43.2 million as compared to Q4 2020. The increase is driven by continued demand for NARCAN (naloxone HCI) Nasal Spray across customer channels in the U.S. and Canada. The increase also reflects the impact of revenues related to the authorized generic of NARCAN (naloxone HCI) Nasal Spray 4mg, a product licensed to Sandoz and launched in late 2021 and one in which the Company retains a financial interest.

Other (4)
For Q4 2021, revenues from other product sales increased $31.7 million as compared to Q4 2020. The increase is largely due to sales of VIGIV [Vaccinia Immune Globulin Intravenous (Human)], driven by timing of deliveries to the USG and based on the June 2021 exercise by the USG of the second of nine annual contract term extension options pursuant to the Company’s 10-year supply agreement with the USG. This latest option is valued at approximately $56 million.

Contract Development and Manufacturing (CDMO)
CDMO Services
For Q4 2021, revenue from contract development and manufacturing services decreased $12.8 million as compared to Q4 2020. This decrease is largely due to the discontinuation of manufacturing activities related to the Company’s arrangement with AstraZeneca as was previously announced in the second quarter of 2021. Additionally, there was less activity as compared to Q4 2020 due to routine maintenance in the Company’s manufacturing network.

CDMO Leases
For Q4 2021, revenue from contract development and manufacturing leases increased $32.0 million as compared to Q4 2020. This increase is largely due to the timing of $155.7 million in final cash collections associated with the Center for Innovation in Advanced Development and Manufacturing (CIADM) public-private partnership with the Biomedical Advanced Research and Development Authority (BARDA), an arrangement that was mutually terminated by both parties in the fourth quarter. The Company anticipates ongoing CDMO lease revenues in subsequent periods related primarily to its existing CDMO manufacturing agreement with Johnson & Johnson, a portion of which is considered a lease.

Contracts and Grants
For Q4 2021, revenues from contracts and grants increased $27.6 million as compared to Q4 2020. The increase is a result of $59.7 million being recognized in Q4 2021, primarily deferred revenue, as a result of the CIADM base contract termination offset by a decrease in third party development activities.

Cost of Product Sales
For Q4 2021, cost of product sales increased $40.6 million as compared to Q4 2020. The increase is primarily due to a higher volume of product sales, specifically nasal naloxone products, AV7909 and VIGIV.

Cost of CDMO
For Q4 2021, cost of CDMO increased $4.0 million as compared to Q4 2020. The increase is primarily due to additional costs at the Company’s Bayview facility to further support enhancements to quality systems and capabilities at the site.

Research and Development
For Q4 2021, research and development expenses increased $23.5 million as compared to Q4 2020. The increase is primarily due to the non-cash write-off of $38.0 million associated with a contract asset balance resulting from the CIADM contract termination.

Selling, General and Administrative
For Q4 2021, selling, general and administrative expenses increased $12.1 million as compared to Q4 2020. The increase is primarily due to professional services costs.

Goodwill Impairment
During Q4 2021, the Company performed its annual impairment testing reflecting its revised reporting unit structure. Pursuant to this analysis, the Company recognized a $41.7 million non-cash impairment of goodwill in the Commercial reporting unit.

ADDITIONAL FINANCIAL INFORMATION

For Q4 2021, product gross margin increased $52.8 million as compared to Q4 2020. The increase is primarily due to the increase in product sales. Product gross margin percent decreased primarily due to changes in product mix.

For Q4 2021, CDMO gross margin decreased $16.8 million as compared to Q4 2020. Adjusted CDMO gross margin decreased $17.7 million as compared to Q4 2020. The decline in CDMO gross margin and adjusted CDMO gross margin is primarily due to routine maintenance activity that occurred in the Company’s manufacturing network in Q4 2021 that did not occur in Q4 2020 as well as increased costs to support remediation efforts for the Company’s manufacturing activities at its Bayview facility.

For Q4 2021, the Company has revised the metrics it provides related to specific aspects of the CDMO business. The Company will continue to provide the CDMO New Business Secured and Backlog metrics. The Company is introducing CDMO Customers as a new metric, and is discontinuing reporting of the CDMO Opportunity Funnel. The Company believes this set of supplemental information provides more valuable and relevant context on the performance and stability of the CDMO business.

For Q4 2021, capital expenditures increased largely due to the Company’s continued investments in expanded capacity and capabilities at the Company’s Rockville manufacturing facility. The increase in gross capital expenditures was offset by the timing of reimbursements of $60.5 million related to arrangements funded by the USG. The capital expenditures related to this reimbursement were incurred in a prior period.

Full Year 2022

For full year 2022, the Company provides the following update to its forecast of key financial metrics, which were originally announced on January 9, 2022.

The Company’s 2022 financial forecast includes the following considerations:

Revised Considerations

The revision to total revenues, CDMO services revenue, Adjusted EBITDA and adjusted net income reflect the impact of the Company’s decision to take the opportunity to initiate a maintenance period that it would normally plan for the Bayview facility earlier than anticipated and also extend it in order to make additional improvements and modifications that will better position Bayview for future non-pandemic work.

Unchanged Considerations

2022 Product/Service Level Revenues – Select Assumptions

Anthrax vaccines revenues are expected to continue at similar levels to 2021 under the terms of the Company’s existing contract with BARDA.
ACAM2000 (Smallpox (Vaccinia) Vaccine, Live) vaccine deliveries are expected to continue under the terms of the Company’s existing contract with the U.S. Department of Health and Human Services (HHS) at unit volume levels consistent with 2021 deliveries.
Nasal naloxone products revenues reflect the formation of a generic market and comprise revenues from a combination of NARCAN(naloxone HCl) Nasal Spray and the authorized generic of NARCAN Nasal Spray, a product licensed to Sandoz and launched in late 2021 and one in which the Company retains a financial interest.
Other Products + Contracts and Grants revenues: 1) other products revenues reflect continued procurement of other products not highlighted on a standalone basis from various government customers under existing multi-year contracts; 2) contracts and grants revenues reflect continued funding of select development programs from various government and other non-dilutive sources.
Other 2022 Assumptions

Gross margin primarily reflects the influence of the mix of product and services revenues.
Pipeline progress is expected across the R&D portfolio with the ongoing advancement of the CHIKV VLP Phase 3 clinical trial, the completion of the BLA filing for AV7909, and anticipated advancements of a number of early-stage programs.
Capital expenditures, net of reimbursement, are expected to be approximately 10% of total revenues at the midpoint, reflecting ongoing investments in capacity and capability expansions related to the CDMO business and the Company’s R&D programs, and aligned with the average over the previous five-year period.
Q1 2022

For Q1 2022, the Company expects total revenues of $280 million to $310 million.

FOOTNOTES

(1) All financial information incorporated within this release is unaudited.
(2) See "Reconciliation of Net Income to Adjusted Net Income," "Reconciliation of Net Income to Adjusted EBITDA," "Reconciliation of Product Gross Margin and Adjusted Product Gross Margin," "Reconciliation of CDMO Gross Margin and Adjusted CDMO Gross Margin" and "Adjusted Revenues" for a definition of terms and the reconciliation tables.
(3) Product sales, net are reported net of variable consideration including returns, rebates, wholesaler fees and prompt pay discounts.
(4) Other can include a combination of sales of any of the following products: BAT, VIGIV, Anthrasil, raxibacumab, RSDL, Trobigard, Vivotif, and Vaxchora.
(5) CDMO New Business Secured is defined as initial value of contracts secured as well as incremental value of existing contracts modified within the indicated period and is incorporated into Backlog.
(6) CDMO Backlog is defined as estimated remaining contract value as of the indicated period pursuant to signed contracts, the majority of which is expected to be recognized over the next 24 months. This excludes any value associated with an extension of the commercial supply agreement (CSA) with Johnson & Johnson.
(7) CDMO Customers is defined as a client (commercial, government, NGO) for whom the Company has performed CDMO services where there is evidence of meeting all of the following criteria: i) completion of any invoiceable project milestones in the preceding 24-month period, indicating ongoing work; ii) secured project work planned in the future, which has not yet been invoiced, capturing future work not yet indicated in the invoice record; and, iii) neither the Company nor the client having yet to formally terminate the last remaining project, thereby removing any client for whom work has fully concluded.

CONFERENCE CALL, PRESENTATION SUPPLEMENT AND WEBCAST INFORMATION

Company management will host a conference call at 5:00 pm (Eastern Time) today, February 24, 2022, to discuss these financial results. The conference call and presentation supplement can be accessed from the Company’s website or through the following:

On February 24, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported financial results for the fourth quarter and full year ended December 31, 2021, and provided an overview of recent business highlights (Press release, Cytori Therapeutics, FEB 24, 2022, View Source [SID1234608960]).

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"In 2021, the Company significantly advanced its lead 186RNL program and expanded its pipeline," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "Our 2022 plan will build on our successful 2021 track record. This year we have planned an aggressive schedule of development activities in conjunction with continued strengthening of our balance sheet".

2021 AND RECENT HIGHLIGHTS

Rhenium-186 NanoLiposome ( 186 RNL), a novel radiotherapy in development for several rare cancer targets

Announced positive interim data from the U.S. ReSPECT-GBM Phase 1/2 trial of 186RNL in patients with recurrent glioblastoma (GBM).
Announced plans to advance into Phase 2 development in 2022 for recurrent GBM.
Initiated ReSPECT-LM Phase 1 dose escalation trial of 186RNL in patients with leptomeningeal metastases (LM).
Received U.S. Food and Drug Administration (FDA) Fast Track designation for 186RNL for the treatment of LM.
Entered into multiple manufacturing, analytical and supply agreements to produce Good Manufacturing Practice (cGMP) grade 186RNL for use in late-stage clinical trials planned for 2022.
Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere ( 188 RNL-BAM), a novel radiotherapy in development for solid organ cancers

In the fourth quarter of 2021, in-licensed a novel targeted radioembolic technology for the treatment of many solid organ tumors.
The in-licensed technology is intended to make and use biodegradable alginate microspheres (BAM) combined with nanoliposomes and imaging and/or therapeutic payloads.
The Company will initially focus on developing 188RNL-BAM as a next-generation radioembolization therapy for rare solid organ cancers including liver cancer.
FULL YEAR 2021 FINANCIAL RESULTS

As of December 31, 2021, the Company’s cash balance was $18.4 million, compared to $8.3 million as of December 31, 2020. In 2021 and in 2022 to date, the Company strengthened its balance sheet by raising $28.5 million. As a result, at January 31, 2022, the Company’s cash balance was $23.0 million.
Through 2021, the Company continued to utilize the $3 million grant from the NIH/National Cancer Institute for funding of the clinical trials for the ReSPECT-GBM Phase 1/2 trial.
Total operating expenses for full year 2021 were $12.5 million, compared to total operating expenses of $9.9 million for full year 2020. This increase is primarily due to increased research and development expenses in 2021.
Net loss for full year 2021 was $13.4 million, or $(1.11) per share, compared to a net loss of $8.2 million, or $(1.86) per share, for full year 2020. The increase in net loss is primarily due to the aforementioned increase in research and development expenses.
UPCOMING EVENTS AND MILESTONES

The Company’s near- and mid-term business objectives include the following:

Recurrent GBM

Initiate a Phase 2 clinical trial in patients with recurrent GBM.
Complete FDA CMC and clinical meetings for the ReSPECT-GBM program.
Complete CMC activities for 186RNL for GMP Phase 2 drug supply.
Continue ReSPECT-GBM Phase 1 trial of 186RNL, dose escalation and report data.
Initiate ReSPECT-GBM retreatment protocol following FDA approval.
Other Indications

Complete initial cohort enrollment and feasibility assessment in ReSPECT-LM Phase 1 trial.
Obtain FDA approval of Investigational New Drug (IND) application for Phase 1 trial of 186RNL in patients with pediatric brain cancer (ReSPECT-PBC).
Complete technology transfer and key CMC, FDA IND-enabling studies for 188RNL-BAM.
FOURTH QUARTER AND FULL YEAR 2021 RESULTS CONFERENCE CALL

The Company will hold a conference call and live audio webcast at 5:00 p.m. Eastern Time today to discuss its financial results and provide a general business update.

Event: Plus Therapeutics Fourth Quarter and Full Year 2021 Results Conference Call
Date: February 24, 2022
Time: 5:00 p.m. Eastern Time
Live Call: 866-342-8591 (toll free); 203-518-9713 (Intl.); Conference ID: PSTVQ421
The webcast can be accessed live via the Investor Relations section of the Plus Therapeutics website at ir.plustherapeutics.com/events and will be available for replay beginning two hours after the conclusion of the conference call.

On February 24, 2022 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its financial results for the fourth quarter ended December 31, 2021 (Press release, Curis, FEB 24, 2022, View Source [SID1234608959]).

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"2021 was a year marked by significant clinical progress across our pipeline of targeted cancer therapies, including our report of positive updated data from our ongoing Phase 1/2 TakeAim Leukemia study of emavusertib (CA-4948) demonstrating a favorable safety profile and encouraging anti-cancer activity, with expansion into multiple combination trials in R/R hematologic malignancies. We have also identified a potential registrational path for CA-4948 as a monotherapy in genetically-defined patient populations, and reported promising initial safety data highlighting the potential of CI-8993 to activate multiple anti-cancer immune mechanisms," said James Dentzer, President and Chief Executive Officer of Curis. "As we look ahead, we expect 2022 to be a year of meaningful clinical updates from across our ongoing clinical trials, as we plan on providing additional updates on expanded clinical data for emavusertib and an update on a potential rapid regulatory path to bring this novel therapy to a genetically-defined patient population in dire need. We will continue our dose-escalation study for CI-8993 to determine the recommended Phase 2 dose and to assess signs of anti-cancer activity. We also look forward to presenting data from both of our combination trials with emavusertib in AML/MDS and in B Cell Cancers this year.

"We are also pleased to have expanded our leadership with three new executives that will bring expertise to strengthen our internal capabilities. We are also delighted with the appointment of John Hohneker, M.D. to the Board of Directors as we continue to grow our team and build our capabilities to deliver a new class of therapies to our patients," added Mr. Dentzer.

Full Year 2021 and Recent Operational Highlights

Precision oncology, emavusertib (IRAK4 Inhibitor; Aurigene collaboration):

Today, Curis announced that it will be implementing the new name "emavusertib" for all future references of CA-4948, including in scientific publications and corporate materials. The Company also announced new branding of its existing clinical trials of emavusertib as TakeAim Leukemia and TakeAim Lymphoma to highlight the targeting mechanisms.
In January 2022, Curis presented an updated expanded data set supporting earlier preliminary efficacy data of emavusertib in R/R AML/MDS whose disease is characterized by spliceosome or FLT3 mutation, suggesting a favorable safety and anti-cancer activity profile compared to standard of care therapies for these patient populations. The safety profile observed showed emavusertib was well-tolerated across multiple dose levels, including at the Recommended Phase 2 Dose of 300 mg BID. Enrollment of the study is currently ongoing, and Curis expects to have discussions with the FDA in the first half of 2022 regarding the potential for a rapid registrational path for emavusertib as a monotherapy in genetically defined patient populations. Curis expects to provide additional data from the R/R AML/MDS study at a medical meeting in 2022.
In October 2021, Curis initiated dosing in the combination stage of the TakeAim Leukemia study of emavusertib plus azacitidine or venetoclax. The combination therapy portion includes two arms: emavusertib plus azacitidine, for patients naïve to HMA, and emavusertib plus venetoclax, for patients naïve to venetoclax.
In October 2021, Curis announced new preclinical data highlighting the potential of emavusertib in additional hematologic malignancies in two presentations at the AACR (Free AACR Whitepaper)-NCI-EORTC Virtual Conference on Molecular Targets and Cancer Therapeutics. The preclinical data concluded emavusertib is synergistic with small molecule therapies targeted BCR signaling and suggest it can overcome or reduce secondary resistance to the therapies in marginal zone lymphoma.
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext collaboration):

In January 2022, Curis announced that the ongoing Phase 1 dose escalation study of CI-8993 demonstrated a promising safety profile, with no dose-limiting toxicities observed, and encouraging PK/PD activity, suggesting the possibility that CI-8993 can activate multiple anti-cancer immune mechanisms, including mechanisms that are not addressed by currently approved checkpoint inhibitors. The initial safety data from this trial is based on 13 patients in the first two dose cohorts of 0.15mg/kg and 0.3mg/kg. Curis expects to report expanded safety and tolerability data, along with PK, PD, and anti-cancer data from the trial in the second half of 2022.
Corporate:

Curis expanded its executive leadership capabilities, adding Felix Geissler, M.D., Ph.D., as Vice President of Medical Affairs, Kimberly Steinmann, M.D., as Vice President of Clinical Development, and Dora Ferrari, as Vice President of Clinical Operations. Drs. Geissler and Steinmann, and Ms. Ferrari are reporting directly to Dr. Reinhard von Roemeling, Senior Vice President, Clinical Development.
Curis expanded its Board of Directors with the appointment of John Hohneker, M.D. to the Board of Directors.
Upcoming 2022 Planned Milestones

In the first half of 2022, discuss potential for rapid registrational path for emavusertib with FDA
In the first half of 2022, report initial data for emavusertib in combination with ibrutinib in NHL
In 2022, report updated data for emavusertib in AML/MDS monotherapy
In the second half of 2022, report initial efficacy data for CI-8993 (VISTA)
In the second half of 2022, report initial data for emavusertib in combination with azacitadine or venetoclax in AML/MDS
Full Year and Fourth Quarter 2021 Financial Results

For the year ended December 31, 2021, Curis reported a net loss of $45.4 million, or $0.50 per share on both a basic and diluted basis, as compared to a net loss of $29.9 million, or $0.61 per share on both a basic and diluted basis in 2020. For the fourth quarter of 2021, Curis reported a net loss of $13.6 million or $0.15 per share on both a basic and diluted basis as compared to a net loss of $7.5 million, or $0.11 per share on both a basic and diluted basis, for the same period in 2020.

Revenues for the year ended December 31, 2021, were $10.6 million as compared to $10.8 million for the same period in 2020. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge. Revenues for the fourth quarters of 2021 and 2020 were $3.1 million and $3.0 million, respectively.

Operating expenses for the year ended December 31, 2021, were $52.7 million, as compared to $35.7 million for the same period in 2020. Operating expenses for the fourth quarter of 2021 were $15.7 million, as compared to $9.3 million for the same period in 2020, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.5 million for the years ended December 31, 2021 and 2020. Cost of royalty revenues were $0.2 million for the fourth quarter of 2021 and 2020.

Research and Development Expenses. Research and development expenses were $34.9 million for the year ended December 31, 2021, as compared to $23.1 million for the same period in 2020. Research and development expenses were $10.8 million for the fourth quarter of 2021 as compared to $5.6 million for the same period in 2020. The increase was primarily attributable to increased clinical and manufacturing costs for our programs and higher personnel counts as a result of additional headcount.

General and Administrative Expenses. General and administrative expenses were $17.3 million for the year ended December 31, 2021, as compared to $12.1 million for the same period in 2020. General and administrative expenses were $4.8 million for the fourth quarter of 2021, as compared to $3.5 million for the same period in 2020. The increase in general administrative expense was driven primarily by higher costs for stock-based compensation, professional and consulting services, personnel, and insurance as compared to the prior year.

Other Expense, Net. Net other expense was $3.4 million for the year ended December 31, 2021, as compared to $5.0 million for the same period in 2020. For the fourth quarter of 2021 and 2020, net other expense was $1.1 million and $1.2 million, respectively. Net other expense primarily consisted of imputed interest expense related to royalty payments.

As of December 31, 2021, Curis’s cash, cash equivalents and investments totaled $139.8 million, and there were approximately 91.6 million shares of common stock outstanding. Curis expects that its existing cash, cash equivalents and investments should enable it to maintain its planned operations into 2024.

Conference Call Information

Curis management will host a conference call today, February 24, 2022, at 4:30 p.m. ET, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.

On February 24, 2022 Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) reported that it will report its financial results for the fourth quarter of 2021, on Thursday, March 3, 2022, before the U.S. financial markets open Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) reported that it will report its financial results for the fourth quarter of 2021, on Thursday, March 3, 2022, before the U.S. financial markets open. The Company will host a conference call and webcast at 8:30 a.m. ET to discuss its fourth quarter 2021 financial results and provide a business update. Individuals interested in participating in the call should dial (855) 354-1855 (U.S. and Canada) or (484) 365-2865 (International).

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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

                  Schedule Your 30 min Free Demo!

A live webcast of the conference call may be accessed in the Investors section of the Company’s website at www.concertpharma.com. A replay of the webcast will be available on Concert’s website for three months.. The Company will host a conference call and webcast at 8:30 a.m. ET to discuss its fourth quarter 2021 financial results and provide a business update. Individuals interested in participating in the call should dial (855) 354-1855 (U.S. and Canada) or (484) 365-2865 (International).

A live webcast of the conference call may be accessed in the Investors section of the Company’s website at www.concertpharma.com. A replay of the webcast will be available on Concert’s website for three months.

On February 24, 2022 Compugen Ltd. (Nasdaq: CGEN, "Compugen", the "Company"), a clinical-stage cancer immunotherapy company and leader in predictive target discovery, reported financial results for the fourth quarter ended December 31, 2021, and full year 2021 and provided an update on recent Company highlights (Press release, Compugen, FEB 24, 2022, View Source [SID1234608957]).

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"Compugen made excellent progress in 2021. As the leader in the DNAM-1 axis we believe that blocking its complementary pathways has the potential to be a game changer in treating inflamed as well as less inflamed tumors, in patients who do not respond to available therapies. I am particularly excited about the translational data we presented across all the regimens with the most potent immune activation in the triple blockade of PVRIG, TIGIT and PD-1, which complements the early signals of anti-tumor activity we reported in our studies. With COM902, we were the first to present early signals of monotherapy anti-tumor activity with an IgG4 anti-TIGIT antibody, with low Fc-effector function. COM902 also avoided depletion of CD8+ T cells, the most effective anti-cancer immune subset, supporting our strategy to develop an antibody with low Fc effector function said," Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "In 2021 we also presented additional research supporting the differentiation of PVRIG from other immune checkpoints, enhancing our belief that PVRIG may be the missing piece when current immunotherapies have failed, by potentially generating new waves of T cells to infiltrate the tumor microenvironment. I am excited that the totality of results we have presented to date support our DNAM-1 axis hypothesis and set the stage for the next steps for the Company’s clinical program."

Dr. Cohen-Dayag further commented, "I am also pleased that we expanded our collaboration with Bristol Myers Squibb with a $20 million strategic investment and I am happy to see AstraZeneca progressing its TIGIT/PD-1 bispecific, which is derived from our COM902 into the clinic."

Dr. Cohen-Dayag continued, "Looking ahead, this year and next year we will focus on completing clinical study enrollment and delivering meaningful clinical and translational results from the expansion cohorts in our three ongoing combination studies with our two proprietary programs, COM701 and COM902. We expect to report data from fully enrolled cohorts in each of our studies as available starting with the COM701/nivolumab study CRC (MSS) cohort in Q4 2022, and complete enrollment in all cohorts by the end of 2023. The data from these studies will guide our regulatory strategy on a cohort-by-cohort basis."

2022-2023 Expected Milestones:
•
Advancing the enrollment of Phase 1 and Phase 1/2 dose expansion studies to evaluate anti-PVRIG and/or anti-TIGIT antibodies in combination with a PD-1 inhibitor:

o
COM701/PVRIG plus nivolumab

o
COM701/PVRIG plus COM902/TIGIT

o
COM701/PVRIG plus nivolumab and Bristol Myers Squibb’s investigational anti-TIGIT antibody, BMS-986207
•
Reporting data from fully enrolled cohorts
•
Announcing initial clinical data from the Phase 1 and Phase 1/2 programs starting with COM701/nivolumab study CRC/MSS cohort in Q4 2022
•
Completing enrollment of all ongoing studies by end of 2023

Phase 1/Phase 1/2 Dose Expansion Combination Program
Clinical Study
Number of cohorts
Tumor types
Patients per cohort
COM701+ nivolumab
4
Ovarian, Endometrial, Breast, CRC/MSS
20
COM701+ nivolumab + BMS986207
4
Ovarian, Endometrial, HNSCC, PVRL2+ patients
20
COM701 +COM902
3
HNSCC, NSCLC, CRC/MSS
20

2021 Corporate Highlights
•
Completed enrollment as planned and presented data from our Phase 1 studies at major medical meetings

o
ASCO 2021

◾
COM701 monotherapy dose escalation and expansion studies

◾
COM701 + nivolumab dose escalation study

o
SITC 2021

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COM902 monotherapy dose escalation

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COM701+ nivolumab + BMS986207 dose escalation
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COM701 as mono, dual, and triple therapy showed early signals of anti-tumor activity with immune activation and a favorable safety profile
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COM902 showed early signals of anti-tumor activity, was well tolerated and translational data support choice of an IgG4 anti-TIGIT antibody with less effector function than IgG1

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Initiated enrollment in the Phase 1, Phase 1/2 dose expansion programs (see table above)
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Expanded the clinical research collaboration agreement with Bristol Myers Squibb with an equity investment of $20 million
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Received $6 million milestone payment triggered by first patient initiation in AstraZeneca’s Phase 1/2 study of a TIGIT/PD-1 bispecific monoclonal antibody, AZD2939, derived from COM902
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Expanded research collaboration with Johns Hopkins University for a novel myeloid target discovered by Compugen
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Published review on biology and potential therapeutic relevance of DNAM-1 axis in cancer immunotherapy in Cancer Discovery, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper)
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Published preclinical data on the potential of COM902 to enhance anti-tumor immune responses, in Cancer Immunology Immunotherapy
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Presented research supporting the differentiation of PVRIG from other immune checkpoint inhibitors at the SITC (Free SITC Whitepaper) 2021 Targets for Cancer Immunotherapy seminar series in June, the SITC (Free SITC Whitepaper) in November and translational data from patient biopsies demonstrating immune activation in the TME after treatment with COM701, at the TIGIT Therapies Digital Summit in December

Fourth Quarter and Full Year 2021 Financial Highlights
Cash: As of December 31, 2021, cash, cash related accounts, short-term and long-term bank deposits totaled to approximately $118 million, compared with approximately $124 million as of December 31, 2020. The Company expects its existing cash and cash equivalents and short-term bank deposits, to be sufficient to fund our current level of operations into 2024.

Revenues: Compugen reported no revenue for the fourth quarter of 2021 and a total of $6 million for the year ended December 31, 2021, compared with $2.0 million for each of the comparable periods in 2020. 2021 revenues are related to the milestone payment from AstraZeneca for dosing the first patient in AstraZeneca’s Phase 1/2 study of a TIGIT bispecific monoclonal antibody, derived from COM902.

Cost of revenues: 2021 expenses of approximately $0.7 million are attributed to royalty and milestone payments.

R&D Expenses: Expenses for the fourth quarter and year ended December 31, 2021 were approximately $5.8 million, and approximately $28.7 million, respectively, compared with approximately $8.1 million and approximately $22.8 million for the comparable periods in 2020. The increase in the annual periods is attributed mainly to higher expenses associated with our various clinical studies, manufacturing and related costs, and headcount as the U.S. based clinical team continues to grow to support the expansion of our studies. The decrease in the quarterly period is due to a decrease in manufacturing and related costs.

G&A Expenses: Expenses for the fourth quarter and year ended December 31, 2021 were approximately $2.7 million and approximately $10.9 million, respectively, compared with approximately $2.7 million and approximately $9.8 million for the comparable periods in 2020. The increase in the annual period is mainly due to increased corporate-related expenses.

Net Income/Loss: Net loss for the fourth quarter of 2021 was approximately $8.6 million, or $0.10 per basic and diluted share, compared with a net loss of approximately $8.6 million, or $0.10 per basic and diluted share in the comparable period of 2020. Net loss for the year ended December 31, 2021 was approximately $34.2 million, or $0.41 per basic and diluted share, compared with net loss of approximately $29.7 million, or $0.37 per basic and diluted share in the comparable period of 2020.

Full financial tables are included below.

Conference Call and Webcast Information
The Company will hold a conference call today, February 24, 2022, at 8:30 AM ET to review its fourth quarter and full year 2021 results. To access the conference call by telephone, please dial 1-866-744-5399 from the United States, or +972-3-918-0610 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.