On March 10, 2022 Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company focused on developing both restorative therapeutics and pan-caspase and caspase selective inhibitors focused on treatments for infectious and inflammatory diseases, reported financial results for the fourth quarter and year ended December 31, 2021 and provided an update on its clinical pipeline and other corporate developments (Press release, Conatus Pharmaceuticals, MAR 10, 2022, View Source [SID1234609892]).

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"We have a diverse pipeline of biologics and small molecule product candidates that we believe address large unmet market needs," said Steven J. Mento, Ph.D., Interim President and Chief Executive Officer. "Looking ahead, we will continue to focus on clinical execution with HST-003 in cartilage repair, and emricasan in COVID-19 with our partner Amerimmune while we explore the feasibility of testing emricasan in animal studies for methicillin resistant staphylococcus aureus infections (MRSA), and continue to evaluate our caspase-1 inhibitors that impact the inflammasome pathway. These activities support our overarching goal of enhancing the lives of patients as we seek to build value for our shareholders."

Highlights from the Fourth Quarter and Year Ended 2021 and Business Updates

HST-003 – In the second half of 2021, we initiated our Phase 1/2 clinical study of HST-003 to evaluate the safety and efficacy of human extracellular matrix (hECM) implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure. We have experienced recruitment challenges due to both the specific nature of the study inclusion criteria and the impact of COVID-19 on the elective surgery environment. Additional qualified clinical sites have been added to help supplement recruitment and we will continue to evaluate the need to add more sites and study resources. We now anticipate top line results in the first half of 2023, assuming we complete enrollment in the fourth quarter of 2022.

HST-004 – Our initial preclinical research has shown that HST-004 stimulates stem cells from the spinal disc to proliferate and secrete aggrecan and collagen II, regenerate normal matrix and cell tissue structure and restores disc height. HST-004 was also shown to reduce inflammation and protease activity and upregulate aggrecan production in an ex vivo spinal disc model. In the second half of 2021, we initiated toxicology studies and other IND enabling activities for HST-004. However, due to pipeline program prioritization, we now anticipate filing IND for HST-004 in the second half of 2023.

Emricasan COVID-19 – In June 2021, we, jointly with Amerimmune LLC ("Amerimmune"), announced positive results from the Phase 1 study of emricasan in mild symptomatic COVID-19 patients. Emricasan was shown to be safe and well-tolerated during the 14 days of dosing and at the day 45 follow-up, as compared to placebo with no reports of serious adverse events. Patients who completed treatment with emricasan showed a statistically significant complete resolution of the symptoms most commonly associated in mild COVID-19, such as a cough, headache, and fatigue at day 7 which continued through day 45. No patients in the placebo arm experienced COVID-19 associated symptom resolution at any time point out to day 14. The mean number of days to recovery for patients in the emricasan arm was 4.8 days compared to 37.5 days in the placebo arm (p=0.001). In March 2022, we filed our demand for arbitration ("Arbitration Demand") as we believe that Amerimmune has failed to undertake commercially reasonable efforts toward conducting and completing the Phase 2 study as required by the Collaborative Development and Commercialization Agreement that we previously entered into with Amerimmune (the "Collaborative Agreement"). As part of our Arbitration Demand, we are seeking a declaratory judgement from the arbitrator to terminate the Collaborative Agreement, which would result in us regaining all rights that we licensed to Amerimmune under the Collaborative Agreement. In such event, we intend to conduct and complete the Phase 2 study independently. If the Collaborative Agreement is not terminated, we will likely continue to jointly develop emricasan pursuant to the terms of the Collaborative Agreement. In either case, we anticipate a Phase 2 study could be initiated in the second half of 2022.

Emricasan MRSA – We are exploring the feasibility of testing emricasan in animal studies of other infectious diseases, initially focused on methicillin-resistant staphylococcus aureus ("MRSA"). We anticipate completing the feasibility assessment in the second half of 2022.

CEO Transition – In November of 2021, the board appointed Steven J. Mento, Ph.D. as Executive Chairman and Interim President and Chief Executive Officer.

Fourth Quarter and Full-Year 2021 Financial Highlights

Fourth Quarter Ended December 31, 2021 and 2020

Product and Service Revenues for the three months ended December 31, 2021 and 2020 were $0 and $0.5 million, respectively. The decrease of $0.5 million was due to fulfillment timing of CCM supply orders to Allergan PLC ("Allergan"). Our obligation to supply CCM to Allergan was satisfied in 2021, and we have no additional purchase orders with Allergan for fulfillment.

Cost of revenues for the three months ended December 31, 2021 and 2020, we recognized cost of product revenue of $0 and $0.3 million, respectively. The decrease of $0.3 million for the three months ended December 31, 2021 as compared to the three months ended December 31, 2020 was due to the decrease in product sales to Allergan.

Research and development expenses for the three months ended December 31, 2021 and 2020 were $1.6 million and $1.9 million, respectively. The decrease of $0.3 million for the three months ended December 31, 2021 as compared to the three months ended December 31, 2020 was primarily due to decreases related to personnel related expenses.

General and administrative expenses for the three months ended December 31, 2021 and 2020 were $1.5 million and $1.8 million, respectively. The $0.3 million decrease for the three months ended December 31, 2021 as compared to the three months ended December 31, 2020 was primarily due to decrease in personnel related expenses and rent expense decrease, partially offset by an increase in legal and other administrative expenses.

Twelve Months Ended December 31, 2021 and 2020

Revenues

For the years ended December 31, 2021 and 2020, we recognized license revenues of $27 thousand and $0.9 million, respectively. The revenue recognized in both periods is associated with the Allergan Agreements. During the period ended December 31, 2021, $19 thousand of deferred revenue was recognized in relation to the Potential Future Improvements remaining performance obligation currently being amortized over the remaining 9-year patent life. The year-over-year decrease is primarily attributable to the recognition of the allocated proceeds received upon the transfer of the expanded license to Allergan in January 2020.

For the years ended December 31, 2021 and 2020, we recognized product revenues of $0.9 million and $0.8 million, respectively. The increase of $0.1 million for the year ended December 31, 2021, as compared to the year ended December 31, 2020 was due to a larger quantity of CCM sales to Allergan.

Grant revenue for the years ended December 31, 2021 and 2020 was $0.1 million and $0, respectively, all of which was related to an NSF research grant awarded to us in 2017. In March 2021, the Company completed all obligations under the NSF development grant and, as such, no longer generates any revenues in connection with the research and development grant.

For the year ended December 31, 2020, we recognized professional services revenue of $0.3 million, related to the transfer of certain technology and know-how, which was completed during 2020. As such, no additional professional services revenue was recognized during the year ended December 31, 2021.

Cost of Revenues

Cost of revenues for the years ended December 31, 2021 and 2020 were $0.2 million and $0.7 million, respectively. The decrease of $0.5 million for the year ended December 31, 2021 as compared to the year ended December 31, 2020 was primarily due to the sale of CCM to Allergan in September 2021 that was originally designated for research and development purposes and therefore had no cost of goods associated with it, and costs related to scrapped inventory.

For the years ended December 31, 2021 and 2020, we recognized costs of professional services of $0 and $0.3 million, respectively, related to the completion of technology transfer obligations of Histogen under the Allergan Agreements

In-process research and development expenses were $7.1 million for the year ended December 31, 2020 for in-process research and development acquired in connection with the Merger in May of 2020.

Research and development expenses for the years ended December 31, 2021 and 2020 were $8.5 million and $6.2 million, respectively. The increase of $2.3 million for the year ended December 31, 2021, as compared to the year ended December 31, 2020 was primarily due to increases in development costs of our clinical and pre-clinical product candidates and personnel related expenses, partially offset by $0.7 million in qualifying reimbursable expenses in connection with the DoD grant.

General and administrative expenses for the years ended December 31, 2021 and 2020 were $7.8 million and $6.6 million, respectively. This increase of $1.2 million for the year ended December 31, 2021 as

compared to the year ended December 31, 2020 was primarily due to increases in personnel related expenses, legal fees and insurance costs.

Cash and cash equivalents as of December 31, 2021 were $18.7 million. Histogen believes that its existing cash and cash equivalents and cash inflow from operations will be sufficient to meet Histogen’s anticipated cash needs into the second quarter of 2023.

On March 10, 2022 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing novel T cell engagers, reported financial results for the fourth quarter and full year ended December 31, 2021 and provided a corporate update (Press release, Harpoon Therapeutics, MAR 10, 2022, View Source [SID1234609891]).

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"We look forward to additional clinical advancements in the year ahead. We are focusing our resources on portfolio programs that show promising activity, including HPN328 and HPN217, while we advance new candidates into the clinic from our technology platforms," said Julie Eastland, President and Chief Executive Officer of Harpoon Therapeutics. "Additionally, we have conducted a careful and thorough analysis of our HPN424 data, including our clinical results to date, and based on those data we have made the decision to discontinue the HPN424 dose escalation study."

"We are committed to ongoing support of those patients who remain on our HPN424 trial. We thank the patients, investigators and our employees for supporting this clinical study," said Natalie Sacks, M.D., Chief Medical Officer of Harpoon Therapeutics.

Fourth Quarter 2021 and Recent Business Highlights and Upcoming Milestones

In March 2022, Harpoon announced Orphan Drug designation for HPN328 in small cell lung cancer

In March 2022, Harpoon announced Fast Track designation for HPN217 in relapsed, refractory multiple myeloma

In December 2021 Harpoon provided a pipeline update and in January 2022 issued milestone updates to highlight its TriTAC clinical progress, as well as its platform technologies and next clinical candidate in development:

oHPN328 (DLL3)
▪In the ongoing Phase 1/2 trial for HPN328, 3 out of 4 patients with small cell lung cancer in the two highest dose cohorts experienced target lesion (TL) reduction, with one patient achieving a confirmed partial response with a 53% TL reduction.
▪Harpoon to continue dose escalation to determine RP2D by year-end 2022.
oHPN217(BCMA)
▪Compelling initial clinical activity observed in escalation phase of ongoing trial;
▪Harpoon to select an RP2D and initiate dose expansion cohort by mid-2022.
oHPN536 (MSLN)
▪Complete dose escalation by year-end 2022.
oHPN601 (EpCAM)
▪Advancing Harpoon’s first ProTriTAC molecule, with an IND submission anticipated by year-end 2022.

In December 2021, at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, the company reported interim data from the Phase 1/2 study of HPN217, a half-life extended TriTAC targeting B cell maturation antigen (BCMA) for the treatment of relapsed, refractory multiple myeloma. An overall response rate of 63% and a

disease control rate of 88% in the HPN217 2150 µg/week cohort was observed. These interim data demonstrated clinical activity at higher dose levels, strong target engagement, and a manageable safety profile.

In November 2021, preclinical data supporting Harpoon’s proprietary TriTAC-XR T cell engager platform was highlighted in a poster presentation at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), demonstrating that the platform could mitigate toxicities such as cytokine release syndrome.

Fourth Quarter and Full Year 2021 Financial Results

Harpoon ended the fourth quarter of 2021 with $136.6 million in cash, cash equivalents, and marketable securities compared to $150.0 million as of December 31, 2020. The decrease of $13.4 million to the cash balance at the end of the fourth quarter includes Harpoon’s follow-on financing that closed on January 11, 2021 resulting in net proceeds of approximately $107.6 million, less cash spend during the twelve months on operating expenses.

The company’s cash used in operating activities for the fiscal year ending December 31, 2021 was $122.1 million, which exclusive of the Maverick litigation resulted in cash OPEX used of $72.1 million compared to our guidance of $75 million to $80 million that was provided in November 2021.

Revenue for the quarter ended December 31, 2021 was $4.3 million compared to $7.5 million for the quarter ended December 31, 2020. Revenue for the year ended December 31, 2021 was $23.7 million, compared to $17.4 million for the year ended December 31, 2020. For the fourth quarter ended December 31, 2021, the decrease in revenue was primarily due to zero revenue recognized related to Harpoon’s Discovery Collaboration agreement with AbbVie. For the twelve months ended December 31, 2021, the increase in revenue was primarily due to revenue recognized from the Development and Option agreement with AbbVie.

Research and development (R&D) expense for the quarter ended December 31, 2021 was $20.7 million compared to $15.1 million for the quarter ended December 31, 2020. R&D expense for the year ended December 31, 2021 was $72.1 million, compared to $52.6 million for the prior year. The increase for both periods primarily arose from higher clinical development and personnel-related expense, which included conducting preclinical studies and clinical trials for HPN424, HPN536, HPN217 and HPN328.

General and administrative (G&A) expense for the quarter ended December 31, 2021 was $5.2 million compared to $3.9 million for the quarter ended December 31, 2020. For the year ended December 31, 2021, G&A expense was $18.3 million compared to $16.2 million for the year ended December 31, 2020. For both periods, the increase was primarily attributable to an increase in personnel expenses related to an increase in headcount and other professional services to support our operations as a public company, partially offset by a decrease in legal expenses associated with Maverick litigation.

Net loss for the quarter ended December 31, 2021 was $21.6 million compared to $11.4 million for the quarter ended December 31, 2020. The net loss for the year ended December 31, 2021 was $116.7 million compared to $49.9 million for the prior year.

On March 10, 2022 Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company with the mission to improve patient outcomes by providing personalized insights that inform critical decisions throughout the patient care journey, reported that financial results for the fourth quarter 2021 ended December 31, 2021, along with a corporate update (Press release, Oncocyte, MAR 10, 2022, View Source [SID1234609890]).

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"Our fourth quarter and the first two months of 2022 were a productive period for Oncocyte. A key accomplishment was forming a strategic collaboration with Thermo Fisher for two distributed in vitro diagnostic (IVD) assays on their Ion Torrent Genexus System" said Ron Andrews, President and CEO of Oncocyte. "By leveraging Thermo Fisher’s proven global capabilities and installed base, we will be able to expand the commercial availability of our proprietary tests as IVD assays beyond the U.S. market."

Mr. Andrews continued, "During the fourth quarter, DetermaRx returned to double-digit quarter over quarter growth as the COVID-19 pandemic receded, and surgical procedures began to recover. In addition to significantly growing our testing volume, we continue to deliver on two metrics used to measure test adoption during the current market environment – new hospital onboards increased by 16% and ordering physicians grew by 17% quarter over quarter. We have now established a solid install base of 429 physicians and are poised to grow our sample volume and revenue once early-stage lung cancer surgeries return to pre-pandemic levels."

"The recent publication of data showing that DetermaCNI detects cancer recurrence with higher sensitivity than the standard of care, propels an important component of our strategy: to provide physicians with a blood-based monitoring test to help them better understand how well a therapy is working. The published data are indicative of the potential value of DetermaCNI in the monitoring of therapeutic response, and given the data published to date in multiple tumor types, we believe this test may ultimately become a valuable treatment monitoring tool that will complement our treatment decision test menu. There is currently a blanket reimbursement approach by CMS for these types of monitoring tests at high value rates. Our recent publications build upon the evidence we need to secure Medicare approval for this very lucrative market."

"In Transplant rejection monitoring, we are on track to launch our TheraSure Transplant Monitor as a lab-developed test (LDT) in the U.S. by the end of March from our Nashville CLIA lab. We continue to believe that our patented digital PCR method can deliver unique capabilities, including absolute quantification and better turn-around time more cost effectively than current methods. We remain in discussions with multiple global digital PCR platform companies, and are confident we will partner with a world-class company as a development and channel partner as we decentralize this important test to transplant centers in the US and Europe."

"In November, we initiated the clinical launch of our DetermaIO test via an early access program (EAP), an important milestone to inform immunotherapy decisions, which strengthens Oncocyte’s differentiated position in precision diagnostics. Physicians are recognizing the importance of DetermaIO as the first commercially available test to evaluate the tumor and its microenvironment (TIME) in a manner that has been shown to inform response to immunotherapy. The tumor microenvironment plays a critical role in treatment response and resistance," continued Mr. Andrews. "We believe that the combination of DetermaIO with our comprehensive genomic profiling test DetermaTx, expected to be launched in mid-Q2, will offer the most complete precision diagnostic solution to inform cancer treatment decisions for the 1.8 million patients diagnosed with cancer in the United States each year, a total addressable market of $5 billion. We anticipate that the launch of DetermaCNI as a research use only test to monitor these patients will enable Oncocyte to become the only company to provide upfront testing to inform immunotherapy treatment via TIME assessment as well as monitor patients on treatment for early detection of progression."

"Looking ahead to 2022, our goals are to concentrate on market-focused initiatives that support clinical utility and adoption of our comprehensive testing portfolio. We expect to launch three major products across oncology and transplant, expanding indications and securing reimbursement over the course of the year. We are well positioned to achieve the promise of the Determa platform, and to help physicians address the unanswered questions in treating patients across all stages of cancer," concluded Mr. Andrews.

Fourth Quarter and Recent Highlights Include:

●Announced co-development and co-marketing with Thermo Fisher to for two distributed in vitro diagnostic (IVD) assays on Thermo Fisher Scientific’s Ion Torrent Genexus System. The agreement also grants Oncocyte rights to develop future companion diagnostics on the Genexus System.

●Oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) on randomized clinical trial data definitively established DetermaIO as a predictive biomarker of immunotherapy response. In the triple negative breast cancer (TNBC) NeoTRIPaPDL1 study, DetermaIO outperformed 80 other immune signatures.

●Published a peer-reviewed study in the journal Cancers with investigators from leading academic institutions MD Anderson and Yale demonstrating the predictive potential for DetermaIO. Study data showed that DetermaIO demonstrates superior accuracy compared to standard of care PD-L1 immunohistochemistry (IHC) for prediction of a patient’s response to immunotherapy in TNBC. Previous data has been presented in lung, bladder, renal, and kidney cancers suggesting a broad pan-cancer utility of the test.

●Strengthened transplant IP portfolio with issuance of a U.S. patent covering digital PCR technology for early detection of organ transplant rejection, building upon prior issued U.S. and EU patent for quantification of donor derived cfDNA, supporting the launch of TheraSure Transplant Monitor as an LDT in the U.S.

●Launched and completed site enrollment of the first Real-World Evidence (RWE) registry intended to evaluate biomarker adoption and precision medicine in creating personalized treatment options for early-stage lung cancer patients, with enrollment targeting more than 1,000 patients at 25 sites across the U.S. beginning in Q4 2021..

Fourth Quarter and Full Year 2021 Financial Results

On December 31, 2021, Oncocyte had cash, cash equivalents and marketable securities of $36.5 million, as compared to $7.8 million on December 31, 2020.

Oncocyte currently derives its revenues from the sale of its lung cancer test, DetermaRx, which was commercially launched in early 2020 and pharma services generated by its wholly owned subsidiary, Insight Genetics, Inc., which was acquired on January 31, 2020. During the first quarter of 2021, after accumulating additional history of cash receipts and other factors considered by management for Medicare and Medicare Advantage-covered DetermaRx tests, including the recently published Medicare rate, the Company transitioned to the accrual basis for tests covered by Medicare Advantage insurance plans. Oncocyte will continue to recognize revenues for commercial and other payors on a cash basis until we have reimbursement contracts with those payors. At that point, those contracts will also progress to the accrual basis for DetermaRx tests. Until that time, for all payors other than Medicare and Medicare Advantage, Oncocyte expects to recognize revenue for DetermaRx tests performed on a cash basis.

Revenues for the three and twelve months ended December 31, 2021, were approximately $3.6 million and $7.7 million, respectively, generated from three sources: DetermaRx tests, pharma services, and licensing revenues. Revenues for the three months and twelve months ended December 31, 2020, were approximately $503,000 and $1.2 million, respectively.

Research and development expenses for the fourth quarter of 2021 were $4.6 million as compared to $1.8 million for the same period in 2020, an increase of $2.8 million. Research and development expenses for the year ended December 31, 2021, were $13.6 million as compared to $9.8 million in 2020, an increase of $3.8 million primarily attributable to the increased investment in clinical studies to support the commercialization of the portfolio of tests in the pipeline.

General and administrative expenses for the three months ended December 31, 2021 were $4.1 million, as compared to $3.4 million for the same period in 2020, an increase of approximately $0.7 million. General and administrative expenses for the year ended December 31, 2021, were $22.3 million, as compared to $16.8 million for the same period in 2020, an increase of $5.5 million, primarily attributable to personnel growth and related expenses.

Sales and Marketing expenses for the three months ended December 31, 2021 were $3.3 million, as compared to $1.9 million for the same period in 2020. For the full year 2021, sales and marketing expenses were approximately $11.2 million, as compared to $6.5 million for the full year 2020, primarily attributable to an increase in headcount and continued ramp in sales and marketing activities to support our continued commercialization efforts of our diagnostic tests.

GAAP loss from operations, as reported, for the three months ended December 31, 2021 was $35.7 million, as compared to a GAAP loss of $6.3 million the fourth quarter of 2020. Operating loss, on an adjusted basis, was $5.3 million for the fourth quarter of 2021, as compared to operating losses of $6.2 million for the fourth quarter of 2020. GAAP loss from operations, as reported, for the year ended December 31, 2021, was $74.2 million, as compared to $29.7 for the full year 2020. Operating loss, on an adjusted basis, was $33.2 million, as compared to an operating loss of $26.5 million for the full year 2020. The principal difference between GAAP and non-GAAP operating losses is the "Change in fair value of contingent consideration" related to the acquisition of Chronix Biomedical in 2021. This increase in Fair Value reflects a favorable risk-adjustment for the CNI product line and the likelihood of larger milestone payments to Chronix shareholders based on an increase in Oncocyte’s predicted revenues. This benefits Oncocyte’s shareholders because of the potential increase in expected revenues.

Oncocyte has provided a reconciliation between GAAP and non-GAAP operating losses in the financial tables, included with this earnings release, which it believes is helpful in understanding its ongoing operations.

For the fourth quarter ended December 31, 2021, Oncocyte reported a net loss of $35.9 million, or ($0.39) per share, as compared to $6.3 million, or ($0.09) per share, for the fourth quarter ended December 31, 2020.

For the year ended December 31, 2021, Oncocyte reported a net loss of $64.1 million, or ($0.72) per share, compared to $29.9 million, or ($0.46) per share for 2020.

Net cash used in operations was approximately $7.1 million for the fourth quarter of 2021.

Conference Call Information

The Company will host a conference call today, March 10th at 4:30 pm EDT / 1:30 pm PDT to discuss the results along with recent corporate developments. The dial-in number in the U.S./Canada is 1-877-407-9716; for international participants, the number is 1-201-493-6779. For all callers, please refer to Conference ID: 13726740. To access the live webcast, go to the investor relations section on the Company’s website, or by clicking here View Source;tp_key=769c96014b. A webcast replay will be available on the Oncocyte website for 90 days following the completion of the call.

On March 10, 2022 Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage biopharmaceutical company pioneering the development of exosome-based therapeutics as a new class of medicines, reported fourth quarter and full year 2021 financial results and recent operational progress (Press release, Codiak Biosciences, MAR 10, 2022, View Source [SID1234609889]).

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"We are making a strong start in 2022 thanks to progress with our development programs in 2021 and into this year, and plan to report clinical data for two of our engineered exosome therapeutic candidates and initiate clinical development for a third candidate all in the first half of the year," said Douglas E. Williams, Ph.D., President and CEO of Codiak. "The platform we’ve developed at Codiak allows us to deliver multiple classes of therapeutics with a high degree of precision to specific cells and our clinical data from two programs has already shown promising safety and predictable PK/PD relationships. The emergence of programs in vaccines and gene delivery highlight the breadth of opportunity across multiple therapeutic areas with the engEx platform."

Fourth Quarter 2021 and Recent Highlights

Reported positive initial data from dose cohorts 1-3 in the Phase 1/2 clinical trial of exoSTING (CDK-002) for the treatment of advanced/metastatic, recurrent and injectable solid tumors; progressed subject dosing to cohorts 4 and 5 and follow up in all dose cohorts

Advanced cutaneous T cell lymphoma (CTCL) portion of Phase 1 trial of exoIL-12 (CDK-003)

Filed and received U.S. FDA clearance of Investigational New Drug (IND) application for exoASO-STAT6 (CDK-004) for the intravenous treatment of hepatocellular carcinoma

Presented three abstracts at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2021), including new preclinical data on exoASO-STAT6 in hepatocellular carcinoma, exoSTING in leptomeningeal disease and the combination of exoSTING and exoIL-12 in solid tumors

Announced new preclinical data from the exoVACC exosome-based vaccine platform at the World Vaccine & Immunotherapy Congress (WVIC) 2021

Published a manuscript describing the full exoASO-STAT6 preclinical program in the American Association for the Advancement of Science’s journal, Science Advances

Anticipated Milestones and Events

Safety, PK, PD, and objective response rate (ORR) data from dose escalation cohorts 1-5 in the Phase 1/2 trial of exoSTING and recommended Phase 2 dose expected in late 1H 2022

First-in-human dosing for exoASO-STAT6 in a Phase 1 clinical trial in hepatocellular carcinomas anticipated in 1H 2022

Initial safety, PK/PD and efficacy data in CTCL patients in the Phase 1 clinical trial of exoIL-12 anticipated in late 1H 2022. While COVID-related restrictions in the UK that impacted clinical trial sites last year are abating, Codiak continues to work with those sites to explore options to facilitate enrollment.

Poster presentation of preclinical data for exoASO-C/EBPß, a proprietary engineered exosome loaded with antisense oligonucleotides targeting C/EBPß, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, to be held April 8-13, 2022

Presentation of new preclinical data from the exoVACC pan-beta coronavirus vaccine program, as part of Codiak’s collaboration with the Ragon Institute, at the World Vaccine Congress, to be held April 18-21, 2022

Fourth Quarter and Full Year 2021 Financial Results

Total revenues for the quarter ended December 31, 2021 were $7.7 million, compared to $1.6 million for the same period in 2020. Total revenues for the year ended December 31, 2021 were $22.9 million, compared to $2.9 million for the same period in 2020. These increases were primarily driven by revenue recognized from the Jazz collaboration for $10.9 million as a result of the mutual decision to discontinue work on STAT3 in Q1 2021 and the early termination of the research agreement with Sarepta, for $7.0 million in Q4 2021.

Net income for the quarter ended December 31, 2021 was $16.7 million, compared to a net loss of $18.0 million for the same period in 2020. Net loss for the year ended December 31, 2021, was $37.2 million, compared to a net loss of $91.7 million for the same period in 2020. The decrease in net loss for the fourth quarter and year was driven primarily by a gain on disposition of $33.3 million related to the agreement with Lonza, as well as collaboration revenue recognition in 2021.

Research and development expenses were $17.4 million for the quarter ended December 31, 2021, compared to $13.3 million for the same period in 2020. The increase in research and development expenses for the quarter was driven primarily by an increase in personnel-related costs and ongoing development of the engEx Platform.

Research and development expenses were $64.9 million for the year ended December 31, 2021, compared to $74.0 million for the same period in 2020. The year-over-year decrease was primarily driven by a licensing payment to Kayla Therapeutics in September 2020, offset by increases in clinical development costs for exoIL-12, exoSTING, and exoASO-STAT6 in 2021.

General and administrative expenses were $6.9 million for the quarter ended December 31, 2021, compared to $5.9 million for the same period in 2020. General and administrative expenses were $27.6 million for the year ended December 31, 2021, compared to $19.9 million for the same period in 2020. These increases were driven primarily by an increase in personnel costs and costs associated with transitioning to a public company.

As of December 31, 2021, Codiak had cash and cash equivalents of approximately $76.9 million.

On March 10, 2022 Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported financial results for the fourth quarter and year ended December 31, 2021 (Press release, Corvus Pharmaceuticals, MAR 10, 2022, View Source [SID1234609888]).

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"We continue to advance three clinical programs for novel product candidates targeting CD73, the adenosine 2A receptor, and ITK, which are involved in immune response to cancers and other diseases," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We have established sound scientific foundations for our product candidates, which give us confidence as we initiate mid-stage clinical trials in front-line treatment of lung cancer and renal cell cancer. In addition, our partnership with Angel Pharmaceuticals has expanded the clinical development of CPI-818 for T cell lymphomas into China and is accelerating global development of this product candidate."

Mupadolimab (anti-CD73)

The Company plans to initiate a randomized Phase 2 clinical trial evaluating mupadolimab as a front-line therapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC). The randomized, blinded trial will compare standard chemotherapy plus pembrolizumab (anti-PDL-1) with or without mupadolimab. The Company intends to enroll approximately 150 patients with any tumor PDL-1 expression in the clinical trial, potentially addressing a large patient population. The primary endpoint for the study will be progression free survival and secondary endpoints will evaluate objective response rate and overall survival.
The Company continues to enroll its two Phase 1b/2 clinical trial expansion cohorts of patients with (1) head and neck cancers that have failed previous treatment with anti-PD-1 therapy and chemotherapy and (2) relapsed refractory NSCLC who have failed previous treatment with anti-PD(L)-1 therapy and chemotherapy. Up to 15 patients will be enrolled in each expansion cohort and initial results are anticipated to be presented in the second half of 2022.
In November 2021, the Company presented results from its Phase 1/1b clinical trial that, along with pre-clinical data, provided further evidence regarding mupadolimab’s mechanism of action and its potential anti-tumor activity in cancer patients. The data showed that mupadolimab doses of 12mg/kg or greater, resulted in complete occupancy of the CD73 target and B cell activation. In the assessment of anti-tumor activity in sixteen evaluable patients receiving the 12mg/kg or greater doses of mupadolimab, tumor regression (not meeting the threshold for partial response by RECIST) was seen in five patients who had progressive disease as the best response to most recent prior therapy, which included anti-PD(L)1. We believe these interim findings support mupadolimab’s potential to cause tumor regression in patients with tumors refractory to anti-PD(L)1.
CPI-818 (selective ITK inhibitor)

The Company’s partner in China, Angel Pharmaceuticals, initiated patient enrollment in a Phase 1/1b clinical trial of CPI-818 for the treatment of refractory T cell lymphomas. Angel Pharmaceuticals is responsible for all expenses related to conducting the clinical trial in China.
The Company continues to enroll patients in its Phase 1/1b clinical trial, which was expanded to include patients with certain types of T cell leukemias in addition to T cell lymphomas.
Based on interim results observed in patients with peripheral T cell lymphoma (PTCL) in these Phase 1/1b clinical trials, the Company believes such results could provide the foundation for a potential global phase 2 clinical trial in advanced PTCL.
Ciforadenant (adenosine 2a receptor antagonist)

The Company plans to collaborate with the Kidney Cancer Clinical Trials Consortium to initiate an open-label Phase 2 clinical trial evaluating ciforadenant as a first-line therapy for metastatic renal cell cancer (RCC) in combination with ipilimumab (anti-PD-1) and nivolumab (anti-CTLA-4). The clinical trial will enroll up to 60 patients and is intended to evaluate the potential for ciforadenant to generate increased complete responses and deep responses in the front-line setting. The Kidney Cancer Clinical Trials Consortium is comprised of a group of leading cancer centers in the United States led by investigators at MD Anderson. The trial design is based on Corvus’ preclinical research published in 2018 in Cancer Immunology Research that demonstrated impressive antitumor control and cures in several animal models using ciforadenant in combination with anti-CTLA4 and anti-PD1.
The Company continues to advance its understanding of the Adenosine Gene Signature biomarker, which has been confirmed by other groups as a means to identify an unfavorable group of renal cell cancer patients. Tumor biopsies from the Phase 2 clinical trial will be evaluated for expression of the Adenosine Gene Signature.
Financial Results
As of December 31, 2021, Corvus had cash, cash equivalents and marketable securities totaling $69.5 million compared to $44.3 million as of December 31, 2020. Corvus expects full year 2022 net cash used in operating activities to be between $34 million and $36 million.

Research and development expenses for the three months and full year ended December 31, 2021 totaled $4.8 million and $29.1 million, respectively, compared to $7.2 million and $31.8 million for the same periods in 2020. In the fourth quarter of 2021, the decrease of $2.4 million was primarily due to a decrease in clinical trial and personnel costs.

Net loss for the three months and full year ended December 31, 2021 was $9.2 million and $43.2 million, respectively, compared to net income of $27.3 million and a net loss of $6.0 million for the same periods in 2020. Results for the year ended December 31, 2020 included a $37.5 million gain from the deconsolidation of Angel Pharmaceuticals. Total stock compensation expense for the three months and year ended December 31, 2021 was $0.7 million and $4.2 million, respectively, compared to $1.2 million and $5.7 million for the same periods in 2020.

Conference Call and Webcast
Corvus will host a conference call and webcast today, March 10, 2022, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the fourth quarter and full year 2021 financial results. The conference call can be accessed by dialing 1-877-407-0784 (toll-free domestic) or 1-201-689-8560 (international) and using the conference ID 13727689. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.