On March 24, 2021 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, 2020 (Press release, Sana Biotechnology, MAR 24, 2021, View Source [SID1234584003]).

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"Engineering cells, whether done in vivo or ex vivo, has the potential to transform outcomes for patients across many diseases. We are excited about our significant progress in 2020 in turning this vision into a reality – continuing to build our scientific team, expanding our technology with key acquisitions and licenses, and generating important data across multiple platforms and programs," said Steve Harr, Sana’s President and Chief Executive Officer. "With the completion of our initial public offering in February, we have additional capital to execute our long-term vision of engineering cells to treat serious diseases such as cancer, various genetic disorders, type 1 diabetes, heart disease, and central nervous system diseases. We look forward to providing updates at multiple scientific conferences throughout the year and driving our multiple programs toward the clinic."

Recent Corporate Highlights

Hired key talent to our senior leadership team, including Ed Rebar, Ph.D., Chief Technology Officer, Terry Fry, M.D., Head of T Cell Therapeutics, and Ke Liu, M.D., Ph.D., Head of Regulatory Affairs & Strategy.
Entered into an exclusive license agreement with Washington University for certain intellectual property rights related to methods of generating, compositions of, and use of cells of endodermal lineage and beta cells.
Acquired Oscine Corp., a privately-held early stage biotechnology company developing glial progenitor cells focused on brain disorders to complement our broader ex vivo cell engineering platform.
Expanded our Board of Directors with the addition of Joshua Bilenker, M.D., former CEO of Loxo Oncology, Alise Reicin, M.D., CEO of Tectonic Therapeutic, and Michelle Seitz, CFA, Chairman and CEO of Russell Investments.
Entered into a non-exclusive license and development agreement with FUJIFILM Cellular Dynamics, Inc. (FCDI) for access to FCDI induced pluripotent stem cells (iPSCs).
Further strengthened our balance sheet with net proceeds of $626.6 million from the sale of 27 million shares of common stock in our initial public offering, bringing pro forma cash to over $1 billion as of February 28, 2021.
Fourth Quarter and 2020 Financial Results

GAAP Results

Cash Position: Cash, cash equivalents, and marketable securities as of December 31, 2020 were $412.0 million compared to $139.0 million as of December 31, 2019, an increase of $273.0 million. During the year ended December 31, 2020, Sana sold 27.2 million shares of its Series B convertible preferred stock at $16.00 per share for gross proceeds of $435.5 million.
Research and Development Expenses: Research and development expenses for the quarter and year ended December 31, 2020, inclusive of non-cash expenses, were $104.1 million and $257.9 million, respectively, compared to $39.3 million and $119.4 million for the same periods in 2019. The increases of $64.8 million and $138.5 million were primarily due to personnel-related expenses related to increased headcount to expand Sana’s research and development capabilities, costs for laboratory supplies and preclinical studies, and facility costs. The increase was also due to non-cash expenses for the increase in the estimated fair value of the success payment liabilities of $31.0 million and $70.2 million for the quarter and year ended December 31, 2020, respectively, and the increase in the estimated fair value of the contingent consideration of $33.8 million and $34.9 million for the quarter and year ended December 31, 2020, respectively. The increases in 2020 were offset by higher costs incurred in 2019 for the acquisition of technology. Research and development expense included stock-based compensation of $2.3 million and $4.9 million for the quarter and year ended December 31, 2020, respectively, and $0.4 million and $1.2 million for the same periods in 2019.
General and Administrative Expenses: General and administrative expenses for the quarter and year ended December 31, 2020, inclusive of non-cash expenses, were $9.2 million and $28.3 million, respectively, compared with $5.8 million and $21.8 million for the same periods in 2019. The increases of $3.4 million and $6.5 million for the quarter and year ended December 31, 2020, respectively, were primarily due to increased personnel-related expenses attributable to an increase in headcount to build our infrastructure, facility costs, and consulting fees.
Net Loss: Net loss for the quarter and year ended December 31, 2020 was $113.2 million, or $7.40 per share, and $285.3 million, or $21.92 per share, respectively. This compares to $43.0 million, or $4.94 per share, and $130.8 million, or $26.68 per share for the same periods in 2019.
Non-GAAP Measures

Non-GAAP Operating Cash Burn: Non-GAAP operating cash burn for the quarter and year ended December 31, 2020 was $37.8 million and $125.0 million, respectively, compared to $27.9 million and $76.2 million for the same periods in 2019. 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 quarter and year ended December 31, 2020 were $36.5 million and $123.0 million, respectively, and $28.3 million and $72.1 million for the same periods in 2019. Non-GAAP research and development expense excludes one-time costs to acquire technology and non-cash expenses related to the change in the estimated fair value of its contingent consideration and success payments.
Non-GAAP Net Loss: Non-GAAP net loss for the quarter and year ended December 31, 2020 was $45.5 million, or $2.98 per share, and $150.4 million, or $11.56 per share, respectively. This compares to $32.1 million, or $3.68 per share, and $83.5 million, or $17.04 per share, respectively, for the same periods in 2019. Non-GAAP net loss excludes one-time costs to acquire technology and non-cash expenses related to the change in the estimated fair value of its contingent consideration and success payments.
A discussion of non-GAAP measures, including a reconciliation of GAAP and non-GAAP measures, is presented below under "Non-GAAP Financial Measures."

On May 24, 2021 Hutchison China MediTech Limited ("HUTCHMED") (Nasdaq/AIM: HCM) reported that it has reached an agreement with GL Mountrose Investment Two Limited, a company controlled and managed by GL Capital Group ("GL Capital"), to sell its entire indirect interest in Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited ("HBYS"), a non-core and non-consolidated over-the-counter ("OTC") drug joint venture business (Press release, Hutchison China MediTech, MAR 24, 2021, View Source [SID1234583629]).

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"HUTCHMED’s focus is the discovery and development of novel therapies in oncology and immunology. Over the past 20 years, we have invested in establishing one of the leading innovation-driven, global biopharmaceutical companies based in China," said Simon To, Chairman of HUTCHMED. "The sale of our shares in HBYS, and exit from the OTC drug arena, will allow us to focus our organization and resources on our primary aim of accelerating investment in our Oncology/Immunology assets in China and beyond."

Jeffrey Li, Founder and Chief Executive Officer of GL Capital, said, "As a long-term shareholder and supporter of HUTCHMED, GL is pleased to acquire its share in one of the best-known OTC businesses in China. This transaction is in-line with GL’s strategy of building a leadership position in the OTC drug area to serve patients’ needs for self-medication and cost containment of their overall healthcare budget."

The aggregate amount to be received by HUTCHMED of approximately $169 million in cash represents about 22 times HBYS’ adjusted net profit attributable to HUTCHMED equity holders of $7.7 million in 20201. Of the proceeds, approximately $127 million is related to its shareholding in HBYS with the approximately $42 million balance related to distributions of the previously announced land compensation and prior year undistributed profits.

A deposit of $15.9 million is payable by GL Capital immediately following signing of the agreement which will be credited against the proceeds due on closing of the transaction. The transaction is subject to regulatory approval in China and is expected to close in mid-2021.

On March 24, 2021 Cello Therapeutics reported new study published in Nature Communications, has shown how their novel nano-sized formulation can inhibit tumor growth and metastasis in multiple mouse models of solid tumors [1]. Cancer remains one of the main causes of morbidity and mortality globally (Press release, Cello Therapeutics, MAR 24, 2021, View Source [SID1234577776]). Solid tumors, in particular, make up ~90% of all newly diagnosed cancer cases as well as cancer deaths [2]. Despite the potential for a surgical "cure," residual and metastatic diseases remain a significant issue. New treatment options such as immunotherapy are urgently needed to control and eliminate these tumors. Breast, colorectal, lung, and prostate cancers, in particular, account for nearly 50% of all new cancer cases in the United States and are responsible for almost 50% of all deaths due to cancer. As the second overall leading cause of death, cancer presents a pressing issue in healthcare affecting a significant portion of the US population.

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Immunotherapy has emerged as an effective therapeutic approach against cancer that harnesses the power of immune cells and the body’s own immune system. Some recent approaches, including immune checkpoint inhibitors and adoptive transfer of chimeric antigen receptor (CAR) T cells, have shown considerable promise. However, each still has its disadvantages. For example, checkpoint inhibitors are oftentimes associated with severe systemic side effects and only benefit a subset of patients with tumors expressing specific receptors, while CAR T therapy has not fared well against solid tumors despite its success in hematological cancers. In particular, systemic administration of such immunotherapies can result in toxicities in the respiratory, GI, hepatic, pulmonary, endocrine, and neurological systems. To overcome such challenges, intratumoral injection is becoming more common as a mode of administration. The localization of immune-activating agents can help to kick start antitumor immunity while reducing their systemic exposure.

Cello Therapeutics combines immunotherapy and localized administration with an innovative approach. Taking cues from nature, Cello has developed a nanoparticle formulation that mimics platelets in their ability to bind to tumors and the tumor microenvironment. Platelets have been implicated in many disease pathologies, including tumor progression. Previous studies have shown that platelets naturally bind to both cancer cells and components of the tumor microenvironment. In addition, platelets have even been shown to facilitate metastasis by binding to circulating tumor cells and "hiding" them from detection.

Cello’s nanoparticles, which are approximately 1,000 times smaller than the width of a strand of human hair in size, are coated with membrane derived from natural platelets. This membrane coating enables the nanoparticles to bind and be retained at the tumor site much longer than fully synthetic nanoparticles, providing greater opportunity for encapsulated payloads to accomplish their intended effect.

In our recent publication in Nature Communications, Cello used these platelet membrane-coated nanoparticles loaded with an immune-stimulating molecule to treat models of colorectal and breast cancer. When administered locally via intratumoral injection, the nanoparticles, dubbed "PNP-R848 (Fig. 1)," exhibited an impressive antitumor immune response.

Transmission electron microscopy
Fig. 1. Transmission electron microscopy image of PNP-R848 (left). Scale bar = 50 nm. Final lyophilized and fill-finished formulation of PNP-R848 (right).

In the colorectal cancer model, PNP-R848 not only entirely eradicated the tumor, but it also induced a sustained long term immunity (Fig. 2). Mice that had been treated initially with PNP-R848 were rechallenged not once, but twice, with increasing tumor burdens. The mice were able to completely reject and kill these tumors without any additional PNP-R848 treatments, suggesting that treatment with PNP-R848 has the potential to prevent future recurrence of the cancer.

Survival Curve
Fig. 2. Survival curve of colorectal cancer-bearing mice after treatment with vehicle, free R848, PEG-NP-R848, or PNP-R848.

In an aggressive metastatic breast cancer model, administration of PNP-R848 was able to significantly inhibit tumor growth compared with free drug or drug loaded into purely synthetic particles. In addition, treatment with PNP-R848 was able to substantially reduce the number of metastatic nodes found in the mice, indicating that localized administration of PNP-R848 is able to induce a system-wide specific immune response against the tumor (Fig. 3).

Tumor Growth Inhibition
Fig. 3. Tumor growth inhibition (left) and quantification of metastatic nodes (right) in breast cancer-bearing mice after treatment with vehicle, free R848, PEG-NP-R848, or PNP-R848.

The nanoparticles are able to generate a superior antitumor immune effect compared to either free drug or PEGylated nanoparticles likely due to their enhanced retention at the tumor site. Upon injection, the PNP-R848 remains at the tumor site, where it is taken up by resident antigen presenting cells (APCs). Once taken up, the PNP-R848 releases its cargo, which activates the APCs. The activated APCs then migrate to the nearest lymph node, where they train other immune cells, called T cells, to recognize and fight the cancer. Some T cells return to the tumor site to battle the tumor, while others circulate and surveil in the body to eliminate any tumor cells that escaped from the original tumor site. The overall mechanism can be seen in Fig. 4.

Antitumor Mechanism
Fig. 4. Schematic representation of PNP-R848’s antitumor mechanism. I.T.: intratumoral, APCs: antigen presenting cells.

Combining the benefits of both manmade and natural materials, the development of therapeutic approaches based on the modification of synthetic nanoparticles with natural cell membranes represents an important advancement in the field of nanomedicine. The ability of PNP-R848 to retain at the tumor site and promote a specific and sustained systemic antitumor immune response is a promising step towards a generalizable cure for cancer.

Cello is currently scaling up manufacturing of PNP-R848 and evaluating its safety profile in preparation for clinical trials.

On March 24, 2021 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated immuno-oncology therapeutics for patients, reported financial results for the fourth quarter and full year ended December 31, 2020 and provided recent business highlights (Press release, iTeos Therapeutics, MAR 24, 2021, View Source [SID1234577161]).

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"In 2020, we laid a strong foundation, growing our leadership team and completing an IPO in July that solidified our cash position to support our clinical trials and operations into the second half of 2023. We are making strong progress advancing the Phase 1/2a trials for our two lead clinical candidates, inupadenant, our adenosine A2A receptor antagonist, and EOS-448, our anti-TIGIT antibody. We look forward to reporting initial data for our TIGIT program at the upcoming AACR (Free AACR Whitepaper) Annual Meeting in April, followed by updated data from our expansion cohorts for inupadenant later this year," said Michel Detheux, PhD, president and chief executive officer of iTeos. "As we approach multiple near-term clinical milestones, we also continue to leverage our deep knowledge of the tumor microenvironment to perform rigorous preclinical evaluations to grow our pipeline of highly differentiated immuno-oncology therapeutics and expect to nominate an additional product candidate by year-end."

Program Highlights

Inupadenant (EOS-850): Designed as a highly selective small molecule insurmountable antagonist of the adenosine A2A receptor, or A2AR, to inhibit the adenosine pathway which is a key driver of immunosuppression in the tumor microenvironment across a broad range of tumors. Currently in a multi-arm Phase 1/2a clinical trial in adult patients with advanced solid tumors.

The company is currently enrolling patients in three distinct cohorts in its Phase 1/2a study as both a monotherapy and in combination. The initial cohort is evaluating inupadenant as a monotherapy in a basket of cancers, and the second cohort is evaluating the safety of inupadenant in combination with pembrolizumab in patients with solid tumors. The final cohort is evaluating inupadenant in combination with chemotherapy in patients with triple-negative breast cancer.
Updated single-agent data, including results from tumor biopsy analyses, and initial pembrolizumab combination data are expected to be reported later in 2021.
EOS-448: Antagonistic antibody specifically designed to target TIGIT (T-cell immunoreceptor with Ig and ITIM domains), a checkpoint with multiple mechanisms leading to immunosuppression. EOS-448 was also selected to engage the Fc gamma receptor, or FcγR, and enhance the anti-tumor response through a multifaceted immune modulatory mechanism. These mechanisms include the activation of macrophages and dendritic cells and the promotion of antibody-dependent cellular cytotoxicity, or ADCC, leading to the selective depletion of cells which express high levels of TIGIT including immunosuppressive regulatory T cells and exhausted T cells. Currently in a Phase 1/2a clinical trial in multiple advanced solid tumors.

Enrollment in the dose escalation portion of the study has now been completed. Following the determination of the recommended Phase 2 dose, the company expects to begin trials in mid-2021 to evaluate EOS-448 in combination with pembrolizumab, an anti-PD-1 antibody, in combination with inupadenant, and in other combinations in specific tumor types.
The company will present initial clinical and safety data as part of a late-breaking e-poster at the first session of the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held virtually April 10-15, 2021. The poster will go live on Saturday, April 10th at 8:30 a.m. ET, and company management will hold a call on Monday, April 12th at 8:00 a.m. ET to discuss the results.
Abstract Title: CT118 – Preliminary data from Phase I first-in-human study of EOS884448, a novel potent anti-TIGIT antibody, monotherapy shows favorable tolerability profile and early signs of clinical activity in immune-resistant advanced cancers.
Abstract Number: IO-002-Abst-001
Preclinical programs: The company continues to progress research programs focused on additional targets that complement the mechanism of action of A2AR and TIGIT programs or address additional pathways of immunosuppression. The company is optimizing its screening and selection process to identify potential product candidates and expects to nominate an additional product candidate for Investigational New Drug-enabling studies before the end of 2021.

Upcoming Events

American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 10-15, 2021
Kempen Life Sciences Conference – European Immuno and Targeted Oncology, April 21, 2021
Jefferies Healthcare Conference, June 1-4, 2021
Fourth Quarter and Full Year 2020 Financial Results

Cash Position: The Company’s cash and cash equivalent position was $336.3 million as of December 31, 2020, as compared to $19.9 million as of December 31, 2019. Cash balance provides runway into second half of 2023.
Research and Development (R&D) Expenses: R&D expenses were $9.2 million for the quarter and $29.9 million for the full year ended December 31, 2020, as compared to $6.0 million for the fourth quarter and $19.2 million for the full year of 2019. The increase was primarily due to an increase in activities related to clinical trials for inupadenant and EOS-448.
General and Administrative (G&A) Expenses: G&A expenses were $5.7 million for the quarter and $15.3 million for the full year ended December 31, 2020, as compared to $2.3 million for the fourth quarter and $8.8 million for the full year of 2019. The increase in both periods was primarily due to increased headcount and professional fees associated with becoming a publicly traded company.
Net Loss: Net loss attributable to common shareholders was $14.9 million, or a net loss of $0.43 per basic and diluted share, for the quarter ended December 31, 2020, as compared to $6.6 million, or a net loss of $23.30 per basic and diluted share, for the fourth quarter of 2019. Net loss was $43.4 million, or a net loss of $2.88 per basic and diluted share, for the year ended December 31, 2020, as compared to $26.5 million, or a net loss of $130.85 per basic and diluted share, for the full year of 2019.

On March 24, 2021 Celyad Oncology SA (Euronext & Nasdaq: CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer (the Company), reported its consolidated financial results for fiscal year 2020 ended December 31, 2020 and provided a business update (Press release, Celyad, MAR 24, 2021, View Source [SID1234577160]).

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"The past twelve months have proven to be an evolutionary period in our Company’s history, as we prioritized our resources for the advancement of our allogeneic portfolio and technology platforms. We believe the development of our differentiated non-gene edited allogeneic therapies to treat both solid tumors and hematological malignancies offers the biggest potential opportunity for patients and our shareholders by potentially expediting and expanding patient access to novel treatment options," commented Filippo Petti, Chief Executive Officer of Celyad Oncology SA. "This past January, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Gastrointestinal Cancers Symposium, we presented encouraging translational data from our ongoing alloSHRINK study, which complements the previously reported tolerability and clinical activity data for CYAD-101 in patients with advanced mCRC. Today, we are excited to disclose initial data from our lead shRNA-based allogeneic program CYAD-211 for relapsed/refractory multiple myeloma. As we look ahead, we expect a data rich calendar year with updates across all three of our clinical candidates as well as the start of the Phase 1b KEYNOTE-B79 trial, positioning 2021 to be a defining year for the advancement of our clinical pipeline."

Recent Highlights

Entered into a committed equity purchase agreement for up to $40 million with Lincoln Park Capital Fund, LLC, a Chicago-based institutional investor
Appointed Marina Udier, Ph.D., a highly regarded leader in the biotechnology industry, to the Company’s Board of Directors
Update on Clinical and Preclinical Program

CYAD-211 – Allogeneic shRNA-based, anti-BCMA CAR T for r/r MM

CYAD-211 is a first-in-class, allogeneic CAR T candidate engineered to co-express a BCMA-targeting chimeric antigen receptor and a single shRNA, which interferes with the expression of the CD3ζ component of the T-cell receptor (TCR) complex. In November 2020, the Company initiated the first-in-human, open-label, dose-escalation Phase 1 IMMUNICY-1 trial to evaluate the safety and efficacy of a single infusion of CYAD-211 following preconditioning chemotherapy cyclophosphamide and fludarabine in patients with relapsed/refractory (r/r) multiple myeloma (MM). The trial seeks to determine the recommended dose of CYAD-211 for the treatment of patients with r/r MM for further development as well as to establish proof-of-concept that single shRNA-mediated knockdown can generate allogeneic CAR T cells in humans without inducing Graft-versus-Host Disease (GvHD).

To date, no safety concerns or evidence of GvHD have been reported in the first three patients treated at dose level 1 (30×106 million cells per infusion) of CYAD-211 in the IMMUNICY-1 trial. Enrollment in dose level 2 (100×106 million cells per infusion) is currently ongoing.

CYAD-101 – Allogeneic TIM-based NKG2D CAR T for mCRC

The Company’s first-in-class, non-gene edited clinical candidate, CYAD-101, which co-expresses the NKG2D receptor and the novel inhibitory peptide TIM (TCR Inhibitory Molecule), continues to advance in the expansion segment of the alloSHRINK Phase 1 trial for the treatment of advanced metastatic colorectal cancer (mCRC). In January 2021, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Gastrointestinal Cancers Symposium, the Company presented additional positive data from the alloSHRINK trial including median overall survival (mOS) of 10.6 months for the dose-escalation segment of the study as well as tumor burden decrease, according to RECIST 1.1 criteria, observed in eight of 15 patients, including six of nine patients at dose level 3. To our knowledge, CYAD-101 is the first investigational allogeneic CAR T candidate to generate evidence of clinical activity for the treatment of a solid tumor indication.

In December 2020, the Company initiated the expansion segment of the alloSHRINK trial, which is evaluating CYAD-101 following FOLFIRI (combination of 5-fluorouracil, leucovorin and irinotecan) preconditioning chemotherapy in refractory mCRC patients, at the recommended dose of one billion cells per infusion. The Company also plans to initiate the Phase 1b KEYNOTE-B79 trial, which will evaluate CYAD-101, following FOLFIRI preconditioning chemotherapy, with Merck’s PD-1 therapy, KEYTRUDA (pembrolizumab), in refractory mCRC patients with microsatellite stable (MSS) / proficient mismatch repair (pMMR) disease. The Company believes the mechanism of actions of CYAD-101 and KEYTRUDA are highly complementary and could help to drive additional clinical benefit in patients with advanced metastatic colorectal cancer.

CYAD-02 – Autologous NKG2D receptor-based CAR T for r/r AML and MDS

In November 2019, the Company initiated the dose-escalation Phase 1 CYCLE-1 trial, evaluating the safety and clinical activity of the next-generation, autologous NKG2D receptor-based CAR T candidate CYAD-02 following preconditioning chemotherapy in patients with relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The next-generation, NKG2D receptor-based CAR T candidate CYAD-02 incorporates a single shRNA to target the NKG2D ligands MICA and MICB.

To date, nine patients have received treatment with CYAD-02 in the CYCLE-1 trial. Treatment with CYAD-02 has been generally well-tolerated. Of seven patients evaluable for clinical activity, five patients demonstrated anti-leukemic activity (at least 50% bone marrow blasts decrease), including a very-high risk MDS patient treated at dose level 3 who achieved a marrow complete response, which is still ongoing. Enrollment in dose level 3 of the CYCLE-1 trial is currently ongoing.

Next-generation shRNA Multiplex Platform

In 2020, the Company began developing a proprietary shRNA platform utilizing a novel framework to optimize and expand the expression of multiple shRNAs with our All-in-One Vector approach. Our novel framework has the capability to knockdown or silence up to six genes simultaneously, while providing several key advantages beyond our first-generation approach. We believe our next-generation shRNA multiplex platform will form the backbone for our future allogeneic CAR T candidates, including several programs which are in the discovery phase of development.

Upcoming Milestones

Additional proof-of-concept data from the initial dose cohorts of the Phase 1 IMMUNICY-1 trial of CYAD-211 for r/r MM are expected by the end of Q2 2021
Preliminary data from the expansion segment of the alloSHRINK trial evaluating CYAD-101 following FOLFIRI preconditioning chemotherapy in refractory mCRC patients are expected in Q2 2021
Initiation of the Phase 1b KEYNOTE-B79 trial evaluating CYAD-101 with KEYTRUDA in mCRC patients with MSS/pMMR disease is anticipated by in the first half of 2021
Additional data from dose level 3 of Phase 1 CYCLE-1 trial of CYAD-02 for r/r AML and MDS are anticipated in the first half of 2021
Full Year 2020 Financial Results

As of December 31, 2020, the Company had a treasury position of approximately €17.2 million ($21.2 million).

On January 8, 2021, the Company entered into a committed equity purchase agreement (the Purchase Agreement) for up to $40 million with Lincoln Park Capital Fund, LLC (LPC), a Chicago-based institutional investor. Over the 24-month term of the Purchase Agreement, the Company will have the right to direct LPC to purchase up to an aggregate amount of $40 million American Depositary Shares (ADSs), each of which represents one of the ordinary shares of the Company. This equity facility is expected to strengthen the Company’s current statement of financial position while also providing the Company with access to future capital on an as needed basis and to ensure sufficient funding to cover its operations for the next 12 months from the date the financial statements are issued.

Based on the Company’s current scope of activities, the Company estimates that its cash and cash equivalents as of December 31, 2020 combined with the $40 million that the Company has access to from the equity purchase agreement established with LPC should be sufficient to fund operations until mid-2022.

Key financial figures for full-year 2020, compared with full-year 2019, are summarized below:

Selected key financial figures (€ millions) Full year 2020 Full year 2019
Revenue - -
Research and development expenses (21.5 ) (25.2 )
General and administrative expenses (9.3 ) (9.1 )
Change in fair value of contingent consideration 9.2 0.4
Other income/(expenses) 4.6 5.0
Operating loss (17.0 ) (28.9 )
Loss for the period/year (17.2 ) (28.6 )
Net cash used in operations (27.7 ) (28.2 )
Treasury position(1) 17.2 39.3
(1) "Treasury position" is an alternative performance measure determined by adding Short-term investments and Cash and cash equivalents from the statement of financial position prepared in accordance with IFRS.

The Company’s license and collaboration agreements generated no revenue in 2020 and in 2019.

The Research and Development (R&D) expenses show a year-over-year decrease of €3.7 million. The decrease is mainly driven by the decrease in preclinical activities, including process development and clinical development of the autologous programs associated with its r/r AML and MDS product candidates.

General and administrative expenses were €9.3 million in 2020 as compared to €9.1 million in 2019, an increase of €0.2 million. This increase primarily relates to higher insurances costs partly compensated by savings on the travel and living expenses due to COVID-19 pandemic travel restrictions.

The fair value adjustment (€9.2 million) relating to the contingent consideration and other financial liabilities as of December 31, 2020, mainly driven by updated assumptions associated with the timing of the potential commercialization of our autologous AML and MDS program as compared to year-end 2020. The decrease of the liability is also driven by the devaluation of the USD foreign exchange rate as of December 31, 2020.

The Company’s other income is associated with grants received from the Walloon Region mainly in the form of recoverable cash advances (RCAs) and R&D tax credit income:

Grant income (RCAs): additional grant income has been recognized in 2020 on grants in the form of recoverable cash advances (RCAs) for contracts, numbered 7685, 8087, 8088, 8212, 8436 and 1910028. According to IFRS standards, the Company has recognized grant income for the period amounting to €2.3 million and a liability component of €1.3 million accounted as a financial liability;
Grant income (Others): additional grant income has been recognized in 2020 on grants received from the Federal Belgian Institute for Health Insurance INAMI (€0.2 million) and from the regional government (contract numbered 8066 for €0.6 million), not referring to RCAs and not subject to reimbursement;
The remeasurement income on the RCAs of €0.9 million which is mainly related to the Company’s decision to update assumptions associated with the timing of the potential commercialization of our autologous AML and MDS program; and,
With respect to R&D tax credit, the decrease compared to 2020 is mainly related to a catch-up effect for €0.7 million which occurred in 2019 and a decrease on the current year income for €0.2 million due to global decrease on R&D expenses in 2020.
Net loss for the year ended December 31, 2020 was €17.2 million, or €1.23 per share, compared to a net loss of €28.6 million, or €2.29 per share, for the same period in 2019. The decrease in net loss between periods was primarily due to the increase change in fair value of contingent consideration combined with the decrease on the R&D expenses.

Net cash used in operations for the year ended December 31, 2020, which excludes non-cash effects, amounted to €27.7 million, which is in line with net cash used in operations of €28.2 million for the year ended December 31, 2019.

Annual Report 2020

The Annual Report for the year ended December 31, 2020 will be published tomorrow, March 25, 2021, and will be available on the Company’s website, www.celyad.com. The Company’s statutory auditor, EY Bedrijfsrevisoren BV/Reviseurs d’Entreprises SRL (EY), has confirmed that the completed audit has not revealed any material misstatement in the consolidated financial statements. EY also confirmed that the accounting data reported in the press release are consistent, in all material respects, with the consolidated financial statements from which it has been derived.

Conference Call and Webcast Details

A conference call will be held on Thursday, 25 March at 1:00 p.m. CET / 8:00 a.m. EDT to review the financial and operating results for full year 2020. Please dial-in five to ten minutes prior to the call start time using the number and conference ID below: