On November 5, 2021 AstraZeneca reported that it will present new data underscoring its commitment to transforming haematologic cancer care at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, 11 to 14 December 2021 (Press release, AstraZeneca, NOV 5, 2021, View Source [SID1234594577]).

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More than 25 abstracts will feature data across the Company’s haematology portfolio and pipeline, including new analyses from the Calquence (acalabrutinib) Phase III programme such as an oral presentation of three-year follow-up data from the ASCEND Phase III trial in relapsed or refractory chronic lymphocytic leukaemia (CLL).

Overall, data will span over 10 types of blood cancers and related conditions with a focus on CLL, mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL) and acute myeloid leukaemia.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "Our robust Calquence data at ASH (Free ASH Whitepaper) will include an important new formulation designed to expand the pool of patients who may benefit from Calquence. Moreover, data from three Phase III trials will show the sustained efficacy and safety of Calquence, which is central to our commitment to prioritise the patient experience while providing long-term control of the disease in those with chronic lymphocytic leukaemia."

Anas Younes, Senior Vice President, Haematology R&D, AstraZeneca, said: "Testing new ways of overcoming drug resistance and continually pushing for better and deeper responses for patients are core focus areas of our early haematology portfolio. The preclinical data we are presenting at this year’s ASH (Free ASH Whitepaper) meeting for capivasertib and AZD4573 add to the emerging body of evidence showing the potential for new approaches to become the cornerstones of tomorrow’s combination therapies for hard-to-treat blood cancers."

AstraZeneca’s commitment to putting CLL patients first

A risk-benefit analysis showing quality-adjusted time without symptoms or toxicity (Q-TWiST) from the ELEVATE-RR and ASCEND trials in relapsed or refractory CLL will report the difference between Calquence and either ibrutinib or the combination of rituximab with idelalisib or bendamustine, balancing risk (toxicity) and benefit (prolonged survival without symptoms of progression or adverse events)
Data introducing a maleate tablet formulation of Calquence will establish bioequivalence to the current capsule and would enable co-administration with proton pump inhibitors or via nasogastric tube for patients with swallowing challenges, offering an opportunity to provide Calquence to patients for whom it was previously not an option
Further analyses from Calquence Phase III trial programme reinforce long-term safety and efficacy for patients with CLL

An oral presentation will show durable efficacy for Calquence over three years in relapsed or refractory CLL from the ASCEND trial, evaluating the treatment versus investigator’s choice of rituximab combined with either idelalisib or bendamustine
A sub-analysis from the head-to-head ELEVATE-RR trial for Calquence versus ibrutinib in relapsed or refractory CLL will further characterise adverse events related to Bruton’s tyrosine kinase (BTK) inhibition
A matching-adjusted indirect comparison using data from the ELEVATE-TN trial will compare the safety profile of Calquence alone or in combination with obinutuzumab to either ibrutinib monotherapy or venetoclax in combination with obinutuzumab
Emerging pipeline molecules show therapeutic potential in novel combinations

Preclinical data will be presented showing that capivasertib (AZD5363), an AKT inhibitor being evaluated in a number of solid and haematological tumours, showed significant activity in murine DLBCL models when combined with venetoclax. This data continues to broaden our understanding of the role of AKT inhibitors in B-cell non-Hodgkin lymphomas (NHL). Capivasertib monotherapy is being explored in sub-sets of relapsed or refractory B-cell NHL in the CAPITAL Phase II trial
Additionally, new data will demonstrate AZD4573, a highly selective and potent cyclin dependent kinase 9 inhibitor from AstraZeneca’s cell death portfolio, effectively induces apoptosis in vivo in relapsed or refractory MCL xenograft models both alone and when combined with Calquence
Key AstraZeneca presentations during the 63rd ASH (Free ASH Whitepaper) Annual Meetingi

Lead author

Abstract title

Presentation details

Calquence (acalabrutinib)

Jurczak, W

Three-Year Follow-Up of the ASCEND Trial Investigating Acalabrutinib vs Rituximab plus Idelalisib or Bendamustine in Relapsed/Refractory Chronic Lymphocytic Leukemia

Abstract # 393

Oral Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological I

12 December 2021

10:00 ET

Location: Room B401-B402

Seymour, JF

Characterization of Bruton Tyrosine Kinase Inhibitor (BTKi)-Related Adverse Events in a Head-to-Head Trial of Acalabrutinib Versus Ibrutinib in Previously Treated Chronic Lymphocytic Leukemia (CLL)

Abstract # 3721

Poster Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III

13 December 2021

18:00-20:00 ET

Location: Hall B5

Sharma, S

New Acalabrutinib Formulation Enables Co-administration with Proton Pump Inhibitors and Dosing in Patients Unable to Swallow Capsules (ELEVATE-PLUS)

Abstract # 4365

Online only

Davids, MS

MAJIC: A Phase 3 Prospective, Multicenter, Randomized, Open-Label Trial of Acalabrutinib plus Venetoclax versus Venetoclax plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Abstract # 1553

Poster Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster I

11 December 2021

17:30-19:30 ET

Location: Room B5

Davids, MS

Matching-Adjusted Indirect Treatment Comparison (MAIC) of Acalabrutinib Alone or in Combination With Obinutuzumab Versus Ibrutinib or Venetoclax Plus Obinutuzumab in Patients With Treatment-naïve Chronic Lymphocytic Leukemia

Abstract # 2633

Poster Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster II

12 December 2021

18:00-20:00 ET

Location: Room B5

Seymour, JF

A Quality-Adjusted Survival (Q-TWiST) Analysis to Assess Benefit-Risk of Acalabrutinib Versus Idelalisib/Bendamustine Plus Rituximab or Ibrutinib Among Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) Patients

Abstract # 3722

Poster Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III

13 December 2021

18:00-20:00 ET

Location: Room B5

Roschewski, M

Phase 2 Study of Acalabrutinib Window Prior to Frontline Therapy in Untreated Diffuse Large B-cell Lymphoma: Preliminary Results and Correlatives of Response to Acalabrutinib

Abstract # 524

Oral Session: 626. Aggressive Lymphomas Prospective Therapeutic Trials: Novel Agents and Combinations

12 December 2021

16:45 ET

Location: Thomas Murphy Ballroom 1-2

Capivasertib (AZD5363)

Willis, B

Combination benefit of capivasertib and venetoclax in preclinical models of Diffuse Large B-cell Lymphoma

Abstract # 802

Poster Session: 802. Chemical Biology and Experimental Therapeutics: Poster I

11 December 2021

17:30-19:30 ET

Location: Room B5

AZD4573

Roderick, J

AZD4573 effectively induces apoptosis in r/r MCL as a monotherapy or in combination with acalabrutinib

Abstract # 605

Poster Session: 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster II

12 December 2021

18:00-20:00 ET

Location: Room B5

i28 company-sponsored or supported abstracts will be presented at ASH (Free ASH Whitepaper) 2021.

Notes

Calquence
Calquence (acalabrutinib) is a next-generation, selective inhibitor of BTK. It binds covalently to BTK, thereby inhibiting its activity.1,2 In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.1

Calquence is approved for the treatment of CLL and small lymphocytic lymphoma (SLL) in the US, approved for CLL in the EU and several other countries worldwide, and approved in Japan for relapsed or refractory CLL and SLL. A Phase I trial is currently underway in Japan for the treatment of front-line CLL.

In the US and several other countries, Calquence is also approved for the treatment of adult patients with MCL who have received at least one prior therapy. The US MCL indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Calquence is not currently approved for the treatment of MCL in Europe or Japan.

As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluating Calquence in more than 20 company-sponsored clinical trials. Calquence is being evaluated for the treatment of multiple B-cell blood cancers including CLL, MCL, DLBCL, Waldenström’s macroglobulinaemia, follicular lymphoma and other haematologic malignancies.

AstraZeneca in haematology
AstraZeneca is pushing the boundaries of science to redefine care in haematology. Applying our deep understanding of blood cancers and leveraging our strength in solid tumour oncology, we are driving the development of novel therapies designed to target underlying drivers of disease across six scientific platforms.

By addressing blood cancers with high unmet medical needs, our aim is to deliver innovative medicines and approaches to healthcare services that have a meaningful impact on patients and caregivers, transforming the haematologic cancer care experience.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On November 5, 2021 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer, bacterial diseases and viral infections, reported the pricing of its follow-on public offering of 3,428,571 American Depositary Shares ("ADSs"), at a public offering price of $7.00 per ADS, with each such ADS representing one ordinary share, DKK 1 nominal value per share, of Evaxion (the "Ordinary Shares") (Press release, Evaxion Biotech, NOV 5, 2021, View Source [SID1234594593]). The gross proceeds from the offering are expected to be approximately $24.0 million before deducting underwriting fees, commissions and other offering expenses. Evaxion has granted the underwriters an option for a period of 30 days from the date of the final prospectus to purchase an additional 514,285 ADSs at the follow-on public offering price.

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The Company is listed on the Nasdaq Capital Market in the United States and the ADSs trade under the symbol "EVAX". The offering is expected to close on November 9, 2021, subject to the satisfaction of customary closing conditions.

Oppenheimer & Co. Inc. is acting as sole book-running manager for the offering. Ladenburg Thalmann & Co. Inc. is acting as lead manager for the offering and Lake Street Capital Markets, LLC is acting as co-manager for the offering.

The Form F-1 registration statement (the "Registration Statement") was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on November 4, 2021. The offering is being made only by means of a prospectus forming part of the effective Registration Statement. The prospectus will be filed with the SEC and will be available on the SEC’s website at: View Source When available, copies of the final prospectus related to the offering may also be obtained from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, by telephone at 212-667-8055, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

The information contained on, or that may be accessed through, the websites referenced in this press release is not incorporated by reference into, and is not a part of, this press release.

On November 5, 2021 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on sickle cell disease, prostate cancer and other rare hematologic diseases and cancers, reported that it will release third quarter 2021 financial results Friday, Nov. 12, 2021 (Press release, Forma Therapeutics, NOV 5, 2021, View Source [SID1234594608]). Forma management will host an investment community conference call at 8 a.m. Eastern Time, on Nov. 12, 2021 to discuss these financial results and provide a business update.

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Investors may participate by dialing (833) 301-1146 in the U.S. or Canada, or (914) 987-7386 internationally, and by referring to Conference ID 6662686. A live webcast of the conference call will be available in the "News & Investors" section of Forma’s website at www.formatherapeutics.com.

On November 5, 2021 Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported preclinical data for GC502, an allogeneic chimeric antigen receptor (CAR) T cell therapy for the treatment of B-cell malignancies, will be presented as a virtual poster at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition as part of the "Cellular Immunotherapies: Basic and Translational" session on December 11, 2021 from 5:30 p.m.-7:30 p.m.(EST) (Press release, Gracell Biotechnologies, NOV 5, 2021, View Source [SID1234594625]).

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GC502 is a CD19/CD7 dual-directed, stand-alone off-the-shelf allogeneic CAR-T therapy for the treatment of B-cell malignancies developed on Gracell’s proprietary TruUCAR technology platform. The novel dual CAR design allows the CD19 CAR moiety to target malignant cells, while the CD7 CAR moiety is designed to suppress host versus graft (HvG) (rejection) response, enabling GC502 to be a stand-alone therapy. Preclinical results demonstrate robust anti-tumor efficacy and promising potential to suppress HvG disease without the need for additional immunosuppressive therapeutics.

TruUCAR is Gracell’s proprietary technology platform designed to generate high-quality allogeneic CAR-T therapies using T cells from non-HLA matched healthy donors, manufactured in large quantities as "off-the-shelf" products at a lower cost.

"Encouraging preclinical data with GC502 validates the functionality of dual CAR developed on our TruUCAR platform and highlights the potential of our proprietary off-the-shelf, stand-alone allogeneic therapies for a broad range of patients." Said Dr. Xinxin Wang, Vice President, Research and Development at Gracell.

"GC502 displays strong anti-tumor potency and suppression of HvG response in the preclinical study. We look forward to further clinical development of GC502 and expanding our early-stage pipeline with more safe, effective and accessible cell therapies for tough to treat hematological malignancies." Commented Dr. Lianjun Shen, Senior Vice President, Head of Research and Development at Gracell.

Details on the poster presentation are shown below:
2021 63rd ASH (Free ASH Whitepaper) Annual Meeting and Exposition
Abstract 148500: Preclinical Results of an Allogeneic, Universal CD19/CD7-Targeting CAR-T Cell Therapy (GC502) for B Cell Malignancies
Abstract Release Time: 9:00 a.m., November 4, 2021
Presentation Session: Cellular Immunotherapies: Basic and Translational
Poster Presentation Time: 5:30 p.m. – 7:30 p.m., December 11, 2021

About GC502

GC502 is a TruUCAR-enabled CD19/CD7 dual-directed, off-the-shelf allogeneic CAR-T product candidate that is being studied for the treatment of B-cell malignancies, including B-ALL and B-NHL. GC502 is manufactured using T cells from non-HLA matched healthy donors. An enhancer molecule is embedded in the basic construct of TruUCAR to enhance proliferation of TruUCAR T cells. Optimized for CD19/CD7 dual CAR functionality and in vivo durability, GC502 has demonstrated robust anti-tumor efficacy with promising potential to suppress host vs graft (HvG) rejection in preclinical models.

About B-ALL and B-NHL

Acute lymphoblastic leukemia (ALL) is a type of blood cancer characterized by proliferation of immature lymphocytes in the bone marrow, which can involve either T lymphocytes (T-ALL), or B lymphocytes (B-ALL). Globally, approximately 64,000 patients are diagnosed with ALL every year with approximately 6,000 diagnosed in the United States, and approximately 7,400 diagnosed in China in 2020[1]. B-ALL accounts for 85%-88% of ALL diagnoses.

Non-Hodgkin’s lymphoma (NHL) is a group of blood cancers that developed from lymphocytes, most commonly derived from B cells (B-NHL). Globally, approximately 510,000 patients are diagnosed with NHL every year with over 77,000 patients diagnosed in the United States, and approximately 68,000 diagnosed in China in 2020[2]. B-NHL accounts for approximately 85% of NHL diagnoses.

About TruUCAR

TruUCAR is Gracell’s proprietary technology platform and is designed to generate high-quality allogeneic CAR-T cell therapies that can be administered "off-the-shelf" at lower cost and with greater convenience. With differentiated design enabled by gene editing, TruUCAR is designed to control host vs graft rejection (HvG) as well as graft versus host disease (GvHD) without the need for being co-administered with immunosuppressive drugs. The novel dual CAR design allows tumor antigen-CAR moiety to target malignant cells, while the CD7 CAR moiety is designed to suppress host versus graft (HvG) response, enabling TruUCAR T cell to be a stand-alone therapy.

On November 5, 2021 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported financial results for the quarter ended September 30, 2021, and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, NOV 5, 2021, View Source [SID1234594609]).

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"Syros made significant progress this quarter as we executed on important milestones across our portfolios in targeted hematology and CDK inhibition as well as strengthened our leadership team with the additions of Conley Chee as Chief Commercial Officer and Jason Haas as Chief Financial Officer," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "In September, we dosed the first patient in our SELECT-AML-1 Phase 2 trial of tamibarotene, as well as in our dose confirmation study of SY-2101 in APL. Taken together, these accomplishments mark important progress toward potentially offering new standards of care for people living with hematologic cancers and showcase our commitment to building a robust and synergistic portfolio in targeted hematology."

Dr. Simonian continued, "Building on our leadership in selective CDK7 inhibition, we presented encouraging clinical data from our Phase 1 trial of SY-5609. The data demonstrated proof-of-activity across multiple difficult-to-treat tumors and suggest that we have identified an optimal dosing schedule for further development. Based on these results, we plan to evaluate SY-5609 as part of a three-pronged combination strategy in areas of high unmet need that are supported by strong mechanistic rationale and clinical or pre-clinical activity. We expect to initiate an expansion cohort in pancreatic cancer as well as a Phase 1b trial in mantle cell lymphoma in the fourth quarter of 2021 and the first half of 2022, respectively, and look forward to working with Roche to evaluate SY-5609 in combination with its PDL1 inhibitor in BRAF-mutant colorectal cancer."

UPCOMING MILESTONES

Targeted Hematology

Tamibarotene: Oral RARa agonist

Report initial data from SELECT-AML-1 trial in 2022.
SY-2101: Oral arsenic trioxide (ATO)

Report confirmatory dose and pharmacokinetic data from the dose confirmation trial in the first half of 2022.
Initiate Phase 3 trial in newly diagnosed APL patients in 2022.
CDK Inhibition

SY-5609: Oral Selective CDK Inhibitor

Initiate expansion cohort of our SY-5609 trial in combination with chemotherapy in second-line pancreatic cancer in the fourth quarter of 2021.
Initiate Phase 1b trial evaluating SY-5609 in combination with a Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma in the first half of 2022.
Gene Control Discovery Engine

Nominate next development candidate in 2022.
RECENT PIPELINE HIGHLIGHTS

In September, Syros dosed the first patient in its dose confirmation study of SY-2101. The study is designed to evaluate the safety, tolerability, and pharmacokinetics of SY-2101 and is expected to enroll up to 24 newly diagnosed APL patients.
Also in September, Syros dosed the first patient in its SELECT-AML-1 Phase 2 trial to evaluate the safety and efficacy of tamibarotene in combination with venetoclax and azacitidine. Following a safety lead-in, approximately 80 patients will be randomized 1:1 to receive tamibarotene in combination with venetoclax and azacitidine, or venetoclax and azacitidine alone. The primary endpoint is composite complete response rate.
At the 2021 ESMO (Free ESMO Whitepaper) Congress in September, Syros presented new data from its Phase 1 trial of SY-5609 in heavily pretreated patients with select-solid tumors, which demonstrated clinical activity at tolerable doses as a single agent across multiple tumor types:
Thirteen patients achieved stable disease (SD) with tumor regressions of up to 20% in six of those patients, across multiple tumor types.
The most substantial clinical activity was observed in heavily pre-treated patients with advanced pancreatic cancer. Five of 13 of these evaluable patients achieved SD, with tumor reductions in two of those patients.
Across all doses and schedules, the majority of adverse events were low-grade and reversible.
Optimal dosing regimen of 7 days on/7 days off was identified for further evaluation.
Based on these data along with pre-clinical data, strong mechanistic rationale, and high unmet need, Syros is evaluating SY-5609 in a three-pronged combination approach:
Combination with chemotherapy for the treatment of pancreatic cancer.
Combination with a BTK inhibitor for the treatment of mantle cell lymphoma.
Combination with PDL1 inhibitor for the treatment of BRAF-mutant colorectal cancer. As previously disclosed, Syros entered into an agreement with Roche to explore this combination in Roche’s Phase 1/1b INTRINSIC trial.
RECENT CORPORATE HIGHLIGHTS

In October, Syros appointed Jason Haas as Chief Financial Officer. Jason brings more than 25 years of healthcare investment banking and corporate finance experience.
In September, Syros appointed Conley Chee as the Company’s first Chief Commercial Officer. Conley brings 20 years of pharmaceutical sales leadership, marketing, and strategy experience.
Also in September, Syros appointed Deborah Dunsire, M.D., a highly respected industry veteran, to the Board of Directors.
THIRD QUARTER 2021 FINANCIAL RESULTS

Revenues were $5.7 million for the third quarter of 2021, consisting of $5.6 million in revenue recognized under Syros’ collaboration with Global Blood Therapeutics, Inc. (GBT) and $0.1 million recognized under its collaboration with Incyte Corporation (Incyte). Syros recognized $3.8 million in revenue in the third quarter of 2020, including $3.5 million under its collaboration with GBT and $0.3 million under its collaboration with Incyte.
Research and development expenses were $27.3 million for the third quarter of 2021, as compared to $17.7 million for the third quarter of 2020. This increase was primarily due to the continued advancement of Syros’ clinical and preclinical programs and an increase in employee-related expenses.
General and administrative (G&A) expenses were $5.3 million for the third quarter of 2021, as compared to $5.2 million for the third quarter of 2020.
For the third quarter of 2021, Syros reported a net loss of $26.0 million, or $0.41 per share, compared to a net loss of $19.5 million, or $0.43 per share, for the same period in 2020.
Cash and Financial Guidance

Cash, cash equivalents and marketable securities as of September 30, 2021 were $166.7 million, as compared with $174 million on December 31, 2020. This reflects cash used to fund Syros’ operations during the nine months ended September 30, 2021, partially offset by gross proceeds of $75.6 million that Syros received from its January 2021 public offering.

Based on its current plans, Syros believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its planned operating expenses and capital expenditure requirements into 2023.

Conference Call and Webcast

Syros will host a conference call today at 8:30 a.m. ET to discuss third quarter 2021 financial results and provide a corporate update.

To access the live conference call, please dial (866) 595-4538 (domestic) or (636) 812-6496 (international) and refer to conference ID 3287324. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.