On April 28, 2019 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported financial results for the year ended December 31, 2019 and provided an update on clinical and corporate progress (Press release, Affimed, APR 28, 2020, View Source [SID1234556675]).

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"Our clinical trials currently remain active, and we are working closely with our participating physicians and clinical sites to minimize the impact on further progress as they focus on addressing the evolving COVID-19 global health crisis," said Dr. Adi Hoess, Affimed’s CEO. "During these unprecedented and challenging times, our top priority continues to be supporting our employees, patients and our healthcare partners, while ensuring the continuity of our operations."

Development Program Updates

Affimed remains committed to continuing its development programs but acknowledges the impact from the evolving COVID-19 pandemic on clinical studies, including potential delays in patient enrollment. The company plans to update expected timing of milestones for its clinical studies after there is more clarity on the duration and magnitude of the impact from the COVID-19 pandemic.

AFM13 (CD30/CD16A)

Patient enrollment is ongoing in the Phase 2 registration-directed study of AFM13 as a monotherapy in relapsed or refractory patients with CD30-positive peripheral T cell lymphoma (pTCL). Affimed has successfully activated 42 clinical study sites across nine countries. To ensure patient safety and to avoid imposing additional burdens on healthcare systems already strained by the COVID-19 pandemic, the company has taken the decision to temporarily pause enrollment in the exploratory cohort of patients with CD30-positive relapsed or refractory transformed mycosis fungoides.

In March 2020, enrollment of all 15 patients was completed in an investigator-sponsored Phase 1b/2a study of AFM13 in patients with relapsed or refractory CD30-positive lymphoma with cutaneous manifestation led by Columbia University. Previously reported data from the study confirmed single-agent activity of AFM13, with an objective response rate (ORR) of 50% (5 of 10 patients).

Affimed is in close collaboration with the University of Texas MD Anderson Cancer Center (MDACC) to initiate an investigator-sponsored Phase 1 study to investigate the combination of AFM13 with allogeneic NK cells. MDACC intends to administer a stable complex of AFM13 pre-mixed with cord blood-derived allogeneic NK cells in different doses (numbers of pre-loaded NK cells) to patients with relapsed/refractory CD30-positive lymphoid malignancies.

AFM24 (EGFR/CD16A)

The first patient was successfully dosed in a first-in-human Phase 1/2a clinical trial of AFM24. The study is an open-label, non-randomized, multi-center, multiple ascending dose escalation/expansion study to evaluate AFM24 as monotherapy in patients with advanced solid malignancies known to be EGFR-positive and whose disease has progressed after treatment with previous anticancer therapies.

Preclinical Pipeline Update

Affimed continues to progress AFM28 and AFM32 as preclinical research currently remains unimpacted by the COVID-19 pandemic.

Genentech Collaboration Update

In November 2019, Genentech exercised its final option for an exclusive target under the ongoing, multi-program strategic oncology collaboration agreement to develop and commercialize novel NK cell engager-based immunotherapeutics generated from Affimed’s ROCK platform to treat multiple cancers. Affimed received a payment from Genentech in an undisclosed amount based on this achievement. Affimed and Genentech

continue to progress multiple programs under the ongoing strategic, multi-target collaboration.

Management Appointments

Dr. Andreas Harstrick joined Affimed as Chief Medical Officer (CMO) in March 2020 and Dr. Arndt Schottelius joined the company as Chief Scientific Officer (CSO) in April 2020. Dr. Harstrick brings a track record of running successful clinical trials that have led to regulatory approvals, deep oncology expertise, and a proven ability to lead large clinical organizations. Dr. Schottelius brings extensive innate immunity expertise, R&D leadership and a successful record of advancing and translating discovery research into preclinical and clinical development.

COVID-19 Impact Mitigation

COVID-19 has significantly impacted the global healthcare system, including the conduct of clinical trials as medical institutions prioritize the treatment of those afflicted with COVID-19. Affimed has taken several important actions to balance the commitment to treat cancer patients and to mitigate potential health and safety risks posed by the COVID-19 pandemic, while maintaining continuity of its operations and preserving financial flexibility for the future.

Full Year 2019 Financial Highlights

Cash, cash equivalents and current financial assets totaled €104.1 million as of December 31, 2019 compared to €108.8 million as of December 31, 2018. During the fourth quarter of 2019, the company raised €29.5 million in net proceeds, after deducting underwriting discounts and commissions and estimated offering expenses, from a completed public offering. Based on its current operating plan and assumptions, Affimed anticipates that its cash, cash equivalents and current financial assets as of December 31, 2019 will support operations at least into the first half of 2022.

Net cash used in operating activities was €29.1 million for the twelve months ended December 31, 2019, compared to net cash from operating activities of €49.4 million for the twelve months ended December 31, 2018. The net cash from operating activities in 2018 includes an initial upfront payment and committed funding of €83.2 million ($96.0 million) from the strategic collaboration Affimed entered into with Genentech Inc. in August 2018.

Total revenue was €21.4 million for the year ended December 31, 2019 compared to €23.7 million for the year ended December 31, 2018. Revenue in both years is attributable primarily to the recognition of revenue from the Genentech collaboration in the respective years.

Research and development (R&D) expenses were €43.8 million for the year ended December 31, 2019, compared to €35.1 million for the year ended December 31, 2018. The increase was primarily related to higher expenses for startup activities for the AFM13 registration-directed study in pTCL, manufacturing activities for AFM13 clinical study material, and early stage development and discovery activities.

General and administrative (G&A) expenses were €10.3 million for the year ended December 31, 2019, compared to €9.6 million for the year ended December 31, 2018. In 2019, G&A expenses were primarily related to personnel expenses and legal, consulting and audit costs.

Net loss was €32.4 million, or €0.50 per common share, for the year ended December 31, 2019, compared to a net loss of €19.5 million, or €0.32 per common share, for the year ended December 31, 2018.

Additional information regarding these results is included in the notes to the consolidated financial statements as of December 31, 2019 and "Item 5. Operating and Financial Review and Prospects," which will be included in Affimed’s Annual Report on Form 20-F as filed with the U.S. Securities and Exchange Commission (SEC).

Note on International Financial Reporting Standards (IFRS)

Affimed prepares and reports the consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles in the United States. Affimed maintains its books and records in Euro.

Conference Call and Webcast Information

Affimed will host a conference call and webcast today, Tuesday, April 28, 2020 at 8:30 a.m. Eastern time to discuss the company’s 2019 financial results and recent corporate developments. The conference call will be available via phone and webcast. To access the call, please dial +1 (877) 870-9135 for U.S. callers, or +44 (0) 2071 928338 for international callers, and reference passcode 7978047 approximately 15 minutes prior to the call.

A live audio webcast of the conference call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source, and a replay of the webcast will be accessible at the same link for 30 days following the call.

On April 28, 2020 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported the closing of its initial public offering of 8,625,000 shares of its common stock, which includes the exercise in full of the underwriters’ option to purchase 1,125,000 additional shares of its common stock, at a price to the public of $16.00 per share (Press release, ORIC Pharmaceuticals, APR 28, 2020, View Source [SID1234556692]). The gross proceeds from the offering were $138.0 million, before deducting underwriting discounts and commissions and estimated offering expenses. All of the shares were offered by ORIC. The shares began trading on The Nasdaq Global Select Market on April 24, 2020, under the symbol "ORIC."

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J.P. Morgan, Citigroup, Jefferies and Guggenheim Securities acted as joint book-running managers for the offering.

Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on April 23, 2020. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected]; Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at (800) 831-9146; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, NY 10017, by telephone at (212) 518-9658 or by email at [email protected].

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

On April 28, 2020 Thrive Earlier Detection Corp., a company dedicated to extending and saving lives by incorporating earlier cancer detection into routine medical care, together with Johns Hopkins University and Geisinger Health, reported data from the landmark DETECT-A study (Press release, Thrive Earlier Detection, APR 28, 2020, View Source [SID1234556711]). DETECT-A (Detecting cancers Earlier Through Elective mutation-based blood Collection and Testing) is the first ever prospective, interventional study to use a blood test to screen for multiple types of cancers in a real-world population. The study was conducted by Johns Hopkins University and Geisinger and enrolled more than 10,000 women with no prior history of cancer. The purpose was to identify multiple cancer types in asymptomatic individuals using an early version of CancerSEEK developed in 2016 ("Thrive’s blood test"). DETECT-A is the first study of a multi-cancer blood-based screening test to deliver results to physicians to manage patient care.

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Cancer is the second leading cause of death in the United States with an estimated 600,000 people expected to die from the disease this year. Most of these cancers are often detected too late, and only after people start to experience symptoms. These "symptom-detected" cancers too frequently coincide with late stage, metastatic disease, and result in poor outcomes. However, when cancer is detected through screening, or are "screen-detected," the disease is often identified earlier when it can be more effectively treated, and in many cases even cured. Unfortunately, current standard-of-care screening tests, like mammography and colonoscopy, only detect less than 30% of all incident cancers. The DETECT-A study provides the first real-world evidence that we can significantly shift the paradigm from "symptom-detected" cancers to more "screen-detected" cancers via a multi-cancer blood-based test.

The key findings from this prospective, interventional study demonstrate the following:

Thrive’s blood test identified cancers in individuals without any history of the disease.
Thrive’s blood test more than doubled the number of cancers that were first "screen-detected." 25% of the women who were diagnosed with cancer were identified by current standard-of-care tests. By incorporating Thrive’s blood test, the percentage of "screen-detected" cancers increased from 25% to 52%.
Thrive’s blood test identified cancers across 10 different organs, seven of which currently have no standard-of-care screening.
Thrive’s blood test can identify cancers prior to clinically evident metastasis. 65% of the cancers identified were localized or regional.
Thrive’s blood test is additive and complementary to standard-of-care and was incorporated into routine medical care without discouraging patients from engaging in other forms of screening.
Thrive’s blood test, in combination with imaging, minimized false positive results with 99.6% specificity.
The study’s workflow (blood test plus imaging) safely guided clinical follow-up in blood test-positive participants with zero adverse events.
"This study is a seminal moment in cancer screening that advances the entire field," said Christoph Lengauer, Ph.D., co-founder and chief innovation officer of Thrive. "For the first time, a blood test was utilized in a real-world setting and was able to more than double the number of cancers first identified through screening methods. We learned that it can be both complementary to existing standard-of-care screening tools, and a significant benefit for many types of cancers like ovarian, appendix and kidney, which do not have any current screening modalities."

These data were published in Science and were presented today during the clinical plenary: Early Detection and CtDNA at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting.

Prospective Interventional Study Design

The ability to identify multiple types of cancers through a blood draw is one of the most exciting advances in cancer diagnostics; however, prospective, interventional studies like DETECT-A are imperative to understand if a test can work in the real world. To date, retrospective and observational studies of blood-based multi-cancer tests have curated samples from participants who were already known to have cancer at the time of testing. Conversely, in DETECT-A, a prospective interventional study, participants were unaware of cancer at the time of enrollment and test results were reported to physicians and guided intervention.

DETECT-A enrolled 10,006 women with no prior history of cancer in a population with high adherence to standard-of-care cancer screening tests, such as mammography and colonoscopy. All participants were enrolled through the Geisinger Health System, enabling access to electronic medical records of participating individuals and minimizing loss to follow up.

DETECT-A utilized an early version of CancerSEEK that was developed in 2016, and analyzes 16 genes and nine proteins causatively linked to multiple types of cancer. Screening began with the analysis of a blood sample to identify potential abnormal values for at least one biomarker. Those with abnormal values were invited back for a confirmatory test to determine whether the identical biomarker was persistently abnormal and if appropriate, the individual was reviewed by a Multidisciplinary Review Committee. If a non-cancerous cause for the abnormal biomarker could not be identified, imaging was ordered. Patients with concerning imaging findings were referred to cancer specialists for further evaluation.

Study Results

Thrive’s blood test doubled the number of cancers first found through screening. Among the eligible participants, 96 women developed cancers: 26 of these were first identified by Thrive’s blood test, 24 were first identified by standard-of-care screening methods, and 46 were first identified by symptoms or other means. Thrive’s blood test detected cancers across ten different organs, including seven organs that do not have standard-of-care screening tools available. Notably, 65% of cancers detected by Thrive’s blood test were identified as local or regional disease, allowing for earlier intervention and if indicated, surgery with intent to cure. Thrive’s blood test’s sensitivity was 27.1% across all cancers and 31.1% for the seven cancers with no screening options. Importantly, Thrive’s blood test plus standard-of-care testing had a combined sensitivity of 52.1%, underscoring that a multi-cancer blood test is both a significant added benefit and complementary to standard-of-care screening tools.

Maintaining a high specificity thereby minimizing "false-positive" results is essential for a multi-cancer blood test. Screening with Thrive’s blood test alone had a 98.9% specificity, and when combined with imaging had a specificity of 99.6%. Thrive’s blood test plus imaging safely and efficiently guided clinical follow-up in blood test-positive participants with zero adverse events. Holistically, in this asymptomatic population with a cancer incidence of approximately 1%, Thrive’s blood test plus imaging resulted in a positive predictive value (PPV) of 40.6%, which is considerably higher than the PPV of existing single-cancer screening tests available today.

"Through this first-ever interventional study, the teams at Johns Hopkins University, Geisinger and Thrive have forged a new path and advanced the field of blood-based earlier cancer detection," said David J. Daly, chief executive officer of Thrive. "Thrive is now one step closer to realizing our vision of providing a comprehensive approach to cancer screening, helping to shift the paradigm so that in the future, most cancers can be identified through earlier detection when there is the greatest opportunity for cure."

On April 28, 2020 BioInvent Interim Report January 1 – March 31, 2020 (Press release, BioInvent, APR 28, 2020, View Source;march-31-2020-301048103.html [SID1234556728])

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Promising progress reported for BI-1206 in combination with rituximab

"We have made a strong start to 2020 and remain on track to deliver on our goals. Our lead candidate, BI-1206, continues to make good progress, while we are developing promising preclinical assets and continuing the good work with our partners."

Martin Welschof, CEO BioInvent

Financial information first quarter 2020

Net sales SEK 16.7 (17.4) million.
Loss after tax SEK -32.6 (-27.8) million.
Loss after tax per share before and after dilution SEK -0.07 (-0.08).
Cash flow from operating activities and investment activities SEK -35.4 (-40.5) million. Liquid funds as of March 31, 2020: SEK 117.1 (28.5) million.
Events in the first quarter

BioInvent and Transgene announced that the first clinical trial application for BT-001 was submitted and that the first-in-human trial is expected to start before the end of 2020 in Europe and the US.
BioInvent announced an agreement with SkylineDx to characterize the gene expression and immunological signatures in tumors of patients pre- and post-treatment with BI-1206.
Events after the reporting period

In April 2020, promising progress was reported in the Phase I/lla trial of lead program BI-1206 in combination with rituximab. A complete response was observed in one follicular lymphoma patient and complete depletion of circulating tumoral cells in a mantle cell lymphoma patient. (R)
(R)= Regulatory event
Comments from the CEO

BioInvent has made a strong start to 2020 and remains on track for delivery on our goals. Our lead candidate, BI-1206, continues to make good progress, while we are developing promising preclinical assets and continuing the good work with our partners.

It was very pleasing to report promising progress in the Phase I/lla trial of BI-1206 in combination with rituximab for the treatment of Non-Hodgkin Lymphoma (NHL). Three separate responses have been observed across different subtypes of NHL at doses of BI-1206 below what is believed to be optimal. Particularly notable was that one patient in the 70mg cohort achieved a complete response and another patient had complete depletion of circulating mantle cell lymphoma cells. Of course, this is a very early stage in the study, and this part of it is designed to evaluate safety and tolerability. All the same, these initial signs of efficacy are very encouraging.

We have also concluded an agreement with SkylineDx, a molecular diagnostics company focusing on discovery of novel gene-based biomarkers, to characterize the gene expression and immunological signatures in tumors of patients pre- and post-treatment with BI-1206. This is particularly interesting because identifying the right patients who are likely to respond to treatment with BI-1206 will constitute a major asset in the development of this promising treatment and, along with FcγRIIB expression levels, should support the extension of its use to other malignancies.

Further along our pipeline, BioInvent and our partner Transgene have submitted the first clinical trial application for BT-001, a multifunctional oncolytic virus which was engineered to encode a Treg-depleting, anti-CTLA4 antibody from our proprietary n-CoDeR/F.I.R.S.TTM platforms. The first-in-human trial is expected to start before the end of 2020 in Europe and the U.S. and we believe that the potential to combine anti-CTLA4, anti-PD-1/PD/L1 and oncolytic immunotherapy could change the treatment paradigm for multiple solid tumors.

Thus, our technology platform continues to produce exciting potential new treatments, ready for developing through clinical trials and to address important unmet medical needs.

As BioInvent continues to bring new programs towards clinical development, financing is of course a priority and we will continue to use a combination of sources for funding. Firstly, we are engaged in several business development discussions with the aim of partnering one or more of the programs in our portfolio. Secondly, the collaboration with Pfizer, which is also a model for other potential collaborations which commercialize our platform. Thirdly, our manufacturing capabilities generate revenue, with the most recent agreement with CRUK expected to generate SEK 30 million. CRUK has the potential to become a long-term strategic partner, as it works with a number of small- to mid-sized companies that need manufacturing support. And our fourth option is to use capital markets for financing. Based on the support from our large institutional investors and increased interest in our programs we feel optimistic that a combination of these four sources will continue to support BioInvent financially. The Board of Directors follows the financing situation and is working on a plan to ensure the Group’s continued financing.

The spread of COVID-19 has changed all our lives and BioInvent is no exception. We are taking all the necessary precautions and continue to monitor its spread and associated measures closely. BioInvent has clinical trials in process and clinical trials soon to be initiated and the global measures against COVID-19 and the need to prioritize healthcare resources will likely affect the timelines for these studies.

The precise impact is difficult to assess at this stage, given the rapidly developing situation. Currently, we still expect the early results from the Phase I open label study with a combination of BI-1206 and rituximab for treatment of NHL in H2 2020. Early clinical trial results for BI-1206 in combination with pembrolizumab and clinical trial initiations in other programs also remain on track. As the situation is still evolving, timelines are still subject to potential changes and we will provide updates as necessary.

BioInvent is delivering consistently on its strategy as we progress through 2020, despite the disruption caused to the world by the spread of COVID-19. We wish you and your families the best of health, and will continue to keep you up to date on our exciting progress.

On April 28, 2020 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported financial results for the first quarter ended March 31, 2020 (Press release, CRISPR Therapeutics, APR 28, 2020, View Source [SID1234556776]).

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"We made substantial progress in the last quarter despite the challenges posed by COVID-19. We are now progressing five cell therapy clinical trials in parallel targeting hemoglobinopathies and various cancers," said Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics. "Our CTX001 and CTX110 programs continue to enroll patients, and we expect to report data for these programs this year. We are pleased to have begun treating patients in our CTX120 trial for the treatment of relapsed or refractory multiple myeloma and we expect to begin treating patients in our CTX130 trial in renal cell carcinoma and T-cell and B-cell hematologic malignancies in the second half of this year. Despite these unprecedented times, we continue to execute on our programs and we remain focused on our commitment to patients and their families."

Recent Highlights and Outlook

Beta Thalassemia and Sickle Cell Disease

CRISPR Therapeutics and its partner Vertex remain on track to provide additional data from the two ongoing Phase 1/2 studies of the investigational CRISPR/Cas9 gene-editing therapy CTX001 in patients with transfusion-dependent beta thalassemia and in patients with severe sickle cell disease in 2020. New data expected in 2020 include initial data from additional patients dosed in each of the Phase 1/2 studies and longer duration follow-up data for the first patients dosed in each study. Screening, enrollment and mobilization in these studies is ongoing, however no additional patients are scheduled to initiate conditioning or dosing at this time due to COVID-19.

Immuno-Oncology

Patient enrollment continues in a clinical trial to assess the safety and efficacy of CTX110, CRISPR Therapeutics’ wholly-owned allogeneic CAR-T cell therapy targeting refractory CD19+ B-cell malignancies. The multi-center, open label clinical trial is designed to enroll up to 95 patients and investigate several dose levels of CTX110. If successful, CTX110 could enable off-the-shelf use of cell therapies and greatly expand their applicability and accessibility in treating patients with these hematologic malignancies. The Company expects to report top-line data for CTX110 at the end of 2020.

CRISPR Therapeutics has begun treating patients in a clinical trial to assess the safety and efficacy of CTX120, its wholly-owned allogeneic CAR-T cell therapy targeting BCMA for the treatment of relapsed or refractory multiple myeloma. The multi-center, open label trial is designed to enroll up to 80 patients and investigate several dose levels of CTX120.

Earlier this year, the U.S. Food and Drug Administration (FDA) accepted CRISPR Therapeutics’ Investigational New Drug (IND) application for CTX130, its wholly-owned allogeneic CAR-T cell therapy targeting CD70 for the treatment of both solid tumors, such as renal cell carcinoma, and T-cell and B-cell hematologic malignancies. Additionally, CRISPR Therapeutics has obtained approval from Health Canada for its Clinical Trial Application (CTA). The Company expects to begin treating patients with CTX130 in the second half of this year.

Other Corporate Matters

Under the June 2019 collaboration agreement with Vertex to discover and develop gene editing therapies for the treatment of Duchenne Muscular Dystrophy (DMD) and Myotonic Dystrophy Type 1 (DM1), CRISPR Therapeutics received a payment of $25 million from Vertex related to the achievement of a research milestone in the DM1 program. CRISPR Therapeutics is eligible to receive additional milestone payments from Vertex of up to $800 million for these two programs.

CRISPR Therapeutics is scheduled to present two posters during the virtual American Society of Gene & Cell Therapy 2020 Annual Meeting, to be held from May 12 to 15, 2020, via View Source, as follows:

Title: Dual Guide CRISPR/Cas9 Editing of the CCR5 Gene Provides Complete Protection Against HIV in Humanized Mouse Models (abstract #1046)
Session Title: Gene Targeting and Gene Correction
Date and Time: Thursday, May 14, 2020; 5:30 PM – 6:30 PM

Title: Multiplexing of Up to 10 Gene Edits Using CRISPR/Cas9 to Generate CAR-T Cells with Improved Function (abstract #1151)
Session Title: Cancer – Immunotherapy, Cancer Vaccines
Date and Time: Thursday, May 14, 2020; 5:30 PM – 6:30 PM

In February, CRISPR Therapeutics announced its proposal to elect Doug Treco, Ph.D. to its Board of Directors at the Company’s upcoming annual general meeting to be held later this year.
First Quarter 2020 Financial Results

Cash Position: Cash and cash equivalents as of March 31, 2020, were $889.7 million, compared to $943.8 million as of December 31, 2019, a decrease of $54.1 million. The decrease in cash was primarily driven by cash used in operating activities of $52.2 million to support spending on the Company’s clinical and pre-clinical programs, as well as payroll and payroll-related expenses to support growth. In April 2020, the Company received a milestone payment of $25 million from Vertex under the collaboration agreement for DMD and DM1, resulting in pro forma cash exceeding $900 million.

Revenue: Total collaboration revenue was $0.2 million for the first quarter of 2020 compared to $0.3 million for first quarter of 2019. Collaboration revenue primarily consisted of charges to partners for research activities.

R&D Expenses: R&D expenses were $54.2 million for the first quarter of 2020 compared to $33.8 million for the first quarter of 2019. The increase in expenses was driven by increased headcount and development activities supporting the advancement of the hemoglobinopathies program and wholly-owned immuno-oncology programs.

G&A Expenses: General and administrative expenses were $19.6 million for the first quarter of 2020 compared to $14.9 million for the first quarter of 2019. The increase in general and administrative expenses for the year was driven by headcount-related expense and higher facilities cost.

Net Loss: Net loss was $69.7 million for the first quarter of 2020 compared to net loss of $48.4 million for the first quarter of 2019.
About CTX001
CTX001 is an investigational ex vivo CRISPR gene-edited therapy that is being evaluated for patients suffering from TDT or severe SCD in which a patient’s hematopoietic stem cells are engineered to produce high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is a form of the oxygen-carrying hemoglobin that is naturally present at birth and is then replaced by the adult form of hemoglobin. The elevation of HbF by CTX001 has the potential to alleviate transfusion requirements for TDT patients and painful and debilitating sickle crises for SCD patients.

CTX001 is being developed under a co-development and co-commercialization agreement between CRISPR Therapeutics and Vertex.

About CTX110
CTX110 is a healthy donor-derived gene-edited allogeneic CAR-T therapy targeting cluster of differentiation 19, or CD19, for the treatment of CD19+ malignancies. A wholly-owned asset of CRISPR Therapeutics, CTX110 is being investigated in a clinical trial designed to assess the safety and efficacy of CTX110 for the treatment of relapsed or refractory B-cell malignancies. The multi-center, open-label clinical trial is designed to enroll up to 95 patients and investigate several dose levels of CTX110.

About CTX120
CTX120 is a healthy donor-derived gene-edited allogeneic CAR-T therapy targeting B-cell maturation antigen, or BCMA. A wholly-owned asset of CRISPR Therapeutics, CTX120 is being investigated in a clinical trial designed to assess the safety and efficacy of CTX120 for the treatment of relapsed or refractory multiple myeloma. The multi-center, open-label clinical trial is designed to enroll up to 80 patients and investigate several dose levels of CTX120.

About CTX130
CTX130 is a healthy donor-derived gene-edited allogeneic CAR-T therapy targeting cluster of differentiation 70, or CD70, an antigen expressed on various solid tumors and hematologic malignancies. A wholly-owned asset of CRISPR Therapeutics, CTX130 is being developed for the treatment of both solid tumors, such as renal cell carcinoma, and T-cell and B-cell hematologic malignancies.