Foreign Filer Report • Nov 12, 2021
Foreign Filer Report
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Washington, D.C. 20549
For the month of November 2021
Commission File Number 000-30902
(Translation of registrant's name into English)
26 Harokmim Street Holon 5885849, Israel (Address of Principal Executive Offices)
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
On November 12, 2021, Compugen Ltd. (the "Company") issued four press releases, copies of which are furnished as Exhibits 99.1, 99.2, 99.3 and 99.4 (collectively, the "Press Releases") to this Form 6-K and incorporated by reference herein.
With the exception of the quotes by each of Ecaterina Elena Dumbrava, M.D., Anat Cohen-Dayag, Ph.D., Eran Ophir, Ph.D., and Rupert Vessey, as applicable, in the Press Releases, the information contained in this Form 6-K is hereby incorporated by reference into the Company's Registration Statement on Form F-3, File No. 333-240183.
| Exhibit Number |
Description of Exhibit |
|---|---|
| 99.1 | Press Release dated November 12, 2021 – "Compugen Presents Preliminary Results from Phase 1/2 Dose Escalation Study of COM701 with Opdivo® and BMS-986207 (Anti-TIGIT Antibody) at SITC 2021". |
| 99.2 | Press Release dated November 12, 2021 – "Compugen Presents Initial Translational Data Supporting the Differentiation of PVRIG Compared to TIGIT and PD-1 as a Novel Checkpoint on the DNAM Axis at SITC 2021". |
| 99.3 | Press Release dated November 12, 2021 – "Compugen Presents Preliminary Results from Phase 1 Dose Escalation Monotherapy Study of COM902 a High Affinity Anti-TIGIT Antibody at SITC 2021". |
| 99.4 | Press Release dated November 12, 2021 – "Compugen Reports Third Quarter 2021 Results". |
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Date: November 12, 2021 By: /s/ Eran Ben Dor
Eran Ben Dor
General Counsel

HOLON, ISRAEL – November 12, 2021 – Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, today announced the presentation of preliminary results from its ongoing Phase 1/2 triple combination dose escalation study evaluating the combination of COM701, Compugen's potentially first-in-class anti-PVRIG antibody, with Bristol Myers Squibb's (NYSE: BMY) anti-PD-1, Opdivo® and BMS-986207, an investigational anti-TIGIT antibody, at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), being held November 10-14, 2021.
"The preliminary data reported from this Phase 1/2 triple combination dose escalation study demonstrate that triple blockade of PVRIG, TIGIT and PD-1 is well tolerated, with a favorable safety and toxicity profile and a maximum tolerated dose was not reached." said principal investigator and presenting author Ecaterina Elena Dumbrava, M.D., Assistant Professor of Investigational Cancer Therapeutics, at the University of Texas MD Anderson Cancer Center. "The totality of the data is encouraging and I look forward to enrolling patients to the expansion cohorts in select tumor types to potentially address the unmet need of patients who do not respond to existing immune checkpoint inhibitors."
Anat Cohen-Dayag, Ph.D., President and CEO of Compugen, added, "Demonstrating a favorable safety profile in the triple combination study is an important milestone, which enables further development of our differentiated blockade of the DNAM axis. We are excited about the translational results which suggest that triple blockade of PD-1, TIGIT and PVRIG, in this heavily pretreated patient population, has the potential to support potent immune activation, which aligns with our extensive preclinical models which predicted this effect."
Rupert Vessey, President of Research and Early Development at Bristol Myers Squibb, said, "We are pleased to continue our collaboration with Compugen to further generate translational data regarding the inhibition of the DNAM axis in a clinical setting. The initial translational data indicate potential potent immune activation with triple blockade of PD-1, TIGIT and PVRIG that is consistent across measures of immune function. We look forward to further studying the DNAM axis hypothesis of triple blockade of these pathways in select biomarker informed indications."
Key findings from the poster presentation titled, "COM701 in combination with BMS-986207 (anti-TIGIT antibody) and nivolumab - preliminary results of safety, tolerability, and pharmacokinetics in patients with advanced solid tumors (NCT04570839)," with a data cutoff date of September 3, 2021, include:
• Expansion cohorts are enrolling patients in biomarker informed select tumors.
The poster is available to conference attendees for the duration of the SITC conference and will be archived on the Publications section of Compugen's website.
Compugen is a clinical-stage discovery and development company utilizing its broadly applicable, predictive computational discovery platforms to identify novel drug targets and develop therapeutics in the field of cancer immunotherapy. Compugen's lead product candidate, COM701, a potentially first-in-class anti-PVRIG antibody, for the treatment of solid tumors, is undergoing Phase 1 studies as a single agent and in dual, and triple combinations. COM902, Compugen's second fully owned clinical antibody targeting TIGIT, for the treatment of solid and hematological tumors, is undergoing Phase 1 studies as a single agent and in dual combination. Partnered programs include bapotulimab, a therapeutic antibody in Phase 1 development targeting ILDR2 licensed to Bayer under a research and discovery collaboration and license agreement, and AZD2936, a TIGIT/PD-1 bispecific in Phase 1 development derived from COM902 through a license agreement with AstraZeneca for the development of bispecific and multi-specific antibodies. Compugen's therapeutic pipeline of early-stage immuno-oncology programs includes myeloid targets. Compugen is headquartered in Israel, with offices in South San Francisco, CA. Compugen's shares are listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN. For additional information, please visit Compugen's corporate website at www.cgen.com.
Opdivo® is a trademark of Bristol-Myers Squibb Company.
This press release contains "forward-looking statements" within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended, and the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on the current beliefs, expectations, and assumptions of Compugen. Forward-looking statements can be identified using terminology such as "will," "may," "expects," "anticipates," "believes," "potential," "plan," "goal," "estimate," "likely," "should," "confident," and "intends," and similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include, but are not limited to, statements to the effect that the dose escalation study clears the path to a comprehensive evaluation of Compugen's DNAM axis hypothesis of triple blockade of PVRIG, TIGIT and PD-1 pathways in select biomarker informed indications; statements relating to enrolment in the expansion cohort in select tumor types; statements regarding the possibility that translational results suggest that triple blockade of PD-1, TIGIT and PVRIG has the potential to support potent immune activation; and statements to the effect that we will further study the DNAM axis hypothesis of triple blockade of pathways in select biomarker informed indications. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance, or achievements of Compugen to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Among these risks: the effect of the global COVID-19 pandemic may negatively impact the global economy and may also adversely affect Compugen's business and operations; Clinical trials of any product candidates that Compugen, or any current or future collaborators, may develop may fail to satisfactorily demonstrate safety and efficacy to the FDA, and Compugen, or any collaborators, may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of these product candidates; Compugen's business model is substantially dependent on entering into collaboration agreements with third parties and Compugen may not be successful in generating adequate revenues or commercializing aspects of its business model. Compugen's approach to the discovery of therapeutic products is based on its proprietary computational target discovery infrastructure, which is unproven clinically; and Compugen does not know whether it will be able to discover and develop additional potential product candidates or products of commercial value. These risks and other risks are more fully discussed in the "Risk Factors" section of Compugen's most recent Annual Report on Form 20-F as filed with the Securities and Exchange Commission (SEC) as well as other documents that may be subsequently filed by Compugen from time to time with the SEC. In addition, any forward-looking statements represent Compugen's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Compugen does not assume any obligation to update any forward-looking statements unless required by law.
Yvonne Naughton, PhD Head of Investor Relations and Corporate Communications Email: [email protected] Tel: +1 (628) 241-0071
John Mullaly LifeSci Advisors, LLC Email: [email protected] Tel: +1 (617) 429-3548

FOR IMMEDIATE RELEASE
HOLON, ISRAEL – November 12, 2021 – Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, today announced the presentation of new translational preliminary data detailing the differentiated profile of PVRIG compared to TIGIT and PD-1 as a novel checkpoint in the DNAM axis, supporting its potential role as a dominant checkpoint involved in stem-like memory T cells and dendritic cell (DCs) interaction at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), being held on November 10-14, 2021.
"We believe evidence is growing to consistently demonstrate that PVRIG is a novel and differentiated checkpoint with a potential unique role in cancer immunotherapy" said Eran Ophir, Ph.D., Vice President of Research and Drug Discovery at Compugen. "For cancer immunotherapy to work, T cells are needed at the tumor site and recent studies suggest that early-memory (stem-like) T cells and DCs play an important role in this process. Here we show for the first-time preliminary data demonstrating greater induction of activated DC markers in the serum of two patients responding to our potentially first in class anti-PVRIG antibody, COM701, in combination with nivolumab compared to non-responders, potentially because of DC- T cell interaction. This preliminary data is in line with our recent scientific finding showing that PVRL2, the ligand of PVRIG, is abundantly expressed across DCs types, while PVRIG, measured by both gene and protein expression, is uniquely and dominantly expressed on early memory cells in contrast to TIGIT and PD-1."
Anat Cohen-Dayag, Ph.D., President and CEO of Compugen, added, "These new preliminary data further support our earlier findings that PVRIG plays a distinct role within the DNAM axis which we believe is important for triggering robust immune responses in the tumor microenvironment. PVRIG blockade may lead to key mechanistic differences as compared to other DNAM axis members, namely TIGIT and PD-1, with the potential to enhance T cell proliferation and tumor infiltration to address both inflamed and less inflamed tumor types where current checkpoint inhibitors have not shown success. With our potentially first-in-class anti- PVRIG antibody, COM701, we are uniquely positioned to target the DNAM axis in combination with TIGIT and PD-1/L1 inhibitors and look forward to continued translation of these scientific learnings across our ongoing clinical programs."
Key findings from the poster presentation titled, "Novel DNAM-1 axis member, PVRIG, is potentially a dominant checkpoint involved in stem-like memory T cells – dendritic cell interaction," presented by Zoya Alteber PhD, Associate Director, Research and Drug Discovery at Compugen include:
The poster is available to conference attendees for the duration of the SITC conference and will be archived on the Publications section of Compugen's website.
Compugen is a clinical-stage discovery and development company utilizing its broadly applicable, predictive computational discovery platforms to identify novel drug targets and develop therapeutics in the field of cancer immunotherapy. Compugen's lead product candidate, COM701, a potentially first-in-class anti-PVRIG antibody, for the treatment of solid tumors, is undergoing Phase 1 studies as a single agent and in dual, and triple combinations. COM902, Compugen's second fully owned clinical antibody targeting TIGIT, for the treatment of solid and hematological tumors, is undergoing Phase 1 studies as a single agent and in dual combination. Partnered programs include bapotulimab, a therapeutic antibody in Phase 1 development targeting ILDR2 licensed to Bayer under a research and discovery collaboration and license agreement, and AZD2936, a TIGIT/PD-1 bispecific in Phase 1 development derived from COM902 through a license agreement with AstraZeneca for the development of bispecific and multi-specific antibodies. Compugen's therapeutic pipeline of early-stage immuno-oncology programs includes myeloid targets. Compugen is headquartered in Israel, with offices in South San Francisco, CA. Compugen's shares are listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN. For additional information, please visit Compugen's corporate website at www.cgen.com.
This press release contains "forward-looking statements" within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended, and the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on the current beliefs, expectations, and assumptions of Compugen. Forward-looking statements can be identified using terminology such as "will," "may," "expects," "anticipates," "believes," "potential," "plan," "goal," "estimate," "likely," "should," "confident," and "intends," and similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include, but are not limited to, statements relating to our belief that preliminary data suggests that blockade of PVRIG/PVRL2 may enhance stem-memory T cell - DC interaction potentially resulting in increased T cell expansion, differentiation, and infiltration in certain tumors; statements regarding PVRIG's potential role as a dominant checkpoint involved in stem-like memory T cell and DC interaction; statements regarding our belief that evidence is growing to consistently demonstrate that PVRIG is a novel and differentiated checkpoint with a potential unique role in cancer immunotherapy; statements regarding the impact of the DC – T cell interaction on the induction of activated DC markers in the serum of two patients responding to our anti-PVRIG antibody COM701 in combination with nivolumab compared to non-responders; statements regarding our belief that PVRIG plays a distinct role within the DNAM axis, and our belief that it is important for triggering robust immune responses in the tumor microenvironment; and statements regarding our expectations for continued translation of scientific learnings across our ongoing clinical programs. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance, or achievements of Compugen to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Among these risks: the effect of the global COVID-19 pandemic may to negatively impact the global economy and may also adversely affect Compugen's business; clinical trials of any product candidates that Compugen, or any current or future collaborators, may develop may fail to satisfactorily demonstrate safety and efficacy to the FDA, and Compugen, or any collaborators, may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of these product candidates; Compugen's business model is substantially dependent on entering into collaboration agreements with third parties and Compugen may not be successful in generating adequate revenues or commercializing aspects of its business model; Compugen's approach to the discovery of therapeutic products is based on its proprietary computational target discovery infrastructure, which is unproven clinically; the success in proving PVRIG's ability to be a novel and differentiated checkpoint with a unique role in cancer immunotherapy, and Compugen does not know whether it will be able to discover and develop additional potential product candidates or products of commercial value. These risks and other risks are more fully discussed in the "Risk Factors" section of Compugen's most recent Annual Report on Form 20-F as filed with the Securities and Exchange Commission (SEC) as well as other documents that may be subsequently filed by Compugen from time to time with the SEC. In addition, any forward-looking statements represent Compugen's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Compugen does not assume any obligation to update any forward-looking statements unless required by law.
Yvonne Naughton, PhD Head of Investor Relations and Corporate Communications Email: [email protected] Tel: +1 (628) 241-0071
John Mullaly LifeSci Advisors, LLC Email: [email protected] Tel: +1 (617) 429-3548

FOR IMMEDIATE RELEASE
HOLON, ISRAEL – November 12, 2021 – Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, today announced the presentation of preliminary results from its ongoing Phase 1 dose escalation study evaluating COM902, Compugen's anti-TIGIT antibody, in patients with advanced solid tumors at the 36th Annual Meeting of the Society for Immunotherapy of Cancer, being held on November 10-14, 2021.
"The primary objective of this Phase 1 dose escalation study of COM902 monotherapy was to evaluate safety and tolerability and we were pleased to see that COM902 was well tolerated with a favorable safety profile. A maximum tolerated dose of COM902 was not reached." said principal investigator and presenting author, Ecaterina Elena Dumbrava, M.D., Assistant Professor of Investigational Cancer Therapeutics at the University of Texas MD Anderson Cancer Center. "It is encouraging to achieve a disease control rate of 50% in these heavily pretreated patients who typically do not respond to PD- (L)1 inhibitors. I look forward to enrolling patients in the combination study with COM701 to continue exploring new therapeutic options for patients in need."
Anat Cohen-Dayag, Ph.D., President and CEO of Compugen, added, "COM902 high- affinity anti-TIGIT antibody was well tolerated, showed early signs of anti-tumor activity in heavily pretreated patients with advanced solid tumors and as we expected avoided depletion of major TIGIT positive expressing lymphocytes, supporting our rationale for choosing a reduced Fc effector function anti-TIGIT antibody. These data are encouraging, in line with our science suggesting that TIGIT is a combination agent and serves as the basis for exploring our differentiated TIGIT combination strategy. In addition to our triplet study blocking PVRIG, TIGIT and PD-1 pathways, we are already enrolling patients in our Phase 1 study of COM902 in combination with COM701 for the first clinical evaluation of dual blockade of TIGIT and PVRIG in a PD-(L)1-free regimen."
Key findings from the poster presentation titled, "COM902 (Anti-TIGIT antibody) monotherapy – preliminary evaluation of safety, tolerability, pharmacokinetics and receptor occupancy in patients with advanced solid tumors," (NCT04354246) with a cutoff of September 3, 2021, include:
The poster is available to conference attendees for the duration of the SITC Congress and will be archived on the Publications section of Compugen's website.
Compugen is a clinical-stage discovery and development company utilizing its broadly applicable, predictive computational discovery platforms to identify novel drug targets and develop therapeutics in the field of cancer immunotherapy. Compugen's lead product candidate, COM701, a potentially first-in-class anti-PVRIG antibody, for the treatment of solid tumors, is undergoing Phase 1 studies as a single agent and in dual, and triple combinations. COM902, Compugen's second fully owned clinical antibody targeting TIGIT, for the treatment of solid and hematological tumors, is undergoing Phase 1 studies as a single agent and in dual combination. Partnered programs include bapotulimab, a therapeutic antibody in Phase 1 development targeting ILDR2 licensed to Bayer under a research and discovery collaboration and license agreement, and AZD2936, a TIGIT/PD-1 bispecific in Phase 1 development derived from COM902 through a license agreement with AstraZeneca for the development of bispecific and multi-specific antibodies. Compugen's therapeutic pipeline of early-stage immuno-oncology programs includes myeloid targets. Compugen is headquartered in Israel, with offices in South San Francisco, CA. Compugen's shares are listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN. For additional information, please visit Compugen's corporate website at www.cgen.com.
This press release contains "forward-looking statements" within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended, and the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on the current beliefs, expectations, and assumptions of Compugen. Forward-looking statements can be identified using terminology such as "will," "may," "expects," "anticipates," "believes," "potential," "plan," "goal," "estimate," "likely," "should," "confident," and "intends," and similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include, but are not limited to, statements relating to the effect that treatment with COM902 avoided depletion of major TIGIT positive expressing lymphocytes including CD4, CD8 and NK cells, and therefore support our rationale for choosing an IgG4, reduced Fc effector function anti-TIGIT antibody, statement regarding enrolling patients in the monotherapy expansion study and the combination study with COM701 and the plans to continue exploring new therapeutic options for patients in need. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance, or achievements of Compugen to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Among these risks: the effect of the global COVID-19 pandemic may negatively impact the global economy and may also adversely affect Compugen's business and operations; clinical trials of any product candidates that Compugen, or any current or future collaborators, may develop may fail to satisfactorily demonstrate safety and efficacy to the FDA, and Compugen, or any collaborators, may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of these product candidates; Compugen's business model is substantially dependent on entering into collaboration agreements with third parties and Compugen may not be successful in generating adequate revenues or commercializing aspects of its business model; Compugen's approach to the discovery of therapeutic products is based on its proprietary computational target discovery infrastructure, which is unproven clinically; and Compugen does not know whether it will be able to discover and develop additional potential product candidates or products of commercial value. These risks and other risks are more fully discussed in the "Risk Factors" section of Compugen's most recent Annual Report on Form 20-F as filed with the Securities and Exchange Commission (SEC) as well as other documents that may be subsequently filed by Compugen from time to time with the SEC. In addition, any forward-looking statements represent Compugen's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Compugen does not assume any obligation to update any forward-looking statements unless required by law.
Yvonne Naughton, PhD Head of Investor Relations and Corporate Communications Email: [email protected] Tel: +1 (628) 241-0071
John Mullaly LifeSci Advisors, LLC Email: [email protected] Tel: +1 (617) 429-3548

HOLON, ISRAEL – November 12, 2021 – Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, today reported financial results for the third quarter ended September 30, 2021.
"Our leadership position in the DNAM axis was strengthened in the third quarter, with key data release, expansion cohort studies initiations and continued progress with our partners including a \$20 million strategic equity investment from Bristol Myers Squibb," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "The favorable safety and tolerability data from the COM701 triple combination dose escalation study combined with the translational results showing potent immune activation are supportive of our DNAM axis hypothesis and serve as an important milestone enabling our continued advancement of the triple blockade of PVRIG, TIGIT and PD-1 in select biomarker informed tumor types. Data from the COM902 dose escalation study support our choice of a reduced Fc function anti-TIGIT antibody with encouraging preliminary anti-tumor activity in the heavily pretreated patients in a dose escalation setting, and showed a favorable safety profile, while avoiding depletion of immune cell populations that are critical for driving anti-tumor activity."
Dr. Cohen-Dayag continued, "We also continue to push forward the scientific foundation that underlies our success in the clinic, and our recent translational data from COM701 at SITC reinforces our hypothesis of PVRIG as a differentiated and distinct checkpoint pathway in the DNAM axis. We are particularly encouraged by the preclinical data that suggest blockade of PVRIG may enhance memory stem-like T cell - dendritic cell interactions to drive T cell expansion and differentiation which ultimately may enable clinical responses in less inflamed tumor types. These data, combined with the translational results from our triple combination study are supportive of our DNAM axis hypothesis. We believe the growing commitment from Bristol Myers Squibb, along with the advancement of AstraZeneca's COM902 derived TIGIT/PD-1 bispecific in the clinic, provide important external validation to our approach, and we will continue our steady execution to maintain our first mover advantage in the space."
Revenues for the third quarter ended September 30, 2021, were \$6 million, related to the milestone from AstraZeneca triggered by the dosing of the first patient in AstraZeneca' Phase 1/2 study of a TIGIT bispecific derived from COM902.
Cost of revenues of \$0.7 million are mainly attributed to royalty and milestone payments.
R&D expenses for the third quarter ended September 30, 2021, were \$8.7 million compared with \$5.5 million for the comparable period in 2020. The increase reflects the expansion and initiation of additional clinical studies during 2021 as well as increased drug manufacturing activities.
Net loss for the third quarter of 2021 was \$6.2 million, or \$0.07 per basic and diluted share, compared with a net loss of \$7.8 million, or \$0.09 per basic and diluted share, in the comparable period of 2020.
As of September 30, 2021, cash, cash related accounts, short-term and long-term bank deposits totaled approximately \$102 million compared with approximately \$124 million on December 31, 2020. The cash balance as of September 30, 2021, does not include the \$20 million equity investment from Bristol Myers Squibb nor the \$6 million milestone payment from AstraZeneca expected in the fourth quarter. The Company has no debt.
Opdivo® is a registered trademark of Bristol Myers Squibb.
The Company will hold a conference call today, November 12, 2021, at 8:30 AM ET to review its third quarter 2021 results including data being presented at SITC. To access the live conference call by telephone, please dial 1-866-744-5399 from the U.S., or +972-3-918-0644 internationally. The call and slides will be available via live webcast through Compugen's website, located at the following link. Following the live webcast, the slides and a replay will be available on the Company's website.
Compugen is a clinical-stage discovery and development company utilizing its broadly applicable, predictive computational discovery platforms to identify novel drug targets and develop therapeutics in the field of cancer immunotherapy. Compugen's lead product candidate, COM701, a potentially first-in-class anti-PVRIG antibody, for the treatment of solid tumors, is undergoing Phase 1 studies as a single agent and in dual, and triple combinations. COM902, Compugen's second fully owned clinical antibody targeting TIGIT, for the treatment of solid and hematological tumors, is undergoing Phase 1 studies as a single agent and in dual combination. Partnered programs include bapotulimab, therapeutic antibody in Phase 1 development targeting ILDR2 licensed to Bayer under a research and discovery collaboration and license agreement, and AZD2936, a TIGIT/PD-1 bispecific in Phase 1 development derived from COM902 through a license agreement with AstraZeneca for the development of bispecific and multi-specific antibodies. Compugen's therapeutic pipeline of early-stage immuno-oncology programs includes myeloid targets. Compugen is headquartered in Israel, with offices in South San Francisco, CA. Compugen's shares are listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN. For additional information, please visit Compugen's corporate website at www.cgen.com.
This press release contains "forward-looking statements" within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended, and the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on the current beliefs, expectations, and assumptions of Compugen. Forward-looking statements can be identified using terminology such as "will," "may," "expects," "anticipates," "believes," "potential," "plan," "goal," "estimate," "likely," "should," "confident," and "intends," and similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include, but are not limited to, statements regarding our expectation that a reduced Fc function anti-TIGIT antibody with preliminary encouraging anti-tumor activity in the heavily pretreated dose escalation setting will show a favorable safety profile, while avoiding depletion of immune cell populations, which will drive anti-tumor activity, our belief that PVRIG serves as a differentiated and distinct checkpoint in the DNAM axis, the possibility that blockade of PVRIG may enhance memory stem-like T cell - dendritic cell interactions to drive T cell expansion and differentiation which ultimately may enable clinical responses in less inflamed tumor types, statements regarding the possibility that COM701 with Opdivo® and BMS-986207 may show potent immune activation with triple combination regimen, statements regarding the differentiation of PVRIG compared to TIGIT and PD-1 as a novel DNAM axis checkpoint. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance, or achievements of Compugen to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Among these risks: the effect of the global COVID-19 pandemic may negatively impact the global economy and may also adversely affect Compugen's Business and operations; Clinical development involves a lengthy and expensive process, with an uncertain outcome and Compugen may encounter substantial delays or even an inability to begin clinical studies for any specific product, or may not be able to conduct or complete its studies on the timelines it expects; Compugen relies and expects to continue to rely on third parties to conduct its clinical studies and these third parties may not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, and Compugen may experience significant delays in the conduct of its clinical studies as well as significant increased expenditures; Compugen's business model is substantially dependent on entering into collaboration agreements with third parties and Compugen may not be successful in generating adequate revenues or commercializing aspects of its business model; Compugen's approach to the discovery of therapeutic products is based on its proprietary computational target discovery infrastructure, which is unproven clinically; and Compugen does not know whether it will be able to discover and develop additional potential product candidates or products of commercial value. These risks and other risks are more fully discussed in the "Risk Factors" section of Compugen's most recent Annual Report on Form 20-F as filed with the Securities and Exchange Commission (SEC) as well as other documents that may be subsequently filed by Compugen from time to time with the SEC. In addition, any forward-looking statements represent Compugen's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Compugen does not assume any obligation to update any forward-looking statements unless required by law.
Yvonne Naughton PhD Head of Investor Relations and Corporate Communications Compugen Ltd. Email: [email protected] Tel: +1 (628) 241-0071
(U.S. dollars in thousands, except for share and per share amounts)
| Three Months Ended September 30, |
Nine Months Ended, September 30, |
|||
|---|---|---|---|---|
| 2021 | 2020 | 2021 | 2020 | |
| Unaudited | Unaudited | |||
| Revenues | 6,000 | - | 6,000 | - |
| Cost of revenues | 680 | - | 680 | - |
| Gross profit | 5,320 | - | 5,320 | - |
| Operating expenses | ||||
| Research and development expenses | 8,728 | 5,502 | 22,851 | 14,661 |
| Marketing and business development expenses | 166 | 219 | 631 | 633 |
| General and administrative expenses | 2,759 | 2,504 | 8,132 | 7,111 |
| Total operating expenses | 11,653 | 8,225 | 31,614 | 22,405 |
| Operating loss | (6,333) | (8,225) | (26,294) | (22,405) |
| Financial and other income, net | 177 | 464 | 736 | 1,270 |
| Loss before taxes on income | (6,156) | (7,761) | (25,558) | (21,135) |
| Taxes on income | - | - | - | - |
| Net loss | (6,156) | (7,761) | (25,558) | (21,135) |
| Basic and diluted net loss per ordinary share | (0.07) | (0.09) | (0.30) | (0.27) |
| Weighted average number of ordinary shares used in computing basic and diluted net loss per share | 83,977,070 | 83,169,989 | 83,819,012 | 78,239,917 |
(U.S. dollars, in thousands)
| September 30, | December 31, | |
|---|---|---|
| 2021 | 2020 | |
| ASSETS | ||
| Current assets | ||
| Cash, cash equivalents, short-term bank deposits and restricted cash | 102,249 | 124,432 |
| Trade receivables | 6,000 | 2,000 |
| Other accounts receivable and prepaid expenses | 4,033 | 2,658 |
| Total current assets | 112,282 | 129,090 |
| Non-current assets | ||
| Long-term prepaid expenses | 1,911 | 1,880 |
| Severance pay fund | 3,130 | 2,863 |
| Operating lease right to use asset | 2,354 | 2,772 |
| Property and equipment, net | 1,619 | 1,711 |
| Total non-current assets | 9,014 | 9,226 |
| Total assets | 121,296 | 138,316 |
| LIABILITIES AND SHAREHOLDERS EQUITY | ||
| Current liabilities | ||
| Other accounts payable, accrued expenses and trade payables | 13,662 | 9,216 |
| Current maturity of operating lease liability | 760 | 639 |
| Short-term deferred participation in R&D expenses | 833 | 668 |
| Total current liabilities | 15,255 | 10,523 |
| Non-current liabilities | ||
| Long-term deferred participation in R&D expenses | 1,493 | 1,968 |
| Long-term operating lease liability | 2,042 | 2,527 |
| Accrued severance pay | 3,683 | 3,516 |
| Total non-current liabilities | 7,218 | 8,011 |
| Total shareholders' equity | 98,823 | 119,782 |
| Total liabilities and shareholders' equity | 121,296 | 138,316 |
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