On August 4, 2022 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that financial results for the second quarter ended June 30, 2022 (Press release, Compugen, AUG 4, 2022, View Source [SID1234617618]).

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Corporate Update

"Adapting to challenging market conditions, we have taken a strategic decision to focus on two prioritized indications, microsatellite stable-colorectal cancer (MSS-CRC) and non-small cell lung cancer (NSCLC), and wind down our broad Phase 1 cohort expansion program resulting in the conclusion of our collaboration with Bristol Myers Squibb," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. "I would like to thank Bristol Myers Squibb for our productive interactions and for their support in providing nivolumab and their anti-TIGIT, BMS-986207, enabling us to initiate the triple and dual combination studies to evaluate our DNAM-1 axis hypothesis at a time when our own differentiated anti-TIGIT, COM902 had not yet reached the clinic. Additionally, my sincere thanks to the investigators, their staff, and the patients for participating in these studies. This strategic decision allows us to extend our cash runway into the end of 2024, execute on our strong belief in COM701 and gives us the freedom to switch to and develop our own differentiated anti-TIGIT antibody, COM902. Concluding the collaboration with Bristol Myers Squibb provides us with what is expected to be the greatest opportunity to advance and partner our clinical assets and support a future path to registration."

Dr. Cohen-Dayag continued, "Our clinical data from the COM701/nivolumab dose escalation and cohort expansion study in a small number of MSS-CRC patients, show a modestly higher response rate compared to what has been reported for standard of care. We believe that this initial data, along with the translational package showing a COM701 driven mechanism, supports the evaluation of COM701 triple combination in a single arm study. The full data from the COM701/nivolumab cohort expansion study in MSS-CRC and details of the new study design along with timelines is expected to be presented once finalized in the fourth quarter of this year. The second indication we have prioritized is NSCLC in anti-PD-(L)1 treated patients. As an inflamed tumor type sensitive to PD-1 and possibly TIGIT checkpoints, NSCLC was selected as a tumor type with increased probability of responding to our triplet combination. We also plan to evaluate the blockade of PVRIG and TIGIT in combination with standard of care in this indication, to build an additional path to randomized studies. The design and timelines of the NSCLC program will be presented once finalized in the fourth quarter of this year. We believe focusing on these indications provides us with the highest probability of success, and we plan to share the progress and initial findings from these studies during 2023."

Dr. Cohen-Dayag added, "I am also extremely proud of the progress we have made in our preclinical portfolio. Several early-stage programs from our computational discovery platform are advancing in our pipeline with the most advanced program about to enter pre-IND enabling studies with first-in-class potential. We are very excited about this program, which is targeting a soluble immune checkpoint upregulated in the tumor microenvironment in response to IFN-γ. We developed a very high affinity antibody, COM503, to block this soluble immune checkpoint pathway and we believe we are the first to do so. The antibody has demonstrated preclinical in-vitro and in-vivo activity as monotherapy and in combination with other checkpoint inhibitors across various models and systems. We intend to share details on this program in the fourth quarter of this year."

Dr. Cohen-Dayag concluded, "With the decisive actions we have taken, we are being cash efficient and may be better positioned to bring value to our stakeholders. I am excited with what we have achieved and look forward to continuing to focus on execution and delivering value to our shareholders and patients."

Financial Results

As of June 30, 2022, cash, cash equivalents, short-term bank deposits and restricted cash totaled approximately $97 million, compared with approximately $118 million as of December 31, 2021. As a result of the Company’s strategic decision to end its Phase 1 program early and focus on two prioritized indications, the Company expects its existing cash and cash related balances to be sufficient to fund its operating plan into the end of 2024, without taking into consideration any cash inflows. Compugen does not have any debt.

R&D expenses for the second quarter ended June 30, 2022, were approximately $6.8 million, no change from the comparable period in 2021. Going into the second half of 2022, the reduction in R&D expenses is expected to be limited and will reflect winding down expenses of the current ongoing studies as well as preparation for the planned prioritized clinical studies. We expect that the full effect of the reduction in expenses will be reflected in 2023.

General and administrative expenses for the second quarter ended June 30, 2022, were approximately $2.6 million compared with approximately $2.7 million for the comparable period in 2021.

Cash balance at the end of 2022 is expected to be approximately $72-$74 million.

Net loss for the second quarter ended June 30, 2022, was approximately $9.1 million, or $0.11 per basic and diluted share, compared with a net loss of approximately $9.5 million, or $0.11 per basic and diluted share, in the comparable period of 2021.

Full financial tables are included below

Conference call and webcast information

The Company will hold a conference call today, August 4, 2022, at 8:30 AM ET to review its second quarter 2022 results. 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 will be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

On August 4, 2022 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), reported that it will report its second quarter 2022 financial results on Thursday, August 11, 2022, after the U.S. financial markets close (Press release, Regulus, AUG 4, 2022, View Source [SID1234617617]).

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In connection with the earnings release, Regulus’ management team will host a live conference call and webcast on the same day at 5:00 PM ET, to discuss the Company’s financial results and provide a corporate update. To access the call, please dial (866) 652-5200 (domestic) or (412) 317-6060 and use the conference ID 10168242. To access the telephone replay of the call, dial (877) 344-7529 (domestic) or (412) 317-0088 and refer to the entry replay code 5578933. The webcast and telephone replay will be archived on the Company’s website at www.regulusrx.com following the call.

On August 4, 2022 Photocure ASA (Photocure, PHO: OSE) reported that it will announce the second quarter and first half year 2022 financial results on Wednesday 10 August 2022 at 08:00 CEST and invites investors, analysts and the media to a presentation at Hotel Continental, Oslo, Norway at 14:00 CEST the same day (Press release, PhotoCure, AUG 4, 2022, View Source [SID1234617616]).

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The investor presentation will also be streamed live and be hosted by Daniel Schneider, CEO and Erik Dahl, CFO. The presentation will be held in English and questions can be submitted throughout the event.

The presentation is scheduled to conclude at 14:45 CEST.

The quarterly report and presentation will be published at 08:00 CEST and will be publicly available at www.photocure.com. The streaming event is available through https://channel.royalcast.com/landingpage/hegnarmedia/20220810_2/

On August 4, 2022 Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the Company") reported financial results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, Protagonist, AUG 4, 2022, View Source [SID1234617615]).

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"We continue to prioritize the development of rusfertide in polycythemia vera, driving the Phase 3 VERIFY study forward with a focus on data readout with the cash we have on hand," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer of Protagonist. "Updated Phase 2 drug suspension and re-dosing data, recently presented at the 2022 ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) conferences, reaffirm rusfertide’s potential to improve patients’ lives and transform the treatment landscape for PV."

Dr. Patel continued, "Our diverse programs, including both partnered and fully owned assets, provide us with several opportunities to bring new medicines forward to patients and create shareholder value. Our partner, Janssen, is pursuing multiple clinical studies of PN-235, including two Phase 2 studies in moderate-to-severe plaque psoriasis. In parallel with partnership exploration for PN-943, we are engaging with regulators for guidance on the next phase of clinical development. Our cash position remains strong, with runway through the end of 2024. Protagonist’s proprietary peptide technology platform confers fundamental strengths that will serve us well in the current environment and over the long term."

Second Quarter 2022 Recent Developments

Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood Disorders

It is the Company’s objective to complete the planned 250-patient enrollment in the Phase 3 VERIFY study by the end of the first half of 2023. Notwithstanding a slower than anticipated pace of initial enrollment, 35 study sites have been activated globally to date. The Company continues to implement measures to increase patient recruitment, screening, and enrollment.
The Company completed patient enrollment in the ongoing Phase 2 REVIVE study of rusfertide in PV in the first quarter of 2022, with a target of approximately 50 patients to be enrolled through the end of the randomized withdrawal portion of the study.
Highlights of the Phase 2 REVIVE study were shared as an oral presentation by Ronald Hoffman, M.D. at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Q2 2022. Dr. Hoffman is principal investigator of the Phase 2 REVIVE study, and the Albert A. and Vera G. List Professor of Medicine and Director of the Myeloproliferative Disorders Research Program at the Icahn School of Medicine at Mount Sinai.
Updated data from the Phase 2 REVIVE study were shared as a poster presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Congress (EHA2022), given by Dr. Andrew Kuykendall, M.D., Assistant Member at the Moffitt Cancer Center in the Department of Malignant Hematology.
Data from the Phase 2 REVIVE study data were presented at the European Iron Club Conference by Dr. Yelena Ginzburg, M.D., Associate Professor of Hematology and Medical Oncology at the Icahn School of Medicine at Mount Sinai.
Chronic arthropathy occurs in a significant subset of patients with hereditary hemochromatosis (HH). HH arthropathy correlates with iron overload and is associated with transferrin saturation (TSAT), ferritin, elevated age, and unresponsiveness to phlebotomy treatment. Protagonist intends to design a Phase 2 study of rusfertide in this HH sub-population, in consultation with regulatory agencies.
PN-235: Oral IL-23 Receptor Antagonist

Four clinical studies of PN-235 (JNJ-77242113), a drug candidate discovered by Protagonist and further developed in collaboration with Janssen, are in different stages of clinical development at Janssen. These include
FRONTIER 1, a Phase 2b multicenter, randomized, placebo controlled, 240-patient dose-ranging study commenced in early 2022 to evaluate the safety and efficacy of PN-235 for the treatment of moderate-to-severe plaque psoriasis;
FRONTIER 2, a long-term extension study;
SUMMIT, a study of an oral tablet formulation of PN-235 for the treatment of moderate-to-severe plaque psoriasis; and
a separate Phase 1 study of PN-235 in healthy Japanese and Chinese participants. More information on these studies can be found at View Source
Protagonist is eligible for a $10 million milestone payment in connection with the start of a second indication-based Phase 2 study. The Company is also eligible for a $50 million milestone upon dosing of a third patient in a Phase 3 study of PN-235.
PN-943: Oral, Gut-restricted, alpha-4-beta-7 Integrin Antagonist for Ulcerative Colitis (UC)

The Company submitted a request to FDA for a clinical protocol guidance meeting and is awaiting written responses from FDA related to the Phase 3 study plan. The Phase 3 study plan is anchored around the 150 mg BID dose of PN-943, pending regulatory guidance.
Protagonist intends to pursue further clinical development of PN-943 in collaboration with a large pharmaceutical partner. As announced previously, the Company has engaged PJT Partners to identify and evaluate such partnering opportunities.
The results of the IDEAL study have been selected for an oral presentation at the United European Gastroenterology Week (UEGW) in October 2022.
Presentation Title: "A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of the Oral, Gut-Restricted α4β7 Integrin Peptide Antagonist PN-943 in Patients with Moderate to Severe Ulcerative Colitis: Results from the IDEAL Study."
Presentation Date and Time: October 10, 2022; 9:30 AM to 10:30 AM PT
Abstract Number: AS-UEG-2022-03120.
Second Quarter 2022 Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of June 30, 2022 were $291.9 million. The Company expects current cash, cash equivalents and marketable securities to be sufficient to fund its planned operating and capital expenditures through the end of 2024.
License and Collaboration Revenue: License and collaboration revenue was $0.9 million and $26.6 million for the three and six months ended June 30, 2022, respectively, as compared to $2.3 million and $8.5 million, respectively, for the same periods in 2021. The decrease in revenue from prior year quarter was primarily due to a decrease in the level of services the Company provided under the Janssen license and collaboration agreement. The Company completed a performance obligation pursuant to the collaboration as of June 30, 2022. The revenue increase from prior year-to-date was primarily due to the $25.0 million milestone that the Company became eligible to receive in March 2022 upon the dosing of the third patient in the Janssen phase 2b Frontier 1 study of PN-235.
Research and Development ("R&D") Expenses: R&D expenses were $34.6 million and $70.9 million for the three and six months ended June 30, 2022 as compared to $26.4 million and $50.7 million for the same periods in 2021. The increases were primarily due to costs associated with advancing rusfertide and PN-943, including current and planned Phase 3 clinical trials.
General and Administrative ("G&A") Expenses: G&A expenses were $7.7 million and $18.2 million for the three and six months ended June 30, 2022 as compared to $6.7 million and $12.7 million for the same periods in 2021. The increases were primarily due to personnel expenses and other expenses to support Company growth.
Net Loss: Net loss was $41.0 million, or $0.84 per share, for the three months ended June 30, 2022 as compared to a net loss of $30.8 million, or $0.69 per share, for the three months ended June 30, 2021. Net loss was $62.0 million, or $1.27 per share, for the six months ended June 30, 2022 as compared to a net loss of $54.8 million, or $1.23 per share for the six months ended June 30, 2021.

On August 4, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that its management team will participate at the 7th Annual Needham Virtual Med Tech & Diagnostics 1×1 Conference on Tuesday, August 16, 2022 (Press release, Personalis, AUG 4, 2022, View Source;1-Conference [SID1234617614]).

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