On August 4, 2022 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported that it will report its second quarter 2022 financial and operating results on Thursday, August 11, 2022, following the close of the U.S. financial markets (Press release, Lineage Cell Therapeutics, AUG 4, 2022, View Source [SID1234617480]). Lineage management will also host a conference call and webcast on Thursday, August 11, 2022, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its second quarter 2022 financial and operating results and to provide a business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Interested parties may access the conference call by dialing (800) 715-9871 from the U.S. and Canada and (646) 307-1952 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call" or provide conference ID number 6448886. A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through August 18, 2022, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 6448886.

On August 4, 2022 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, reported financial results for the fiscal first quarter ended June 30, 2022 and provided a business update (Press release, Replimune, AUG 4, 2022, View Source [SID1234617479]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our ambition to establish a major skin cancer franchise, built off of our lead RP1 program, is progressing to plan. We are pleased to have reached target enrollment in the CERPASS registration-directed clinical trial in CSCC and expect to complete enrollment in the IGNYTE clinical trial cohort evaluating RP1 combined with Opdivo in anti-PD1 failed melanoma around the end of year. We look forward to sharing the primary analysis data from the CERPASS clinical trial in H1 2023 and a data snapshot from the first 75 patients enrolled in the IGNYTE anti-PD1 failed melanoma cohort in the fourth quarter of 2022. In addition to RP1, we remain excited about the previously reported data with RP2 and look forward to providing further updates from the RP2/3 program as we move towards initiation of our Phase 2 programs in head and neck cancer, hepatocellular carcinoma and colorectal cancer. Looking even further ahead, we are well financed as we continue to prepare for the potential commercialization of our oncolytic immunotherapies and remain on course to achieve our ultimate ambition of establishing our products as a cornerstone treatment for a variety of solid tumor indications."

Corporate Updates & Upcoming Milestones

RP1 Update

Reached target enrollment in the CERPASS registration-directed clinical trial evaluating RP1 combined with Libtayo (cemiplimab-rwlc) in cutaneous squamous cell carcinoma (CSCC)

Replimune has enrolled the pre-specified target of 180 patients in the CERPASS trial evaluating RP1 combined with Libtayo in patients with CSCC; additional patients screened this month will also be enrolled with the last patient expected to initiate dosing this quarter.
Topline primary analysis data from this clinical trial is expected to be released in H1 2023.

Recruited the first 75 patients treated with RP1 combined with Opdivo in the anti-PD1 failed melanoma cohort with registrational intent of the IGNYTE clinical trial with a data snapshot from the first 75 patients with 6 months follow-up expected in Q4 2022

The anti-PD1 failed melanoma cohort of the IGNYTE clinical trial of RP1 combined with Opdivo is intended to ultimately enroll a total of approximately 125 patients, with enrollment expected to complete around the end of this year. The data snapshot from the first 75 patients followed for 6 months will be investigator assessed as compared to the primary endpoint of ORR for all patients in the cohort which is to be assessed by central review.
Other IGNYTE cohorts with RP1 combined with Opdivo: Recruitment remains ongoing into the cohorts of patients with anti-PD1 failed non-melanoma skin cancers, including CSCC, anti-PD1 failed non-small cell lung cancer, and anti-PD1 failed MSI-high cancers, with a data update expected in H1 2023.

RP1 in solid organ transplant recipients with skin cancers (ARTACUS): The Company continues to enroll patients into its ARTACUS clinical trial of RP1 monotherapy in solid organ transplant recipients with skin cancers and expects to provide a data update in H1 2023.

Development of RP1 for the neoadjuvant treatment of CSCC: Protocol development is underway for the testing of RP1 alone and combined with anti-PD1 therapy for the neoadjuvant treatment of CSCC, with clinical trial initiation expected in H1 2023.
RP2 and RP3 Update

RP2 alone and in combination with Opdivo in difficult-to-treat cancers: The Company continues to enroll patients in the expansion cohorts of the Phase 1 clinical trial evaluating RP2 in patients with tumor types of particular interest (gastro-intestinal [GI] cancers, breast cancer, lung cancer, head and neck cancer and uveal melanoma). The Company had previously fully enrolled the cohorts evaluating RP2 monotherapy (n=9) and RP2 in combination with Opdivo (n=30) (data presented in Nov 2020 and Nov 2021). Initial data from the RP2 expansion cohorts is expected around the end of this year.

RP3 alone and in combination with Opdivo in difficult-to-treat cancers: The Company completed enrollment in the initial part of its Phase 1 clinical trial with RP3 alone. Following determination of the recommended Phase 2 dose (RP2D), the Company is enrolling patients in the cohort evaluating RP3 combined with Opdivo, with focus on patients with GI cancers, breast cancer, lung cancer and head and neck cancer. Initial data for this RP3 combination cohort is expected around the end of this year. Additional monotherapy patients will also be enrolled.

Phase 2 development program: The Company remains on track to initiate its Phase 2 development program with RP2/3 in the first quarter of 2023. As previously announced, this program is intended to include Phase 2 clinical trials in squamous cell carcinoma of the head and neck (SCCHN; locally advanced and recurrent/metastatic), hepatocellular carcinoma (HCC; first line and second line) and colorectal cancer (CRC; third line), combined with current standard of care where appropriate.
Financial Highlights

Cash Position: As of June 30, 2022, cash, cash equivalents and short-term investments were $395.1 million, as compared to $395.7 million as of March 31, 2022. Cash utilized in operating activities in advancing the Company’s expanded clinical development plan was offset by $31.0 million in net proceeds generated from the sale of common stock under the Company’s at-the-market facility.

Based on the current operating plan, Replimune believes that existing cash, cash equivalents and short-term investments will fund operating expenses and capital expenditure requirements into the second half of 2024, excluding any confirmatory trial required by the FDA or other regulatory body.
R&D Expenses: Research and development expenses were $29.5 million for the first quarter ended June 30, 2022, as compared to $18.6 million for the first quarter ended June 30, 2021. This increase was primarily due to increased clinical and manufacturing expenses driven by the Company’s lead programs and increased personnel expenses. Research and development expenses included $2.6 million in stock-based compensation expenses for the first quarter ended June 30, 2022.

S,G&A Expenses: Selling, general and administrative expenses were $11.4 million for the first quarter ended June 30, 2022, as compared to $8.8 million for the first quarter ended June 30, 2021. The increase was primarily driven by personnel related costs, including sales and marketing personnel associated with pre-launch planning and build of the Company’s commercial infrastructure. Selling, general and administrative expenses included $4.6 million in stock-based compensation expenses for the first quarter ended June 30, 2022.

Net Loss: Net loss was $42.3 million for the first quarter ended June 30, 2022, as compared to a net loss of $27.3 million for the first quarter ended June 30, 2021.
About CERPASS
CERPASS is Replimune’s registration-directed randomized, global Phase 2 clinical study to compare the effects of Libtayo (cemiplimab-rwlc) alone versus a combination of Libtayo and Replimune’s investigational oncolytic immunotherapy RP1. The clinical trial comprises approximately 180 evaluable patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) who are naïve to anti-PD-1 therapy. The clinical trial will evaluate complete response (CR) rate and overall response rate (ORR) as its two independent primary efficacy endpoints as assessed by independent review, as well as secondary endpoints including duration of response, progression-free survival (PFS), and overall survival (OS). The study is being conducted under a clinical trial collaboration agreement with Regeneron in which the costs of the trial are shared and full commercial rights retained by Replimune. Libtayo is being jointly developed by Regeneron and Sanofi. Libtayo is a registered trademark of Regeneron.

About IGNYTE
IGNYTE is Replimune’s multi-cohort Phase 1/2 trial of RP1 plus Opdivo (nivolumab). There are 4 tumor specific cohorts currently enrolling in this clinical trial including a 125-patient cohort in anti-PD-1 failed cutaneous melanoma with registrational intent. This cohort was initiated after completing enrollment in a prior Phase 2 cohort in the same clinical trial of approximately 30 patients with melanoma. The additional cohorts are in non-melanoma skin cancers which includes both naïve and anti-PD-1 failed CSCC, in anti-PD1 failed microsatellite instability high, or MSI-H/dMMR tumors and anti-PD(L)-1 failed non-small cell lung cancer, or NSCLC. This trial is being conducted under a collaboration and supply agreement with Bristol-Myers Squibb Company. Opdivo is a registered trademark of Bristol-Myers Squibb Company.

About RP1
RP1 is Replimune’s lead product candidate and is based on a proprietary new strain of herpes simplex virus engineered and genetically armed to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About RP2 & RP3
RP2 and RP3 are derivatives of RP1 that express additional immune-activating proteins. RP2 expresses an anti-CTLA-4 antibody-like molecule and RP3 additionally expresses the immune co-stimulatory pathway activating proteins CD40L and 4-1BBL. RP2 and RP3 are intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic immune-based efficacy on tumors and limiting off-target toxicity.

On August 4, 2022 Avalo Therapeutics, Inc. (Nasdaq: AVTX), reported business updates and financial results for the second quarter of 2022 (Press release, Avalo Therapeutics, AUG 4, 2022, View Source [SID1234617478]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We have made significant progress advancing our clinical trials while also securing critical nondilutive capital since our first quarter business update," said Dr. Garry Neil, President and Chief Executive Officer of Avalo Therapeutics. "We are pleased to have enrolled the first patient in both our Phase 2 PEAK trial of AVTX-002 in NEA as well as our pivotal LADDER trial of ATX-803 in LAD II. Additionally, it’s critically important that we secured approximately $15 million of initial consideration from our license and transfer of our AVTX-007 program. The transaction allows us to operationally and financially focus on our most promising programs, most notably AVTX-002."

Business Updates:

In July 2022, Avalo granted an exclusive license to Apollo Therapeutics Group Limited (Apollo) granting rights to Apollo to research, develop, manufacture and commercialize AVTX-007. The AVTX-007 program was originally licensed to Avalo by MedImmune Limited, a subsidiary of AstraZeneca plc, and such license was transferred to Apollo as part of the transaction.
Avalo received approximately $15 million of upfront consideration.
Avalo is also entitled to up to $74 million of milestone payments, as well as a royalty payment of a low single digit percentage of annual net sales.
On July 7, 2022, Avalo effected a 1-for-12 reverse stock split to increase the per share price of its common stock to regain compliance with the listing requirements of the Nasdaq Capital Market. On July 22, 2022, the Company received written notification from Nasdaq that Avalo had regained compliance and that the matter is now closed.
In June 2022, Avalo, prepaid $15 million under its loan venture loan and security agreement (the Loan Agreement), of which $14.8 million was applied to principal and the remainder applied to accrued interest. As of June 30, 2022, the remaining principal payments were $21.2 million.
Program Updates and Milestones:

AVTX-002: Anti-LIGHT monoclonal antibody (mAb) targeting immune-inflammatory diseases.
NEA: Avalo has initiated its Phase 2 PEAK trial (A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma K) evaluating the safety and efficacy of AVTX-002 in 80 patients with poorly controlled NEA. The first patient was dosed in May 2022. Top-line data from the trial are expected in the first half of 2023.
AVTX-800 programs (AVTX-803 and AVTX-801): Monosaccharide therapies for two congenital disorders of glycosylation (CDGs): leukocyte adhesion deficiency type II (LAD II, also known as SLC35C1-CDG) and PGM1-CDG.
LAD II: Avalo has initiated its pivotal LADDER trial (A Phase 3, Randomized, Double-blind, Two-period, Crossover, Withdrawal Study to Assess the Efficacy and Safety of AVTX-803 in Subjects with Leukocyte Adhesion Deficiency Type II (LAD II) ER) evaluating the safety and efficacy of AVTX-803 in patients with LAD II (n=2). The first patient was dosed in July 2022. Data from this pivotal trial are expected in the first half of 2023.
PGM1-CDG: Milestone timing and the development plan is under review as a result of recent feedback from the U.S. Food and Drug Administration (FDA).
Second Quarter 2022 Financial Update:

Avalo had $11.2 million in cash and cash equivalents as of June 30, 2022, representing a $43.4 million decrease as compared to December 31, 2021. The decrease was primarily driven by operating expenditures to fund and support pipeline development and a $15.0 million partial prepayment under the Loan Agreement. Subsequent to June 30, 2022, Avalo received the approximate $15 million of upfront payment from its transfer of AVTX-007.

Total operating expenses decreased $16.7 million for the six months ended June 30, 2022 as compared to the same period in 2021. Research and development expenses decreased $19.7 million due to a $10.0 million upfront license fee incurred in the first quarter of 2021, which did not repeat, and a $9.2 million reduction due to specific timing of manufacturing, non-clinical activities and clinical trial activities. Selling, general and administrative expenses increased $1.7 million mainly due to severance and stock-based compensation expense driven by headcount reductions from the pipeline prioritization plan announced in the first quarter of 2022 and other separations, partially offset by decreases to legal, consulting and marketing expenses from cost savings initiatives. Cost of product sales increased $2.1 million due to the net profit share of our non-core commercialized product, Millipred, that began in the third quarter of 2021. Additionally, in the second quarter of 2022, we fully reserved the $1.0 million receivable due in December 2024 pursuant to the transition service agreement with the third party that previously managed Millipred’s commercial operations. The net loss and change in net loss was largely driven by operating expenses.

The unaudited condensed consolidated balance sheets as of June 30, 2022 and December 31, 2021 have been derived from the reviewed financial statements, but do not include all of the information and footnotes required by accounting principles accepted in the United States for complete financial statements.

The unaudited condensed consolidated statements of operations for the three and six months ended June 30, 2022 and 2021 have been derived from the reviewed financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.

On August 4, 2022 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, reported financial results for the second quarter ended June 30, 2022 and provided a business update (Press release, Adaptimmune, AUG 4, 2022, View Source [SID1234617476]). For the three months ended June 30, 2022, Revenue was $5.5 million, Total Operating Expenses (Research and Development and General and Administrative) were $49.3 million, and Net Loss was $44.5 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continue to demonstrate progress with our four focus areas for 2022: submitting our BLA for afami-cel, building a MAGE-A4 franchise, scaling up manufacturing capabilities, and advancing our allogeneic platform, pipeline and collaborations," said Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer. "The data presented at ASCO (Free ASCO Whitepaper) further confirm the potential of afami-cel for the initial indication of synovial sarcoma with the BLA submission on-track for Q4 this year. To support commercialization of afami-cel and other products both near- and longer-term, we are investing in focused but scalable operational infrastructure to set us up for success. At the same time, we are carefully monitoring market conditions. We will continue to prudently manage expenses and stop or delay non-core activities."

Adaptimmune’s first potential commercial product, afami-cel, supported by positive data readouts

Biologics License Application (BLA) submission for afami-cel on track for Q4 2022

Adaptimmune is preparing its BLA and continues to target submission to the U.S. Food and Drug Administration (FDA) in the fourth-quarter 2022 for the treatment of synovial sarcoma. This BLA is supported by data from Cohort 1 of the pivotal trial SPEARHEAD-1, which met its primary endpoint for efficacy. In addition, the Company has the following progress updates:

●Miltenyi Biotec vector facility released for cGMP manufacture
●Vector and T-cell product characterization nearing completion
●Method validation for commercial T-cell lot release assays (including potency assays) in progress
●Vector process performance qualification (PPQ) initiated
●Pre-market approval (PMA) for the companion diagnostic is on-track to be submitted simultaneously with BLA

Afami-cel presentation at ASCO (Free ASCO Whitepaper) 2022 – responses reported across all patient subgroups

As reported in June, data based on pooled analyses of characteristics associated with clinical responses (per investigator assessment) from both Cohort 1 of the SPEARHEAD-1 trial, as well as the Phase 1 trial of afami-cel in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma (MRCLS), were presented at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper)

●Overall response rate was 36% in heavily pre-treated patients across both types of sarcomas (41% in synovial sarcoma and 10% for MRCLS), with a median duration of response of 52 weeks
●Patients who responded to afami-cel had longer progression-free survival (median 58 weeks) compared to non-responders (median 12 weeks)

●Responses occurred across all clinical subgroups, with greater response rates associated with lower baseline tumor burden, fewer prior lines of therapy, and higher MAGE-A4 expression
●Benefit:risk profile of afami-cel has been favorable, to date

Potential of next-gen MAGE-A4 targeted cell therapy in multiple solid tumors

Phase 1 signal-finding SURPASS trial update at ESMO (Free ESMO Whitepaper) in September

●The purpose of the next-generation ADP-A2M4CD8 program is to improve the potency of Adaptimmune’s first-generation product targeting MAGE-A4, afami-cel, to achieve meaningful clinical responses beyond sarcoma
●ADP-A2M4CD8 is being investigated in the SURPASS family of trials
●Last year, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2021 Congress, Adaptimmune reported data from 22 evaluable patients with confirmed responses in ovarian, head and neck, esophagogastric junction, and bladder cancers from the Phase 1 signal-finding SURPASS trial, with this next-generation cell therapy
●Based on positive signals in gastroesophageal cancers in the Phase 1 SURPASS trial, Adaptimmune initiated a Phase 2 SURPASS-2 trial last year
●The Company plans to initiate an additional Phase 2 trial, SURPASS-3, this year for people with ovarian cancer, based on positive signals from the SURPASS Phase 1 trial
●On September 10, 2022 at 15:45 CET, Dr. David Hong from the MD Anderson Cancer Center, will present a data update from the Phase 1 signal-finding SURPASS trial at the ESMO (Free ESMO Whitepaper) 2022 Congress
●Data at ESMO (Free ESMO Whitepaper) will include 44 patients who received ADP-A2M4CD8 and 43 patients will be evaluable for efficacy (as of the data cut-off date of August 01, 2022)
●On September 9th, the Company will host a live virtual event from 8 a.m. to 9 a.m. EDT to discuss the ESMO (Free ESMO Whitepaper) data and its SURPASS family of trials

Corporate and other news

●Adaptimmune has implemented rigorous cost containment measures to enable delivery against its four key focus areas: submitting the BLA for afami-cel, building its MAGE-A4 franchise, scaling up manufacturing capabilities, and progressing the allogeneic platform
●To prioritize near- and mid-term value creation from its MAGE-A4 franchise, including the BLA submission for afami-cel and the SURPASS family of trials, Adaptimmune will delay submission of an IND for its new next-generation cell therapy ADP-A2M4N7X19, which it is developing in collaboration with Noile-Immune. Core preclinical activities will continue.
●Construction is underway to increase the Company’s cGMP manufacturing space at its Navy Yard site in Philadelphia, PA to support current clinical trials and future commercial products
●A dedicated allogeneic manufacturing facility in the United Kingdom is nearing completion, which will support the IND planned for 2023 for Adaptimmune’s wholly owned allogeneic cell therapy targeting MAGE-A4

Financial Results for the three and six months ended June 30, 2022

●Cash / liquidity position: As of June 30, 2022, Adaptimmune had cash and cash equivalents of $97.8 million and Total Liquidity1 of $258.1 million, compared to $149.9 million and $369.6 million, respectively, as of December 31, 2021.
●Revenue: Revenue for the three and six months ended June 30, 2022 was $5.5 million and $9.1 million, respectively, compared to $3.1 million and $3.5 million for the same periods in 2021. Revenue has increased primarily due to an increase in development activities under our
1 Total liquidity is a non-GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below

collaboration arrangements, in particular due to development activities under the Genentech Strategic Collaboration and License Agreement, which become effective in October 2021.
●Research and development (R&D) expenses: R&D expenses for the three and six months ended June 30, 2022 were $34.7 million and $71.5 million, respectively, compared to $28.9 million and $53.4 million for the same periods in 2021. R&D expenses increased due to an increase in the average number of employees engaged in research and development, increases in subcontracted expenditures and increases in in-process research and development costs. These were offset by an increase in reimbursements receivable for research and development tax and expenditure credits.
●General and administrative (G&A) expenses: G&A expenses for the three and six months ended June 30, 2022 were $14.6 million and $31.4 million, respectively, compared to $13.5 million and $27.4 million for the same periods in 2021 due to increases in employee-related costs and other corporate costs.
●Net loss: Net loss attributable to holders of the Company’s ordinary shares for the three and six months ended June 30, 2022 was $44.5 million and $94.8 million, respectively ($(0.05) and $(0.10) per ordinary share), compared to $39.1 million and $76.8 million, respectively ($(0.04) and $(0.08) per ordinary share), for the same periods in 2021.

Financial Guidance

The Company believes that its existing cash, cash equivalents and marketable securities, together with the additional payments under the Strategic Collaboration and License Agreement with Genentech, will fund the Company’s current operations into early 2024, as further detailed in the Company’s Quarterly Report on Form 10-Q for the three and six months ended June 30, 2022, to be filed with the Securities and Exchange Commission following this earnings release.

Conference Call Information

The Company will host a live teleconference and webcast to provide additional details at 8:00 a.m. EDT (1:00 p.m. BST) today, August 4, 2022. A live webcast of the conference call and replay can be accessed at View Source Call in information is as follows: (800)-952-5114 (US or Canada) or +1 (416)-406-0743 (International and additional options available HERE). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (5869059).

On August 4, 2022 Purple Biotech Ltd. ("Purple Biotech", or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies by harnessing the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, reported financial results for the second quarter ended June 30, 2022 (Press release, Purple Biotech, AUG 4, 2022, View Source [SID1234617475]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This is the first report of Purple Biotech financial results since my appointment as Chief Executive Officer," said Gil Efron, Chief Executive Officer of Purple Biotech. "It is an opportunity for me to emphasize our main objectives. Purple Biotech has two exciting and innovative lead assets in development. We are focused on performing robust studies aiming to achieve meaningful clinical data and are continuing to explore opportunities to expand our current clinical programs to additional indications, while maintaining our cash runway, currently through the end of 2024. We are seeking opportunities for additional assets and collaborations to increase our footprint, through accretive transactions. I believe that together with strong science and by leveraging on our capabilities we can achieve these objectives and solidify Purple Biotech as a significant player within the oncology field."

Recent Corporate Highlights

NT219

In June, Purple presented Phase 1 interim monotherapy data of the ongoing Phase 1/2 clinical trial of NT219 at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, demonstrating encouraging safety & efficacy profile including one confirmed partial response in gastroesophageal junction cancer patient and stable disease in 75% of patients with mutated-KRAS colorectal cancer.

CM24

The Company initiated the Phase 2 portion of its ongoing study of CM24, a first-in-class monoclonal antibody with the potential to treat multiple cancers. The Phase 2 is an open-label, multicenter study in patients with metastatic pancreatic cancer (PDAC) to evaluate the safety and tolerability of CM24 in combination with the PD-1 inhibitor Opdivo (nivolumab) and chemotherapy. The primary study endpoint is to evaluate preliminary efficacy in 2nd line PDAC.

This follows the recent favorable safety and efficacy data supporting the advancement of CM24 at the recommended phase 2 dose of 20 mg/Kg. The data from the Phase 1b study of CM24 in combination with Opdivo (nivolumab) was presented in a poster entitled "Interim Safety and Efficacy Results from a Phase 1b Study of CM24 in Combination with Nivolumab in Adults with Advanced Solid Tumors" at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting in May.

"Based on this progress last quarter, starting from phase 2, we will be performing randomized studies, such as our CM24 study in PDAC, which we are now in the process of expanding accordingly," added Efron. "The recent clinical data for NT219 together with previously published preclinical results have shown the potential of NT219 on solid tumors harboring KRAS mutation and we are looking into the development of NT219 for treatment of mutated KRAS patients. In addition, Insulin Receptor Substrates 1/2 (IRS) was identified as one of the pathways for resistance mechanism to other treatments in this field, opening this opportunity for NT219, which is the only IRS inhibitor in clinical development to date."

"We are ending the quarter in a strong financial position with $38.7 million in cash, cash equivalent short term and long term deposits and a cash runway of two and a half years as we continue to control our costs while advancing our programs. I’m proud of the progress made in the last quarter and we look forward to continuing to advance our clinical stage programs on behalf of cancer patients."

Financial Results for the three Months Ended June 30, 2022

Research and Development Expenses were $2 million, same as to $2 million in the same period of 2021.

Selling, General and Administrative Expenses were $1.5 million, same as to $1.5 million in the same period of 2021.

Operating Loss was $3.6 million, same as the $3.6 million in the same period of 2021.

On a non-IFRS basis (as reconciled below), adjusted operating loss was $3 million, an increase of $0.1 million, compared to $2.9 million in the same period of 2021.

Net Loss for the three months ended June 30, 2022 was $3.6 million, or $0.20 per basic and diluted ADS, compared to a net loss of $3.6 million, or $0.21 per basic and diluted ADS, in the three months ended June 30, 2021. Adjusted net loss for the three months ended June 30, 2022 was $2.9 million, the same as in the three months ended June 30, 2021.

Financial Results for the Six Months Ended June 30, 2022

Research and Development Expenses were $8.0 million, an increase of $1.1 million, or 15.9%, compared to $6.9 million in the same period of 2021. The increase was mainly due to an increase of $500 thousand in CMC expenses in support of our clinical studies and $300 thousands in wages in support of our growing development activities.

Sales, General and Administrative Expenses were $2.9 million, compared to $3.1 million in the same period of 2021, a decrease of $0.2 million. The decrease was mainly due to a decrease in employee equity-based compensation (ESOP) costs.

Operating Loss from continuing operations was $10.9 million, an increase of $0.8 million, or 7.9%, compared to $10.1 million in the same period of 2021.

On a non-IFRS basis (as reconciled below), adjusted operating loss was $10 million, an increase of $1.3 million, compared to $8.7 million in the same period of 2021, mainly due to an increase in R&D expenses.

Net Loss for the first six months ended June 30, 2022 was $10.8 million, or $0.61 per basic and diluted ADS, compared to a net loss of $10.2 million, or $0.58 per basic and diluted ADS, in the same period of 2021. The increase in net loss was mainly due to an increase of $0.8 million in operating expenses. Adjusted net loss for the first six months ended June 30, 2022 was $10 million, an increase from $8.7 million in the first six months ended June 30, 2021.

During the six months ended June 30, 2022, the Company sold, under the Open Market Sale Agreementsm with Jefferies LLC, approximately 179 thousand ADSs, at an average price of $3.64 per ADS. Net proceeds to the Company, were approximately $0.57 million, net of issuance expenses.