On August 25, 2022 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company") reported its half-yearly results for the six months ended June 30, 2022 (Press release, PureTech Health, AUG 25, 2022, View Source [SID1234618677]). The following information will be filed on Form 6-K with the United States Securities and Exchange Commission (the "SEC") and is also available at View Source

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"We look forward to carrying this success forward into another catalyst rich period as we unlock the potential of validated efficacy to deliver new classes of medicine for patients with devastating diseases."

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Webcast and conference call details

Members of the PureTech management team will host a conference call at 9:00am EDT / 2:00pm BST today, August 25, 2022, to discuss these results. A live webcast and presentation slides will be available on the investors section of PureTech’s website under the Events and Presentations tab. To join by phone, please dial:

United Kingdom Toll-Free: +44 800 640 6441
United Kingdom Toll/International: +44 20 3936 2999
United States: +1 646 664 1960
United States Toll-Free: +1 855 979 6654 / +1 800 249 2588
Access Code: 563263

For those unable to listen to the call live, a replay will be available on the PureTech website.

Commenting on PureTech’s half-yearly results, Daphne Zohar, Founder and Chief Executive Officer of PureTech, said:

"The first half of 2022 has been an exceedingly strong period for PureTech. Our mission is to change the treatment paradigm for patients with devastating diseases, and we have made great progress towards that goal, particularly on the heels of stellar topline results from Karuna’s Phase 3 trial evaluating KarXT in adults with schizophrenia. Schizophrenia is a severe and debilitating disorder affecting approximately 21 million people worldwide. KarXT, which was invented at PureTech, demonstrated notable improvements across symptom domains, and was not associated with the debilitating side effects of weight gain, sedation and movement disorders seen with existing treatments. It is now poised to potentially be the first new class of medicine in over 50 years for patients living with schizophrenia. As a co-inventor of KarXT, we have the right to receive royalties, sublicense income and milestone payments in addition to the value of our equity.

"Across our Wholly Owned Pipeline are examples of other programs that we have developed in a similar way to Karuna’s KarXT, where we start with an approach or candidate that has proof of human efficacy, but key limitations have hindered the class from reaching its full potential. Through the expertise of our experienced R&D team and our network of industry-leading collaborators, we strive to overcome barriers to unlock potential new classes of therapeutics for the benefit of patients.

"Another example of our clinically de-risked development approach is LYT-300, which is an oral form of natural allopregnanolone. LYT-300 could make a difference for patients with a range of mental health conditions, such as depression, where there is a growing need but standard of care treatments like selective serotonin reuptake inhibitors (SSRIs) can have mixed efficacy, delayed onset of action and poor tolerability. In June, we announced that we can orally administer LYT-300 and achieve therapeutic levels of allopregnanolone in systemic circulation. This is exciting because allopregnanolone has proven efficacy but is only available for the treatment of postpartum depression as a 60-hour IV infusion. Demonstration of human oral bioavailability of allopregnanolone is therefore a key milestone for LYT-300 and for our Glyph platform, which enabled this innovation. Similarly, we are advancing LYT-100, a deuterated form of pirfenidone, to make a meaningful difference in the lives of patients with lung fibrosis and other inflammatory and fibrotic conditions by potentially offering better therapeutic effect without the poor tolerability associated with current standard of care drugs. In the first half of 2022, we initiated a late-stage clinical trial of LYT-100 for the potential treatment of idiopathic pulmonary fibrosis (IPF), a terminal condition that affects about three million people worldwide. These milestones are just a few of the many accomplishments from our Wholly Owned Pipeline that demonstrate our commitment to improving the lives of millions of patients.

"In addition to Karuna, several of our other Founded Entities also made notable progress. Most recently, Akili began trading on Nasdaq, becoming the fourth of our Founded Entities to be publicly traded, and – together with Karuna, Gelesis and Vor Bio – bringing the value of publicly traded Founded Entities created by PureTech to over $9 billion. Gelesis also continued to grow its revenue from Plenity4 sales, generating $16.5 million in net product revenue in the first half of 2022, resulting in an increase of 212% year-over-year.

"I’m particularly proud of our track record of clinical success, which is approximately six times better than the biopharma industry average.5 This clinical success has led us to financial success as one of a few cash generating biotech companies in the world. We have generated over $680 million in non-dilutive cash in less than three years3 and have not had to raise money from the capital markets in over four years. Based on a strong balance sheet, our Board approved a share buyback program in May. We are delighted to have received positive feedback from shareholders thus far, and we are confident that we can maintain sufficient cash on hand to support the advancement of our Wholly Owned Pipeline, including the completion of all currently initiated clinical trials and certain strategic investments in our Founded Entities. Additionally, we have updated our guidance to extend our operational runway to the first quarter of 2026.

"We look forward to carrying this success forward into another catalyst rich period as we unlock the potential of validated efficacy to deliver new classes of medicine for patients with devastating diseases."

Operational Highlights

Strong progress across our Wholly Owned Programs6, including the progression of four clinical trials

Initiated a registration-enabling trial of LYT-100 (deupirfenidone) for the potential treatment of IPF
Completed four clinical trials with LYT-100 to validate the thesis of the anti-fibrotic and anti-inflammatory activity of pirfenidone with a differentiated pharmacokinetic (PK) profile, affirming both the strong safety and tolerability profile of LYT-100
Completed the bi-monthly, monotherapy dose escalation portion of the Phase 1 program assessing the safety and tolerability of escalating doses of LYT-200 (anti-galectin-9 mAb) as a potential treatment for metastatic solid tumors
Achieved oral bioavailability of LYT-300 (oral allopregnanolone) in a multi-part Phase 1 program, representing the first mechanistic proof-of-principle in the clinic for our Glyph platform
Momentum across Founded Entities7, which we initiated and co-invented, demonstrates success of our R&D model

Karuna Therapeutics, Inc. (Nasdaq: KRTX) (Karuna) announced positive topline Phase 3 data evaluating the efficacy, safety and tolerability of KarXT in adults with schizophrenia, meeting its primary endpoint and key secondary endpoints in the August 2022 post-period.
Akili, Inc. (Nasdaq: AKLI) (Akili) recently began trading on the Nasdaq Stock Market and announced its partner, Shionogi, had started a pivotal Phase 3 randomized, controlled study of SDT-001 in children with attention-deficit hyperactivity disorder (ADHD), both in the August post-period, and Akili partnered with Roblox (NYSE: RBLX) in May.
Gelesis Holdings, Inc. (NYSE: GLS) (Gelesis) began trading on the New York Stock Exchange in January 2022, and generated net product revenue of $16.5 million in the first half of 2022 for Plenity4, an increase of 212% year-over-year.
Gelesis presented results from a clinical trial demonstrating that approximately 6 out of 10 adults in the trial who were treated with GS200 lost on average 11% of their body weight; Akili announced the publication of data in adults with systemic lupus erythematosus (SLE), adults with major depressive disorder (MDD) and children with ADHD in major scientific journals; and Vedanta Biosciences, Inc. (Vedanta) published data in a major journal for its lead program, VE303.
Financial Highlights:

PureTech Level Cash and Cash Equivalents as of June 30, 2022, were $341.4 million1 (December 31, 2021: $418.9 million) and Consolidated Cash and Cash Equivalents as of June 30, 2022, were $365.9 million2 (December 31, 2021: $465.7 million).
Founded Entities have strengthened their collective balance sheets by attracting gross proceeds of $113.5 million8 in equity investments during the six months ended June 30, 2022. In the post-period, Founded Entities attracted additional gross proceeds of more than $1 billion.9 Since July 2018 through the date of this report, our Founded Entities have raised funding of $3.1 billion,8 of which $2.9 billion (95.3%) was from third parties.
Operating Expenses for the period were $108.2 million (June 30, 2021: 73.9 million).
PureTech initiated a share buyback program up to a maximum consideration of $50 million.
PureTech will receive aggregate proceeds of up to approximately $115.4 million, net of transaction fees, through the sale of Karuna shares in the August 2022 post-period.3
Key Upcoming Milestones (next 12 to 24 months)

Multiple important milestones are anticipated, including those announced by our Founded Entities:

Wholly Owned Pipeline

We expect topline results from the registration-enabling trial of LYT-100 in IPF by the end of 2023 as part of a streamlined development program that capitalizes on efficiencies of the 505(b)(2) pathway. Pending positive clinical and regulatory feedback, we believe the results of the Phase 2 clinical trial, together with a Phase 3 clinical trial, could serve as the basis for registration in the U.S.
We expect results from the Phase 1/2 clinical trial evaluating LYT-200 in single agent cohorts by the end of 2022 and will soon begin to enroll patients in cohorts designed to evaluate LYT-200 in combination with chemotherapy. Results from the combination cohorts are expected in 2023.
We plan to initiate a clinical trial to evaluate LYT-200 as a single agent for the treatment of acute myeloid leukemia (AML) by the end of 2022.
We expect to complete the multi-part Phase 1 program of LYT-300 by the end of 2022, and – based on the data – a Phase 1b/2a clinical trial is planned to initiate in 2023.
We expect additional preclinical validation of our key technology platforms.
Founded Entities

Karuna plans to submit a New Drug Application (NDA) for KarXT in schizophrenia with the U.S. Food and Drug Administration (FDA) in mid-2023 and Karuna’s Phase 3 ADEPT program, evaluating KarXT for the treatment of psychosis in elderly patients with Alzheimer’s disease (AD) is expected to initiate in the third quarter of 2022.
Akili expects to bring its digital therapeutic to more families and healthcare providers with the broader commercial launch of EndeavorRx10 in the second half of 2022.
Vor Biopharma Inc. (Nasdaq: VOR) (Vor) expects to report initial clinical data from VBP101, a Phase 1/2a clinical trial for VOR33 for patients with AML, in the fourth quarter of 2022, and data from the ongoing Phase 1/2 National Marrow Donor Program (NMDP)-sponsored clinical trial evaluating VCAR33AUTO in young adult and pediatric patients with relapsed/refractory AML in a bridge-to-transplant study are expected in 2022, depending on investigator’s timing of data release.11
Vedanta plans to initiate a Phase 3 clinical trial of VE303 in patients at high risk for recurrent Clostridioides difficile infection (CDI) in the first half of 2023.
Four additional Founded Entities also expect multiple near-term milestones.
Components of Value

Wholly Owned Candidates

Ownership

Indication

LYT-100

(deupirfenidone)

100%

Conditions involving inflammation and fibrosis, including idiopathic pulmonary fibrosis

LYT-200

(anti-galectin-9 mAb)

100%

Solid tumors, including pancreatic ductal adenocarcinoma, colorectal cancer and cholangiocarcinoma, as well as acute myeloid leukemia

LYT-210

(anti-delta-1 mAb)

100%

A range of cancer indications

LYT-300

(oral allopregnanolone)

100%

A range of neurological and neuropsychological conditions, including depression

LYT-510

(oral immunosuppressant)

100%

Inflammatory bowel disease and chronic pouchitis

LYT-500

(oral IL-22 + immunosuppressant)

100%

Inflammatory bowel disease

LYT-503/IMB-150

(non-opioid)

Partnered

Interstitial cystitis or bladder pain syndrome

Founded Entities

Ownership

Overview

Karuna

4.3% Equity plus Royalties, Milestone Payments & Sublicense Revenues

Advancing transformative medicines for people living with psychiatric and neurological conditions

Akili

14.7% Equity

Pioneering the development of cognitive treatments through game-changing technologies

Gelesis

23.4% Equity plus Royalties

Advancing a novel category of treatments for weight management and gut related chronic diseases

Vor Bio

8.3% Equity

Engineering hematopoietic stem cells to enable targeted therapies post-transplant

Vedanta

40.5% Equity

Pioneering a new category of oral therapies based on defined bacterial consortia

Follica

75.9% Equity plus Royalties

Building a regenerative biology platform for androgenetic alopecia, epithelial aging and other medical indications

Sonde

42.7% Equity

Developing a voice-based technology platform to detect changes of health conditions

Entrega

73.8% Equity

Engineering hydrogels to enable the oral administration of biologics

PureTech Level Cash and Cash Equivalents as of June 30, 2022, represent cash and cash equivalents held at PureTech Health plc and its wholly-owned subsidiaries only. Please refer to the Financial Review section of this report for additional detail.
Consolidated Cash and Cash Equivalents as of June 30, 2022, represent cash and cash equivalents of $365.9 million as shown on the Consolidated Statements of Financial Position.
Presumes the exercise of all call options written by the Company covering 477,100 Karuna shares.
Important Safety Information about Plenity: Patients who are pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide should not take Plenity. To avoid impact on the absorption of medications: For all medications that should be taken with food, take them after starting a meal. For all medications that should be taken without food (on an empty stomach), continue taking on an empty stomach or as recommended by your physician. The overall incidence of side effects with Plenity was no different than placebo. The most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence. Contact a doctor right away if problems occur. If you have a severe allergic reaction, severe stomach pain, or severe diarrhea, stop using Plenity until you can speak to your doctor. Rx Only. For the safe and proper use of Plenity or more information, talk to a healthcare professional, read the Patient Instructions for Use, or call 1-844-PLENITY.
Clinical success is measured as the probability of transition success from Phase 1 to regulatory filing. PureTech’s probability is 47%, and the industry average is 8%. The cumulative percentages are calculated by multiplying the individual phase percentages. Industry average data measures the probability of clinical trial success of therapeutics by calculating the number of programs progressing to the next phase vs. the number progressing and suspended (Phase 1=52%, Phase 2=29%, Phase 3=58%). BIO, PharmaIntelligence, QLS (2021) Clinical Development Success Rates 2011 – 2020. This report did not include therapeutics regulated as devices. PureTech average data measures aggregate percentages including all therapeutic candidates advanced through at least Phase 1 by PureTech or its Founded Entities from 2009 onward, using the aforementioned calculation method based on the following individual phase percentages, Phase 1 (n = 6/8; 75%), Phase 2 (n = 10/12; 83%), Phase 3 (n = 3/4; 75%), last updated on August 8, 2022; Phase 2 and Phase 3 percentages include some therapeutic candidates where Phase 1 trials were not conducted by PureTech or its Founded Entities (i) due to the requirements of the medical device regulatory pathway or (ii) because a prior Phase 1 trial was conducted by a third party, which Phase 1 trials were not included in this analysis.
References in this report to "Wholly Owned Programs" refer to the Company’s seven therapeutic candidates (LYT-100, LYT-200, LYT-210, LYT-300, LYT-510, LYT-500 and LYT-503/IMB-150), lymphatic and inflammation platforms and potential future therapeutic candidates and platforms that the Company may develop or obtain. References to "Wholly Owned Pipeline" refer to LYT-100, LYT-200, LYT-210, LYT-300, LYT-510, LYT-500 and LYT-503/IMB-150. On July 23, 2021, Imbrium Therapeutics exercised its option to license LYT-503/IMB-150 pursuant to which it is responsible for all future development activities and funding for LYT-503/IMB-150.
While PureTech maintains ownership of equity interests in its Founded Entities, the Company does not, in all cases, maintain control over these entities (by virtue of (i) majority voting control and (ii) the right to elect representation to the entities’ board of directors) or direct the management and development efforts for these entities. Consequently, not all such entities are consolidated in the financial statements. Where PureTech maintains control, the entity is referred to as a Controlled Founded Entity in this report and is consolidated in the financial statements. Where PureTech does not maintain control, the entity is referred to as a Non-Controlled Founded Entity in this report and is not consolidated in the financial statements. As of June 30, 2022, Controlled Founded Entities include Follica Incorporated, Vedanta Biosciences, Inc. and Entrega, Inc., and Non-Controlled Founded Entities include Gelesis Holdings, Inc., Karuna Therapeutics, Inc., Akili, Inc., Sonde Health, Inc. and Vor Biopharma Inc. Relevant ownership interests for Founded Entities contained in this strategic report were calculated on a partially diluted basis (as opposed to a voting basis) as of June 30, 2022, including outstanding shares, options and warrants, but excluding unallocated shares authorized to be issued pursuant to equity incentive plans. Gelesis, Karuna, Vor Bio and Akili ownerships were calculated on a beneficial ownership basis in accordance with SEC rules as of August 15, 2022, August 19, 2022, August 19, 2022 and August 22, 2022, respectively.
Funding figure can include private equity financings, loans and promissory notes, public offerings or grant awards, and gross proceeds from SPAC mergers. Funding figure excludes future milestone considerations received in conjunction with partnerships and collaborations.
Karuna’s gross proceeds from an equity offering of approximately $862.5 million before underwriting discounts and expenses and Akili’s gross proceeds resulting from SPAC merger of $163 million before deducting transaction expenses and advisory fees.
EndeavorRx is a digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure, Test of Variables of Attention (TOVA), of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx should be considered for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder. There were no serious adverse events; 9.3% of subjects experienced side effects, including frustration, headache, dizziness, emotional reaction, nausea or aggression. EndeavorRx is only available to your patients through a prescription, and is not intended as a stand-alone therapeutic or a substitute for your patient’s medication.
The VCAR33 construct is being studied in a Phase 1/2 clinical trial sponsored by the National Marrow Donor Program ("NMDP"), and the timing of data release is dependent on the investigators conducting the trial.

On August 25, 2022 Genexine (KOSDAQ: 095700), a publicly traded, clinical-stage Korean biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, reported that late-breaking results from the Phase 2 clinical trial study of its therapeutic DNA vaccine GX-188E in combination with MSD’s (Merck & Co., Inc., Rahway, NJ., USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), were selected for an oral presentation at the 2022 European Society for Medical Oncology Congress which is being held from September 9-13 in Paris, France (Press release, Genexine, AUG 25, 2022, View Source [SID1234618676]).

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Presentation Details:

Oral Presentation
Title

Efficacy and safety of GX-188E, a therapeutic DNA vaccine, combined with pembrolizumab in HPV 16- and/or 18- positive advanced cervical cancer (Phase II): Safe & effective both in PD-L1 positive and negative

Date and Time

Sat, 10th September 2022 at 08:35~08:40 AM CEST

Session

Mini Oral Session 1: Gynaecological cancers (#LBA32)

Location

7.2.E – Évry Auditorium

"We are delighted to have been invited to present these very important clinical results of Genexine’s innovative immuno-oncology DNA vaccine, GX-188E in combination with pembrolizumab, an approved immune checkpoint inhibitor," said Neil Warma Genexine’s CEO. "With the completion of this Phase 2 clinical trial, we plan to submit for conditional approval to the Korean MFDS (Ministry of Food and Drug Safety). We believe this could offer hope for a new immunotherapy treatment option to patients with recurrent/metastatic end-stage cervical cancer."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On August 25, 2022 Kriya Therapeutics, Inc., a fully integrated gene therapy company advancing a broad portfolio of innovative therapeutics, reported that it has appointed Curt Herberts, M.B.S., as President and Chief Operating Officer (Press release, Kriya Therapeutics, AUG 25, 2022, View Source [SID1234618674]). Herberts will oversee all general and administrative functions at Kriya .

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"Curt’s extensive experience building successful biotech companies will be a great asset for Kriya, as we expand our operations and capabilities for developing gene therapies to treat patients in need," said Shankar Ramaswamy, M.D., Co-Founder and Chief Executive Officer of Kriya. "Curt and I will be working in close partnership to build value for patients, investors, and employees."

Herberts joins Kriya from Senti Biosciences, Inc., where he was Chief Financial Officer and Chief Business Officer from 2018 to 2021, and Chief Operating Officer from 2021 to 2022. Prior to joining Senti, Herberts held various positions at Sangamo Therapeutics including as the company’s Chief Business Officer, as well as at Campbell Alliance Group, a leading management consulting firm specializing in the life science industry. Herberts earned his B.A. from Stanford University in human biology, and his Master of Business and Science from the Keck Graduate Institute of Applied Life Sciences.

"I am excited to join a company with a fully-integrated gene therapy engine that has the potential to develop a robust pipeline of therapies to treat a wide range of diseases," Herberts said. "I’m looking forward to helping the company lead the industry in ushering in a new era of innovative gene therapies for a broad range of therapeutic areas."

On August 25, 2022 Horizon Therapeutics plc (Nasdaq: HZNP) reported that the Company will participate in the following conference in September (Press release, Horizon Therapeutics, AUG 25, 2022, View Source [SID1234618673]):

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Morgan Stanley 20th Annual Global Healthcare Conference

Date: Tuesday, Sept. 13, 2022
Presentation Time: 2:05 p.m. ET
Location: New York, NY
The conference presentation will be webcast live and may be accessed by visiting Horizon’s website at View Source A replay of the webcast will be available for one year following the event.

On August 25, 2022 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported financial results for the quarter ended June 30, 2022 (Press release, Can-Fite BioPharma, AUG 25, 2022, View Source [SID1234618671]).

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Corporate and Clinical Development Highlights Include:

Strong Balance Sheet – On June 30, 2022, Can-Fite had approximately $12.72 million in cash, cash equivalents, and short-term deposits.

Namodenoson Approved for Compassionate Use in Romania, Pivotal Phase III Liver Cancer Study Open for Enrollment – In August, Can-Fite announced Romania became the second country, following Israel, to approve Namodenoson for compassionate use in patients with advanced liver cancer. Namodenoson induced a complete response with disappearance of all metastases in a Romanian patient who was enrolled in Can-Fite’s prior Phase IIb liver cancer study, and the patient will now continue treatment under the compassionate use program.Can-Fite’s pivotal Phase III liver cancer study for Namodenoson is open for enrollment of approximately 450 patients diagnosed with hepatocellular carcinoma (HCC) and underlying Child Pugh B7 (CPB7) who have not responded to other approved therapies.

Phase III COMFORT Trial for Psoriasis Meets Primary Endpoint – Topline results were announced during the second quarter, and further data are expected in the coming weeks. Piclidenoson, Can-Fite’s lead drug candidate, successfully met its primary endpoint in the Phase III COMFORT trial in more than 400 adults with moderate to severe plaque psoriasis. At week 16, patients receiving Piclidenoson 3mg demonstrated statistically significant improvement when compared with placebo, as measured by the Psoriasis Area and Severity Index (PASI) 75 response (representing a 75% reduction in psoriasis severity): Piclidenoson 3mg: 9.7% vs. placebo: 2.6% (P< 0.04). A linear increase in the response of patients to Piclidenoson was achieved along the study period, on week 48 reaching a PASI 50 response (50% reduction in psoriasis severity) in 90% of patients, a PASI 90 response (90% reduction in psoriasis severity) in 10% of patients, and Psoriasis Disability Index (PDI) improvement in 60% of patients.

Company to Submit FDA & EMA Registration Plans for Piclidenoson for the Treatment Psoriasis – Following the successful COMFORT study, Can-Fite is planning to submit its marketing registration plans to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for Piclidenoson in the treatment of moderate to severe psoriasis. The pivotal Phase III study’s protocol is being developed in conjunction with Dr. Kim Papp, a Key Opinion Leader in dermatology and an investigator in the COMFORT study. Current chemistry, manufacturing, and controls (CMC), nonclinical data, and human pharmacokinetic data will be submitted to the FDA and EMA along with the pivotal Phase III protocol and other supporting clinical pharmacology plans.

Data show Piclidenoson’s Superior Safety Profile and Higher Patient Compliance Compared to Otezla – In July, Can-Fite announced that further analysis of the Phase III COMFORT data point toward a better safety profile for Piclidenoson as compared to Otezla, which induced gastrointestinal adverse events in 6% of patients compared with 1% in patients treated with placebo or Piclidenoson. Discontinuation of treatment amongst patients treated with Otezla was significantly higher compared to that of the Piclidenoson treated patients.

Piclidenoson Demonstrates Higher Efficacy in Patients with More Severe Disease – Also announced in July a sub-analysis of the efficacy data that divided patients into those who had PASI>25 (more severe psoriasis) and PASI<25 (less severe) at baseline revealed that patients who started with higher PASI values at entry benefitted more from treatment with Piclidenoson as compared to placebo.

NASH Patent Granted in Israel, Phase IIb Study is Ongoing – Patient enrollment is ongoing in Can-Fite’s Phase IIb study evaluating Namodenoson in 140 subjects with biopsy-confirmed NASH. Can-Fite was granted a patent for NASH titled "An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation" in Israel, adding to the approximately 40 other countries in which the same patent has been issued.

Piclidenoson to Enter Clinical Trial for Osteoarthritis in Dogs – Through a development and commercialization agreement signed with Vetbiolix, a France based veterinary biotech company in June of 2021, Piclidenoson is set to enter a clinical trial for the treatment of osteoarthritis in dogs. This follows a successfully completed safety study in dogs exploring dose-range safety and pharmacokinetics. Piclidenoson was well tolerated, with the pharmacokinetic data proportional to dose. Vetbiolix is financially responsible for the clinical studies. The canine osteoarthritis market is projected to reach $3 billion by 2028.

"Positive data from our Phase III COMFORT study further supports our belief that Piclidenoson’s excellent safety profile, combined with its efficacy as compared to placebo, position it very favorably in the market for psoriasis patients who seek an oral drug that can be used long-term," stated Can-Fite CEO Dr. Pnina Fishman. "As we prepare for a Phase III registration trial for Piclidenoson in psoriasis, we are concurrently advancing our portfolio in several other indications with an aim toward monetizing our significant progress through distribution and collaboration agreements."

Financial Results

Revenues for the six months ended June 30, 2022 were $0.40 million, an increase of $0.01 million, or 2.7%, compared to $0.39 million for the six months ended June 30, 2021. The increase considered to be not material.

Research and development expenses for the six months ended June 30, 2022 were $3.27 million, a decrease of $0.54 million, or 14.2%, compared to $3.81 million for the six months ended June 30, 2021. Research and development expenses for the six months ended June 30, 2022 comprised primarily of expenses associated with the completion of the Phase III study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase III study in the treatment of advanced liver cancer and a Phase IIb study for NASH. The decrease is primarily due to lower costs incurred in 2022 associated with the two studies for Namodenoson and due to the wrap up of the Phase III study of Piclidenoson for the treatment of psoriasis in 2022.

General and administrative expenses for the six months ended June 30, 2022 were $1.57 million a decrease of $0.32 million, or 16.9%, compared to $1.89 million for the six months ended June 30, 2021. The decrease is primarily due to the decrease in professional services and public and investor relations expenses. We expect that general and administrative expenses will remain at the same level through 2022.

Financial expenses, net for the six months ended June 30, 2022 were $0.18 million compared to finance income, net of $0.20 million for the six months ended June 30, 2021. The decrease in financial income, net was mainly due to revaluation of the Company’s short-term investment which in 2021 was recorded as income and in 2022 was recorded as expense.

Net loss for the six months ended June 30, 2022 was $4.62 million compared with a net loss of $5.09 million for the six months ended June 30, 2021. The decrease in net loss for the six months ended June 30, 2022 was primarily attributable to a decrease in research and development expenses and a decrease in general and administrative expenses.

As of June 30, 2022, Can-Fite had cash and cash equivalents and short term deposits of $12.72 million as compared to $18.90 million at December 31, 2021. The decrease in cash during the six months ended June 30, 2022 is due to the ongoing operations of the Company.

The Company’s consolidated financial results for the six months ended June 30, 2022 are presented in accordance with US GAAP Reporting Standards.