On June 30, 2022, Propanc Biopharma, Inc. (the "Company") reported that entered into a securities purchase agreement (the "Purchase Agreement") with 1800 DIAGONAL LENDING LLC ("Diagonal"), pursuant to which Diagonal purchased a convertible promissory note (the "Note") from the Company in the aggregate principal amount of $105,000, such principal and the interest thereon convertible into shares of the Company’s common stock at the option of Diagonal (Filing, 8-K, Propanc, JUN 30, 2022, View Source [SID1234616538]). The transaction contemplated by the Purchase Agreement is expected to close on or about July 8, 2022. The Company intends to use the net proceeds ($101,250) from the Note for general working capital purposes.

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The maturity date of the Note is June 30, 2023 (the "Maturity Date"). The Note shall bear interest at a rate of 8% per annum, which interest may be paid by the Company to Diagonal in shares of common stock, but shall not be payable until the Note becomes payable, whether at the Maturity Date or upon acceleration or by prepayment, as described below. Diagonal has the option to convert all or any amount of the principal face amount of the Note, beginning on the date which is one hundred eighty (180) days following the date of this Note and ending on the later of: (i) the Maturity Date and (ii) the date of payment of the Default Amount (as defined below), each in respect of the remaining outstanding amount of this Note, to convert all or any part of the outstanding and unpaid amount of this Note into common stock at the then-applicable conversion price. The conversion price for the Note shall be equal to the Variable Conversion Price (as defined herein) (subject to equitable adjustments for stock splits, stock dividends or rights offerings by the Company relating to the Company’s securities or the securities of any subsidiary of the Company, combinations, recapitalization, reclassifications, extraordinary distributions and similar events). The "Variable Conversion Price" shall mean 65% multiplied by the Market Price (as defined herein) (representing a discount rate of 35%). "Market Price" means the average of the lowest three (3) Trading Prices (as defined below) for the common stock during the ten (10) Trading Day period ending on the latest complete Trading Day (as defined below) prior to the conversion date. "Trading Price" means, for any security as of any date, the closing bid price on the OTCQB, OTCQX, Pink Sheets electronic quotation system or applicable trading market (the "OTC") as reported by a reliable reporting service designated by Diagonal (i.e. Bloomberg) or, if the OTC is not the principal trading market for such security, the closing bid price of such security on the principal securities exchange or trading market where such security is listed or traded or, if no closing bid price of such security is available in any of the foregoing manners, the average of the closing bid prices of any market makers for such security that are listed in the "pink sheets". "Trading Day" shall mean any day on which the common stock is tradable for any period on the OTC, or on the principal securities exchange or other securities market on which the common stock is then being traded. Notwithstanding the foregoing, Diagonal shall be restricted from effecting a conversion if such conversion, along with other shares of the Company’s common stock beneficially owned by Diagonal and its affiliates, exceeds 4.99% of the outstanding shares of the Company’s common stock.

The Note may be prepaid until 180 days from the issuance date. If the Note is prepaid within 60 days of the issuance date, then the prepayment premium shall be 110% of the face amount plus any accrued interest, if prepaid after 60 days from the issuance date, but less than 91 days from the issuance date, then the prepayment premium shall be 115% of the face amount plus any accrued interest, if prepaid after 90 days from the issuance date, but less than 121 days from the issuance date, then the prepayment premium shall be 120% of the face amount plus any accrued interest, if prepaid after 120 days from the issuance date, but less than 151 days from the issuance date, then the prepayment premium shall be 125% of the face amount plus any accrued interest, and if prepaid after 150 days from the issuance date, but less than 181 days from the issuance date, then the prepayment premium shall be 129% of the face amount plus any accrued interest. So long as the Note is outstanding, the Company covenants not to, without prior written consent from Diagonal, sell, lease or otherwise dispose of all or substantially all of its assets outside the ordinary course of business which would render the Company a "shell company" as such term is defined in Rule 144.

Pursuant to the terms of the Purchase Agreement, the Company paid Diagonal’s legal fees and due diligence expenses in the aggregate amount of $3,750.

Other than as described above, the Note contains certain events of default, including failure to timely issue shares upon receipt of a notice of conversion, as well as certain customary events of default, including, among others, breach of covenants, representations or warranties, insolvency, bankruptcy, liquidation and failure by the Company to pay the principal and interest due under the Note. Additional events of default shall include, among others: (i) failure to reserve at least five times the number of shares issuable upon full conversion of the Note; (ii) bankruptcy, insolvency, reorganization or liquidation proceedings or other proceedings, voluntary or involuntary, for relief under any bankruptcy law or any law for the relief of debtors shall be instituted by or against the Company or any subsidiary of the Company; provided, that in the event such event is triggered without the Company’s consent, the Company shall have sixty (60) days after such event is triggered to discharge such event, (iii) the Company’s failure to maintain the listing of the common stock on at least one of the OTC markets (which specifically includes the quotation platforms maintained by the OTC Markets Group) or an equivalent replacement exchange, the Nasdaq National Market, the Nasdaq Small Cap Market, the New York Stock Exchange, or the American Stock Exchange, (iv) The restatement of any financial statements filed by the Company with the SEC at any time after 180 days after the issuance date for any date or period until this note is no longer outstanding, if the result of such restatement would, by comparison to the un-restated financial statement, have reasonably constituted a material adverse effect on the rights of Diagonal with respect to this note or the Purchase Agreement, and (v) the Company’s failure to comply with its reporting requirements of the Securities and Exchange Act of 1934 (the "Exchange Act"), and/or the Company ceases to be subject to the reporting requirements of the Exchange Act.

In the event that the Company fails to deliver to Diagonal shares of common stock issuable upon conversion of principal or interest under the Note within three business days of a notice of conversion by Diagonal, the Company shall incur a penalty of $1,000 per day, provided, however, that such fee shall not be due if the failure to deliver the shares is a result of a third party such as the transfer agent.

Upon the occurrence and during the continuation of certain events of default, the Note will become immediately due and payable and the Company will pay Diagonal in full satisfaction of its obligations in the Note an amount equal to 150% of an amount equal to the then outstanding principal amount of the Note plus any interest accrued upon such event of default or prior events of default (the "Default Amount").

The Note was issued, and any shares to be issued pursuant to any conversion of the Note shall be issued in a private placement in reliance upon an exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder.

The foregoing description of the Note and the Purchase Agreement does not purport to be complete and is qualified in their entirety by reference to the full text of the Note and the Purchase Agreement, which are filed as Exhibits 4.1 and 10.1, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.

On June 30, 2022 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, reported the initiation of a clinical study of LYT-100 (deupirfenidone), PureTech’s wholly-owned therapeutic candidate for the potential treatment of idiopathic pulmonary fibrosis (IPF), to support its registration-enabling package (Press release, PureTech Health, JUN 30, 2022, View Source [SID1234616397]). LYT-100 is a selectively deuterated form of pirfenidone. Pirfenidone is a proven therapy for IPF, a devastating condition where the favorable tolerability, safety and potentially higher exposure of LYT-100 could have an important impact on patient adherence and outcomes.

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"The initiation of this study is supported by substantial clinical data demonstrating favorable safety and tolerability of LYT-100," said Julie Krop, M.D., Chief Medical Officer of PureTech. "The unique profile of LYT-100, coupled with the established efficacy of pirfenidone, has the potential to significantly improve care for these patients. We believe that enabling patients to stay on a therapeutic dose longer – even at a dose with comparable exposure to the FDA-approved dose of pirfenidone – has the potential to drive better efficacy. In addition, achieving higher exposure levels than the FDA-approved dose of pirfenidone has the potential to offer even better efficacy, which is our rationale for pursuing a higher dose of LYT-100 in this study. We are excited to be taking this important step towards our goal of helping patients with this devastating condition."

IPF is a chronic orphan condition that causes progressive scarring of the lungs, and approximately 130,000 people in the U.S. are living with the disease. The prognosis of IPF is poor, with the median survival after diagnosis generally estimated at two to five years. Pirfenidone is approved by the U.S. Food and Drug Administration (FDA) for IPF, yet there are serious limitations to pirfenidone’s clinical use, primarily due to severe gastrointestinal (GI)-related tolerability issues.1,2

"Pirfenidone has proven efficacy to slow the decline in lung function in patients with IPF. However, many patients with IPF who start pirfenidone have side effects that cause them to either discontinue therapy or reduce their dose," said Kevin Flaherty, M.D., Professor of Internal Medicine at the University of Michigan specializing in IPF and other interstitial lung diseases and an advisor to PureTech. "I am excited by the safety and tolerability data generated to date with LYT-100, particularly the most recent data demonstrating how well-tolerated it was in a relatively sick, older patient population with multiple comorbidities, as I believe it could represent great potential in patients with IPF."

LYT-100 is designed to retain the potent and clinically validated anti-fibrotic and anti-inflammatory activity of pirfenidone but has demonstrated a highly differentiated pharmacokinetic (PK) profile that has translated into improved tolerability in PureTech’s ongoing clinical development program. To date, LYT-100 has been studied in more than 400 subjects and demonstrated a favorable safety and tolerability profile. In a crossover study in healthy older adults with similar median age to patients with IPF, PureTech showed that approximately 50% fewer subjects experienced GI-related adverse events (AEs) with LYT-100 compared with pirfenidone (17.4% vs. 34.0%) and substantially fewer subjects experienced AEs with LYT-100 vs. pirfenidone. PureTech also recently showed that LYT-100 can be safely dosed with a higher total drug exposure than the currently approved dose of pirfenidone, which could translate into improved efficacy over pirfenidone.

The global, randomized, placebo-controlled registration-enabling study is designed to evaluate the efficacy, tolerability, safety and dosing regimen of LYT-100 to help inform the study design for a potential pivotal study and to assess the relative efficacy of LYT-100 compared to pirfenidone. A total of approximately 240 patients will be randomized 1:1:1:1 to receive either one of two dose levels of LYT-100, the FDA-approved dose of pirfenidone, or a placebo. One of the LYT-100 arms will evaluate 550 mg three times a day (TID) of LYT-100, which has previously demonstrated the comparable exposure as the currently approved dose of pirfenidone (801 mg TID), and the other arm will evaluate an 825 mg TID dose of LYT-100, which has demonstrated higher exposure than the currently approved dose of pirfenidone with the potential for improved efficacy. The primary objective of the study is to demonstrate a statistically significant and clinically meaningful difference in the slope of decline in a measure of lung function, Forced Vital Capacity (FVC), in the LYT-100 treatment arms compared to placebo over 6 months. The study will also evaluate safety, tolerability and the slope of FVC decline in the LYT-100 treatment arms compared to pirfenidone, though this analysis is not powered to demonstrate strict non-inferiority. FVC is an established measure of pulmonary function in IPF and has served as the basis for FDA approval of the currently marketed treatments for IPF. Topline results from the study are expected by the end of 2023.

Advancement of LYT-200 Clinical Program

PureTech’s LYT-200 program is also progressing through clinical development. Following the completion of the monotherapy dose escalation portion of the Phase 1 program, PureTech has begun to evaluate weekly doses of LYT-200 and will soon begin to enroll patients in cohorts designed to evaluate LYT-200 in combination with chemotherapy or an anti-PD-1 monoclonal antibody. Results from the single agent cohorts are expected by the end of 2022, and results from the combination cohorts are expected in 2023.

LYT-200 is a fully human IgG4 monoclonal antibody (mAb) designed to inhibit the activity of galectin-9, a key molecule expressed by tumors and immune cells and shown in preclinical models to suppress the immune system from recognizing and destroying cancer cells. The primary objective of the Phase 1 portion of the ongoing adaptive Phase 1/2 study is to assess the safety and tolerability of escalating doses of LYT-200 in order to identify an appropriate dose and dosing interval to carry forward into the Phase 2 portion of the trial. Six cohorts were treated with escalating, bi-monthly doses from 0.2-16 mg/kg, and no dose limiting toxicities were reported to date.

Additionally, compelling preclinical data have been generated with LYT-200 in leukemia models, which will be submitted for presentation in a scientific forum. Based on these data, PureTech plans to initiate a study of LYT-200 as a single agent in leukemia patients by the end of 2022.

"We are very pleased with the progress of our Phase 1 evaluation of LYT-200, which has demonstrated favorable safety and tolerability as a single agent at all doses studied to date without any dose limiting toxicities," said Aleksandra Filipovic, M.D., Ph.D., Head of Oncology at PureTech. "We look forward to the continued evaluation of this novel therapy as a potential treatment for metastatic solid tumors as well as the initiation of clinical studies in leukemia."

About LYT-100

LYT-100 is one of seven therapeutic candidates within PureTech’s Wholly Owned Pipeline. It is a selectively deuterated form of pirfenidone that is designed to retain the potent and clinically-validated anti-fibrotic and anti-inflammatory activity of pirfenidone with a differentiated pharmacokinetic profile that has translated into favorable tolerability, as supported by data from multiple human clinical studies. LYT-100 is being advanced for the potential treatment of conditions involving inflammation and fibrosis, including idiopathic pulmonary fibrosis and breast cancer-related, upper limb secondary lymphedema. PureTech is also exploring the potential evaluation of LYT-100 in other inflammatory and fibrotic conditions such as myocardial and other organ system fibrosis based on the strength of existing clinical data around the use of pirfenidone in these indications.

About LYT-200

LYT-200 is a fully human IgG4 monoclonal antibody targeting a foundational immunosuppressive protein, galectin-9, for the potential treatment of solid tumors, including pancreatic ductal adenocarcinoma, colorectal cancer and cholangiocarcinoma, that are difficult to treat and have poor survival rates. PureTech has presented preclinical data demonstrating high expression of galectin-9 across breast cancer, pancreatic and cholangiocarcinoma samples and found that the highest levels of galectin-9 correlated with shorter time to disease relapse and poor survival. These data suggest that galectin-9 could be significant both as a therapeutic target for a range of cancers and as a cancer biomarker. Preclinical animal and patient-derived organoid tumor models also showed the potential efficacy of LYT-200 and the importance of galectin-9 as a target. LYT-200 is currently being evaluated in a Phase 1/2 adaptive design trial.

On June 30, 2022 Novartis reported that results from the Phase III RATIONALE 306 trial showing tislelizumab plus chemotherapy significantly improved overall survival (OS) as a first-line treatment for adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC), regardless of PD-L1 status (Press release, Novartis, JUN 30, 2022, View Source [SID1234616413]). Tislelizumab plus chemotherapy demonstrated a median OS of 17.2 months (CI, 15.8-20.1 months) versus 10.6 months (CI, 9.3-12.1 months) in patients receiving chemotherapy plus placebo and reduced the risk of death by 34% (hazard ratio=0.66; CI, 0.54-0.80, p<0.0001).1 In collaboration with BeiGene, these data were presented today during a late-breaking oral session at the 2022 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer (Abstract #LBA-1).

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"These data, which show tislelizumab plus chemotherapy extended patients’ lives by a median of more than six months, are a promising outcome in the treatment of this aggressive cancer," said Dr. Ken Kato, Chief of Head and Neck Medical Oncology, National Cancer Center Hospital, Tokyo, Japan. "Importantly, the significant overall survival benefit was observed across all patient subgroups in the trial, indicating that tislelizumab plus chemotherapy may be a viable treatment option for patients regardless of their PD-L1 score."

In patients with PD-L1 score ≥10% (secondary endpoint), tislelizumab plus chemotherapy showed a median OS of 16.6 months (CI, 15.3-24.4 months) versus 10.0 months (CI, 8.6-13.0 months) in patients receiving chemotherapy plus placebo and reduced risk of death by 38% (HR=0.62; CI, 0.44-0.86, p=0.0020). In those with PD-L1 score <10% (exploratory analysis), median OS with tislelizumab plus chemotherapy was 16.7 months (CI, 13.0-20.1 months) versus 10.4 months (CI, 9.1-13.0 months; HR=0.72; CI, 0.55-0.94). Survival benefit was consistent across all other subgroups, including race, geographical region and investigator choice of chemotherapy. Tislelizumab plus chemotherapy also significantly improved progression-free survival (7.3 months vs 5.6 months; HR=0.62; CI, 0.52-0.75, p<0.0001) and objective response rate (63.5% vs 42.4%; odds ratio=2.38, p<0.0001).1

"The prognosis for ESCC remains poor, with a five-year survival rate of just five percent, and patients are in need of more treatment options, especially in earlier lines of therapy," said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development, Novartis. "These results add to the growing body of evidence demonstrating the potential for tislelizumab to help patients with esophageal cancer, and reinforce our commitment to studying tislelizumab alone and in synergistic combinations across additional tumor types that may benefit from an immunotherapy."

The incidence of treatment-related adverse events (TRAEs) was similar in both arms. Most common TRAEs for tislelizumab plus chemotherapy versus chemotherapy were anemia (68% vs 61%), decreased neutrophils (78% vs 80%), decreased white blood cell count (55% vs 65%), decreased appetite (39% vs 38%), nausea (37% vs 42%) and peripheral sensory neuropathy (26% vs 21%).1

ESCC is the most common type of esophageal cancer globally, with an estimated 604,000 new cases and 544,000 deaths from esophageal cancer internationally in 2020.2 In the United States, it is estimated there will be more than 20,000 new diagnoses and more than 16,000 deaths from esophageal cancers.3

RATIONALE 306 (NCT03783442) is a multi-regional Phase III, randomized, placebo-controlled, double-blind study of tislelizumab in combination with chemotherapy versus chemotherapy in patients with unresectable, locally advanced recurrent or metastatic ESCC. Approximately 649 study participants were randomized 1:1 to receive either tislelizumab plus chemotherapy or chemotherapy plus placebo. The primary endpoint is OS in the all-comer intent-to-treat population. Secondary endpoints include OS in patients with PD-L1 score ≥10%, progression-free survival, objective response rate, duration of response, health-related quality of life measures and safety.

About Tislelizumab
Tislelizumab is currently under review by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for advanced or metastatic ESCC after prior chemotherapy. The EMA is also reviewing tislelizumab for advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy, and in combination with chemotherapy for previously untreated advanced or metastatic NSCLC.

Tislelizumab is a uniquely designed anti-PD-1 monoclonal antibody, in a global clinical development program consisting of 17 pivotal clinical trials across a broad array of solid tumors, with more than 9,000 patients enrolled to date in 35 countries and regions. Novartis broad portfolio of advanced therapeutic approaches offer a unique opportunity to study tislelizumab in differentiated, potentially synergistic combinations.

Novartis has the rights to develop, manufacture and commercialize tislelizumab in North America, Europe and Japan through a collaboration and license agreement with BeiGene.

On June 30, 2022 Race Oncology Limited ("Race") reported to share further interim results from our preclinical cardioprotection program in collaboration with researchers from the University of Newcastle (ASX announcement: 28 April 2021) (Press release, Race Oncology, JUN 30, 2022, View Source [SID1234616398]). This program aimed at exploring the use of Zantrene (bisantrene dihydrochloride) as a cardioprotective agent which offered synergy with anti-cancer treatments.

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Zantrene was found to protect the hearts of mice from the damaging effects of anthracyclines (specifically doxorubicin) even when the chemotherapeutic dose was increased without significant additional toxicity or bone marrow suppression.

On June 30, 2022 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported that it has achieved key business objectives in the first half of 2022 and provided a review of progress with its two clinical stage drug candidates (Press release, Cyclacel, JUN 30, 2022, View Source [SID1234616414]).

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"We are highly encouraged by clinical safety and anticancer activity observed with oral fadraciclib monotherapy to date," said Spiro Rombotis, President and Chief Executive Officer. "Based on available information we believe that a favorable tolerability profile, daily dosing and target engagement against CDK2 and CDK9 differentiates fadraciclib as potentially best-in-class. Data collected to date in fifteen patients suggest that fadraciclib may have activity across a range of solid tumors and lymphomas. With respect to our second strategic priority, we are actively advancing development of CYC140, our oral PLK1 inhibitor, and enrolling patients in a registration-directed Phase 1/2 study in solid tumors and lymphomas. We look forward to reporting additional data at our R&D Day in the fall of 2022."

"It is exciting to observe dose-related efficacy signals in certain solid tumors and lymphomas, and in particular endometrial cancer and T-cell lymphoma," noted Mark Kirschbaum M.D., Senior Vice President and Chief Medical Officer. "Based on the absence of dose-limiting toxicities at all dose levels, we are adding two dose levels in a protocol amendment to test higher doses of oral fadraciclib before determining the recommended Phase 2 dose which we anticipate in the second half of 2022."

1H 2022 Key Achievements and Corporate Updates

Fadraciclib

Fifteen patients with advanced solid tumors and lymphomas treated with oral fadraciclib at all five dose levels as per protocol in the 065-101 dose escalation study.
Demonstrated evidence of target engagement for CDK2 and CDK9 in cell assay system and patient PK data suggested that these targets are potentially inhibited at 100mg twice daily levels.
A cutaneous T cell lymphoma (CTCL) patient achieved partial response (PR) in the first oral treatment cycle.
A peripheral T cell lymphoma (PTCL) patient achieved 38% reduction in target lesions by PET scan in the first oral treatment cycle.
An endometrial cancer patient achieved stable disease with 15% reduction of target lesions after the first oral treatment cycle. In an earlier study of intravenous fadraciclib as monotherapy, a patient with MCL1 amplified endometrial cancer achieved confirmed complete response (CR) and remains on study after two and a half years of treatment.
A pancreatic cancer patient achieved stable disease by confirmatory scan for five oral treatment cycles.
As no dose limiting toxicities have been observed, the Company has submitted a protocol amendment to the U.S. Food and Drug Administration (FDA) to escalate to two additional dose levels before determining recommended Phase 2 dose (RP2D).
Based on good tolerability in 065-101, a protocol amendment in the 065-102 study of oral fadraciclib in patients with leukemia or myelodysplastic syndromes has enabled acceleration of the study by omitting dose levels two and three and now enrolling at dose level 4.
CYC140

No dose limiting toxicities observed to date in 140-101, a Phase 1/2 study of oral CYC140 in solid tumors.
An ovarian cancer patient in 140-101 achieved stable disease with tumor shrinkage after the first cycle.
Corporate Updates

The Company is planning an R&D Day in the fall of 2022 to present updated data from the 065-101 and 140-101 clinical trials.
The Company has also submitted an abstract to potentially present fadraciclib data from 065-101 at a cancer conference in the fall of 2022.