On November 30, 2021 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that management will participate in the JMP Securities Hematology and Oncology Summit, a virtual presentation is scheduled for Tuesday, December 7, 2021 at 2:40 p.m. ET / 11:40 a.m. PT (Press release, Spectrum Pharmaceuticals, NOV 30, 2021, View Source [SID1234596274]).

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A live webcast of the presentation will be available from the Investor Relations section of the company’s website at View Source with a replay available shortly after the event.

On November 30, 2021 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), reported the closing of its previously announced private placement of equity (Press release, Regulus, NOV 30, 2021, View Source [SID1234596294]). The Company received gross proceeds of approximately $34.6 million from the sale of 58,923,352 shares of the Company’s common stock ("Common Stock") at a purchase price of $0.36 per share. In addition, the Company sold 3,725,720 shares of non-voting Class A-4 convertible preferred stock, in lieu of shares of Common Stock, at a price of $3.60 per share. Each share of non-voting Class A-4 convertible preferred stock is convertible into 10 shares of Common Stock, subject to certain beneficial ownership conversion limitations. The Company expects to use the net proceeds from the transaction for non-clinical and clinical development activities for its product candidates and general corporate purposes. SVB Leerink acted as the lead placement agent for the financing. H.C. Wainwright and Co. acted as co-placement agent for the financing.

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The offer and sale of the foregoing securities were made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state.

Additional details regarding the private placement are included in the current reports on Form 8-K filed with the Securities and Exchange Commission on November 24, 2021 and November 30, 2021.

On November 30, 2021 Molecular Templates, Inc.(Nasdaq: MTEM, "Molecular Templates," or "MTEM" or "the Company"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported a corporate update and outlined expected 2022 milestones (Press release, Molecular Templates, NOV 30, 2021, View Source [SID1234596311]).

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"2021 was a year of growth for MTEM as we advanced our multiple pipeline programs," said Eric Poma, Ph.D., Chief Executive and Chief Scientific Officer of Molecular Templates. "As we end the year and move into 2022, we look forward to generating further clinical data that builds on the unique biology we are seeing from three ongoing studies with MT-6402, MT-5111, and MT-0169. We expect to file an IND in 2H22 for our CTLA-4 program and will continue to advance our earlier stage pipeline with ETBs in preclinical development targeting TIGIT, TROP-2, and SLAMF7."

2021 Accomplishments, Status Updates, and Expected 2022 Milestones

MT-6402 (PD-L1 ETB with Antigen Seeding)

MT-6402 is the first of the Company’s 3rd-generation ETBs to enter the clinic. It targets PD-L1 and incorporates the Company’s antigen seeding technology. MT-6402 was designed to directly destroy PD-L1+ tumor cells and alter the immunosuppressive tumor microenvironment through direct cell-kill of PD-L1+ immune cells. In addition, antigen seeding allows MT-6402 to induce the presentation of an MHC class I CMV antigen on tumor cells for pre-existing CD8 T-cell recognition and destruction in HLA-A2+ CMV+ patients. A Phase I study in relapsed/refractory patients with PD-L1-expressing tumors and/or immune cells in the tumor microenvironment was initiated in 2H21 at a starting dose of 16 mcg/kg. Highlights from the on-going Phase I study include:

4 patients have been treated (2 NSCLC, 1 melanoma, 1 ovarian) with no dose limiting toxicities (DLTs) to date
1 patient with stable disease (SD) at 5+ months with reduction in non-measurable bone metastasis
3 patients with progressive disease
Target-mediated, HLA type-independent pharmacodynamic effects after MT-6402 treatment observed in majority of patients including peripheral CD14+ monocyte depletion
One patient had monocyte depletion of >95% that was achieved in cycle 2 and is maintained and on-going at 5+ months of treatment, demonstrating potential for sustained effect with repeat dosing
One patient had monocyte depletion of 90% that was achieved in cycle 2 and sustained through two cycles of therapy before the patient discontinued the study for disease progression at the end of cycle 2
One patient had monocyte depletion of ~21% but discontinued at the end of cycle 1 for disease progression
One patient had no evidence of monocyte depletion but discontinued after 10 days on therapy for disease progression and did not complete cycle 1
Similar depletion was not observed in non-PD-L1-expressing cells (i.e., NK cells, B-cells, etc) nor was monocyte depletion noted in patients treated with other ETBs (MT-3724, MT-0169, or MT-5111)
Significant increases in key cytokines including IL- 2 and activated CD8+ T-cell markers including CD69 noted in patients
Comparable immune subset and/or cytokine changes not seen with approved PD-L1 agents
One HLA-A2 CMV+ patient (i.e., antigen-seeding eligible patient) has been treated to date
Patient is a NSCLC chemotherapy-ineligible patient whose disease had progressed following treatment with a combination of checkpoint inhibitors (ipilimumab and nivolumab); patient has non-measurable bone disease
On-going monocyte depletion of >95% observed at 5+ months of dosing
Initial increase of ~ 50% in CMV antigen-specific T-cells after dosing with MT-6402 with subsequent near-complete extravasation of CMV antigen-specific T-cells from the periphery despite a general increase in total peripheral CD8+ effector T-cells (effect not seen in non-HLA-A2 CMV-negative patients)
Multiple sites of bone disease had resolved on bone scan with only one remaining site which showed decreased uptake
Dose escalation continues as planned
In November, MT-6402 was granted Fast Track Designation for the treatment of patients with advanced NSCLC expressing PD-L1
"We are excited to see pharmacodynamic effects with MT-6402 this early in dose escalation in the Phase I study. No approved checkpoint agent has shown an ability to alter immune subset composition or induce cytokine changes in a PD-L1-targeted fashion," said Roger Waltzman, MD, Chief Medical Officer of Molecular Templates. "We believe that the actual clearance of PD-L1+ immune cells and not merely the steric inhibition of PD-L1 on immune cells may work to more potently alleviate tumor-mediated immunosuppression by removing immunosuppressive myeloid cells acting as a barrier to immunotherapy. Additionally, we are seeing early evidence supporting our unique antigen seeding approach to alter tumor immunophenotype. We are excited to see this unique biology potentially driving patient benefit and believe these data support both monotherapy treatment in relapsed/refractory patients as well as future combination studies in earlier lines of therapy with PD-1 antibodies or other therapies."

MT-5111 (HER2 ETB)

MT-5111 is the Company’s 2nd-generation ETB targeting HER2. It is designed to avoid competition with and to overcome the primary mechanisms of tumor resistance to current therapies that target HER2. MT-5111 destroys HER2-positive tumor cells through a novel mechanism of action (enzymatic ribosomal destruction), targeting HER2 via a distinct epitope from trastuzumab and pertuzumab, and improving tumor penetration with a smaller size compared to HER2 antibodies (55 kDa vs 146 kDa). Dose escalation is on-going in the Phase I study with dose levels now at drug concentrations that are predicted to be active in metastatic breast cancer. Dose escalation will continue in solid tumor HER2-positive patients, and an expansion cohort in patients with metastatic breast cancer was initiated in 4Q21. Highlights from the on-going Phase I include:

27 patients have been treated to date with MT-5111 across 7 dose escalation cohorts ranging from 0.5 mcg/kg to 10 mcg/kg without any DLT’s
MT-5111 has been well-tolerated with no significant immuno- or cardiotoxicity observed
The expansion cohort for patients with metastatic breast cancer is open for enrollment
Dosing in the cohort is at 10 mcg/kg with the potential for dose-escalation
Dose levels of 10 mcg/kg or higher are expected to be required to achieve drug concentration levels that could drive efficacy in breast cancer
"We believe we are now at dose levels in the Phase I study that should be in the therapeutic range for MT-5111, and, with the opening of the breast cancer cohort, we are assessing the activity in the patient population we believe is most likely to respond," said Dr. Roger Waltzman. "We believe the tolerability to date supports further dose escalation."

MT-0169

MT-0169 is the Company’s 2nd-generation ETB targeting the CD38 receptor, found on the surface of multiple myeloma and non-Hodgkin lymphoma (NHL) cells. MT-0169 was designed to destroy CD38+ tumor cells through induced internalization of CD38 and cell destruction through a novel mechanism of action (enzymatic ribosomal destruction). MT-0169 is the most potent ETB developed to date and the study initiated with the highest starting dose for any ETB. Relevant pharmacodynamic data from patients treated in the first dose cohort show NK cell depletion consistent with maximal levels achieved with CD38 antibody therapy. MTEM assumed full rights to MT-0169 in August 2021 and is opening new sites for the Phase I study. As part of a protocol amendment, CD38+ NHL patients will be dosed in addition to myeloma patients. Highlights from the on-going phase I include:

5 multiple myeloma patients have been treated to date
No serious adverse events (SAEs) have been observed. Two cardiac adverse events were observed that meet criteria for DLT. Both evaluations were triggered by asymptomatic elevations in high-sensitivity troponin values. As previously disclosed, the first DLT was an asymptomatic, rapidly reversible episode of myocarditis that did not require treatment. The second DLT occurred recently and is an asymptomatic, nonischemic cardiomyopathy. We believe both DLTs may be due to activity against low CD38-expressing cells in the cardiac endothelium. We have not seen evidence of any clinically relevant cardiac adverse event such as myocarditis or cardiomyopathy in any other ETB program (MT-3724, MT-5111, MT-6402) at any dose.
Clearance of CD38+ NK cells noted in all patients with maximal levels of depletion occurring within 24 hours and consistent with maximal depletion seen with CD38 antibodies
Rapidity and depth of CD38+ NK cell-kill is substantially higher in humans than what was seen in non-human primate studies
One patient has shown symptomatic benefit with a reduction in myeloma-induced bone pain
A revised protocol will be submitted to explore dose reduction with MT-0169 to reduce the risk of toxicity caused by the destruction of low CD38-expressing cells and enable patients to continue MT-0169 therapy for a duration that may drive tumor benefit
"MT-0169 has shown potent and rapid pharmacodynamic activity against CD38+ NK cells with early signs of clinical benefit," said Dr. Roger Waltzman. "The pharmacodynamic activity of NK cell-kill at 50 mcg/kg exceeded what was expected based on the non-human primate data and is consistent with maximal achievable levels. In general, we have observed that MT-3724, MT-6402, and MT-0169 have all shown substantially more pharmacodynamic activity in patients compared to what was seen in NHPs at equivalent or higher doses. We will be exploring lower doses in the proposed revised protocol and expect to report additional data in 2022."

Preclinical Pipeline

MTEM continues to advance its pipeline with its CTLA-4 and TIGIT ETBs representing novel approaches to key immune-oncology targets and its TROP2 and SLAMF7 ETBs applying unique biology to validated targets. MTEM also continues to expand the capabilities of the ETB technology.

IND filing of CTLA-4 program expected in 2H22
Lead selection for TIGIT, TROP-2 with antigen seeding, and SLAMF-7 is ongoing
Additional target selection and scaffold improvements expected in 2022
"We continue to move forward with programs against new targets using the unique biology of ETBs, and we continue to advance the biology of the ETB scaffold," continued Dr. Poma. "We believe MT-6402 and our CTLA-4 and TIGIT programs represent a new way of altering the immune environment in patients with cancer through targeting and destroying myeloid-derived suppressor cells and regulatory T cells (Tregs). Additionally, we believe that new mechanisms of action against validated targets like TROP-2 and SLAMF-7 are needed in these diseases with high unmet medical need."

Key Milestones for 2022

"We believe that 2022 will be another exciting year for the Company with potentially transformational data across our three ongoing clinical programs, an IND filing expected for our CTLA-4 ETB and continued preclinical development," concluded Dr. Poma. "We have substantial cash reserves into 4Q23 to drive development of a broad range of compounds at MTEM."

Continued data read-outs on all three clinical programs
IND filing for ETB targeting CTLA-4
Advancement of ETBs targeting TROP2, TIGIT, SLAMF-7
The Company has cash runway into 4Q23
Participation in Evercore ISI 4th Annual HealthCONx

The Company will participate in a fireside chat and hold 1-on-1 investor meetings at the Evercore ISI 4th Annual HealthCONx, to take place November 30 – December 2, 2021.

On November 30, 2021 IMV Inc. (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and blood cancers while preserving patients’ quality of life, reported that the first patient with hormone receptor positive/HER2-negative (HR+/HER2-) breast cancer has been dosed with its lead compound, maveropepimut-S (MVP-S, formerly known as DPX-Survivac) (Press release, IMV, NOV 30, 2021, View Source [SID1234596257]). In this trial, MVP-S is being administered in combination with an aromatase inhibitor, with or without radiotherapy or cyclophosphamide prior to surgery.

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"We are excited to see maveropepimut-S evaluated in this new clinical study and in an indication where survivin is known to play a critical role in resistance to treatment," said Jeremy Graff Ph.D., Chief Scientific Officer at IMV. "This is a new opportunity not only to explore the clinical benefit of MVP-S in breast cancer patients but also to deepen and enrich our understanding of the MVP-S therapeutic mechanism of action".

Kristina H. Young, M.D., Ph.D., Principal investigator of the study, and Assistant Member, Tumor Microenvironment Lab in the Earle A. Chiles Research Institute, a division of the Providence Cancer Institute commented, "Upregulation of survivin expression in HR+/HER- breast cancer is known to be associated with resistance to aromatase inhibitors. The combination of MVP-S may help overcome this mechanism of resistance and provide benefit to these women while limiting adverse events." She added that "Women with HR+/HER2- breast cancer are in need of treatments that are effective and allow a good quality of life."

About the Study

This investigator-initiated clinical study is a Phase 1b, non-randomized, open-label study to evaluate the combination of maveropepimut-S (MVP-S, formerly named DPX-Survivac) and an aromatase inhibitor with/without radiotherapy or cyclophosphamide (CPA) prior to surgery. Across the three arms of this study, MVP-S will be evaluated in 18 subjects with resectable, non-metastatic HR+/HER2- breast cancer.

The primary objective is to evaluate the safety in this neoadjuvant trial of the combination of maveropepimut-S with an aromatase inhibitor and with/without radiation, or CPA in each arm. The generation of survivin-specific T cells in PBMCs and in tumor tissue both pre and on treatment will be evaluated as secondary objectives. Extensive translational studies will be conducted to explore further the MVP-S mechanism of action in the tumor, the tumor environment and in peripheral circulation. The study is being conducted at the Providence Cancer Institute in Portland, Oregon, and is expected to be completed in 2026 with primary results in 2023. For more information, refer to ClinicalTrials.gov Identifier: NCT04895761.

On November 30, 2021 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported its financial results and operational highlights for the third quarter ended September 30, 2021 (Press release, RedHill Biopharma, NOV 30, 2021, View Source [SID1234596275]).

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Dror Ben-Asher, RedHill’s Chief Executive Officer, said: "Our U.S. commercial business continues to drive growth, delivering a second consecutive quarterly net revenue record of $21.6 million despite the continuously challenging pandemic environment. Talicia generated another record quarter with 15% growth in new prescriptions, while Movantik continues to perform adding a 1.1% increase to new prescriptions. Both products are also continuing to make strides in gaining both commercial and government formulary coverage. In addition, gross margin increased from 51% in the second quarter to 57% in the third quarter. The Company has successfully attracted a strategic investment from South Korea’s Kukbo and continues to demonstrate responsible financial discipline across the entire business as we strive to achieve our long-term growth aims."

Mr. Ben-Asher added: "Given the recent emergence of the heavily mutated Omicron variant as well as likely emergence of other variants over time, the importance of drug candidates that act independently of the viral spike protein is growing. This makes both opaganib and RHB-107’s host-targeted mechanism of action, and expected maintenance of effect against new variants, increasingly more relevant in the battle against COVID-19. This quarter saw significant focus on our opaganib Phase 2/3 COVID-19 study. The initial top-line results demanded further investigation and our rigorous post-hoc analysis provided much greater clarity into the potential of novel, orally-administered opaganib in the underserved hospitalized moderately severe patient group. This is a group of patients for which no novel therapeutic pill has shown a benefit until opaganib, which demonstrated a 62% reduction in mortality, improved return to room air and earlier hospital discharge for opaganib-treated patients. The results of this analysis, in a group of more than half the total study population, were consistent with what we had seen in our Phase 2 study and compassionate use experience. Despite being a post-hoc analysis, the consistency across multiple endpoints and territories provides us with a high degree of confidence in the results showing opaganib’s effect in this patient population. This analysis also shed light on key issues of the COVID-19 disease severity classification, suggesting that FiO2 might be an improved method for classifying disease severity and predictor of treatment outcome. We have now provided regulators in various countries with all the necessary data to facilitate discussions on the next steps and we continue to provide the data to regulators in additional countries."

"In parallel, we continue to progress our Phase 2/3 study in the U.S. and South Africa with our other novel, once-daily, oral COVID-19 antiviral drug candidate, RHB-107, which has now completed enrollment for Part A of the study, with top-line results expected in the first quarter of 2022. Our Phase 3 study of RHB-204 in pulmonary nontuberculous mycobacteria (NTM) disease continues to enroll patients in the U.S. and progress with Phase 3-stage RHB-104 for Crohn’s disease is expected to speed up thanks to recent, much-awaited, potential progress in Mycobacterium avium subspecies paratuberculosis (MAP) detection research2."

"With a steep reduction in quarterly operating and net loss and continued commercial business growth, leading to a potential commercial operational breakeven before the end of the year, coupled with advanced, exciting and timely R&D pipeline progress, I believe RedHill is well positioned for short, medium and long-term success."

2

Financial highlights for the quarter ended September 30, 20213

Net Revenues were $21.6 million for the third quarter of 2021, as compared with $21.5 million for the second quarter of 2021. The increase is attributable to an increase in sales of Talicia and Movantik, partially offset by an increase in gross-to-net deductions, mainly commercial rebates and Medicare discounts.

Gross Profit was $12.4 million for the third quarter of 2021, compared to $10.9 million for the second quarter of 2021 – an increase of 14%. Gross margin increased from 51% in the second quarter of 2021 to 57% in the third quarter of 2021. The increase in gross profit was mainly attributable to a reversal of inventory write-off recognized in the third quarter of 2021 following the FDA approval of an extension to Talicia stock expiration date.

Research and Development Expenses were $5.8 million for the third quarter of 2021, a decrease of $4.5 million, a 44% reduction compared to the second quarter of 2021, mainly attributable to the completion of our global COVID-19 Phase 2/3 study with opaganib.

Selling, Marketing and General and Administrative Expenses were $24 million for the third quarter of 2021, a decrease of $1.5 million compared to the second quarter of 2021. The decrease was mainly attributable to expenses related to share-based compensation in the previous quarter.

Operating Loss and Net Loss were $17.4 million and $21.4 million, respectively, for the third quarter of 2021 compared to $24.9 million and $29.1 million, respectively, in the second quarter of 2021. The decrease was mainly attributable to the Talicia inventory expiration date extension, completion of our opaganib Phase 2/3 COVID-19 study and a decrease in expenses related to share-based compensation, as detailed above.

Net Cash Used in Operating Activities was $19 million for the third quarter of 2021, similar to the second quarter of 2021.

Net Cash Used in Financing Activities was $1 million for the third quarter of 2021, comprised primarily of payables with respect to the Movantik acquisition, partially offset by proceeds from utilization of ATM and from exercise of options.

Cash Balance as of September 30, 2021, was $51.5 million.

3
Additional Financial Highlights

In November 2021, the Company announced that it had entered into a strategic agreement with Kukbo Co. Ltd., a South Korean corporation, for the sale of RedHill’s American Depositary Shares (ADSs) in a private placement of up to $10 million, of which the first tranche of $5 million has been paid. As part of the agreement, the Company granted Kukbo a six month right of first offer for a license with respect to one or more of opaganib, RHB-107 (upamostat) and Talicia for South Korea and other Asian territories.

In addition, this month, the Company completed an underwritten public offering of approximately 4.7 million ADSs for gross proceeds of approximately $15.5 million, led by Cantor Fitzgerald.

Commercial Highlights

Movantik (naloxegol)4
The Company’s focus on driving Movantik performance and strengthening of market share continues unabated, resulting in another quarter of new prescription growth, increasing by 1.1% compared to the previous quarter.

The Company has achieved significant market access successes with U.S. major payors, continuing to increase the levels of payor coverage.

In July, one of America’s largest payors, serving many Blue Cross and Blue Shield Plans and more than 30 million members, had added Movantik as a preferred brand with no restrictions to its Commercial NetResults "A" series formularies and as a preferred brand on its other commercial formularies starting July 1, 2021. In April, Movantik was also included on the Part D formulary of another major payor with no restrictions. Almost 9 out of 10 U.S. commercial lives are now covered, and we continue to work toward additional formulary coverage for the remaining patients.

In September 2021 RedHill Biopharma Inc., AstraZeneca AB, AstraZeneca Pharmaceuticals LP and Nektar Therapeutics entered into a settlement and license agreement with Aurobindo Pharma USA, Inc. resolving their patent litigation in the U.S. in response to Aurobindo’s Abbreviated New Drug Application (ANDA) seeking approval by the FDA to market a generic version of Movantik. This follows the previously announced resolution of the Apotex litigation and brings to a close all presently pending Movantik patent litigation brought pursuant to The Drug Price Competition and Patent Term Restoration Act (the Hatch-Waxman Act). The earliest licensed entry date of any generic naloxegol in the U.S. is October 1, 2030.

Talicia (omeprazole magnesium, amoxicillin and rifabutin)5
Talicia achieved another record quarter, delivering a 15% increase in new prescriptions, compared to the previous quarter, reflecting 117% growth of Talicia as compared to Q3/2020.

In October, Medi-Cal – California’s Medicaid Health Care program covering two million beneficiaries – had added Talicia to its Contract Drug List (CDL) for H. pylori treatment, with no prior authorization required. This coverage is expected to expand to 14 million beneficiaries on January 1, 2022. During the same month, a new U.S. Patent covering Talicia was granted. This patent reinforces the protection for Talicia through 2034, and the Company has listed this patent in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.

4
In July, the Company significantly expanded commercial coverage for Talicia, announcing that OptumRx, part of the UnitedHealth Group, a leader in healthcare coverage, partnered with more than 1.3 million healthcare professionals and 6,500 hospitals, had added Talicia to its Commercial Formulary as an unrestricted brand for H. pylori treatment, effective July 1, 2021. This agreement expanded access to Talicia to 26 million additional Americans and increased overall patient access to Talicia to greater than 8 out of 10 covered U.S. Commercial lives.

Aemcolo (rifamycin)6
The Company has maintained promotion of Aemcolo in the third quarter of 2021 supporting the initial momentum that Aemcolo was generating pre-COVID-19 travel restrictions. RedHill and Cosmo Pharmaceuticals N.V are currently in discussions with respect to the amendment of the Aemcolo License Agreement.

R&D Highlights

COVID-19 Program: Opaganib (ABC294640)7
In September 2021, the Company announced top-line results from the global 475-patient Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia (NCT04467840). Whilst results showed consistent trends in favor of the opaganib arm, the study endpoints did not achieve statistical significance.

A post-hoc analysis of data from 251 study participants requiring a Fraction of inspired Oxygen (FiO2) up to 60% at baseline (54% of the study participants), was subsequently reported in October 2021, demonstrating that treatment with oral opaganib resulted in a 62% reduction in mortality as well as improved outcomes in time to room air and median time to hospital discharge, in this large group of hospitalized, moderately severe COVID-19 patients.

The results provide a strong rationale for opaganib’s potential efficacy in hospitalized patients in need of oxygen supplementation up to 60% FiO2, a large proportion of hospitalized COVID-19 patients. The Phase 2/3 study results are also consistent with opaganib’s earlier U.S Phase 2 study results and the demonstrated potent antiviral inhibition of SARS-CoV-2 variants in human bronchial epithelial cells, providing further support for its potential in earlier stages of disease where viral load is higher.

Additional new preclinical results demonstrating opaganib’s efficacy in significantly decreasing renal fibrosis in a unilateral ureteral obstruction-induced renal interstitial fibrosis mode were also reported by the Company in September 2021.

5
The Company has submitted data packages for opaganib to the regulatory agencies in the U.S., EU, UK and other territories, ahead of planned regulatory advice, with the European Medicines Agency (EMA) having provided expedited evaluation process timelines. As previously stated, additional studies to support the potential of such applications and the use or marketing of opaganib are likely to be required. For example, the FDA has previously indicated that we will need to complete additional studies to support applications in the U.S. The strength of the safety and efficacy data generated from the opaganib studies will be key to regulatory applications.

The Company also continues its discussions with U.S. and other government agencies and non-governmental organizations around potential funding to support the ongoing development of opaganib. Discussions are also ongoing with potential partners who are interested in the rights to opaganib in various territories.

COVID-19 Program: RHB-107 (upamostat)8
RedHill continues to advance the Phase 2/3 study of novel, once-daily, orally-administered, antiviral drug candidate, RHB-107, in the treatment of non-hospitalized patients with symptomatic COVID-19 in the early course of the disease who do not require supplemental oxygen – the vast majority of COVID-19 patients. The study plans to test for the Omicron variant.

Further to announcing in September 2021 that South Africa had joined the U.S. in approving the Phase 2/3 study, along with the expansion to additional U.S. sites, the Company announced this month that the last patient had been enrolled in Part A of the Phase 2/3 study. The study is a 2-part trial designed to evaluate time to sustained recovery from illness as the primary endpoint and for dose selection. A total of 61 patients have been enrolled in Part A and based on safety and tolerability results of part A, a dose for part B will be selected. Top-line results from Part A of the study are expected in the first quarter of 2022, with Part B of the study expected to follow subsequent to discussions with regulators.

RHB-204 – Pulmonary Nontuberculous Mycobacteria (NTM) Disease
A U.S. Phase 3 study is ongoing to evaluate the efficacy and safety of RHB-204 in adults with pulmonary NTM disease caused by Mycobacterium avium Complex (MAC) infection. The Company is also assessing potential expansion of the RHB-204 Phase 3 study to additional territories.

The Company previously announced that the FDA granted Fast Track designation for RHB-204, providing early and frequent communications and a rolling review of any New Drug Application (NDA). RHB-204 is also eligible for NDA Priority Review and Accelerated Approval.

RHB-204 was granted FDA Orphan Drug designation and Qualified Infectious Disease Product designation, extending its U.S. market exclusivity to a potential total of 12 years upon potential FDA approval.

6
RHB-104 – Crohn’s Disease
Based on recent published research, potential progress in Mycobacterium avium subspecies paratuberculosis (MAP) diagnostic technology may enable us to advance the program towards a confirmatory study in approximately 150 MAP positive moderate-severe Crohn’s patients, subject to required regulatory input.

Opaganib – Prostate Cancer and Cholangiocarcinoma
In August 2021, we announced that, based on a preliminary review of partial and unaudited data, the ongoing Phase 2 study for prostate cancer had met its primary endpoint of at least six subjects demonstrating disease control (defined as stable disease or better after 16 weeks on treatment) among at least 27 evaluable subjects. Upon further review and analysis of the unaudited data, the Company reported that the study did not meet its primary endpoint in the study arm evaluating opaganib in combination with enzalutamide. Patient enrolment continues for the study’s other arm, evaluating a combination of opaganib and abiraterone. Accrual and data entry are ongoing and results for the study remain subject to further review and analysis.

The Phase 2a study evaluating the activity of opaganib in advanced cholangiocarcinoma (bile duct cancer) is ongoing at Mayo Clinics in Arizona and Minnesota, Emory University and the Huntsman Cancer Institute at the University of Utah. Enrollment has been completed for the first cohort of 39 patients, evaluating the activity of orally-administered opaganib as a stand-alone treatment. Preliminary data from this cohort indicated a signal of activity in a number of subjects with advanced cholangiocarcinoma. Enrollment is ongoing for a second cohort, evaluating opaganib in combination with hydroxychloroquine, an anti-autophagy agent.

Conference Call and Webcast Information:

The Company will host a webcast today, Tuesday, November 30, 2021, at 8:30 a.m. EST, during which it will present key highlights for the third quarter of 2021.

The webcast including slides will be broadcast live on the Company’s website, View Source, and will be available for replay for 30 days.

To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-877-870-9135; International: +1-646-741-3167 and Israel: +972-3-530-8845; the access code for the call is: 9753927.