On November 11, 2022 Aucentra Therapeutics reported the appointment of Dr David Fuller as ‘Chief Medical Officer’ and a member of the executive management team commencing 16 November 2022 (Press release, Aucentra, NOV 11, 2022, View Source [SID1234623850]).

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Dr Fuller will lead the company’s Australia and global clinical development at a crucial time of significant growth. His extensive experience and background as a biopharmaceutical executive and physician will pave the way with Aucentra Therapeutics lead candidate Auceliciclib Phase II/III clinical trial and progress the pipeline of clinical and pre-clinical drug programs.

During his career, Dr Fuller has led successful major market drug approvals including Moraxen (UK), Busulfex (US Paediatrics and EU Adult indications), Xyrem (US) and Renagel (EU). He has also designed and executed multiple Phase I, II and III studies (US, EU, Asia) for both orphan and non-orphan drug products.

Dr Fuller brings with him international prowess and extensive knowledge of research development & commercialisation of novel pharmaceuticals. His 30 years’ experience spans large, mid, and small cap companies including pre-clinical and clinical development, medical and regulatory affairs, and commercialisation.

On November 11, 2022 Intensity Therapeutics, Inc. ("Intensity"), a clinical-stage biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral therapies designed to kill tumors and increase immune system recognition of cancers, reported that data from its ongoing phase 1/2 clinical trial demonstrating the efficacy and tolerability of INT230-6, either as monotherapy or in combination with pembrolizumab in patients with relapsed, refractory and metastatic solid tumors, will be presented today at the 2022 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting being held in Boston and virtually November 8-12, 2022 (Press release, Intensity Therapeutics, NOV 11, 2022, View Source [SID1234623849]).

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Abstract Number: 710
Title: Safety and Survival Results From a Phase 1/2 Trial of Intratumoral Agent INT230-6 (cisplatin vinblastine) Induces Immunological Cancer Cell Death Alone or With Pembrolizumab in Patients with Refractory, Metastatic Cancers
First Author: Jacob Stephen Thomas, M.D.
Session Date and Time: Friday, November 11, 2022, 9:00 am – 9:00 pm EST
Location: Boston Convention Center Hall C; In-Person & On Demand

Copies of the presentation materials will be available on the Intensity Therapeutics website on the publications and posters page.

"Despite significant innovation in immunotherapeutic and checkpoint inhibitor therapy approaches for cancer treatment, patients with metastatic and refractory disease continue to have poor survival and response rates remain low in many tumor types," stated Jacob S. Thomas, M.D., Assistant Professor of Clinical Medicine, Keck School of Medicine of USC at the University of Southern California (USC) and an oncologist at USC’s Norris Comprehensive Cancer Center, part of Keck Medicine of USC. "The active drug agents of INT230-6 remain in the tumor following injection and cause some cancer cell death and tumor shrinkage, as suggested by this study. This effect appears to have some positive impact on the tumor immune microenvironment with increasing levels of CD4+ and CD8+ T-cells. While the analysis is exploratory, survival seems to be extended with increased dosing, relative to incoming tumor burden. That said, using the tumor diffusive product, INT230-6, appears to be a new approach in metastatic and refractory disease alone and in combination with pembrolizumab."

"We continue to see exciting safety and efficacy data with INT230-6 in patients with metastatic and refractory disease," stated Lewis H. Bender, President and Chief Executive Officer of Intensity Therapeutics. "The ability of our drug to both cause necrosis and induce the influx of immune cells into tumors provides strong proof-of-concept evidence for our immunological cell death mechanism and underscores the potential of this novel, new treatment. There remains a high unmet need for improved therapeutic approaches for many solid tumors. With that in mind, we are planning later stage studies to advance INT230-6 toward potential, future commercialization."

The presentation reports the mOS and disease control rate (DCR: CR + PD + SD per the Response Evaluation Criteria in Solid Tumors (RECIST)). As previously reported, RECIST metrics (sum of longest diameters) to gauge efficacy are only validated for use with systemically delivered therapies. Significant data generated and previously reported suggests that RECIST is inadequate as a measure of efficacy for the highly-absorbed intratumorally (IT) administered INT230-6.

The presentation reports results from 94 patients on the preliminary efficacy and safety of either INT230-6 alone (n=64) or in combination with Merck’s anti-PD-1 therapy, pembrolizumab (n=30) from Intensity’s ongoing open-label phase 1/2 clinical trial. Patients enrolled had over 20 different types of relapsed, refractory metastatic solid tumors and progressed following a median of four prior therapies (monotherapy) and three prior therapies (combination). INT230-6 was administered intratumorally every two weeks for five doses either alone or with 200 mg pembrolizumab dosed every three weeks. Using RECIST criteria, the DCR rate >50 days for monotherapy was 50.9%; INT230-6 in combination with pembrolizumab showed a DCR of 47.6%.

Survival in phase 1/2 studies can be predicted using the Royal Marsden Hospital Index (RMHI), a validated score that uses 3 incoming enrollment criteria (number of metastatic sites, albumin concentrations, and lactose dehydrogenase levels) to assess a patient’s likelihood of survival (Cancer 2012;118:1422–8). The mOS of historical basket studies, INT230-6 alone all subjects, INT230-6 relative to the subject’s reported incoming total tumor burden (TTB), are shown in the table below. The INT230-6 all patients and those receiving a cumulative dose ≥40% of TTB compare favorable to historical phase 1/2 data (Chau et al. BMC Cancer 10/2011) where the mOS typically is 3 to 6 months for patients with one or more risk factors in mixed cancer populations.

Phase 1/2 studies Historical (Chau) INT230-6 all INT230-6 <40% TTB INT230-6 >40% TTB
Median OS 90 to 180 days 373 days 96 days 570 days
Confidence Interval – (221, 649) (75, 373) (361, 1621)
Sample size 64 17 47
The mOS of the INT230-6 in combination with pembrolizumab arm was 205 days (n=24). Six patients were not included in the combination efficacy analysis after results obtained following enrollment showed those subjects had not met all required inclusion criteria.

The pharmacokinetic profiles for the individual drug components of INT230-6 (cisplatin and vinblastine sulfate) were measured and indicate that more than 95% of the active agents remain in the tumor. INT230-6, either as monotherapy or in combination with pembrolizumab, was well tolerated. The most common treatment related adverse events (TRAEs) were localized tumor-related pain, nausea, fatigue, and vomiting. TRAEs were mild to moderate with 11% grade 3 in the monotherapy group and 20% in combination with pembrolizumab. There was one Grade 4 (neutrophil decline that resolved) in the combination arm that resolved quickly and no grade 5 TRAEs.

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor resulting in a favorable safety profile. In addition to local disease control, direct killing of the tumor by INT230-6 releases a bolus of neoantigens specific to the patient’s malignancy, leading to engagement of the immune system and systemic anti-tumor effects. Importantly, these effects are mediated without the immunosuppression of concomitant systemic chemotherapy.

About Intensity Therapeutics’ Clinical Studies

INT230-6 is currently being evaluated in several phase 2 cohorts (NCT 03058289) in patients with various advanced solid tumors as part of Study IT-01. In 2019, the Company signed a clinical collaboration agreement with Merck Sharpe & Dohme (Merck) to evaluate the combination of INT230-6, Intensity’s lead product candidate, and KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in patients with advanced pancreatic, colon, squamous cell and bile duct malignancies. In 2020, the Company executed a clinical collaboration agreement with Bristol-Myers Squibb to evaluate the combination INT230-6 with Bristol-Myers Squibb’s anti-CTLA-4 antibody, Yervoy (ipilimumab), in patients with advanced liver, breast and sarcoma cancers. Intensity is managing the individual combination arms separately with each respective partner via a joint development committee. In 2021, the Company executed agreements with the Ottawa Hospital Research Institute (OHRI) and the Ontario Institute of Cancer Research (OICR) to study INT230-6 in a randomized controlled neoadjuvant phase 2 study in women with early stage breast cancer (the INVINCIBLE study) (NCT 04781725).

On November 11, 2022 Chemomab Therapeutics, Ltd. (Nasdaq: CMMB), a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, reported financial and operating results for the third quarter ended September 30, 2022 and provided a corporate update (Press release, Chemomab, NOV 11, 2022, View Source [SID1234623848]).

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"We continued to make good progress in advancing our clinical programs for CM-101 during the third quarter," said Dale Pfost, PhD, Chief Executive Officer of Chemomab. "We have been preparing to report the results of our liver fibrosis biomarker trial in NASH patients in the coming weeks, while continuing to implement the expansion of our Phase 2 trial in primary sclerosing cholangitis, or PSC. Activities included opening additional clinical sites in the U.S. and Europe and filing regulatory submissions for the dose-finding cohorts and open label extension we are adding. We also are ramping up recruitment activities with patients and physicians to ensure enrollment is on-track. Importantly, during the quarter we wrapped up the design process for our upcoming Phase 2 trial in systemic sclerosis, or SSc. We are very pleased with the design, which was developed with input from a number of systemic sclerosis experts. In this trial we seek to confirm the critical role of CCL24 in SSc, and to generate data that can establish biological and clinical proof of concept for CM-101. The study should also enable us to identify the optimal patient population for CM-101 and to inform the selection of appropriate endpoints for subsequent trials. We anticipate launching the new trial around year-end and enrolling the first patients early in 2023."

Dr. Pfost continued, "In support of our ongoing efforts to educate the scientific and medical communities about the critical role of CCL24 and CM-101 in fibro-inflammatory diseases, our researchers made presentations at important scientific meetings during the quarter. A poster at the recent AASLD Liver Meeting presented new preclinical data supporting the key role of CCL24 in the pathophysiology of PSC and showing how CM-101 can interfere with these disease processes. A featured presentation at the Anti-Fibrosis Drug Development Summit highlighted how Chemomab has used biomarkers as a strategic translational tool to inform and de-risk our drug development programs. A third presentation at an international conference on lung health unveiled new clinical data from an investigator-initiated open label study assessing CM-101 in COVID patients with acute lung injury. It showed that CM-101 administration was well tolerated and was associated with decreases in inflammatory and fibrogenic biomarkers that are also relevant in other fibro-inflammatory diseases like systemic sclerosis. This is an excellent example of the types of data we also hope to see in the liver fibrosis biomarker study that we are looking forward to reporting later this year."

Clinical Update

Phase 2 Liver Fibrosis Trial in NASH patients
Chemomab has concluded the treatment phase of its randomized, placebo-controlled Phase 2 liver fibrosis trial in NASH patients. Preparations for a planned topline read-out continued in the third quarter. The main study outcome is safety and tolerability, with secondary outcomes including a variety of biomarkers associated with inflammation and fibrosis. These may provide useful insights in support of the overall CM-101 clinical development program and should also generate the pharmacokinetic and tolerability data needed to inform next steps in the development of the current subcutaneous formulation of CM-101. The company is on-track to report study results before year-end.

Phase 2 Trial in Primary Sclerosing Cholangitis patients
The company has been adding additional clinical sites, along with an open label extension and a dose finding component intended to inform selection of the optimal dose of CM-101 to advance in later development. Global regulatory filings supporting these changes are proceeding, with a number of new sites in Europe and the U.S. now open. An interim Drug Monitoring Committee safety review of the current PSC cohort is targeted for later this year. Additionally, a number of outreach and education initiatives have been implemented to support ongoing patient recruitment.

Phase 2 Trial in Systemic Sclerosis patients
Chemomab has completed the design of its upcoming Phase 2 trial in systemic sclerosis. The company aims to establish biological proof of concept for clinically relevant aspects of this complex disease, focusing on CM-101’s potential activity in modifying the skin, lung and vascular pathophysiology observed in SSc patients. To that end, we will enrich the study with SSc patients who have higher levels of CCL24 and may therefore be more likely to respond to neutralization of this critical chemokine.

Key design elements include the following:

The trial is a randomized, double-blind, placebo-controlled study that will enroll sixty (60) SSc patients.
To be eligible for the study, patients must manifest two key characteristics: the presence of clinically active disease, either dermatologic or pulmonary, and high serum levels of circulating CCL24.
Forty (40) patients will be randomized to treatment with CM-101 and twenty (20) will be randomized to placebo.
Of the 40 patients on active treatment, approximately half will have limited SSc, and half will have diffuse cutaneous disease.
The study includes a 24-week double blind period during which patients assigned to active treatment will receive CM-101 at a dose of 10 mg/kg, via intravenous infusion, every three weeks.
Following the double-blind period, patients will enter a 24-week open label treatment period, where all patients will receive CM-101 at a dose of 20 mg/kg via intravenous infusion every three weeks.
All patients enrolled will undergo a skin biopsy at baseline and again after the double-blind treatment period, along with multiple clinical assessments of skin, vascular and pulmonary function.
The primary outcome measure for the trial will be demonstration of the safety and tolerability of treatment with CM-101.
All other outcome measures will be principally assessed as changes from baseline to the end of the double-blind treatment period.
The secondary outcome measures of the trial are focused on highly relevant and informative biological read-outs. Key secondary outcomes include:

Evaluation of multiple serum-based biological markers that are known to be associated with different manifestations of SSc including:
Inflammatory cytokines (such a CCL2, IL6 and CXCL10)
Vascular and growth factor-related biomarkers (such as VEGF and PDGF)
Pulmonary-related biomarkers (such as KL-6, SPD and CCL18), and
Fibrogenesis and extracellular matrix biomarkers (collagens, MMPs and ELF score).
Inflammatory, fibrotic and target expression markers in skin biopsies, including but not limited to CCL24 and CCR3 expression levels.
Pharmacokinetics and target engagement of CM-101.
Monitoring for the presence of any potential anti-drug antibodies during the study.
Exploratory biological outcomes assessments will include immune cell phenotyping, assessments of neutrophil function, and ex-vivo biological assays.

Exploratory clinical outcomes will include evaluation of:

Vascular involvement, using nail fold capillaroscopy, vascular imaging and digital ulcer burden
Skin involvement using modified Rodnan scoring
Pulmonary disease involvement using pulmonary function tests, and
Multiple patient-reported outcome measures.
The data collected should also enable us to evaluate global effects of intervention with CM-101 using the revised CRISS scale.

We intend to conduct this study at multiple sites in the U.S., the E.U. and Israel. We are currently finalizing the required regulatory documents and we intend to file an Investigational New Drug application with the U.S. Food and Drug Administration in the coming weeks.

Recent Highlights

At the American Association for the Study of Liver Disease (AASLD) Liver Meeting 2022, Chemomab presented a poster, CCL24 Blockade Attenuates Biliary Inflammation by Interfering with Monocyte and Neutrophil Recruitment, that reinforces the key role of CCL24 in the pathophysiology of primary sclerosing cholangitis. Using two in-vivo models for immune cell trafficking, Chemomab researchers demonstrated that CCL24 plays a critical role in the recruitment and migration of monocytes and neutrophils, which are major players in PSC pathophysiology. Chemomab’s CM-101, a first-in-class CCL24 neutralizing monoclonal antibody, demonstrated an anti-inflammatory effect by interfering with migration of these cells to the damaged biliary area in an animal model of PSC. This study adds to the growing body of evidence validating CCL24 as a target for PSC and confirming the therapeutic potential of Chemomab’s CCL24-neutralizing antibody.
At the Union World Conference on Lung Health 2022, Chemomab CSO Adi Mor presented Treatment with CM-101 Reduced Inflammatory & Fibrotic Biomarkers in Patients with COVID-19-Derived Lung Damage, unveiling promising clinical data from an investigator-initiated open label clinical study showing that a single 10 mg/kg dose of CM-101 reduced biomarkers of lung inflammation and fibrogenesis in hospitalized COVID patients with serious lung involvement. Some of the mechanisms underlying lung inflammation resulting from COVID-19 infection are similar to those seen in chronic diseases that involve lung inflammation and fibrosis. The objective of the study was to assess the safety and activity of CM-101, including its impact on biomarkers related to lung inflammation and systemic sclerosis. CM-101 was well tolerated and demonstrated activity on these key biomarkers of inflammation and fibrogenesis that are relevant for systemic sclerosis and other fibro-inflammatory diseases.
At the Sixth Anti-Fibrotic Drug Development Summit in Boston, Dr. Mor was a featured speaker, highlighting the growing use of inflammatory and fibrotic biomarkers to inform clinical trial design and de-risk drug development. In her presentation, Crossing the Divide: Leveraging Fibrosis-Inflammatory Biomarkers to Inform Clinical Trial Design, Dr. Mor showed how Chemomab has strategically used biomarkers throughout the drug discovery and development process as a key translational tool for competitive advantage, and how the company is continuing to use them today.
Third Quarter 2022 Financial Highlights

Cash Position: Cash and cash equivalents were $46.5 million as of September 30, 2022, compared to $51.8 million as of June 30, 2022. The Company currently expects its runway to last through year-end 2023.
Research and Development (R&D) Expenses: R&D expenses were $5.4 million for the third quarter ended September 30, 2022, compared to $1.5 million for the same quarter in 2021. The increase in R&D expense year-over-year primarily reflects the increase in activities in support of the company’s preclinical and clinical programs.
General and Administrative (G&A) Expenses: G&A expenses were $2.9 million for the third quarter ended September 30, 2022, compared to $1.4 million for the same quarter in 2021. The increase was primarily due to increases in salaries and related benefits expenses mainly related to key additions to the senior management team, as well as an increase in non-cash share-based expenses.
Net Loss: Net loss was $8.1 million, or a net loss of approximately $0.035 per basic and diluted share, for the third quarter ended September 30, 2022, compared to $3.0 million, or a net loss of approximately $0.013 per basic and diluted share, for the quarter ended September 30, 2021.
The weighted average number of ordinary shares outstanding, basic and diluted were 228,773,418 (equal to 11,438,671 American Depository Shares) and 228,349,115 (equal to 11,417,456 American Depository Shares) for the quarters ended September 30, 2022, and September 30, 2021, respectively.

For further details on Chemomab’s financial results for the quarter ended September 30, 2022, refer to the Form 10-Q, which was filed with the SEC on November 10, 2022.

Conference Call
Chemomab management will host a conference call for investors today, Friday, November 11, 2022, beginning at 8:00 a.m. Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may access the live webcast or replay at Webcast link or at Chemomab’s website at View Source, or by dialing +1 877-407-9208 (in the U.S.) or +1 201-493-6784 (outside the U.S. and in Israel) and entering passcode 13732524. Upon dialing in, please request the Chemomab conference call.

A replay of the call will be available on Chemomab’s website for 90 days at www.chemomab.com.

On November 11, 2022 Vivesto reported that it will publish its Q3 report for 2022 on November 17, 2022, at 8.00 am CET. The company will hold a conference call and an online presentation on the same day at 10.00 am CET (Press release, Vivesto, NOV 11, 2022, View Source [SID1234623847]). The call will be hosted by Acting CEO Christer Nordstedt and Acting CFO Robert Maiorana. The presentation will be in English and followed by a question-and-answer session.

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On November 11, 2022 The HAMLET Pharma reported that drug candidates has remarkable effects and continues to show great promise for the prevention and treatment of cancer (Press release, HAMLET Pharma, NOV 11, 2022, View Source;utm_medium=rss&utm_campaign=hamlet-pharma-q1-interim-report-july-2022-september-2022 [SID1234623845]). Alpha1H kills tumor cell efficiently and attacks tumor tissue in patients with bladder cancer. A unique mechanism of action permits Alpha1H to target the tumor without damaging healthy bladder tissue. In bladder cancer patients, the tumor responds by releasing large numbers of tumor cells and tumor fragment into the urine, which is an efficient way of removing tumor tissue without causing a toxic effect. These positive findings suggest that Alpha1H can be used liberally to treat different types of cancer in the future.

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During the first quarter of the new fiscal year, Hamlet Pharma has strengthened the clinical trial program for stand-alone use of Alpha1H in bladder cancer patients, continued the collaboration with Neurochase Ltd for the treatment of brain tumors with Alpha1H and, in collaboration with external partners, intensified the development of BAMLET as a drug candidate.

After a successful dose-finding study with positive clinical effects, the clinical program is aimed at defining the optimal treatment regimen. We are currently testing the effects of repeated treatment using a five times higher dose of Alpha1H compared to placebo. The patients will receive two rounds of treatment and the clinical outcome will be compared to the placebo group and to patients receiving one round of treatment. The dialogue with the US (FDA) and European (EMA) authorities has, with the help of experienced consultant organizations, been intensified during this first quarter.

The ongoing collaboration with Neurochase Ltd will explore Alpha1H for brain tumor therapy, where a novel drug delivery technology and methods to treat tumors in the central nervous system with Alpha1H will be developed. The work includes technology development and testing of the new device with Alpha1H in an animal study. The goal is to provide adequate materials and data to prepare for the first clinical study for this indication.

BAMLET, with strong tumoricidal effects, is the third member of the HAMLET family of compounds. In the first quarter, we have continued the development of BAMLET as a drug candidate, primarily in colon cancer. In an animal study in mice we have found that daily, long-term treatment with BAMLET in the drinking water inhibits tumor development and increases long-term survival, compared to mice not receiving BAMLET. The frequency of polyps and the polyp size was reduced already after eight weeks and with continued treatment. The mice remained symptom-free and survived significantly longer than control mice. Hamlet Pharma has also initiated discussions regarding the manufacturing of BAMLET for future clinical studies with external partners.

The stable financial position enables Hamlet Pharma to secure the development of the projects in the Hamlet Pharma portfolio. Hamlet Pharma is committed to improving the treatment options for cancer patients, initially patients with bladder cancer, where there is a significant unmet medical need for new therapies.

Catharina Svanborg and Martin Erixon

Chairperson of the Board and CMO, and CEO, respectively, of Hamlet Pharma AB

Significant events during the first quarter

Q1

On August 2, 2022, Hamlet Pharma published "Full speed ahead! – Hamlet Pharma adapts the clinical trial program for stand-alone use". Hamlet Pharma highlights the development of the clinical protocol in bladder cancer with Alpha 1H. The company has decided to interrupt the combination study where Alpha1H was used together with a chemotherapy drug. There was no evidence of a therapeutic advantage and the patients experienced side effects, which were not seen with Alpha1H alone. It was also announced that Hamlet Pharma is taking one more step towards the design of the Phase III clinical trial protocol by adding a second treatment round after the completion of the first round of treatment in the ongoing study. These decisions strengthen Hamlet Pharma’s position as a company developing drug candidates with a more beneficial profile than traditional chemotherapeutic drugs.

On August 9, 2022, Hamlet Pharma published "Hamlet Pharma receives a new rapid approval in the Czech Republic". Hamlet Pharma announced the rapid approval of Hamlet Pharma’s application to amend the clinical trial of Alpha1H in bladder cancer by the Czech regulatory authorities. This important new part of the ongoing study is now ready to start.

On September 29, 2022, Hamlet Pharma presented at the Nordic Life Science Days, a pharmaceutical and biotechnology conference held in Malmö. The title of the presentation was "High precision cancer treatment with low side effects".

Significant events after the first quarter

On October 2022, Catharina Svanborg attended the 17th Annual Peptide Therapeutics Symposium held at the Salk Institute in La Jolla, California and presented the Hamlet project to leaders in the field of peptide drug development. The title of the presentation was "A new approach to Cancer Therapy with Documented Clinical Effects".

On November 3, 2022, the annual report for the fiscal year 2021/2022 was published. It can be found on our updated homepage or on spotlight Stock Market’s home page.

On November 9, Hamlet Pharma published ‘’BAMLET in the drinking water; protection against intestinal cancer and potent beneficial health effects’’. We show that daily, long-term treatment with BAMLET in the drinking water inhibits intestinal tumor development in mice genetically susceptible to intestinal tumors, compared to mice not receiving BAMLET. The frequency of tumors and the tumor size was reduced already after short-term BAMLET treatment but with continued treatment, the mice remained symptom-free and survived significantly longer than control mice. BAMLET treatment also protected the mice from extra-intestinal manifestations of disease. These findings are conceptually important, as they suggest that local treatment of the intestine, by supplying BAMLET in the drinking water, can affect cancer development as well as disease states in other organs, suggesting a systemic as well as a local effect.

The findings highlight the beneficial properties of BAMLET and a broad range of effects affecting health and disease.

The period in summary

FIRST QUARTER (JUL 1, 2022-SEP 30, 2022)

– Net sales for the quarter totaled KSEK 0 (0)

– Other operating income totaled KSEK 0 (3,927)

– Loss before tax amounted to KSEK -5,618 (-2,048)

– Loss after tax amounted to KSEK -5,618 (-2,048)

– Loss per share* was SEK -0.0508 (-0.0188), and SEK -0.0491 after dilution

– On September 30, 2022, the equity/assets ratio** was 94.0 (88.7) %

Amounts in parentheses above and below indicate the corresponding value in the preceding year.

* Profit/loss after tax for the period divided by 110,529,666 (108,761,179) and 114,472,907, respectively, where 110,529,666 is the number of shares outstanding on September 30, 2022, and 114,472,907 will be the number of shares if the subscription warrants issued by the Company are exercised. The comparative figure in parentheses was the number of shares on September 30, 2021.