On May 30, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported the signing of a definitive agreement under which Evotec will acquire 100% of the capital of Rigenerand Srl, a leading cell technology company, for a purchase price of € 23 m (Press release, Evotec, MAY 30, 2022, View Source [SID1234615226]). Founded in 2009 as a spin-off of the University of Modena and Reggio Emilia, Rigenerand is a pioneering company in the field of cGMP manufacturing of cell therapies. The acquisition adds a great team of cell therapy cGMP manufacturing experts to Evotec.

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Rigenerand is based in Medolla, Italy, approx. 100 km south of Evotec’s Campus Levi-Montalcini in Verona. With their highly specialised team, Rigenerand operates a first-class certified facility that integrates state-of-the-art cGMP production with R&D and QC labs and development labs. The production facility, called "cell factory", comprises a series of fully equipped clean rooms for the manufacturing of complex cell-based therapies. In total, the site in Medolla close to Modena comprises 1,200 sqm of high-tech manufacturing space, with potential for significant further expansion.

The acquisition expands Evotec’s cell therapy platform EVOcells by adding a dedicated, high-quality cGMP manufacturing site. The seamless integration of discovery and development of innovative cures combined with in-house capabilities in GMP manufacturing are mandatory within this field. While the revenue contribution will not be significant at the beginning, the manufacturing capability of Rigenerand along with the exceptional R&D power of Evotec will strengthen Evotec’s ability to successfully win new integrated partnerships within the innovative field of cell therapy.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "Cell therapies are an exciting emerging therapeutic modality with broad applicability across many indications. Originating from our leading iPSC platform, Evotec’s EVOcells platform enables the delivery of innovative cell therapeutics from inception to the patient. The acquisition of Rigenerand adds manufacturing capacity and expertise to the EVOcells platform. Our conversations with our partners as well as our own industry observations have made it clear that horizontal expansion and rapid iteration at the scale-up are critical within the cell therapy space. As we see very strong demand for our standalone Just – Evotec Biologics J.PODs in the US and EU, it is strategically the logical step to build separate capability and capacity internally. We warmly welcome the Rigenerand team into the Evotec family and are excited to leverage their skill and expertise for our partners and ultimately the patients."

Prof. Massimo Dominici, founder and CSO of Rigenerand and Professor of Oncology at the University of Modena and Reggio Emilia, said: "The combination of Rigenerand and Evotec is a unique opportunity to grow and a natural evolution for our team. The field of cell therapies is rapidly expanding with new products and novel technologies requiring R&D skills, flexibility in manufacturing and experience in pharmaceutical development. Evotec’s EVOcells platform and Rigenerand’s technologies and capacity to transform cells into therapeutic products combining an R&D vocation and manufacturing skills, is a unique combination with technological and logistic synergies that will make a very relevant impact in the cell therapy field with a state-of-the art cGMP Technological Center for Cell Therapy Manufacturing at a European scale." ‘

Luca Marini, CEO of Xyence Capital SGR, the majority shareholder of Rigenerand, said: "We are very proud of the success of this deal because it shows our expertise in identifying high-potential scientific areas, such as cell therapies, and in providing a fair financial return to our investors that have chosen to contribute to the incubation and growth of Rigenerand since 2016. Evotec is the optimal industrial partner to bring Rigenerand to further global growth. Last but not least, we are happy to have created the conditions for a number of benefits for the local economy, as well as the basis for an evident scientific progress that remains the purpose and ethical core of our investment philosophy."

About Cell Therapy and EVOcells
Cell therapy is a recent and innovative therapeutic modality that has the potential to deliver unprecedented therapeutic effects. Cell therapies can be used as a regenerative strategy, replacing a patient’s dysfunctional cells or are used as adoptive immunotherapy to help the immune system fight cancer. Sources for cell therapeutics range from the patient’s own material, a healthy donor or from stem cells. The advent of induced pluripotent stem cells ("iPS cells" or "iPSCs") that can be generated directly from somatic cells has opened up stem cells as an almost unlimited source of consistent-quality material for such cell therapies. iPSC-derived, off-the shelf therapeutics are considered to be one of the most promising approaches in the cell therapy space.

Building on its many years of experience with iPSCs, Evotec has developed EVOcells as an integrated, versatile platform for the discovery, development and manufacturing of cell therapies. The Company’s aim is to develop innovative but cost-effective therapies for large patient numbers based on human cells to cure life-threatening diseases. Evotec’s current EVOcells project portfolio covers immuno-oncology, metabolic diseases, heart repair as well as exosome-based therapies. Evotec leverages the EVOcells platform for both proprietary and partnered projects, and is aiming to accelerate these projects towards transformative therapies, both within existing and new disease areas.

On May 30, 2022 Herantis Pharma Plc ("Herantis" or the "Company"), an innovative biotech company developing new disease modifying therapies for Parkinson’s disease, reported on 3 May 2022 that the Board of Directors of Herantis had decided to offer Herantis’ shareholders up to 4,831,426 new shares (the "Offer Shares") in a rights issue on the basis of shareholders’ pre-emptive subscription rights in the same proportion as they already hold shares in the Company and secondarily by other shareholders or by other persons (the "Offering") (Press release, Herantis Pharma, MAY 30, 2022, View Source,c3576694 [SID1234615227]). The subscription period for the Offering ended on 24 May 2022 in Sweden and on 27 May 2022 in Finland and according to the preliminary result, Herantis will receive gross proceeds of approximately EUR 7.25 million, from the Offering.

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According to the preliminary results of the Offering, the Offering was subscribed in full. Approximately 79.9 per cent of the 4,831,426 Offer Shares were subscribed for with subscription rights, and approximately 20.1 per cent were subscribed for without subscription rights. The subscription price in the Offering was EUR 1.50 per Offer Share in Finland and SEK 15.60 per Offer Share in Sweden.

"We are pleased with the great interest to participate in the Offering and we are thankful for the continued support of our current shareholders. We will use the net proceeds from this Offering to obtain regulatory approval and perform the first in-human study with the Herantis’ lead product candidate HER-096 that is planned to start in 2023.", comments Frans Wuite, the interim CEO of Herantis.

The final results of the Offering will be published on or about 1 June 2022 after the Board of Directors of Herantis has approved the subscriptions made in the Offering. Allotment of Offer Shares will be made in accordance with the terms and conditions of the Offering. As a result of the Offering, the total number of shares in Herantis will increase by 4,831,426 from 12,078,568 to 16,909,994 provided that the Board of Directors of Herantis approves the subscriptions made in the Offering. The Offer Shares issued in the Offering amount to approximately 28.6 per cent of the outstanding shares in Herantis following the Offering.

The last day of trading in the interim shares on Nasdaq First North Growth Market Finland ("First North Finland") will be on or about 2 June 2022 and on Nasdaq First North Growth Market Sweden ("First North Sweden") on or about 9 June 2022. The Offer Shares will be registered with the Finnish Trade Register maintained by the Finnish Patent and Registration Office on or about 3 June 2022. The interim shares will be combined with the Company’s existing shares once the Offer Shares have been registered with the Finnish Trade Register. The combination will take place on or about 3 June 2022 in Finland and on or about 10 June 2022 in Sweden. The trading in the Offer Shares on First North Finland will commence on or about 3 June 2022 and on First North Sweden on or about 10 June 2022. The Offer Shares confer the same rights as Herantis’ other shares, after being registered with the Finnish Trade Register and delivered on the investor’s book-entry account, on or about 3 June 2022 in Finland and on or about 10 June 2022 in Sweden.

UB Securities Ltd is acting as the lead manager of the Offering. Krogerus Attorneys Ltd is acting as the legal counsel to the Company as to Finnish law and Advokatfirman Cederquist KB as to Swedish law.

On May 30, 2022 Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated PhotoDynamic Compounds ("PDC") and their associated drug formulations intended to safely and effectively destroy various cancers reported that it has released the Company’s unaudited 1Q2022 condensed interim consolidated Financial Statements ("Financial Statements") (Press release, Theralase, MAY 30, 2022, View Source [SID1234615268]).

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(1) Other represents gain from legal settlement, (gain) loss on foreign exchange, interest accretion on lease liabilities and interest income

Total revenue increased 70%, year over year, and is primarily attributed to the anticipated Canadian and US economic recovery from the COVID-19 pandemic in 2020 and 2021.

Cost of sales for the three-month period ended March 31, 2022 was $120,430 or 57% of revenue resulting in a gross margin of $91,232 or 43% of revenue. In comparison, the cost of sales in 2021 was $74,463 or 60% of revenue resulting in a gross margin of $50,320 or 40% of revenue. The gross margin increase, as a percentage of sales, year over year, is primarily attributed to a decrease in labour and material costs.

Selling expenses for the three-month period ended March 31, 2022, decreased to $87,640, from $95,780 in 2021, an 8% decrease. The decrease in selling expenses is primarily attributed to the COVID-19 pandemic, resulting in reduced advertising (48%), and salaries (8%).

Administrative expenses for the three-month period ended March 31, 2022, decreased slightly to $418,087 from $418,454 in 2021, a 1% decrease. The decrease in administrative expenses is primarily attributed to decreased spending in administrative salaries (4%) and insurance expenses (8%). Stock based compensation expense decreased 61% in 2022 due to a reduction in stock options granted.

Net research and development expenses for the three-month period ended March 31, 2022, increased to $1,298,035 from $589,567 in 2021, a 120%. The increase in research and development expenses for the three-month period ended March 31, 2022, is primarily attributed to the costs related to Study II. Research and development expenses represented 72% of the Company’s operating expenses and represents investment into the research and development of the Company’s ACT technology.

The net loss for the three-month period ended March 31, 2022 was $1,701,489 which included $99,600 of net non-cash expenses (i.e.: amortization, stock-based compensation expense and foreign exchange gain/loss). This compared to a net loss in 2021 of $919,093 which included $179,925 of net non-cash expenses. The ACT division represented $1,436,985 of this loss (84%) for the three-month period ended March 31, 2022.

The increase in net loss is primarily attributed to Increased spending in research and development expenses in Study II.

Operational Highlights:

1. Break Through Designation Update. In 2020, the FDA granted Theralase Fast Track Designation ("FTD") for Study II. As a Fast Track designee, Theralase has access to early and frequent communications with the FDA to discuss Theralase’s development plans and ensure the timely collection of clinical data to support the approval process. FTD can also lead to Break Through Designation ("BTD"), Accelerated Approval ("AA") and/or Priority Review, if certain criteria are met, which the FDA has previously defined to the Company for BTD to represent a complete clinical dataset on approximately 20 to 25 patients enrolled, treated and followed-up, who demonstrate significant safety and efficacy clinical outcomes.

In 2021, Theralase completed its first significant milestone of Study II by enrolling and treating 25 patients. The Company will compile a clinical data report for submission to the FDA in support of the grant of a BTD approval after completion of the 450 day assessment for 25 patients, expected in 4Q2022, subject to the Clinical Study Sites ("CSS") availability to complete all required assessments.

2. COVID-19 Pandemic Update. In the ACT division, the Company continues to experience delays in patient enrollment and treatment rates in Study II due to the ongoing COVID-19 pandemic; however, these rates have improved as Canada and the US commence their recovery from the business and economic impacts of the COVID-19 pandemic.

In the CLT division, the Company continues to experience variations in sales and the timing of these sales due to the ongoing COVID-19 pandemic and has taken actions to minimize expenses by eliminating non-essential personnel and imposing a temporary hiring freeze commencing in March 2020. The Company lifted the temporary hiring freeze in 4Q2021, now that the Canadian and United States ("US") economies have started to demonstrate a sustainable business and economic recovery from COVID-19.

3. Clinical study site status and update. The Company has successfully launched five CSS in Canada and seven CSSs in the US that are open for patient enrollment and treatment for a total of 12 CSSs.

To date, the phase II NMIBC clinical study has enrolled and provided the primary study treatment for 38 patients (including three patients from Phase Ib study treated at the Therapeutic Dose) for a total of 41 patients.

An analysis of Evaluable Patients (defined as patients who have been evaluated by the principal investigator and thus excludes data pending), Study II clinical data provides the following interim analysis:

For all Evaluable Patients, who achieved a CR at 90 days, 88% demonstrate that CR at 180 days, 69% at 270 days, 50% at 360 days and 56% at 450 days, demonstrating a strong duration of complete response.

Note: The current interim data analysis presented above should be read with caution, as the clinical data is interim in its presentation, as Study II is ongoing and new clinical data collected may or may not continue to support the current trends, with significant data still pending.

For a more comprehensive analysis of the interim data please refer to Managements Discussion and Analysis ("MD&A") for the three-month period ended March 31, 2022.

4. Additional cancer indications. The Company has demonstrated significant anti-cancer efficacy of Rutherrin, when activated by laser light or radiation treatment across numerous preclinical models; including: Glio Blastoma Multiforme ("GBM") and Non-Small Cell Lung Cancer ("NSCLC"). The Company has commenced Non – Good Laboratory Practices ("GLP") toxicology studies with Rutherrin in animals to help determine the maximum recommended human dose of the drug when administered systemically into the human body, via intravenous injections. Theralase plans to commence GLP toxicology studies in animals in 4Q2022.

5. COVID-19 Research Update. In April 2021, Theralase executed a Collaborative Research Agreement ("CRA") with the National Microbiology Laboratory, Public Health Agency of Canada ("PHAC") for the research and development of a Canadian-based SARS-CoV-2 ("COVID-19") vaccine. Under the terms of the agreement, Theralase and PHAC are collaborating on the development and optimization of a COVID-19 vaccine by treating the SARS-CoV-2 virus grown on cell lines with Theralase’s patented PDC and then light activating it with Theralase’s proprietary TLC-3000A light technology to inactivate the virus and create the fundamental building blocks of a COVID-19 vaccine. This inactivated virus would then be purified and used to inoculate naive animals followed by challenge with the SARS-CoV-2 virus, to ascertain the efficacy of the vaccine. The project is entitled, "Photo Dynamic Compound Inactivation of SARS-CoV-2 Vaccine" and commenced in mid-April 2021.

In February, 2022 Theralase reported that PHAC had demonstrated that light-activated TLD-1433, was effective in rapidly inactivating the SARS-CoV-2 virus by up to 99.99%, compared to control in an in vitro study. Further research is required to confirm these findings.

These results have now laid the groundwork for the next phase of the CRA, which is evaluating the Theralase COVID-19 vaccine in the ability to prevent animals from contracting COVID-19, when exposed to the virus, which is expected to commence in 2Q2022 and be completed by 4Q2022.

Note: The Company does not claim or profess that they have the ability to treat, cure or prevent the contraction of the COVID-19 coronavirus.

About Study II
Study II utilizes the therapeutic dose of TLD-1433 (0.70 mg/cm2) activated by the proprietary TLC-3200 medical laser system. Study II is focused on enrolling and treating approximately 100 to 125 BCG-Unresponsive NMIBC Carcinoma In-Situ ("CIS") patients in up to 15 Clinical Study Sites ("CSS") located in Canada and the United States.

About TLD-1433
TLD-1433 is a patented PDC with over 10 years of published peer reviewed preclinical research and is currently under investigation in Study II.

On May 30, 2022 NNL reported that have made a breakthrough for producing Lead-212, a very important medical radioisotope for treating cancer, but which is difficult to produce and therefore in short supply (Press release, National Nuclear Laboratory, MAY 30, 2022, View Source [SID1234615228]).

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Used in an emerging medical treatment known as Targeted Alpha Therapy (TAT), Lead-212 labelled targeting molecules destroy cancer cells while minimising damage to healthy parts of the body. TATs have gained traction because they fight cancer while limiting the side effects experienced by patients. Yet the supply of Lead-212, like other key medical radioisotopes, faces a global shortage which constrains their use, with no production route in existence in the UK.

The production process for the UK’s first home-grown supply of Lead-212 has been developed at NNL’s Preston Laboratory. It is currently going through quality assurance and scale-up work. To achieve this, NNL is working closely with clinicians and academics including at Queen Mary University of London and King’s College London and their associated nuclear medicine departments at St Bartholomew’s Hospital and Guy’s and St Thomas’ NHS Foundation Trust.

Dr Jane Sosabowski is Reader in Molecular Imaging at Queen Mary’s Barts Cancer Institute and researcher at City of London Cancer Research UK-RadNET, one of a network of centres of excellence and state-of-the-art facilities working to tackle the major challenges of radiobiology and radiation oncology. She said:

"This new initiative is immensely exciting, offering a huge boost to the future of molecular radiotherapy treatment and personalised medicine in the UK. Barts Cancer Institute and Radionuclides for Health UK welcomes the leadership that NNL is showing on this issue. It is an important step in re-establishing UK supply of medical radioisotopes and securing the future of research in this important sphere of human health."

Dr Paul Howarth, Chief Executive Officer for NNL, said:

"Fifty years ago, the UK led the world in medical radioisotope research and production, yet today we rely on imports often from ageing facilities. Establishing a sovereign home-grown supply of these important medical radioisotopes would be transformative for healthcare in the UK and, given the global nature of the supply challenge, citizens of the other countries we supply.

"There is great demand from the healthcare profession for the UK to develop an indigenous supply of medical radioisotopes and this work is core to NNL’s purpose of nuclear science to benefit society."

Nick Hanigan, NNL’s Health and Nuclear Medicine Director, said:

"The production process we have developed, which requires complex chemical separation and purification of nuclear material, builds on NNL’s world-leading capability in this area. Lead-212 limits the side effects of cancer treatment because it is delivered directly to cancerous cells. Our plan now is to scale the production route in order to remove the significant supply constraints currently faced by hospitals.

"This breakthrough development is a single aspect of our work on medical radioisotopes, a tool used on a daily basis by every hospital in the UK to diagnose and treat health conditions including many types of cancer, heart disease and thyroid disease and for the early detection and assessment of brain disorders such as epilepsy, Alzheimer’s disease and other forms of dementia."

On May 30, 2022 Endeavor BioMedicines, a clinical-stage biotechnology company targeting the core drivers of terminal diseases including oncology and fibrosis, and xCures, a company that aims to improve cancer outcomes and accelerate cancer research using artificial intelligence, reported a partnership that gives patients enrolling in Endeavor’s clinical trials access to the xCures platform to find the best available treatment options suited to their individual tumor profile (Press release, xCures, MAY 30, 2022, View Source [SID1234615229]). The partnership helps identify patients whose cancers harbor the PTCH1 mutation and may be eligible for Endeavor’s clinical trial. The xCures platform also enables patients to find more suitable treatment options if they are ineligible.

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"Endeavor’s partnership with xCures aligns with our patient-first focus and will help guide any patients with cancer who contact us to find the best treatment options for them," said Anita DiFrancesco, Vice President of Clinical Operations at Endeavor BioMedicines. "We recently dosed the first patient in a Phase 2 study evaluating ENV-101 (taladegib), a small molecule inhibitor of the Hedgehog signaling pathway, in patients with advanced solid tumors harboring PTCH1 loss of function mutations. Endeavor and xCures will work together to identify PTCH1 mutations while also providing alternative treatment options for patients who are ineligible for our trials."

Patients will be registered on the xINFORM platform. Once a patient is registered, xCures will review their cancer history. For patients without molecular profiling, xCures will assist patients with tumor sequencing. After the genomic information is added to a patient’s profile, they will receive a report that lists the best treatment options based on their cancer history and their genomic profile. If the patient has the PTCH1 mutation, they and their physician will be made aware of the option to enroll in the Endeavor clinical trial. Patients whose tumors are negative for the PTCH1 mutation will receive a personalized list of treatment options that they should discuss with their oncologist.

"xCures is pleased to partner with Endeavor to help improve outcomes for cancer patients by helping them understand their treatment options and support them and their physician with access," said Bryan Federowicz, Vice President of Clinical Operations at xCures. "This partnership is an example of how collaboration between industry, doctors and patients can provide the best, uniquely tailored medicine for each individual patient."

ENV-101: Targeting the Hedgehog Signaling Pathway in Oncology and Fibrosis

ENV-101 (taladegib), an orally available small molecule inhibitor of the Hedgehog signaling pathway, has already demonstrated preliminary clinical efficacy and safety in nearly 200 subjects enrolled across six completed studies. Initially targeted for a broad group of patients with basal cell carcinoma (BCC), Endeavor is now investigating precision therapy approaches for ENV-101 in multiple types of cancers driven by oncogenic driver mutations in PTCH1, as well as in idiopathic pulmonary fibrosis (IPF).

PTCH1 oncogenic driver mutations in the Hedgehog signaling pathway are found in approximately 2% of all cancers. Because of its prevalence across multiple types of cancer, Endeavor plans to enroll patients in a tumor agnostic study that includes any patient with oncogenic hedgehog mutations irrespective of tissue of origin. Endeavor is currently enrolling patients in an open label Phase 2 clinical trial in oncology (www.clinicaltrials.gov identifier NCT05199584).