On February 7, 2023 TILT Biotherapeutics (TILT), a clinical-stage biotechnology company developing cancer immunotherapies, reported the final close of its EUR 22 million (approximately USD 23.8 million) round (Press release, TILT Biotherapeutics, FEB 7, 2023, View Source [SID1234626948]). This follows on from the first close of EUR 10 million in June 2022. The financing was led by Finland’s Lifeline Ventures, an early-stage venture capital firm founded by serial entrepreneurs.

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The funding will be used to advance to Phase II the company’s combination trials which use oncolytic immunotherapies synergistically with checkpoint inhibitors.

This final close of €12 million includes €5.9 million equity from the European Innovation Council (EIC) Fund as well as a €2.1 million grant from EIC’s Accelerator programme, as well as investments from Stephen Industries Inc Oy and ACME Investments SPF Sàrl. The EIC Fund is TILT’s first significant international investor. The EIC investment decision followed a due diligence process by the European Investment Bank, which supports the EIC Fund as Investment Advisor.

TILT Biotherapeutics’ founder and CEO, Akseli Hemminki, a cancer clinician who has personally treated hundreds of cancer patients with oncolytic viruses, said, "We’re pleased to have achieved this round of €22 million to advance our promising pipeline of armed oncolytic viruses. Our trials are progressing well through Phase I, and this new funding will support us in progressing them into Phase II, another key step for these new therapies to reach patients in a range of cancers".

Timo Ahopelto, Founding Partner of Lifeline Ventures, said, "We invest in future category-leading companies with strong founders, and support them through their growth. We saw the potential in TILT’s cancer immunotherapies early on and continue to build on that potential in Europe as well as the U.S market with this funding round."

Hermann Hauser, member of the EIC Fund Board said, "Combining grants and equity is unique to the European Innovation Council. It bridges the funding gap for highly innovative companies, unlocks additional private investments and enables them to scale up in Europe."

The heart of TILT’s innovative approach revolves around the use of armed oncolytic adenoviruses, using cytokines and other molecules to boost the patient’s immune response to better enable it to find and destroy cancer cells. The company is advancing its pipeline of programs including its lead asset TILT-123, in further clinical trials, including in combination with immune checkpoint inhibitors.

On February 7, 2023 Ankyra Therapeutics, a biotech company developing targeted immune activating agents for the treatment of cancer, reported that is has entered into a strategic collaboration with the Lung Cancer Initiative (LCI) at Johnson & Johnson* (Press release, Ankyra Therapeutics, FEB 7, 2023, View Source [SID1234626947]). The collaboration will focus on the advancement of Ankyra’s lead product candidate, ANK-101, an IL-12-based locally administered immunotherapy, as a potential treatment for lung cancer. Ankyra is currently advancing ANK-101 through Investigational New Drug (IND) enabling studies for the treatment of solid tumors and plans to submit an IND to the U.S. Food and Drug Administration in the third quarter of 2023.

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Under the terms of the agreement, Ankyra together with LCI scientists will evaluate ANK-101 in a Phase 1b clinical trial. Ankyra has received an upfront payment and is eligible for additional undisclosed clinical milestone payments.

"We are delighted to enter this collaboration in our mission to bring forward new, impactful treatments for cancer," said Howard Kaufman, M.D., president and chief executive officer. "We have designed our ANK-101 immunotherapy candidate to increase the therapeutic window of IL-12, a potent cytokine, while also aiming to ensure patient tolerability. Patients with lung cancer need new effective treatments with fewer side effects, and we hope to meet this need in the future."

On February 7, 2023 Wellmarker Bio Co., Ltd (WMBIO) (CEO: Dong-Hoon Jin, Department of Convergence Medicine, Ulsan College of Medicine and Asan Medical Center,), a predictive biomarker-driven biotech company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer, reported the company has entered a clinical trial collaboration and supply agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA) on 7th Feb (Press release, Merck & Co, FEB 7, 2023, View Source [SID1234626945]).

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Under the agreement, WMBIO will sponsor the Phase 1 (or Phase 1b) clinical trial for WM-A1-3389, a novel therapeutic antibody for Non-Small Cell Lung Cancer (NSCLC) patients with low or no PD-L1 expression, in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy. Some NSCLC patients with low or no PD-L1 expression have shown limited response to treatment with immunotherapies alone and there is a high unmet need in these patient populations. WMBIO is also planning to expand the target patient group to other solid tumor indications.

WM-A1-3389 is a novel therapeutic antibody targeting a new immune checkpoint protein discovered by Wellmarker Bio and has demonstrated efficacy across different PBMC humanized models. An additive benefit of WM-A1-3389 and anti-PD-1 antibody was evidenced in preclinical mouse models including PD-1-resistant CT26 and LLC-1 mouse models.

"This clinical trial collaboration with MSD holds great significance for WMBIO as it allows us to evaluate a first-in-class drug with a novel mechanism in combination with KEYTRUDA," said Dong-Hoon Jin, CEO of Wellmarker Bio. "Now that we have seen WM-A1-3389 demonstrates a favorable safety margin in combination with immunotherapies in preclinical studies, we are excited to collaborate with MSD to further investigate the therapeutic potential of an additive benefit when combining WM-A1-3389 with KEYTRUDA."

WM-A1-3389 development was funded by Korea Drug Development Fund (KDDF). In eary 2022, this study was selected by the follow-up project of Korea Drug Development Fund (KDDF, Director. Muk, Hyunsang) in the preclinical stage.In addition, Wellmarker Bio is co-developing liquid biopsy companion diagnostics (CDx) with Cytogen. PharmaVentures Ltd., a UK-based premier transaction advisory firm, acted as the exclusive advisor for this collaboration and the ongoing partnering efforts for WM-A1-3389.

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

For further information, please contact:
Jai-Hee Moon
Strategy planning manager (email: [email protected])

On February 7, 2023 Regen BioPharma, Inc. (OTC PINK: RGBP) and (OTC PINK: RGBPP), a biotechnology company advancing a diverse pre-clinical pipeline spanning cell therapies, RNA vaccines, RNA and DNA therapeutics and small molecule drugs reported that it will be presenting at the Emerging Growth Conference on February 8, 2023 (View Source) (Press release, Regen BioPharma, FEB 7, 2023, View Source [SID1234626943]).

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This live, interactive online event will give existing shareholders and the investment community the opportunity to interact with the Company’s CEO, Dr. David Koos, in real time. Please ask your questions during the event and Dr. Koos and his team will do their best to address as many of them as possible.

"We plan to use this time to update our stakeholders on our corporate strategic plans, drug pipeline, drug development strategy and answer shareholder questions," says Dr. David Koos, CEO and Chairman of the Company. "We also plan to address Regen’s forthcoming 1for1500 reverse stock split affecting all series of stock. We feel that effecting this change is integral to furthering the Company’s objectives of seeking uplistings for our Common and series A Preferred Stock as well as making our stock more attractive to institutional investors." The reverse stock split will be effective March 6, 2023.

Regen BioPharma, Inc. will be presenting from 2:20 – 2:50 Eastern time on Wednesday, February 8, 2023. Please register here to ensure you are able to attend the conference and receive any updates that are released View Source;tp_key=60f8292c14&sti=rgbp.

If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available on EmergingGrowth.com.

About the Emerging Growth Conference

The Emerging Growth conference is an effective way for public companies to present and communicate their new products, services and other major announcements to the investment community from the convenience of their office, in a time efficient manner.

The Conference focus and coverage includes companies in a wide range of growth sectors, with strong management teams, innovative products & services, focused strategy, execution, and the overall potential for long term growth. Its audience includes potentially tens of thousands of individual and institutional investors, as well as investment advisors and analysts.

On February 7, 2023 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported a corporate update and reported financial results for the fiscal first quarter ended December 31, 2022 (Press release, ESSA, FEB 7, 2023, View Source [SID1234626942]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

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"Building on our momentum and encouraging clinical results observed in 2022, we continue to advance our studies of EPI-7386, ESSA’s first-in-class N-terminal domain androgen receptor inhibitor, in patients with metastatic castration-resistant prostate cancer ("mCRPC")," stated David Parkinson, MD, President and CEO of ESSA. "In the first half of 2023, we expect to complete the Phase 1 EPI-7386 combination study with Xtandi (enzalutamide) in patients with mCRPC naïve to second generation anti-androgens and to initiate the Phase 2 randomized study in the same patient population shortly thereafter. In addition, our cash runway continues to be strong and is expected to fund our operations and clinical programs through 2025."

Clinical and Corporate Highlights for the First Quarter Ended December 31, 2022
EPI-7386 Combination Studies

The Company continues to enroll patients in the third cohort of the Phase 1/2 study of EPI-7386 in combination with enzalutamide in patients with mCRPC naïve to second generation antiandrogens. The Company expects to complete the Phase 1 portion of the study and establish the recommended Phase 2 combination doses (for both EPI-7386 and enzalutamide when used in combination) in the first half of 2023, followed by initiation of the Phase 2 study. The open-label, randomized Phase 2 study will assess the anti-tumor activity of EPI-7386 in combination with enzalutamide at the recommended phase 2 combination dose of EPI-7386 and enzalutamide versus single agent enzalutamide at the standard of care dose.
Initial results from the first two cohorts of the Phase 1/2 study of EPI-7386 in combination with enzalutamide were presented at the Prostate Cancer Foundation Scientific Retreat in October 2022. Further analysis of these data will be presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium ("ASCO GU"), taking place February 16-19, 2023, in San Francisco, CA and online.
The Company continues to anticipate that enrollment of additional combination regimens of EPI-7386 with other antiandrogens in different studies will begin in 2023 in different prostate cancer patient populations.
EPI-7386 Monotherapy

The Phase 1b dose expansion study is ongoing and evaluating two doses/schedules of single agent EPI-7386 in mCRPC patients with less than three prior lines of therapy, no visceral disease and no prior chemotherapy who have progressed on second-generation antiandrogens
The Company is continuing to seek to enroll patients in the Window of Opportunity study in non-metastatic CRPC patients. Patients will receive 12 weeks of EPI-7386 monotherapy treatment before starting standard of care therapy.
Summary Financial Results
Net Loss. ESSA recorded a comprehensive loss of $6.7 million for the first quarter ended December 31, 2022, compared to a comprehensive loss of $9.1 million for the first quarter ended December 31, 2021. For the first quarter ended December 31, 2022, this included non-cash share-based payments of $1.6 million compared to $2.5 million for the prior year, recognized for stock options granted and vesting. The decrease in the first quarter was primarily attributed to decreases in research and development expenditures and general and administration expenditures in addition to an increase of $1.1 million in interest income.

Research and Development ("R&D") expenditures. R&D expenditures for the first quarter ended December 31, 2022 were $5.3 million compared to $6.0 million for the first quarter ended December 31, 2021 and include non-cash costs related to share-based payments ($791,192 for the first quarter ended 2022 compared to $1.3 million for the first quarter ended 2021). The R&D expenditures for the year ended December 31, 2022 is the result of decreased non-cash share-based payments, legal patents and license fees and manufacturing costs related to the Phase 1 clinical trial of EPI-7386.

General and administration ("G&A") expenditures. G&A expenditures for the first quarter ended December 31, 2022 were $2.5 million compared to $3.1 million for the first quarter ended December 31, 2021 and include non-cash costs related to share-based payments of $772,419 for the first quarter ended 2022 compared to $1.2 million for the first quarter ended 2021. The decrease in the first quarter is the result of decreased non-cash share-based payments and professional fees.
Liquidity and Outstanding Share Capital

At December 31, 2022, the Company had available cash reserves and short-term investments of $163.1 million reflecting the gross proceeds of the February 2021 financing of approximately $150.0 million and July 2020 financing of $48.9 million, less operating expenses in the intervening period. The Company’s cash position is expected to be sufficient to fund current and planned operations through 2025.

As of December 31, 2022, the Company had 44,092,374 common shares issued and outstanding.

In addition, as of December 31, 2022 there were 3,234,750 common shares issuable upon the exercise of warrants and broker warrants. This includes 2,920,000 prefunded warrants at an exercise price of $0.0001, and 314,750 warrants at a weighted average exercise price of $49.69. There were 7,922,061 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $5.13 per common share.