On May 6, 2021 Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, reported its first quarter 2021 results (Press release, Targovax, MAY 6, 2021, View Source [SID1234579418]).

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An online presentation by Targovax’s management to investors, analysts and the press will take place at 10:00 CET today (details below).

FIRST QUARTER HIGHLIGHTS

REASEARCH & DEVELOPMENT

Reported continued survival benefit in Targovax’s ONCOS-102 trial in mesothelioma at the 21-month follow-up
Median Overall Survival (mOS) has still not been met for randomized first-line patients receiving ONCOS-102 plus chemotherapy
mOS will be at least 20.5 months for randomized first-line patients receiving ONCOS-102 plus chemotherapy, compared to mOS of 13.5 months in the chemotherapy-only control group
Received Fast-Track designation from the US FDA for ONCOS-102 in malignant pleural mesothelioma. This opens the potential for expedited development path and review
Entered a research collaboration with Papyrus Therapeutics to develop novel ONCOS viruses with receptor tyrosine kinase (RTK) inhibitor functionality
CORPORATE

Announced Dr Sonia Quaratino as a new member of the Board of Directors
Obtained US Patent for ONCOS-102 in combination with checkpoint inhibitors
Maintained TG + chemo patent as granted after opposition in European Patent Office
FINANCIALS

The interim financial information has not been subject to audit

Øystein Soug, CEO commented: "Targovax is at the beginning of a new and exciting development phase. Based on impressive ONCOS-102 clinical data, our main priority going forward is to start a next trial in PD1 refractory melanoma. At the same time, it is also important that we do it right and discuss our strategy with the FDA, since the aim of this trial is to support an accelerated approval. Moreover, based on the strength and breadth of the clinical and immune data, we believe our technology warrants a broader application. Hence, we envision several expansion possibilities beyond melanoma in other indications, with other novel combinations, and for our next generation pipeline products."

Presentation

We invite to a live webcast today at 10.00 CET. You can join the webcast here. It will be possible to ask questions during the presentation.

On May 6, 2021 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, reported financial results for the first quarter ended March 31, 2021 and highlighted recent activity (Press release, Immunic, MAY 6, 2021, View Source [SID1234579417]).

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"Our clinical program activities have continued unabated, with significant progress having recently been achieved for our lead asset, selective oral DHODH inhibitor, IMU-838," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "Last month, we announced key interim data from our phase 2 EMPhASIS Cohort 2 sub-trial of IMU-838 in patients with relapsing-remitting multiple sclerosis (RRMS), confirming 30 mg as the most appropriate dose for our envisaged phase 3 program. We will now move directly to the filing of an Investigational New Drug (IND) application in the United States and are currently working to complete the package, with the expectation of initiating the phase 3 program in the second half of this year."

"Beyond RRMS, during the first quarter, we reported positive top-line data from the investigator-sponsored, open-label phase 2 proof-of-concept trial of IMU-838 in primary sclerosing cholangitis (PSC), conducted in collaboration with the Mayo Clinic. Results confirmed safety and tolerability and provided encouraging activity signals. In order to find the optimized dose for future clinical activities in PSC, we plan to initiate a phase 1 trial in hepatic impaired patients. Backed by the promising results from our phase 2 CALVID-1 trial of IMU-838 which underlined its broad antiviral activity, our phase 2 trial in ulcerative colitis (UC) has seen recent strong recruitment which we expect to be completed in the second half of this year."

Dr. Vitt added, "With the ongoing accumulation of robust data for IMU-838, including repeated confirmation of safety and efficacy across multiple indications, we made a strategic decision during the first quarter to settle our remaining royalty obligation to 4SC AG, giving us full rights to our most advanced asset and securing our ability to unlock its future potential."

First Quarter 2021 and Subsequent Highlights

April 2021: Announced EMPhASIS interim analysis of 10 mg Cohort 2 confirming IMU-838’s dose response in RRMS and supporting phase 3 dose selection. Previously published data from Cohort 1, together with Cohort 2 data from 59 randomized patients who completed week 12 magnetic resonance imaging assessments, confirmed that 30 mg once daily IMU-838 is the most appropriate dose for the company’s planned phase 3 program in RRMS.
March 2021: Announced the signing of an agreement with 4SC AG to settle the remaining obligation of a 4.4% royalty on net sales of IMU-838, for $17.25 million. The payment was made 50% in cash and 50% in shares of Immunic’s common stock. No further payment obligations remain between Immunic and 4SC AG.
February 2021: Reported positive top-line data from the investigator-sponsored phase 2 proof-of-concept clinical trial of IMU-838 in PSC, conducted in collaboration with investigators at Mayo Clinic. Data showed a statistically significant decrease in serum alkaline phosphatase (ALP) levels (p=0.041) in the 11-patient per-protocol (PP) population after 24-weeks of treatment, as compared to baseline. Additionally, IMU-838’s favorable safety and tolerability profile was confirmed in the patient population.
February 2021: Announced top-line clinical efficacy, safety, disease marker and virology data from the main analysis of the phase 2 CALVID-1 trial of IMU-838 in hospitalized patients with moderate COVID-19. The data showed clinical activity based on multiple secondary endpoints and confirmed IMU-838 to be safe and well-tolerated in this patient population.
Meanwhile, additional available data from the full analysis of all 223 randomized patients support the conclusions made in the main analysis and have provided data on a few additional endpoints. Notably, the rate and timing of anti-SARS-CoV-2 antibodies patients are developing in response to the infection was found to be identical between the IMU-838 and placebo treatment arms. The full analysis was also able to detect a relationship between drug trough levels in blood plasma and the clinical recovery endpoint.

With the progressing rollout of vaccines in many countries, however, the company believes that the opportunity to execute a phase 3 program as a monotherapy and to benefit from any potential commercialization in this indication within a reasonable time frame is no longer viable.

Anticipated Clinical Milestones

IMU-838 in RRMS: As previously announced, Immunic remains in discussions with regulatory authorities, including the FDA and the European Medicines Agency, regarding the planned phase 3 program in RRMS. At the FDA’s request, the company is proceeding directly to submission of an IND application, instead of holding an end-of-phase 2 meeting. Feasibility and other preparatory activities for the phase 3 program are ongoing and initiation is expected in the second half of 2021.
IMU-838 in UC: Recruitment of the phase 2 CALDOSE-1 trial of IMU-838 in patients with UC is expected to be completed in the second half of 2021 and top-line data of the induction phase is expected to be available in the first half of 2022, as previously announced.
IMU-838 in PSC: Immunic plans to perform a phase 1 trial in hepatic impaired patients which will allow for dose optimization of IMU-838 for potential future clinical activities in PSC.
IMU-935 phase 1 program: Based on a positive outcome of the single ascending dose (SAD) cohort of the phase 1 trial of IMU-935, the company received approval from the Ethics Committee in Australia, during first quarter of 2021, to proceed with the multiple ascending dose (MAD) portion of the trial and subjects in the first cohort are currently being dosed. Unblinded safety, pharmacodynamics and pharmacokinetics data from the SAD and MAD parts in healthy volunteers is expected to be available in the second half of 2021. Initiation of a third portion of the phase 1 trial in patients with mild-to-moderate psoriasis is expected in the third quarter of 2021 and is anticipated to last approximately 12 months.
IMU-856 phase 1 program: The SAD part of the ongoing phase 1 trial of IMU-856 has been completed. Based on the favorable data available, the company expects to receive clearance from the Ethics Committee in Australia to proceed to the MAD part in healthy volunteers, in the near future. Unblinded safety data from the SAD and MAD parts in healthy volunteers is expected to be available in the second half of 2021. Initiation of the third portion of the phase 1 trial in patients with several diseases involving bowel barrier dysfunction is expected in the second half of 2021.
Financial and Operating Results

Research and Development (R&D) Expenses were $11.5 million for the three months ended March 31, 2021, as compared to $6.4 million for the same period ended March 31, 2020. The $5.1 million increase was primarily due to (i) a $1.7 million increase in external development costs related to the phase 2 clinical trial in patients with COVID-19 as trials did not start until the second quarter of 2020, (ii) a $1.4 million increase in drug supply costs related to IMU-838 to support the company’s ongoing and future clinical trials, (iii) a $0.9 million increase in preparation costs related to the phase 3 program of IMU-838 in multiple sclerosis, (iv) $0.4 million related to increased cost for the ulcerative colitis trial, and (v) $0.7 million related to increased costs across numerous categories.
General and Administrative (G&A) Expenses were $20.9 million for the three months ended March 31, 2021, as compared to $2.6 million for the same period ended March 31, 2020. The $18.3 million increase was primarily due to (i) a $17.3 million settlement of royalty obligations to 4SC AG, and (ii) a $1.3 million increase in personnel expenses of which $1.2 million is related to non-cash stock compensation expense, partially offset by a $0.3 million decrease in travel related costs.
Other Income (Expense) was $(2.1) million for the three months ended March 31, 2021, as compared to $0.5 million for the same period ended March 31, 2020. The $2.6 million decrease was primarily attributable to (i) a $2.5 million foreign exchange loss on a $52.0 million intercompany loan between Immunic, Inc. and Immunic AG, and (ii) a $0.4 million decrease in recognized deferred income attributable to reimbursements of R&D expenses in connection with the option agreement with Daiichi Sankyo Co., Ltd. realized in the first quarter of 2020. The decrease was partially offset by a $0.2 million increase in R&D tax incentives for clinical trials in Australia as a result of increased spending on clinical trials in Australia.
Net Loss for the three months ended March 31, 2021 was approximately $34.5 million, or $1.63 per basic and diluted share, based on 21,174,698 weighted average common shares outstanding, compared to a net loss of approximately $8.5 million, or $0.79 per basic and diluted share, based on 10,749,460 weighted average common shares outstanding for the same period ended March 31, 2020.
Cash and Cash Equivalents as of March 31, 2021 were $114.8 million, which management expects to be sufficient to fund operations into the second half of 2022.

On May 6, 2021 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 financial results for the fiscal second quarter ended March 31, 2021 (Press release, ESSA, MAY 6, 2021, View Source [SID1234579416]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

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"This quarter was a very productive period for ESSA. We continue to advance our lead product candidate, EPI-7386, in an ongoing Phase 1 trial in patients with metastatic castration-resistant prostate cancer who are resistant to standard-of-care treatments. We recently reported promising preliminary pharmacokinetic and clinical data from the study and expect to provide a clinical update in the fourth quarter of this calendar year," said Dr. David R. Parkinson, M.D., President and Chief Executive Officer of ESSA Pharma. "During the quarter, we also announced clinical collaborations with Janssen and Astellas, and recently on April 28th entered into a partnership with Bayer, all focused on evaluating EPI-7386 in Phase 1/2 clinical studies in combination with their respective anti-androgen therapies."

Dr. David R. Parkinson added, "With the completion of a successful public offering in which we raised approximately $150 million, we are well-positioned to fund our monotherapy and collaboration studies of EPI-7386 in prostate cancer. In addition, the funding will expand and accelerate our discovery and preclinical research and development efforts to continue to build value across our overall pipeline."

Recent Clinical and Corporate Highlights

On April 28, 2021, the Company announced a clinical collaboration with Bayer to evaluate EPI-7386 in combination with Bayer’s androgen receptor inhibitor, darolutamide, in patients with metastatic castration-resistant prostate cancer ("mCRPC"). Under the terms of the agreement, Bayer may sponsor and conduct a Phase 1/2 study to evaluate the safety, pharmacokinetics and efficacy of the combination of EPI-7386 and darolutamide in mCRPC patients. ESSA will supply EPI-7386 for the trial and will retain all rights to EPI-7386. The clinical study is expected to start in the second half of calendar 2021.

On April 10, 2021, the Company reported updated preclinical data on EPI-7386 at the 2021 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrating that the product candidate can inhibit in vitro androgen receptor ("AR") splice variants including AR-v567es. The results also suggest that EPI-7386 can inhibit AR related transcription and EPI-7386 in combination with enzalutamide may result in broader and deeper inhibition of the AR pathway.

On February 25, 2021, the Company announced a clinical collaboration with Astellas Pharma Inc. ("Astellas") to evaluate the combination of EPI-7386 and Astellas/Pfizer’s androgen receptor inhibitor, enzalutamide, for patients with mCRPC. Under the terms of the agreement, ESSA will sponsor and conduct a Phase 1/2 study to evaluate the safety, tolerability and preliminary efficacy of the combination of EPI-7386 and enzalutamide in mCRPC patients who have not yet been treated with second-generation antiandrogen therapies. Astellas will supply enzalutamide for the trial. ESSA will retain all rights to EPI-7386. The clinical study remains on track to start in the second half of calendar 2021.

On February 22, 2021, the Company completed an underwritten public offering for aggregate gross proceeds of $149,999,985. The Company issued a total of 5,555,555 common shares of the Company at a public offering price of $27.00 per share, including the underwriters’ fully exercised option to purchase an additional 724,637 shares.

On January 13, 2021, the Company announced a clinical collaboration with Janssen Research & Development, LLC ("Janssen") to evaluate EPI-7386 in combination with abiraterone acetate/prednisone or apalutamide for patients with mCRPC. Under the terms of the agreement, Janssen may sponsor and conduct up to two Phase 1/2 studies evaluating the safety, tolerability and preliminary efficacy of the combination of EPI-7386 and apalutamide as well as the combination of EPI-7386 with abiraterone acetate plus prednisone in patients with mCRPC who have failed a second-generation antiandrogen therapy. Janssen will assume all costs associated with these studies other than the manufacturing costs associated with the clinical drug supply of EPI-7386. The parties will form a joint oversight committee for the clinical studies, which are planned to start in 2021. ESSA will retain all rights to EPI-7386.
Summary Financial Results

Net Loss. ESSA recorded a net loss of $13.0 million ($0.36 loss per common share based on 36,484,041 weighted average common shares outstanding) for the quarter ended March 31, 2021, compared to a net loss of $9.4 million ($0.45 loss per common share based on 20,821,956 weighted average common shares outstanding) for the quarter ended March 31, 2020. For the period ended March 31, 2021, this included non-cash share-based payments of $2.7 million compared to $3.6 million for the prior year, recognized for stock options granted and vesting.

Research and Development ("R&D") expenditures. R&D expenditures for the quarter ended March 31, 2021 were $7.3 million compared to $4.6 million for the quarter ended March 31, 2020 and includes non-cash costs related to share-based payments ($791,969 for period ended March 31, 2021 compared to $1.0 million for period ended March 31, 2020). The increase in R&D expenditures for the second quarter were primarily related to the increased expenditure on chemistry and manufacturing of the drug product, and clinical costs related to the Phase 1 clinical trial of EPI-7386, which commenced with the dosing of the first patient in July 2020.

General and administration ("G&A") expenditures. G&A expenditures for the quarter ended March 31, 2021 were $4.6 million compared to $4.9 million for the quarter ended March 31, 2020 and include non-cash costs related to share-based payments of $1.9 million for the period ended March 31, 2021 compared to $2.6 million for the period ended March 31, 2020. The increase in the second quarter is the result of increased share-based payments related the expense recognized in relation to the grant and vesting of these equity instruments.
Liquidity and Outstanding Share Capital
At March 31, 2021, the Company had available cash reserves and short-term investments of $208,597,224 reflecting the gross proceeds of the February 2021 financing of $150.0 million and July 2020 financing of $48.9 million, less operating expenses in the intervening period.

As of March 31, 2021, the Company had 40,417,857 common shares issued and outstanding.

In addition, as of March 31, 2021 there were 6,728,398 common shares issuable upon the exercise of warrants and broker warrants. This includes 6,370,000 prefunded warrants at an exercise price of $0.0001, and 358,398 warrants at a weighted average exercise price of $44.13. There are 6,726,642 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $4.53 per common share.

About EPI-7386
EPI-7386 is an investigational, highly-selective, oral, small molecule inhibitor of the N-terminal domain of the androgen receptor. EPI-7386 is currently being studied in a Phase 1 clinical trial (NCT04421222) in men with mCRPC whose tumors have progressed on current standard-of-care therapies. The Phase I clinical trial of EPI-7386 began in calendar Q3 of 2020 following FDA allowance of our Investigational New Drug application and Health Canada acceptance. The U.S. FDA has granted Fast Track designation to EPI-7386 for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment. ESSA retains all rights to EPI-7386 worldwide.

On May 6, 2021 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported financial results for the first quarter ended March 31, 2021 and provided a corporate update (Press release, Lipocine, MAY 6, 2021, View Source [SID1234579415]).

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First Quarter Recent Corporate Highlights

Announced positive topline results from the Phase 2 LiFT ("Liver Fat intervention with oral Testosterone") clinical study, investigating LPCN 1144 in biopsy-confirmed NASH male subjects
Both LPCN 1144 treatment arms met the primary endpoint, change in hepatic fat fraction via magnetic resonance imaging proton density fat fraction ("MRI-PDFF"), with statistical significance
36-week biopsy data from the LiFT study are expected in August 2021
Continued enrolling patients into an open label extension to the LiFT clinical study in which all patients will have access to LPCN 1144
Announced the publication of results supporting the therapeutic potential of LPCN 1144 in the treatment of non-alcoholic steatohepatitis ("NASH") and hepatic fibrosis
The results were featured in a paper entitled "Treatment Potential of LPCN 1144 on Liver Health and Metabolic Regulation in a Non–Genomic, High Fat Diet Induced NASH Rabbit Model" (Comeglio et al), published in the Journal of Endocrinological Investigation
Continued to evaluate commercial options for TLANDO, our oral testosterone product for testosterone replacement therapy ("TRT") in adult males with hypogonadism
Posters featuring clinical data on TLANDO were presented at the ENDO 2021 Conference
Raised gross proceeds of approximately $28.7 million in a public offering of approximately 16.4 million shares of common stock
First Quarter Ended March 31, 2021 Financial Results
Lipocine reported a net loss of $3.4million, or ($0.04) per diluted share, for the first quarter ended March 31, 2021, compared with a net loss of $5.8 million, or ($0.14) per diluted share, for the first quarter ended March 31, 2020.

Research and development expenses were $1.6 million for the first quarter ended March 31, 2021, compared with $2.5 million for the first quarter ended March 31, 2020. The decrease in research and development expenses during the three months ended March 31, 2021 was primarily due to a decrease in contract research organization expense and outside consulting costs related to the LPCN 1144 LiFT Phase 2 clinical study in NASH subjects and a decrease in raw material costs of TLANDO XR offset by increases in personnel expense and other R&D expenses.

General and administrative expenses were $1.5 million for the first quarter ended March 31, 2021, compared with $2.1 million for the first quarter ended March 31, 2020. The decrease in general and administrative expenses during the three months ended March 31, 2021 was primarily due to a decrease in legal costs due to less activity in 2021 as compared to 2020 in the following activities: lawsuit filed against Clarus Therapeutics Inc. for patent infringement in April 2019 and the on-going class action lawsuit defense. Additionally, personnel costs decreased in 2021. These decreases were offset by an increase in corporate insurance expenses.

As of March 31, 2021, the Company had $50.0 million of unrestricted cash, cash equivalents, and marketable investments, compared to $19.7 million of unrestricted cash, cash equivalents and marketable investment securities as of December 31, 2020.

On May 6, 2021 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported it will host a conference call on Wednesday May 12, at 8:00 a.m. Eastern time to discuss its financial and operating results for the first quarter of 2021, in addition to providing a business update (Press release, VolitionRX, MAY 6, 2021, View Source [SID1234579414]).

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Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with Terig Hughes, Chief Financial Officer and Scott Powell, Executive Vice President, Investor Relations. The call will provide an update on recent developments and Volition’s activities, including details of new and ongoing clinical trials, important events which have taken place in the first quarter of 2021, and milestones for 2021 and beyond.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source In addition, a telephone replay of the call will be available until May 26, 2021. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13719633.