On May 8, 2020 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, 2020 and highlighted recent activity (Press release, Immunic, MAY 8, 2020, View Source [SID1234557435]).

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"The global coronavirus disease 2019 (COVID-19) pandemic has led to a period of intense, additional focus for Immunic, as we quickly recognized the potential of our lead asset, selective oral DHODH inhibitor, IMU-838, as a possible therapeutic for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections, given its already well-recognized, broad-spectrum antiviral effects," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "After performing preclinical testing, we recently announced that, in cellular assays, IMU-838 successfully demonstrated antiviral activity against SARS-CoV-2 at blood concentrations which are well below those associated with IMU-838 dosing regimens studied in our ongoing and previous clinical trials. Based on these positive results, we are preparing a phase 2 clinical development program for IMU-838 as a potential treatment for this devastating disease."

Dr. Vitt continued, "On the heels of this encouraging preclinical data, we were able to bolster our financial position with a successful $15.0 million financing. As a result, we expect to be well funded through key, near-term milestones including top-line data from both our phase 2 trial of IMU-838 for relapsing-remitting multiple sclerosis (RRMS), expected in the third quarter of this year, as well as results from the investigator-sponsored phase 2 trial for IMU-838 in primary sclerosing cholangitis (PSC), expected in early 2021."

First Quarter 2020 and Subsequent Highlights

April 2020: Completed a $15.0 million registered direct offering led by institutional investor, Altium Capital.
April 2020: Announced that lead asset, IMU-838, has successfully demonstrated preclinical activity against clinical isolates of SARS-CoV-2 associated with COVID-19. As a result, the company is now exploring the feasibility of conducting a prospective, multicenter, randomized, placebo-controlled, double-blind phase 2 clinical trial in patients with moderate COVID-19.
April 2020: Reported several changes to the company’s executive team, including the resignation of Chief Financial Officer, Sanjay S. Patel, CFA, and the promotion of Glenn Whaley to the position of Vice President Finance, Principal Financial and Accounting Officer. Additionally, announced that Duane Nash, MD, JD, MBA, current Chairman of the Board of Directors, has temporarily assumed the role of Executive Chairman.
January 2020: Exercised option to obtain the exclusive worldwide rights to commercialization of a group of compounds, designated by the company as IMU-856, aimed at restoring intestinal barrier function, from Daiichi Sankyo Co., Ltd.
Anticipated Clinical Milestones

Top-line data from the phase 2 EMPhASIS trial of IMU-838 in RRMS is expected to be available in the third quarter of 2020.
Completion of preclinical and manufacturing activities necessary for initiation of phase 1 clinical studies of IMU-856 are expected during the first half of 2020.
The current, single ascending dose part of the ongoing phase 1 trial of IMU-935, being conducted in Australia, is planned to be followed by a multiple ascending dose (MAD) portion in healthy volunteers and a safety evaluation in patients with mild-to-moderate psoriasis as a third part of this phase 1 trial. Based on the temporary pausing of trials in healthy volunteers imposed by Ethics Committees in Australia due to COVID-19, the MAD portion of the trial is expected to start in the second half of 2020.
Top-line data from the phase 2, investigator-sponsored proof-of-concept clinical trial for IMU-838 in PSC, being conducted at the Mayo Clinic, is expected to be available in early 2021.
Top-line data from the phase 2 CALDOSE-1 trial in ulcerative colitis (UC) is expected to be available during the fourth quarter of 2021.
Upcoming Events

Immunic will host a virtual R&D Day on May 19, 2020. Immunic’s management and invited key opinion leaders, specializing in multiple sclerosis and inflammatory bowel disease, will discuss today’s treatment options for, and the unmet medical needs of, chronic inflammatory and autoimmune diseases, as well as clinical progress of the company’s selective oral immunology programs and their potential advantages over the current treatment landscape. Management will also discuss the company’s COVID-19 program.
Financial and Operating Results

Research and Development (R&D) Expenses were $6.4 million for the three months ended March 31, 2020, as compared to $3.4 million for the same period ended March 31, 2019. The $3.1 million increase was primarily attributable to (i) increased development costs for the phase 2 clinical trials of IMU-838 in RRMS and UC, the IMU-935 phase 1 clinical trial, and preclinical activities with IMU-856, (ii) increased employee costs related to the growth in headcount and (iii) other expenses.
General and Administrative (G&A) Expenses were $2.6 million for the three months ended March 31, 2020, as compared to $1.3 million for the same period ended March 31, 2019. The $1.3 million increase is primarily due to becoming a public company and expanding operations into the United States.
Other Income was $0.5 million for the three months ended March 31, 2020, as compared to $0.3 million for the same period ended March 31, 2019. The $0.2 million increase is primarily attributable to research and development 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, 2020 was approximately $8.5 million, or $0.79 per basic and diluted share, based on 10,749,460 weighted average common shares outstanding, compared to a net loss of approximately $4.3 million, or $5.09 per basic and diluted share, based on 846,953 weighted average common shares outstanding for the same period ended March 31, 2019.
Cash and Cash Equivalents, as of March 31, 2020, were $18.6 million. With these funds and the money raised in equity issuances in April 2020, including approximately $13.9 million in net proceeds from the registered direct offering closed on April 27, 2020, and an additional $2.3 million in net proceeds from ATM issuances, the company expects to be able to fund operations beyond twelve months from the date of the issuance of this earnings release.

On May 8, 2020 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported financial results for the first quarter ended March 31, 2020 and provided a corporate update (Press release, Crinetics Pharmaceuticals, MAY 8, 2020, View Source [SID1234557376]).

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"So far, 2020 has proven to be a transformational time for Crinetics, highlighted by the positive interim Phase 2 results for paltusotine, our lead product candidate for the treatment of acromegaly," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "The interim data we reported showed that acromegaly patients switching from injectable depot therapy to once daily oral paltusotine maintained IGF-1 levels previously achieved with commercially available depot injections of somatostatin receptor ligands. We plan to report topline data from our ongoing Phase 2 trials in the fourth quarter of 2020 and advance paltusotine into Phase 3 development for patients with acromegaly in the first half of 2021 following conversations with regulatory agencies. Additionally, our successful follow-on offering in April strengthened our balance sheet and provided us with sufficient resources to advance our pipeline through key milestones, including our planned Phase 3 trial in acromegaly, a Phase 2 trial of paltusotine in carcinoid syndrome associated with neuroendocrine tumors (NETs), as well as Phase 1 trials to demonstrate proof-of-concept and PK/PD with our ACTH antagonist and SST5 agonist programs."

"We are both grateful and inspired by the dedication of staff and patients at our clinical trial sites around the world who have worked through the global COVID-19 pandemic to continue their participation in these important studies," said Alan Krasner, M.D., Chief Medical Officer or Crinetics. "Their commitment suggests a strong desire by the global acromegaly patient community and their healthcare providers to seek new therapies to manage their disease."

First Quarter and Subsequent Highlights

Reported positive interim results for the ACROBAT Edge Phase 2 trial of paltusotine in acromegaly patients. In April 2020, Crinetics reported interim results from its ongoing ACROBAT Edge Phase 2 trial. Results as of the February 23, 2020 data cutoff showed that acromegaly patients switching from injectable depot therapy to once daily oral paltusotine maintained IGF-1 levels previously achieved with commercially available depot injections of somatostatin receptor ligands. Interim results from an exploratory analysis of the first 13 patients who entered the Edge trial on octreotide or lanreotide depot monotherapy (group 1) showed that patient IGF-1 levels were maintained after switching to once daily oral paltusotine when compared to IGF-1 levels achieved with prior depot therapy [mean change from baseline = -0.015 x ULN (95% CI = -0.123, +0.092)]. Ten of the 11 (91%) patients in group 1 who completed paltusotine treatment maintained IGF-1 levels within 15% of their respective baseline levels at week 13. No patient required "rescue therapy" with prior injected peptide acromegaly therapy after switching to paltusotine. As a result of these data, new enrollment in the ACROBAT Evolve trial has been discontinued. The patients already enrolled in both the Edge and Evolve Phase 2 trials will continue in the studies and topline data is expected to be reported in the fourth quarter.

Provided a corporate update on the pipeline. In April 2020, Crinetics also provided an update on its other development programs, including an announcement that Phase 1 data for CRN01941 in healthy volunteers showed that the compound did not represent an improvement over paltusotine. Therefore, the company has discontinued development of CRN01941 in order to focus resources on paltusotine for both acromegaly and NETs. Crinetics believes that the acceleration and increased efficiency offered by focusing on paltusotine provides the best path forward for its SST2 franchise. Additionally, first-in-human enabling activities are ongoing for both the oral nonpeptide ACTH antagonist for the treatment of Cushing’s disease and congenital adrenal hyperplasia, and the oral nonpeptide SST5 agonist for the treatment of hyperinsulinism. The start of Phase 1 clinical trials for

these programs is planned for late 2020 or early 2021 and, if successful, the company anticipates PK/PD data from these human proof-of-concept studies in the first half of 2021.

Successful public offering strengthens cash position. In April 2020, Crinetics completed a public offering in which the company sold an aggregate of 8,222,500 shares of common stock at a price to the public of $14.00 per share. Net proceeds from the public offering after deducting underwriting discounts, commissions and offering expenses, were approximately $107.9 million.

COVID-19 Impact

During these challenging times, Crinetics remains committed to the health and safety of our employees, as well as the clinical sites and patients involved in its clinical trials. The company is closely monitoring public health guidance as it aims to continue to treat patients in its ongoing and planned clinical trials, which, so far, have remained on track. The overall impact of the COVID-19 pandemic on Crinetics’ business, its ability to obtain clinical material, and to conduct preclinical research and clinical trials in a timely manner is currently unknown. So far, the pandemic has not had a significant negative impact on the company’s ability to conduct business activities, but that could change, and the company is continuously monitoring the impact of the outbreak of the virus.

First Quarter 2020 Financial Results

Research and development expenses were $13.9 million for the three months ended March 31, 2020, compared to $7.3 million for the same period in 2019. The increases were primarily attributable to development and manufacturing activities for paltusotine as well as the advancement of the company’s preclinical programs and higher personnel costs.

General and administrative expenses were $4.0 million for the three months ended March 31, 2020, compared to $3.2 million for the same period in 2019. The increases were primarily due to personnel costs to support the company’s growth.
e months ended March 31, 2020 was $17.4 million, compared to a net loss of $9.0 million for the three months ended March 31, 2019.

Cash, cash equivalents and investments totaled $112.8 million as of March 31, 2020, compared with $118.4 million as of December 31, 2019. The cash balance at the end of March does not include the $107.9 million net proceeds from the public equity offering completed in April.

As of April 30, 2020, the company had 32,845,572 common shares outstanding.

On May 8, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported its financial results and operational highlights for the quarter ended March 31, 2020 (Press release, Oncolytics Biotech, MAY 8, 2020, View Source [SID1234557410]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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"With the rapid global spread of COVID-19 in the first quarter of 2020, the operational environment has become challenging. Despite these challenges, we have successfully progressed our clinical objectives," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech Inc. "The first part of 2020 saw positive clinical updates not only in our breast cancer program but also in pancreatic, colorectal, and multiple myeloma. Through our collaborations with academia, the National Cancer Institute, and industry partners, including Roche, Pfizer, and Merck, we have been able to demonstrate that pelareorep is a potent stimulator of both the innate and adaptive immune response across a spectrum of malignancies. These collaborations dramatically expanded our understanding of how pelareorep mobilizes the immune system to combat these malignancies, and we have characterized new biomarkers to more readily identify patients who are most likely to derive benefit from our agent. These new teachings significantly de-risk our clinical program as we move towards a registration study in metastatic breast cancer while pursuing new emerging clinical signals for pelareorep. Looking beyond the first quarter, the COVID-19 pandemic may affect the timelines of our clinical programs. At this point, we are not able to quantify to what extent our programs may be impacted, but we will provide additional guidance as to any such impact as it becomes known to us."

"We have strengthened our balance sheet significantly with a cash balance in excess of $30.0 million at the end of the first quarter. The Company raised $18.4 million in financing during the three months ended March 30, 2020. This funding extends our financial runway into the second half of 2021," said Kirk Look, Chief Financial Officer of Oncolytics Biotech. "Importantly, we expect to accomplish multiple data catalysts and operational milestones during this time."

First Quarter Highlights

Clinical & Scientific Highlights

Favourable Safety Committee Assessment for AWARE-1

During the quarter, Oncolytics received a favourable assessment from the Safety Committee following review of data from the AWARE-1 early-stage breast cancer study. Patients receiving pelareorep and Tecentriq demonstrated productive and tumor cell-specific pelareorep replication along with the creation of a pro-inflammatory effect in the tumor microenvironment. No negative effects to healthy tissue were noted.

Statistically Significant CEACAM6 Biomarker Data

Statistically significant data identifying CEACAM6 as a prospective biomarker for pelareorep in the treatment of pancreatic cancer was presented at the 2020 Gastrointestinal Cancers Symposium sponsored by ASCO (Free ASCO Whitepaper) in San Francisco. Low levels of the gene CEACAM6 were associated with prolonged progression free survival increasing over 80%, from 5.72 months on the control arm to 10.32 months (p=0.05) on the test arm.

Publication in Molecular Cancer Therapeutics

During the quarter, Molecular Cancer Therapeutics published a paper highlighting positive clinical data from a phase 1 colorectal cancer study combining FOLFIRI, bevacizumab and pelareorep in colorectal cancer patients. The data demonstrated this combination triggered a robust adaptive immune response highlighted by a unique pattern of dendritic cell maturation followed by CD8 T cell activation observed after every dose of pelareorep. Among 30 evaluable patients, 20% of patients had a partial response, and 73.3% had stable disease, for a clinical benefit rate of 93.3%.

Key Opinion Leader Call

A Key Opinion Leader call was held featuring Dr. Craig Hofmeister of Winship Cancer Institute at Emory University and Dr. Flavia Pichiorri of the Judy and Bernard Briskin Center for Multiple Myeloma at the City of Hope. Data deliberated on the call demonstrated that carfilzomib promotes pelareorep infection by suppressing the innate antiviral response and suggested that the combination does not interfere with T cell activation. Further, it was noted that pelareorep infection, not proteasome inhibition, upregulated PD-L1 expression on myeloma cells, and the adaptive immune system can then assist in clearing infected tumor cells.

Milestones & News Flow

AWARE-1 breast cancer study – interim biomarker data (ESMO Breast Cancer): Q2 2020
Multiple myeloma study (NCI-9603) – interim data (ASCO) (Free ASCO Whitepaper)*: Q2 2020
· Phase 2 second-line pancreatic cancer study – interim data (ASCO) (Free ASCO Whitepaper)*: Q2 2020

Phase 2 second-line pancreatic cancer study – final data*: Q4 2020
Multiple myeloma study (Opdivo combination) – interim data (ASH) (Free ASH Whitepaper)*: Q4 2020
Anticipated Milestones & News Flow

While we are making every effort to maintain the timing of our future milestones, the full impact of the pandemic is currently unknown. Patient safety is our foremost concern, and we will provide updates as they become known.

Initiate phase 2 BRACELET-1 study in HR+ / HER2- mBC
AWARE-1 breast cancer study – final biomarker data
Phase 2 BRACELET-1 metastatic breast cancer study – interim safety update
Complete enrollment in BRACELET-1 metastatic breast cancer study
Phase 2 BRACELET-1 metastatic breast cancer study – final data
*Guidance provided by clinical investigators

Financial Highlights

As at March 31, 2020, the Company reported $30.6 million in cash and cash equivalents. The Company raised $18.4 million during the first quarter through option and warrants exercises and issuing common stock through our ATM facility.
Operating expense for the first quarter of 2020 was $3.0 million, compared to $1.8 million in the first quarter of 2019.
R&D expense for the first quarter of 2020 was $2.5 million, compared to $3.1 million in the first quarter of 2019.
Net cash used in operating activities for the first quarter of 2020 was $4.0 million, compared to $3.4 million for the first quarter of 2019.
The net income for the first quarter of 2020 was $0.4 million, compared to a net loss of $4.9 million in the first quarter of 2019. The basic earnings and diluted loss per share were $0.01 and $0.04, respectively, in the first quarter of 2020, compared to a basic and diluted loss per share of $0.27 in the first quarter of 2019. The diluted loss per share in the first quarter of 2020 was due to the warrant derivative. The net income for the first quarter of 2020 reflected a $4.2 million non-cash gain in fair value of warrant derivative, compared to nil in the first quarter of 2019. The warrants issued in connection with our August 2019 public offering are required to be treated as a financial instrument and are revalued at each exercise date and reporting period. Gains and losses resulting from the revaluation are non-cash, do not impact our cash flow and are recorded as a change in fair value of warrant derivative. In addition, the net income for the first quarter of 2020 reflected a $1.7 million foreign exchange gain, compared to a $0.1 million foreign exchange loss in the first quarter of 2019. The foreign exchange gain and loss incurred was primarily due to unrealized translation gain and loss on U.S. dollar denominated cash balances.
Subsequent to Quarter End

Financial Highlights

As at May 5, 2020, the Company had approximately $31.6 million in cash and cash equivalents, an unlimited number of authorized common shares with 39,289,208 common shares issued and outstanding, 16,443,500 warrants (exercisable into 1,730,894 common shares) issued in 2017 with a $9.025 strike price, 478,938 warrants issued in 2019 with a US$0.90 strike price and 2,465,550 options and share units.
About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic dsRNA virus in development for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On May 8, 2020 Perrigo Company plc (NYSE; TASE: PRGO) reported that President and CEO Murray S. Kessler will host a fireside chat at the RBC Capital Markets Global Healthcare Conference at 11:30 AM EDT on Wednesday, May 20, 2020 (Press release, Perrigo Company, MAY 8, 2020, View Source [SID1234557378]). Interested parties can access the presentation webcast at View Source

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On May 8, 2020 FibroGen, Inc. (NASDAQ: FGEN) reported that it will participate in the Bank of America Securities 2020 Health Care Conference that is being held virtually on May 12-14, 2020 (Press release, FibroGen, MAY 8, 2020, View Source [SID1234557411]). Enrique Conterno, Chief Executive Officer, will participate in a fireside chat at 11:00 AM Eastern Time on Thursday, May 14. A live audio webcast will be available on the "Events & Presentations" section of the FibroGen website at www.fibrogen.com. A replay of the fireside chat will be available for 30 days.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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