On March 8, 2019 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 and year ended December 31, 2018 (Press release, Oncolytics Biotech, MAR 8, 2019, View Source [SID1234534139]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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”With a growing number of large pharma collaborations, continued advancement with our registration program in metastatic breast cancer and recently announced biomarker data, we have made tremendous progress in a short period of time,” said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. ”In 2019 we expect to generate data that will allow us to finalize our registration program in breast cancer, while at the same time advancing studies in indications with prior evidence of clinical activity, as defined by an inflamed phenotype. With the global market for checkpoint inhibitors expected to reach $25 billion in 2022 and checkpoint inhibitors only able to treat approximately twenty percent of patients, the data demonstrating pelareorep’s ability to create an inflamed phenotype and boost PD-L1 expression makes it a potential backbone for this drug class. Furthermore, we believe pelareorep can potentially expand the utility of checkpoint inhibitors into additional indications and this work is already underway with Merck’s Keytruda in both multiple myeloma and pancreatic cancer, Bristol-Myers Squibb’s Opdivo in multiple myeloma and Roche’s Tecentriq in breast cancer.”

Selected highlights since January 1, 2018

Clinical & Scientific Updates

Received confirmation from the FDA and EMA that only a single phase 3 study is required for approval
Granted a Special Protocol Assessment (SPA) from the FDA
Advised to identify a biomarker prior to the final study design
Announced a Master Clinical Supply Agreement (MCSA) with F. Hoffmann-La Roche Ltd (Roche) to supply Tecentriq for use in the company’s clinical development program
Announced an abstract identifying a potentially predictive and prognostic biomarker to be presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting
Entered into a clinical collaboration with SOLTI, a world-leading cooperative group specializing in breast cancer, to conduct our AWARE-1 window of opportunity breast cancer study, to confirm the utility of our recently identified biomarker
Marks the first use of our MCSA with Roche
Presented data highlighting increased expression of PD-L1 on multiple myeloma cells in patients treated with pelareorep at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, leading to our phase 1b combination study with Bristol-Myers Squibb’s Opdivo in multiple myeloma
Presented data suggesting efficacy signal in combination with PD-1 inhibitor at the Gastrointestinal Cancers Symposium sponsored by ASCO (Free ASCO Whitepaper), leading to a phase 2 combination study with Merck’s Keytruda in second line pancreatic cancer
Presented data at the European Society for Medical Oncology 2018 Congress highlighting patients with KRAS mutant metastatic colorectal cancer who were treated with pelareorep and FOLFIRI/Bevacizumab had progression-free survival of 65.6 weeks and overall survival of 107.5 weeks, exceeding expectations when compared to analogous historical data
Initiated additional clinical collaborations:
Pelareorep plus Merck’s checkpoint inhibitor Keytruda in pancreatic cancer
Pelareorep plus Bristol-Myers Squibb’s checkpoint inhibitor Opdivo in multiple myeloma
Pelareorep plus Merck’s checkpoint inhibitor Keytruda in multiple myeloma
Announced a publication in Cancer Immunology Research demonstrating that intravenously administered pelareorep effectively targets tumors even in the presence of neutralizing antibodies
Corporate Updates

Announced the appointment of Dr. Rita Laeufle, M.D., Ph.D., as Chief Medical Officer
Dr. Laeufle brings more than 15 years of experience in oncology drug development, having previously served at Coherus Biosciences, Clovis Oncology, Roche, Genentech and Novartis
Announced the listing of the company’s shares of common stock on the Nasdaq Capital Market and commenced trading on June 1, 2018, under the symbol "ONCY"
Closed an underwritten public share offering of 1,532,278 common shares at a purchase price of USD $5.83 for gross proceeds of approximately USD $8.9 million
Announced a USD $30.0 million At-the-Market facility with Canaccord Genuity LLC
Entered into a common stock purchase agreement for up to USD $26.0 million with Lincoln Park Capital Fund, LLC
Anticipated Milestones

Initiate AWARE-1 in the coming weeks
Initiate combination study with Merck’s Keytruda in multiple myeloma in mid-2019*
Data from AWARE-1 study in the second half of 2019
Prepare for registration study with pelareorep in mBC after AWARE-1 data is available
* Guidance provided by principal investigator

Financial

At December 31, 2018, the company reported $13.7 million in cash and cash equivalents
As at March 7, 2019, the company had an unlimited number of authorized common shares with 18,840,010 common shares issued and outstanding, 16,443,500 warrants exercisable into 1,730,894 common shares with a $9.025 strike price and 1,569,326 options and share units
Operating expense for the fourth quarter of 2018 was $2.4 million and $7.2 million for the year 2018, compared to $2.2 million in the fourth quarter 2017 and $6.2 million for the year 2017
R&D expense for the fourth quarter of 2018 was $2.5 million and $9.4 million for the year 2018, compared to $2.5 million in the fourth quarter 2017 and $9.4 million for the year 2017
The net loss for the fourth quarter of 2018 was $4.8 million and $17.0 million for the year 2018, compared to $4.7 million in the fourth quarter 2017 and $15.6 million for the year 2017, which equates to a loss of $1.06 per share in 2018 compared to a net loss of $1.12 per share in 2017, on a consolidated basis
Webcast and Conference Call

Management will host a conference call for Analysts and Institutional Investors at 8:30 a.m. ET, today, Friday, March 8, 2019. The live call may be accessed by dialing (877) 407-9205 for callers in North America. Overseas callers should contact investor relations for the toll-free dial information for their country. A live webcast of the call will be accessible on the Investor Relations page of Oncolytics’ website at www.oncolyticsbiotech.com and will be archived for three months. A replay of the call will be available approximately two hours after the call has ended at (877) 481-4010, using the replay code 44902 and will remain available for one week.

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus 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 March 8, 2019 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on dermatological and immuno-inflammatory diseases, reported it will report financial results for the fourth quarter and full year 2018, Monday, March 18th, before U.S. financial markets open (Press release, Aclaris Therapeutics, MAR 8, 2019, View Source [SID1234534135]).

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Management will conduct a conference call at 8:00 AM ET to discuss Aclaris’ financial results and provide a general business update. The conference call will be webcast live over the Internet and can be accessed by logging on to the "Investors" page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days following the call.

To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 9765869prior to the start of the call.

On March 8, 2019 Eli Lilly and Company (NYSE:LLY) reported that it will participate in the Barclays Global Healthcare Conference on Wednesday, March 13, 2019. Daniel Skovronsky, M.D., Ph.D., Lilly’s Chief Scientific Officer and President of Lilly Research Laboratories, will participate in a fireside chat at 8:30 a.m., Eastern Time (Press release, Eli Lilly, MAR 8, 2019, View Source [SID1234534133]).

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

On March 8, 2019 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, reported it has entered into a purchase agreement with two institutional investors for the purchase of common units and pre-funded units for a combined total of 4,361,370 units in a registered direct offering, for expected gross proceeds of approximately $14 million before placement agent fees and other offering expenses payable by Altimmune (Press release, Altimmune, MAR 8, 2019, View Source [SID1234534132]). Today we disclosed in a Form 8-K cash, cash equivalents and restricted cash of approximately $34.4 million as of December 31, 2018,

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Each common unit is being sold at a public offering price of $3.21 and consists of one share of common stock and 0.70 of a warrant to purchase one share of common stock at an exercise price of $3.21. Each pre-funded unit is being sold at a public offering price of $3.20 and consists of a pre-funded warrant to purchase one share of common stock at an exercise price of $0.01 per share and 0.70 of a warrant to purchase one share of common stock at an exercise price of $3.21. The public offering price of each pre-funded unit is equal to the public offering price of each common unit being sold to the public in this offering, minus $0.01. The pre-funded warrants will be immediately exercisable and may be exercised at any time until all of the pre-funded warrants are exercised in full. The other warrants will be exercisable immediately and will expire five years from the date of issuance. The terms of the warrants and the pre-funded warrants will be substantially the same as the terms of the warrants and the pre-funded warrants issued in connection with our registered direct offering completed October 10, 2018. For a summary of the material terms of the warrants and pre-funded warrants, please refer to Exhibit A attached to this press release.

The offering is expected to close on or about March 12, 2019, subject to customary closing conditions. Altimmune intends to use the net proceeds from this offering for the continued advancement of development activities for our product pipeline, strategic growth opportunities (including potential acquisitions and/or licensing transactions), and general working capital purposes.

Roth Capital Partners is acting as sole placement agent for the offering.

The securities described above are being offered by Altimmune pursuant to a registration statement on Form S-3 (File No. 333-217034) that was declared effective by the Securities and Exchange Commission (SEC) on April 6, 2017. A final prospectus supplement and an accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, by contacting Roth Capital Partners, LLC, Attention: Equity Capital Markets, 888 San Clemente Drive, Suite 400, Newport Beach, California 92660, by telephone at (800) 678-9147 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On March 8, 2019 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, reported fourth quarter and full-year 2018 financial results for the periods ended December 31, 2018 (Press release, Allogene, MAR 8, 2019, View Source [SID1234534130]).

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"We are very proud of what Allogene has accomplished in just ten months. Every move we have made has been toward achieving one goal, making allogeneic CAR T therapy available to patients," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "We are excited to soon embark upon our first company sponsored trial for ALLO-501 in relapsed/refractory non-Hodgkin lymphoma (NHL) and progress the buildout of our planned state-of-the-art manufacturing facility in Newark, California. With our focus and drive to progress our pipeline of cell therapy candidates, which includes the planned IND submission of ALLO-715 in multiple myeloma (MM) later this year, we feel confident in Allogene’s ability to be a leader in the development of AlloCAR T therapies."

2018 and Recent Highlights

Corporate

In September 2018, the company completed a $120.2 million private financing and in October 2018, Allogene’s Initial Public Offering (IPO) raised $372.6 million in gross proceeds.

In February 2019, Allogene entered into a lease agreement to develop a 118,000 square foot state-of-the-art cell therapy manufacturing facility in Newark, California. World class manufacturing is core to the Allogene strategy to deliver readily available cell therapy faster, more reliably and at greater scale. The manufacturing facility is being designed for both clinical and commercial supply, upon potential regulatory approval, of AlloCAR T therapy.

ALLO-501 (Allogene-Sponsored Program in Collaboration with Servier)

In January, the U.S. Food & Drug Administration (FDA) cleared Allogene’s first Investigational New Drug (IND) application for ALLO-501 in patients with relapsed/refractory NHL.

The planned Phase 1 study will utilize ALLO-647, Allogene’s proprietary anti-CD52 monoclonal antibody (mAb) as a part of the lymphodepletion regimen.

Site qualification is underway, and the trial is on-track to initiate in the 1H of 2019.

The Phase 1 portion will enroll approximately 24 patients with relapsed/refractory large B-cell lymphoma or follicular lymphoma.

The primary objective of the study is to evaluate the safety and tolerability of ALLO-501 and ALLO-647.

The Phase 1 portion of the trial is designed to determine the optimal dose of ALLO-501 for the Phase 2 portion of the trial.

ALLO-715

On track to file an IND application in 2019 for ALLO-715, a wholly-owned CAR T product candidate targeting B cell maturation antigen (BCMA) for multiple myeloma.

UCART19 (Servier-Sponsored Program in Collaboration with Allogene)

Servier and Allogene presented pooled data from the Phase 1 trials of UCART19 in relapsed/refractory acute lymphoblastic leukemia (ALL) at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) meeting. The analysis suggested that an anti-CD52 mAb may be an important contributor for AlloCAR T cell expansion, and the use of anti-CD52 mAb will now be mandated in the UCART19 trials.

Fourth Quarter and Full Year 2018 Financial Results

Research and development expenses were $18.5 million for the fourth quarter of 2018, which includes $1.3 million of non-cash stock-based compensation expense. For the full year of 2018, research and development expenses were $151.9 million which includes $109.4 million related to the asset acquisition from Pfizer. The total research and development expense for the year includes $1.7 million of non-cash stock-based compensation expense.

General and administrative expenses were $14.5 million for the fourth quarter of 2018, which includes $4.6 million of non-cash stock-based compensation expense. For the full year of 2018, general and administrative expenses were $41.0 million, which includes $16.9 million of non-cash stock-based compensation expense.

Net loss for the fourth quarter of 2018 was $30.5 million, or $0.37 per share, including non-cash stock-based compensation expense of $5.9 million. For the full year of 2018, net loss was $211.5 million, or $7.31 per share, including non-cash stock-based compensation expense of $18.6 million.

As of December 31, 2018, Allogene had $721.4 million in cash, cash equivalents, and investments.

2019 Financial Guidance

Allogene expects full year 2019 net losses to be between $200 million and $210 million including estimated non-cash stock-based compensation expense of $45 million to $50 million and excluding any impact from potential business development activities.

Conference Call and Webcast Details

Allogene will host a live conference call and webcast today at 5:30 AM Pacific Time/8:30 AM Eastern Time to discuss financial results and provide a business update. To access the live

conference call by telephone, please dial 1 (866) 940-5062 (U.S.) or 1 (409) 216-0618 (International). The conference ID number for the live call is 3589112. The webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.