Precision BioSciences Reports Second Quarter 2019 Financial Results and Highlights Ongoing Operational Progress

On August 14, 2019 Precision BioSciences, Inc. (Nasdaq: DTIL) ("Precision"), a genome editing company dedicated to improving life through the application of its pioneering, proprietary ARCUS platform, reported financial results for the second quarter ended June 30, 2019, and provided a corporate update (Press release, Precision Biosciences, AUG 14, 2019, View Source [SID1234538814]).

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Key Highlights and Recent Developments

Initiated a Phase 1/2a clinical trial of Precision’s first off-the-shelf (allogeneic) chimeric antigen receptor (CAR) T cell therapy candidate, PBCAR0191. PBCAR0191 will be evaluated in adult patients with relapsed or refractory ("R/R") non-Hodgkin lymphoma ("NHL") or R/R B-cell precursor acute lymphoblastic leukemia ("B-ALL").

Enrolled and dosed patients in the Phase 1/2a clinical trial of PBCAR0191 consistent with expected timelines at three leading US sites with expertise in CAR T cell therapies: Moffitt Cancer Center, Dana Farber Cancer Institute, and City of Hope National Medical Center.

Enhanced senior leadership team with key appointments including Chief Medical Officer Christopher R. Heery, MD, and General Counsel, Dario Scimeca.

Presented pre-clinical updates for multiple in vivo gene editing programs at the American Society for Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting.

Opened an in-house Current Good Manufacturing Practice (cGMP) compliant manufacturing facility, believed to be the first in the United States dedicated to genome-edited, off-the-shelf CAR T cell therapy product candidates.

Celebrated Mario Pennisi, Resident Director of wholly-owned subsidiary Elo Life Systems Inc. (Elo Life Systems), being awarded the BIO Leadership and Legacy Award in Industrial Biotech and Agriculture.

Ended the quarter with $226 million in cash and cash equivalents, expected to fund operating expenses and capital expenditure requirements into 2021.

"Following the closing of our successful IPO at the beginning of April, we have continued to leverage the unique capabilities of our proprietary ARCUS genome editing platform for therapeutic and human health applications. We achieved a significant milestone in our mission to deliver transformative, off-the-shelf CAR T cell therapies to cancer patients by dosing the first subjects with our lead allogeneic product candidate, PBCAR0191. Our portfolio of in vivo gene correction candidates continues to progress towards the clinic, and we are excited by the ongoing momentum at Elo Life Systems," commented Matt Kane, Chief Executive Officer and Co-Founder of Precision. "In the second quarter of 2019, we also successfully expanded our senior leadership team and are pleased to welcome Christopher Heery, MD, as Precision’s first Chief Medical Officer, and Dario Scimeca as General Counsel. In addition, we expect that our newly opened, in-house CAR T cell manufacturing facility, which we believe to be the first of its kind in the United States, will be able to support multiple simultaneous clinical trials and, in time, the commercialization of our product candidates, if approved. Our focus on manufacturing continues to demonstrate our commitment to rapidly deliver our advanced therapeutic candidates to patients in need."

Other Highlights and Upcoming Milestones

Program updates

On April 15, 2019, Precision initiated dosing of its first allogeneic CAR T cell therapy candidate, PBCAR0191, in a Phase 1/2a clinical trial. PBCAR0191 is being developed in collaboration with Servier, an international pharmaceutical company. Made from donor-derived T cells modified using Precision’s ARCUS genome editing technology, PBCAR0191 recognizes the tumor cell surface protein CD19, an important and validated target in several B-cell cancers, and is designed to avoid graft-versus-host disease, a significant complication associated with donor-derived, cell-based therapies. Precision believes this to be the first US-based clinical trial to evaluate an allogeneic CAR T therapy for R/R NHL. The trial is designed to assess safety and tolerability of PBCAR0191 at increasing dose levels, with secondary objectives including evaluation of anti-tumor activity. Dosing of subjects continues to progress as planned. Precision expects to present interim data from this trial at a scientific conference no later than the first quarter of 2020.

Precision’s second allogeneic CAR T cell therapy product candidate, PBCAR20A, is expected to enter a Phase 1/2a clinical trial in the fourth quarter of 2019. PBCAR20A is wholly owned by Precision and targets the validated tumor cell surface target CD20. It will be investigated in subjects with two subtypes of NHL, chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

At the ASGCT (Free ASGCT Whitepaper) Annual Meeting held in Washington, DC from April 29 to May 2, 2019, Precision presented several updates on its in vivo gene editing programs. During the meeting, Precision’s scientists and collaborators shared updates on four pre-clinical programs: hepatitis B (HBV, being developed in partnership with Gilead), autosomal dominant retinitis pigmentosa (adRP), primary hyperoxaluria (PH1), and familial amyloid polyneuropathy (FAP). Discussions with the US Food and Drug Administration (FDA) for the HBV program are planned for the second half of 2019.

Senior management additions

On May 14, 2019, Precision announced the first of two significant hires in the second quarter with Christopher R. Heery, MD, joining as the Company’s first Chief Medical Officer (CMO). Dr. Heery has strong experience managing translational clinical programs, having served as head of the Clinical Trials Group of the Laboratory of Tumor Immunology and Biology at the National Cancer Institute where he was the lead associate investigator of the Phase 1 study of the anti-PD1 immunotherapy avelumab. He also served as CMO at Bavarian Nordic and is board certified in both medical oncology and internal medicine.

On June 12, 2019, Precision announced the appointment of Dario Scimeca as General Counsel. Mr. Scimeca joined Precision from Genentech where he supported the development and commercialization of multiple drug products including Rituxan, Tecentriq, Gazyva, Venclexta and Hemlibra as associate general counsel. A graduate of UC Berkeley Law School, in his previous roles Mr. Scimeca has overseen US FDA and European Medicines Agency regulatory matters, managed securities and intellectual property litigation, and been responsible for commercial contracts and compliance matters.

Manufacturing Center for Advanced Therapeutics

On July 18, 2019, Precision announced the opening of its in-house cGMP compliant manufacturing facility, located in Research Triangle Park, North Carolina, which the Company believes to be the first in the United States dedicated to genome-edited, off- the-shelf CAR T cell therapy product candidates. The Manufacturing Center for Advanced Therapeutics (MCAT) is designed to enable in-house production of three different drug substances: allogeneic CAR T cells, messenger RNA (including formulations development) and adeno-associated viral vectors. Precision intends to use this new manufacturing center to create clinical trial material for its planned Phase 1/2 clinical trials starting in 2020. In the longer term, Precision believes MCAT has the potential to be a commercial launch facility with the capacity to generate up to 10,000 allogeneic doses of CAR T cell therapies and 4,000 doses of gene therapies per year.

Elo Life Systems

Also in July 2019, the Company’s wholly owned subsidiary, Elo Life Systems, which is dedicated to creating novel products that enhance the nutrition and diversity of the global food supply, announced that Mario Pennisi, Resident Director of Elo Life Systems – Australia was awarded the prestigious BIO Leadership and Legacy Award in Industrial Biotech and Agriculture. The award is presented to individuals who have shown exemplary leadership and dedicated a significant portion of their career to advancing industrial biotechnology and growing the bio-based economy. This award further demonstrates the depth of talent at Precision, and the pioneering work ongoing at Elo Life Systems.

Upcoming Corporate Presentations

Precision’s senior management team will be presenting and meeting with investors at the following upcoming conferences:

Baird Global Healthcare Conference, New York, NY, Sept. 4 – 5, 2019

Presentation and panel discussion at The Alliance for Regenerative Medicine’s Cell and Gene Meeting on the Mesa, Carlsbad, CA, Oct. 2 – 4, 2019

Chardan Genetic Medicines Conference, New York, NY, Oct. 7 – 8, 2019

Jefferies Gene Therapy Summit Presentation, New York, NY, Oct. 9, 2019

Stifel 2019 Healthcare Conference, New York, NY, Nov. 19 – 20, 2019

Jefferies London Healthcare Conference, London, UK, Nov. 20 – 21, 2019

Piper Jaffray Annual Health Care Conference, New York, NY, Dec. 3 – 5, 2019

Second Quarter 2019 Financial Results

Cash and Cash Equivalents: As of June 30, 2019, Precision had approximately $226.1 million in cash and cash equivalents. We expect that existing cash and cash equivalents will be sufficient to fund operating expenses and capital expenditure requirements into 2021.

Revenues: Total revenues for the quarter ended June 30, 2019 were $5.4 million, compared to $1.9 million for the quarter ended June 30, 2018. This increase was primarily due to research funding from our joint development collaboration partners.

Research and Development Expenses: Research and development expenses were $22.8 million for the quarter ended June 30, 2019, as compared to $10.9 million for the same period in 2018. This increase of $11.9 million was primarily due to increases in platform development and early-stage research expenses due to contract manufacturing costs and an increase in personnel costs and expenses to support our technology platform development and manufacturing capabilities, partially offset by a decrease in direct research and development expenses related to our CD19 program.

General and Administrative Expenses: General and administrative expenses were $6.5 million for the quarter ended June 30, 2019, as compared to $3.1 million for the same period in 2018. The increase of $3.4 million was primarily due to employee-related costs for our additional personnel and facility costs associated with our growing infrastructure needs.

Net Loss: Net loss was $19.4 million, or $(0.39) per share, for the quarter ended June 30, 2019, compared to a net loss of $11.8 million, or $(0.75) per share, for the same period in 2018.

https://www.sec.gov/Archives/edgar/data/1498382/000121390019015648/f8k081419_delmarpharma.htm

On August 14, 2019, DelMar Pharmaceuticals, Inc. (the "Company") reported that it has entered into an underwriting agreement (the "Underwriting Agreement") with Maxim Group LLC and Dawson James Securities, Inc. (the "Representatives"), as representatives of the several underwriters named therein, relating to the sale of 6,750,000 shares of its common stock, par value $0.001 per share (the "Common Stock") (or pre-funded warrants to purchase Common Stock in lieu thereof) and common warrants to purchase up to an aggregate of 6,750,000 shares of Common Stock (the "Offering") (Filing, 8-K, DelMar Pharmaceuticals, AUG 14, 2019, View Source [SID1234538810]). Each share of Common Stock or pre-funded warrant, as applicable, was sold together with a common warrant to purchase one share of Common Stock at a combined effective price to the public of $1.00 per share and accompanying common warrant. The Offering is expected to close on or about August 16, 2019.

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The Company expects the net proceeds from the Offering will be approximately $6.0 million after deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the Offering for its clinical trials and for general corporate purposes, which may include working capital, capital expenditures, research and development and other commercial expenditures. In addition, the Company may use the net proceeds from the Offering for investments in businesses, products or technologies that are complementary to its business.

The common warrants are exercisable immediately at an exercise price of $1.00 per share and will expire five years from the date of issuance. The pre-funded warrants are exercisable immediately at an exercise price of $0.01 per share and will remain outstanding until they are exercised in full. The exercise price and number of shares of Common Stock issuable upon exercise of the common warrants and pre-funded warrants will be subject to adjustment in the event of any stock split, reverse stock split, stock dividend, recapitalization, reorganization or similar transaction, among other events as described in the common warrants and pre-funded warrants. The shares of Common Stock or pre-funded warrants, as applicable, and the accompanying common warrants can only be purchased together in this Offering but will be issued separately.

The Company has granted the underwriters a 45-day option, ending September 28, 2019, to purchase up to an additional 1,012,500 shares of Common Stock and/or common warrants to purchase up to 1,012,500 shares of Common Stock, at the public offering price less discounts and commissions.

Maxim Group LLC is acting as the book-running manager and Dawson James Securities, Inc. is acting as a co-manager in connection with the Offering, which was a firm commitment underwritten public offering pursuant to a registration statement on Form S-1 (Registration No. 333-232931) that was declared effective by the Securities and Exchange Commission (the "SEC") on August 14, 2019. The Offering was made only by means of a prospectus forming a part of the effective registration statement. The Company will pay the underwriters a commission equal to 8.0% of the gross proceeds of the Offering and other expenses. As additional compensation, the Company will issue warrants to the Representatives to purchase a number of shares equal to five percent (5%) of the total number of shares of Common Stock sold in the Offering (the "Underwriter Warrants"). The Underwriter Warrants will have an exercise price of $1.15 per share, will be exercisable for three years from the date of the Underwriting Agreement and may be exercised on a cashless basis in certain circumstances specified therein.

The Underwriting Agreement contains customary representations, warranties, and agreements by the Company, and customary conditions to closing, indemnification obligations of the Company and the underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties, and termination provisions. Pursuant to the Underwriting Agreement, the Company agreed, subject to certain exceptions, not to offer, issue or sell any shares of Common Stock or securities convertible into or exercisable or exchangeable for shares of Common Stock for a period of ninety (90) days following the Offering without the prior written consent of the Representatives.

In connection with the Offering, on August 14, 2019, certain purchasers entered into leak-out agreements with the Company (each a "Leak-Out Agreement" and collectively, the "Leak-Out Agreements"). Pursuant to the Leak-Out Agreements, for a period beginning on the date of the Underwriting Agreement and ending on September 24, 2019 (the "Leak-Out Period"), if any of the purchasers that are signatory to the Leak-Out Agreements decide to sell any securities during the Leak-Out Period, they will only be permitted to sell securities in such amount as shall equal up to 35% in the aggregate of the average daily volume of the Common Stock on any given trading day, as reported by Bloomberg, LP. However, the foregoing restriction shall not apply to (a) any sales of the common warrants sold in the Offering or (b) any actual "long" (as defined in Regulation SHO of the Securities Exchange Act of 1934, as amended) sales of Common Stock by the purchaser or any of the purchaser’s affiliates at a price per share greater than $2.25 (in each case, as adjusted for stock splits, stock dividends, stock combinations, recapitalizations or other similar events occurring after the pricing date).

On August 14, 2019, the Company also entered into a Warrant Agency Agreement (the "Warrant Agency Agreement") with Mountain Share Transfer, LLC (the "Transfer Agent") pursuant to which the Transfer Agent agreed to act as transfer agent with respect to the common warrants.

The foregoing descriptions of the Underwriting Agreement, the Warrant Agency Agreement, the Underwriter Warrants, the common warrants and the pre-funded warrants are not complete and are qualified in their entirety by reference to the full text of the Underwriting Agreement, the Warrant Agency Agreement and the forms of the Underwriter Warrant, common warrant and pre-funded warrant, copies of which will be filed as exhibits to an amendment to this Current Report on Form 8-K.

NeuBase Therapeutics Reports Financial Results for the Fiscal Third Quarter of 2019

On August 14, 2019 NeuBase Therapeutics, Inc. (NASDAQ: NBSE) ("NeuBase" or the "Company"), a biotechnology company developing next-generation antisense therapies to address genetic diseases, reported financial results for the three and nine month periods ended June 30, 2019, which only include the financial results for Ohr Pharmaceutical prior to the merger and associated financings (Press release, Ohr Pharmaceutical, AUG 14, 2019, View Source [SID1234538799]).

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"Over the past several months, we have positioned the Company with the capital and industry expertise required to advance our strategy to develop antisense oligonucleotide therapeutics by leveraging our PATrOL platform," said Dietrich Stephan, Ph.D., chairman and chief executive officer of NeuBase. "Looking ahead, we are developing next-generation antisense oligonucleotide therapeutics for rare genetic diseases with a goal of transforming patients’ lives. We are currently advancing several preclinical programs, including NT0100 to target Huntington’s Disease and NT0200 to target myotonic dystrophy."

Fiscal Third Quarter of 2019 and Recent Operating Highlights

●Shares of the Company’s common stock commenced trading on the Nasdaq Capital Market under the ticker symbol "NBSE" as of market open on July 15, 2019.
●Completed two financings raising an aggregate of approximately $14 million in gross proceeds, which occurred alongside the Nasdaq listing and included a $5 million investment from Greenlight Capital.
●Appointed four experienced executives from the biotechnology industry to the board of directors: Dr. Dov Goldstein, Dr. Diego Miralles, Dr. Franklyn Prendergast, and Eric Richman.
●Appointed Dr. Danith Ly, the primary inventor of NeuBase’s peptide nucleic acid (PNA) antisense oligonucleotide (PATrOL) platform technology, as the Company’s chief scientific officer.
●Expanded the scientific advisory board with the appointments of Dr. Samuel Broder (former National Cancer Institute Director) and Dr. George Church (Harvard Medical School professor).

Financial Results for the Three Months Ended June 30, 2019:

●For the three months ended June 30, 2019, the Company reported a net loss of approximately $1.1 million, or ($0.40) per share, compared to a net loss of approximately $0.5 million, or ($0.19) per share, in the three months ended June 30, 2018. Loss per share amounts have been retroactively adjusted for the reverse stock split effected on February 4, 2019.
●For the three months ended June 30, 2019, total operating expenses were approximately $1.1 million, consisting of approximately $0.9 million in general and administrative expenses, $0.1 million of research and development expenses, and $0.2 million in depreciation and amortization. This compares to total operating expenses of $1.2 million in the three months ended June 30, 2018, comprised of approximately $0.8 million in general and administrative expenses, $0.1 million in research and development expenses, and $0.3 million in depreciation and amortization.
●At June 30, 2019, the Company had cash and cash equivalents of approximately $1.4 million, compared to cash and equivalents of approximately $3.8 million at September 30, 2018. Subsequent to the end of the quarter, NeuBase completed two financings alongside the closing of the merger in July 2019, raising gross proceeds of approximately $14 million. The Company believes that its current cash balance will provide sufficient capital to fund operations through the end of fiscal 2020.

Financial Results for the Nine Months Ended June 30, 2019:

●For the nine months ended June 30, 2019, the Company reported a net loss of approximately $3.2 million, or ($1.12) per share, compared to a net loss of approximately $6.9 million, or ($3.36) per share, in the same period of 2018. Loss per share amounts have been retroactively adjusted for the reverse stock split effected on February 4, 2019.
●For the nine months ended June 30, 2019, total operating expenses were approximately $3.2 million, consisting of approximately $2.5 million in general and administrative expenses, $0.2 million of research and development expenses, and $0.5 million in depreciation and amortization. This compares to total operating expenses of approximately $7.5 million in the same period of 2018, consisting of approximately $2.9 million in general and administrative expenses, $4.2 million of research and development expenses, $0.8 million in depreciation and amortization, $0.7 million in impairment of goodwill, and $1.2 million in gain on settlement of accounts payable and long term liabilities.

Y-mAbs Announces Second Quarter 2019 Financial Results and Recent Corporate Developments

On August 14, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported financial results for the second quarter of 2019 (Press release, Y-mAbs Therapeutics, AUG 14, 2019, View Source [SID1234538780]).

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"We are very pleased with our second quarter results, highlighted by prudent spending combined with notable progress in the preparation of the initial portions of our rolling BLAs for our two lead product candidates, naxitamab and omburtamab, for submission to the FDA later this year. We continue to solidify our position as a leader in pediatric oncology and as a company focused on rapidly developing therapies to extend and enhance the lives of those living with rare pediatric cancers," stated Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.

Dr. Claus Moller, Chief Executive Officer, continued, "We believe our recent pre-BLA meeting with the FDA supports our ambition of initiating submission of a rolling BLA for naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma in the fourth quarter of 2019, with the expectation that the final portion will be submitted in early 2020. We are also excited to initiate the submission of a rolling BLA for omburtamab for the treatment of central nervous system/leptomeningeal metastasis from neuroblastoma by the end of 2019, and expect to submit the two rolling BLAs almost concurrently. These are exciting times for Y-mAbs."

Second Quarter 2019 and Recent Corporate Developments

Subsequent to the end of the second quarter, on July 8, 2019, Y-mAbs announced that it has completed a successful pre-BLA meeting with the FDA regarding a potential pathway for FDA approval of naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma. During the meeting, the Company reached alignment with the FDA on an Accelerated Approval Pathway for naxitamab along with a rolling BLA submission. The Company expects to submit the Clinical/Safety portion and the non-Clinical portion of the BLA in November 2019. For the Chemistry, Manufacturing and Controls (CMC) portion, the Company believes it will have sufficient data from the Process Performance Qualification (PPQ) batches to complete the CMC portion in early 2020. Y-mAbs continues to evaluate potential avenues to accelerate the submission of the CMC portion, and hopes to comply with FDA requirements at an earlier time.

Also subsequent to the end of the second quarter, on July 1, 2019, Y-mAbs announced the status of patient recruitment for the Company’s two pivotal phase II trials, one for omburtamab for the treatment of central nervous system/leptomeningeal metastasis (CNS/LM) from neuroblastoma and the other for naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma. As of June 30, 2019, all of the 18 planned omburtamab patients had been enrolled in the study. The Company believes it remains on track to start submission of a rolling BLA in 2019 under the Breakthrough Therapy Designation that the Company previously received from the FDA. For naxitamab, more than 30 patients of a planned total of 37 patients in the Company’s Study 201 had been enrolled in the study as of June 30, 2019.

After the close of the second quarter, on July 1, 2019, Y-mAbs announced that the Company has entered into a development, manufacturing and supply agreement with SpectronRx in South Bend, Indiana, to secure access to clinical and commercial scale radiolabeling capacity for omburtamab. Under the terms of the agreement, SpectronRx has agreed to establish a manufacturing unit designated for Y-mAbs within its existing facilities, at which Y-mAbs believes both clinical and commercial supply of radiolabeled omburtamab can be produced.

On June 26, 2019, Y-mAbs announced the acceptance of two oral presentations and five poster presentations at the International Society of Pediatric Oncology (SIOP) Annual Congress for its two lead product candidates, naxitamab and omburtamab.

On May 15, 2019, Y-mAbs announced the acceptance of three poster presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting for its two lead product candidates, naxitamab and omburtamab.

On May 14, 2019, Y-mAbs announced an update on its GD2-GD3 Vaccine program for relapsed high-risk neuroblastoma. A total of 230 patients have received the GD2-GD3 Vaccine to date and Y-mAbs plans to begin using a newly manufactured Current Good Manufacturing Practice (cGMP) drug product in the fourth quarter of 2019.
Second Quarter 2019 Financial Results

Y-mAbs reported a net loss of $18.0 million, or $0.53 per basic and diluted share, for the three months ended June 30, 2019, compared to a net loss of $10.3 million, or $0.39 per basic and diluted share, for the three months ended June 30, 2018.

For the six months ended June 30, 2019, Y-mAbs reported a net loss of $34.0 million, or $0.99 per basic and diluted share, compared to a net loss of $17.8 million, or $0.66 per basic and diluted share, reported for the six months ended June 30, 2018.

Operating Expenses

Research and Development
Research and development expenses were $14.5 million for the three months ended June 30, 2019, compared to $8.3 million for the three months ended June 30, 2018, an increase of $6.2 million. The increase in research and development expenses primarily reflects the following:

$2.9 million increase in outsourced manufacturing for our two lead product candidates, naxitamab and omburtamab;
$2.2 million increase in outsourced research and supplies to support expanding development activities; and
$0.7 million increase in personnel costs.
Research and development expenses were $27.0 million for the six months ended June 30, 2019, compared to $14.5 million for the six months ended June 30, 2018, an increase of $12.5 million. The increase in research and development expenses primarily reflects the following:

$7.2 million increase in outsourced manufacturing for our two lead product candidates, naxitamab and omburtamab;
$3.5 million increase in outsourced research and supplies to support expanding development activities; and
$1.4 million increase in personnel costs.
General and Administration
General and administrative expenses were $4.1 million for the three months ended June 30, 2019, compared to $2.0 million for the three months ended June 30, 2018, an increase of $2.1 million. Such increase in general and administrative expenses primarily reflects the following:

$1.4 million increase in personnel costs; and
$0.5 million increase in commercial infrastructure.
General and administrative expenses were $7.9 million for the six months ended June 30, 2019, compared to $3.2 million for the six months ended June 30, 2018, an increase of $4.7 million. Such increase in general and administrative expenses primarily reflects the following:

$2.8 million increase in personnel costs; and
$0.8 million increase in commercial infrastructure costs.
Cash and Cash Equivalents
The Company had approximately $120.2 million in cash and cash equivalents as of June 30, 2019, compared to $147.8 million as of December 31, 2018. The decrease of $27.6 million was primarily attributable to the increased costs of operation as the Company prepares for its submission of rolling BLAs for naxitamab and omburtamab and the build-up of the Company’s commercial infrastructure.

Webcast and Conference Call

The Company will host a conference call today at 4:30 pm Eastern Time. To participate in the call, please dial (877) 407-0792 (domestic) or (201) 689-8263 (international) and reference the access code 13693605. A webcast will be available at: View Source

Oncolytics Biotech® Announces Pricing of Its USD $3.7M – CDN $4.9M Public Offering of Common Share and Warrants

ON August 14, 2019 Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) (the "Company"), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported an update to confirm that its previously announced underwritten public offering of USD $3.7M (CDN $4.9M) was priced at USD $0.81 (CDN $1.07) (Press release, Oncolytics Biotech, AUG 14, 2019, View Source [SID1234538779]).

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All other details of the previous release are correct and copied below:

Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) (the "Company"), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported the pricing of its previously announced underwritten public offering (the "Offering") of 4,619,773 common shares and warrants to purchase up to 4,619,773 common shares at a combined public offering price of $0.81 per share and warrant, resulting in gross proceeds of approximately USD 3.7M. Each warrant has an exercise price of $0.90 per common share, is exercisable immediately and will expire 5 years from the date of issuance. The common shares and the accompanying warrants can only be purchased together in this Offering but will be issued separately.

The Offering is expected to close on or about August 16, 2019, subject to the satisfaction of customary closing conditions. Oncolytics has also granted to the underwriter a 30-day option to purchase up to an additional 692,965 common shares and/or warrants to purchase up to 692,965 common shares, at the public offering price per common share and warrant, less underwriter discounts and commissions. The Offering is subject to customary closing conditions, including Nasdaq and TSX approvals.

The Company intends to use the net proceeds of this Offering for research and development activities and working capital purposes.

Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (LTS), is acting as the sole book-running manager in connection with the Offering.

The Offering is being made pursuant to a U.S. registration statement on Form F-10, declared effective by the United States Securities and Exchange Commission (the "SEC") on May 7, 2018 (the "Registration Statement"), and the Company’s existing Canadian short form base shelf prospectus (the "Base Shelf Prospectus") dated May 4, 2018. The prospectus supplements relating to the Offering (together with the Base Shelf Prospectus and the Registration Statement, the "Offering Documents") have been filed with the Alberta Securities Commission in Canada, and with the SEC in the United States. No common shares or warrants will be offered or sold to Canadian purchasers. The Offering Documents will contain important detailed information about the securities being offered. Before you invest, you should read the Offering Documents and the other documents the Company has filed with the SEC for more complete information about the Company and the Offering. Copies of the Offering Documents will be available for free by visiting the Company’s profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC’s website at www.sec.gov. Alternatively, when available, copies of the final prospectus supplement can also be obtained from Ladenburg Thalmann & Co. Inc., Attn: Prospectus Department, 277 Park Avenue, 26th Floor, New York, New York 10172 or by email at [email protected].

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