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Oncolytics Biotech® Reports 2019 Third Quarter Financial Results and Operational Highlights

On November 12, 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 ended September 30, 2019 (Press release, Oncolytics Biotech, NOV 12, 2019, View Source [SID1234551161]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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"We finished the third quarter with a little over twelve million dollars on the balance sheet and have since added to that balance with warrants exercised since the quarter’s end" said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "The quarter was marked by continued clinical execution and additional clinical validation of our systemically delivered oncolytic virus, as we continued to advance two key clinical studies that will determine the design of the phase three program for pelareorep in metastatic breast cancer. First is the AWARE-1 study, which is enrolling patients and will report additional data before year end, and second is the BRACELET-1 study, which we are co-developing with Pfizer and Merck KGaA, and will begin enrolling in Q1 2020. Both studies are designed to evaluate pelareorep in combination with leading checkpoint inhibitors and confirm the clinical utility of our novel biomarker measuring T cell clonality to predict patient response to the combination regimen."

"In parallel, pelareorep continues to gain validation and recognition among the medical community," said Dr. Rita Laeufle, Chief Medical Officer at Oncolytics. "We announced that a meta-analysis of thirteen clinical studies of pelareorep was presented, providing definitive proof that our virus can selectively infiltrate, replicate within, and inflame a diverse range of solid and hematological tumors, including metastatic disease, following systemic delivery. This is a key differentiator for pelareorep and speaks to the breadth of commercial opportunities that may be available to Oncolytics beyond our lead indication of breast cancer. Other opportunities include additional synergies, such as the recent data from preclinical combinations with CDK 4/6 inhibitors that was presented at the International Oncolytics Virus Conference in October. The preliminary data suggests that pelareorep synergizes with CDK4/6 inhibitors by blocking cellular signaling pathways triggering a process called immunogenic cell death, resulting in another very effective way to make a cold tumor very hot. These are early results, but this drug class is important enough that these advancements can definitely play a role in our business development activities."

Select highlights since July 1, 2019

Clinical & Scientific Updates

Announced preliminary AWARE-1 data demonstrating viral replication and promotion of inflammation following systemic administration of pelareorep when combined with Tecentriq.
Presented AWARE-1 data at the Society of Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) conference highlighting the replication of pelareorep exclusively in tumor tissue and an increase in inflammatory cells through the expansion of existing T cell clones, as well as the creation of new T cell clones. Data also demonstrated that pelareorep changes the immunogenetic environment within the tumor, and the results of this early stage breast cancer study support the use of T cell clonality as a biomarker and its potential value in predicting tumor response in BRACELET-1.
Presented the results of a meta-analysis of 13 clinical studies of pelareorep during a podium presentation at the annual International Oncolytic Virus Conference (IOVC). The analyses examined the effectiveness of viral replication within the tumors of patients treated systemically with pelareorep and demonstrated that, unlike other oncolytic viruses that require intra-tumoral delivery, intravenous systemic delivery of pelareorep resulted in 81% of patient tumor samples across multiple types of cancer testing positive for virus replication, with no infection in normal tissue. These results are from studies across a broad range of solid and liquid tumors, including metastatic disease, and the average increases to 96% when melanoma skin biopsies are excluded.
Provided an update on Adlai Nortye’s clinical progress and approval by the National Medical Products Administration (NMPA) of China for initiating a phase 3 clinical trial for pelareorep. The proposed study, initially based on positive results from the randomized phase 2 metastatic breast cancer study IND-213, will be finalized based on data from Oncolytics’ AWARE-1 breast cancer study in combination with Roche’s Tecentriq and BRACELET-1 metastatic breast cancer study in combination with Pfizer’s and Merck KGaA’s Bavencio.
Announced the publication of positive results from its previously announced phase 1b REO 024 study of pelareorep in combination with Merck’s Keytruda in the peer-reviewed medical journal Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). Academic collaborators presented preclinical data at IOVC on the synergies between pelareorep and CDK 4/6 inhibitors, suggesting pelareorep synergizes with CDK4/6 inhibitors by blocking cellular signaling pathways and releasing more double-stranded RNA into the tumor cell, triggering immunogenic cell death, resulting in another effective way to make a cold tumor very hot.
Corporate Updates

Announced the appointment of Leonard Kruimer, MBA, CPA, to Oncolytics’ Board of Directors.
Announced that President and Chief Executive Officer, Matt Coffey, Ph.D., MBA, was presented with the Scientific Achievement and Innovation Award by BioAlberta, the province’s life sciences industry association.
Closed an underwritten public share offering of USD $3.7 million.
Near-term Anticipated Milestones

Interim data from AWARE-1 breast cancer study – Q4 2019.
Complete enrollment in AWARE-1 breast cancer study – Q1 2020.
Initiate phase 2 study BRACELET-1 study in HR+ / HER2- mBC – Q1 2020.
Final data from AWARE-1 breast cancer study – Q2 2020.
Financial

At September 30, 2019, the company reported $12.3 million in cash and cash equivalents.
As at November 8, 2019, the company had an unlimited number of authorized common shares with 26,357,724 common shares issued and outstanding, 16,443,500 warrants exercisable into 1,730,894 common shares with a $9.025 strike price, 3,567,989 warrants with a US$0.90 strike price, and 1,577,230 options and share units.
Operating expense for the third quarter of 2019 was $1.8 million compared to $1.5 million in the third quarter 2018.
Research and development expense for the third quarter of 2019 was $1.6 million compared to $1.9 million in the third quarter 2018.
The net loss for the third quarter of 2019 was $3.5 million compared to $3.3 million in the third quarter 2018, which equates to a net loss of $0.16 per share in 2019 compared to a net loss of $0.20 per share in 2018.
Webcast and Conference Call

Management will host a conference call for Analysts and Institutional Investors at 5:00 pm ET, today, Tuesday, November 12, 2019. The live call may be accessed by dialing 844-407-9500 or callers in North America. Overseas callers should contact investor relations for the toll-free dial information for their country. A replay of this call will be available approximately two hours after the call is ended at (877)-481-4010, using the replay code 56787 and will be available for one week.

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.

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.

Reata Pharmaceuticals, Inc. Announces Proposed Public Offering of Class A Common Stock

On November 12, 2019 Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata" or the "Company"), a clinical-stage biopharmaceutical company, reported its intention to offer and sell 2,000,000 shares of its Class A common stock in an underwritten public offering pursuant to an existing shelf registration statement (Press release, Reata Pharmaceuticals, NOV 12, 2019, View Source [SID1234551160]). The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.

Citigroup, Jefferies, SVB Leerink and Stifel are acting as the joint book-running managers for the offering. Reata intends to grant the underwriters a 30-day option to purchase up to 300,000 additional shares of its Class A common stock, on the same terms and conditions as the shares offered in the public offering.

Reata intends to use the net proceeds from the offering for working capital and general corporate purposes, which include, but are not limited to, advancing the development of bardoxolone methyl and omaveloxolone through clinical trials, preparing to file New Drug Applications for bardoxolone for the treatment of patients with Alport syndrome and omaveloxolone for the treatment of patients with Friedreich’s ataxia, planning for commercialization of its potential products, and making payments due under its agreement with AbbVie Inc.

The securities described above are being offered pursuant to an effective shelf registration statement on Form S-3. The offering may be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering has been filed with the Securities and Exchange Commission (the "SEC") and is available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained by request at Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 (Tel: 800-831-9146); at Jefferies, Attention: Equity Syndicate Prospectus Departments, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by phone at (877) 821-7388, or by email at [email protected]; at SVB Leerink, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6132, or by email at [email protected]; or Stifel, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, or by telephone at (415) 364-2720, or by email at [email protected].

This news release is for informational purposes only and shall not constitute an offer to sell or the 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 of these securities would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

argenx announces closing of global offering

On November 12, 2019 argenx (Euronext & Nasdaq: ARGX) a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported the closing of its global offering of an aggregate of 4,600,000 ordinary shares (including in the form of American Depositary Shares (ADSs)), which includes the full exercise of the underwriters’ option to purchase 600,000 additional ADSs (Press release, argenx, NOV 12, 2019, View Source [SID1234551159]). The global offering consisted of (i) a public offering of 2,010,057 ADSs in the United States and certain other countries outside the European Economic Area (EEA) at a price to the public of $121.00 and (ii) a concurrent private placement of 2,589,943 of ordinary shares in the EEA at an offering price of €109.18. The gross proceeds from the global offering were approximately $557 million (approximately €502 million).

Morgan Stanley, Cowen, BofA Securities and Evercore acted as joint bookrunning managers for the offering. Kempen acted as lead manager for the offering and Wolfe Capital Markets and Advisory acted as co-manager.

The securities were offered pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC). A preliminary prospectus supplement relating to the securities was filed with the SEC on November 6, 2019 and a final prospectus supplement relating to the securities was filed with the SEC on November 8, 2019 and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the global offering may be obtained for free from Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, New York 10014, United States, Attention: Prospectus Department; from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected], or by telephone at (833) 297-2926; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, North Carolina 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, or by telephone at (888) 474-0200.

In addition, argenx announced today the listing of and the commencement of dealings in its 4,600,000 new ordinary shares (including those underlying the ADSs) on the regulated market of Euronext Brussels, effective today, November 12, 2019.

This press release is for information purposes only and does not constitute, and should not be construed as, an offer to sell or the solicitation of an offer to buy or subscribe to any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale is not permitted or to any person or entity to whom it is unlawful to make such offer, solicitation or sale. Reference is also made to the restrictions set out in "Important information" below. This press release is not for publication or distribution, directly or indirectly, in or into any state or jurisdiction into which doing so would be unlawful or where a prior registration or approval is required for such purpose.

TCR2 Therapeutics Reports Third Quarter 2019 Financial Results and Provides Corporate Update

On November 12, 2019 TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage immunotherapy company developing the next generation of novel T cell therapies for patients suffering from cancer, reported financial results for the third quarter ended September 30, 2019 and provided a corporate update (Press release, TCR2 Therapeutics, NOV 12, 2019, View Source [SID1234551113]).

"We continued to make clinical progress in the third quarter of 2019 and are positioned to deliver data for our two lead programs next year with interim updates anticipated from the ongoing Phase 1 portion of the TC-210 trial and the upcoming Phase 1 portion of the TC-110 trial," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "2020 represents an important period for the Company in establishing TRuC-T Cells as a viable therapeutic option for cancer patients. We look forward to providing updates not only on TC-210 and TC-110 but also on additional targets and enhancements designed to combat the harsh tumor microenvironment."

Recent Developments

TCR2 expanded the executive team with the appointment of Angela Justice, Ph.D., as its first Chief People Officer. In her new role, Dr. Justice will be responsible for leading all aspects of TCR2’s human resources function including further development of the Company’s commitment to a performance-driven culture of innovation and Human Capital strategy.

Anticipated Milestones

TCR2 anticipates an interim update of the Phase 1 portion of the TC-210 Phase 1/2 clinical trial for patients with mesothelin-expressing solid tumors in 1H20.

TCR2 anticipates an interim update of the upcoming Phase 1 portion of the TC-110 Phase 1/2 clinical trial for patients with CD19+ non-Hodgkin lymphoma or adult acute lymphoblastic leukemia in 2H20.

TCR2 remains on track to be operational at its manufacturing facility in Stevenage, UK, by year end.

Financial Highlights

Cash Position: TCR2 ended the third quarter of 2019 with $169.0 million in cash, cash equivalents, and investments compared to $123.2 million as of December 31, 2018. Net cash used in operations was $31.0 million in the first nine months of 2019 compared to $12.3 million in the first nine months of 2018. TCR2 projects net cash use of $45-50 million in 2019.

R&D Expenses: Research and development expenses were $11.4 million for the third quarter of 2019 compared to $5.4 million for the third quarter of 2018. The increase in R&D expenses is primarily related to increase in headcount, activities related to the Phase 1/2 clinical trial of the Company’s lead solid tumor product candidate, TC-210, and activities related to the IND submission of the Company’s lead hematologic cancer product candidate, TC-110.

G&A Expenses: General and administrative expenses were $3.5 million for the third quarter of 2019 compared to $1.7 million for the third quarter of 2018. The increase in general and administrative expenses was primarily due to an increase in personnel costs and costs associated with operations as a public company.

Net loss: Net loss was $13.8 million for the third quarter of 2019 compared to $6.4 million for the third quarter of 2018, driven predominantly by increased R&D expense in the quarter.

Upcoming Events

TCR2 Therapeutics management are scheduled to participate at the following upcoming conferences.

Jefferies 2019 London Healthcare Conference: Garry E. Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics, will present on Wednesday, November 20, 2019 at 11:20AM GMT in London, UK.

The 31st Annual Piper Jaffray Healthcare Conference: M. Ian Somaiya, Chief Financial Officer of TCR2 Therapeutics, will present on Wednesday, December 4, 2019 at 9:30AM ET in New York, NY.

Galectin Therapeutics Reports Q3 2019 Financial Results Provides Update on NASH-RX Trial Plan

On November 12, 2019 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results and provided a business update for the three months ended September 30, 2019 (Press release, Galectin Therapeutics, NOV 12, 2019, View Source [SID1234551112]). These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

Harold H. Shlevin, Ph.D., President and Chief Executive Officer of Galectin Therapeutics, said, "Our team continues to vigorously pursue the implementation of additional trials of our proprietary compound, belapectin (GR-MD-02), including constructive, ongoing dialogue with the Food and Drug Administration (FDA). Representative of our most recent progress, Covance, our clinical research organization, has identified over 125 clinical trial sites in 11 countries interested in the trial, many of which have been qualified by pre-study visits. It is an exciting time at Galectin. We are well-prepared to advance the investigation of this valuable compound, which is the first drug to show positive results in a clinical trial in patients with compensated NASH cirrhosis without esophageal varices."

Richard E. Uihlein, Chairman of the Board, added, "The growing, global incidence of NASH has raised the stakes in finding effective means to treat this debilitating disease. With our valuable science, which has shown positive results in a clinical trial in patients with compensated NASH cirrhosis without esophageal varices, and our world-class scientific team, we have the extensive and experienced resources needed to help develop therapies that have the potential to save lives."

NASH-RX Trial Update

The NASH-RX Trial was initially designed as a Phase 3 trial of GR-MD-02 in NASH cirrhosis patients based on United States Food and Drug Administration (FDA) feedback from a February 2019 meeting between the Company and the FDA. The trial design is being refined as a result of further input received from the FDA in late October 2019 and ongoing input from the FDA.

The late October 2019 FDA comments are being evaluated by the Company in conjunction with its external hepatology experts and medical and other experts at Covance. In its comments, the FDA seemingly is departing from its earlier implied potential support of the use of progression to varices as a surrogate endpoint for accelerated approval. A follow up call with the FDA is scheduled for later in November to clarify aspects of its communication. The FDA also made additional constructive comments and suggestions mostly of an operational nature. Based on updated feedback, the Company is redesigning the trial protocol. We will continue to seek approval in a manner consistent with the data derived from the results of the trial. The pathway pursued will be based on the assessment of that data.

Currently, as a result of the Agency’s feedback and after consultation with external experts, the Company plans to conduct an adaptive-designed trial that confirms dose selection and data observed in the NASH-CX trial and where, in a seamless fashion with pre-planned adaptations, an interim analysis informs the larger Phase 3 trial component. The adaptive design being considered allows pre-planned adjustments of the trial which may include, amongst other factors, optimization of dose selection, confirmation of efficacy and proof of concept, optimized sizing and statistical powering of the Phase 3 component, and possible inclusion of more advanced cirrhotic patients. We believe that these adaptations taken together should optimize conduct of the NASH-RX trial giving GR-MD-02 the best opportunity to show a positive therapeutic effect. Existing patients in the first component of the trial are expected to be seamlessly transitioned to the Phase 3 trial component. An important aspect of the adaptive design is potential early termination of the study for futility after evaluation of the results from the first part of the trial, thereby saving the company resources that it could expend on other trials. Conversely, if the final results of the NASH-RX trial are compelling there could be the potential for FDA approval and/or partnership opportunity with a large pharmaceutical company.

In the Phase 3 component of this trial, the primary endpoint would likely be a composite clinical outcomes endpoint, including varices requiring treatment (development of large varices or varices with a red wale), decompensated events, all-cause mortality, MELD score increase as defined earlier and liver transplant. Patient selection would be based on clinical criteria indicative of clinically significant portal hypertension, amongst others, including presence or absence of varices, platelet count, spleen size and evidence of collaterals by imaging. In addition, in parallel, a hepatic impairment study in patients with Child-Turcotte-Pugh (CTP) classes A, B, and C would be conducted to potentially allow inclusion of patients with CTP Class B and/or C who are at increased risk of decompensating. Subject to additional assessments to assure appropriate study sizing and other operational considerations, these changes are believed to be relatively straight-forward modifications of the protocols submitted to the Agency in July 2019, and we believe the changes will increase the likelihood of success of the Phase 3 component of the study. These current plans are subject to modification after discussion with FDA. The final study design will be announced when available.

The focus and goal of the therapeutic program is to stop the progression of and reverse the fibrosis and/or portal hypertension in the liver and thereby improve liver function and prevent the development of varices and clinical complications of fibrosis/cirrhosis and liver-related mortality in patients. Based on the results of the NASH-CX trial and subject to confirmation in later stage clinical trials, we believe that this goal is achievable in a significant portion of the NASH cirrhosis patient population i.e. those NASH cirrhosis patients with portal hypertension.

The key milestones and associated target dates for the NASH-RX trial will be announced as elements of design of the trial are finalized based on the recent FDA feedback. However, we currently expect the first patient to be enrolled in the first quarter of 2020. The study likely will involve at least 500 patients at up to approximately 130 sites in 11 countries in North America, Europe, Asia, and Australia and will continue for at least two years of dosing.

Other Updates

Along with Providence Cancer Institute, received a notice of issuance of a U.S. patent titled "Method for Enhancing Specific Immunotherapies in Cancer Treatment" to cover the method of use of belapectin (GR-MD-02) as a means to enhance the effectiveness of specific immunotherapies in cancer treatment. The patent coverage extends to 2033.

Revamped the corporate and investor websites to increase transparency and improve mobile accessibility.

Scientific Presentations and Conferences

An abstract based on results obtained in a subsequent ad hoc analysis of Galectin Therapeutics’ NASH-CX Phase 2 Clinical Trial by investigators at the University of Indiana was presented at The Liver Meeting (AASLD) in Boston, Massachusetts on November 8-12. The poster presentation was titled "Enhanced liver fibrosis (ELF) score significantly predicts 52-week liver decompensation in patients with compensated NASH cirrhosis."

Eliezer Zomer, Vice President, will present at the 3rd Annual Anti-Fibrotic Drug Development Summit (AFDD) on November 19, 2019, in Cambridge, Massachusetts. Dr. Zomer’s presentation, titled "Therapeutic Integrin Inhibition," will discuss the next generation of Galectin-3 inhibitors as well as the discovery of functional allosteric inhibitors as part of efforts of Galectin Sciences LLC, our majority owned subsidiary.

Financial Results

For the three months ended September 30, 2019, the Company reported a net loss applicable to common stockholders of $2.8 million, or $0.05 per share, compared to a net loss applicable to common stockholders of $3.0 million, or $0.07 per share, for the three months ended September 30, 2018. The decrease in net loss per share was primarily due to an increase in weighted average shares outstanding in the current period compared to the prior year period.

Research and development expense for the three months ended September 30, 2019, was $1.5 million compared with $1.5 million for the three months ended September 30, 2018. There was an increase of about $0.3 million in clinical and pre-clinical development expenses which was offset by a similar amount of decrease in non-cash stock-based compensation expense. General and administrative expense for the three months ended September 30, 2019, were $1.4 million, compared to $1.2 million for the three months ended September 30, 2018, primarily due to increases in legal and business development expenses.

As of September 30, 2019, the Company had $50.3 million of cash and cash equivalents. The Company also has a $10 million unsecured line of credit, under which no borrowings have been made to date, and potential additional capital under its At the Market common stock issuance agreement. The Company believes there is sufficient cash, including availability of the line of credit, to fund currently planned operations at least through December 31, 2020. The Company expects that it will require more cash to fund operations after December 31, 2020 and believes it will be able to obtain additional financing as needed. The total cost of the planned trial, including general overhead, is estimated to be approximately $100 to $115 million; however, the costs and timing of such trial are not yet completely finalized. These costs will require additional funding. There can be no assurance that we will be successful in obtaining financing to support our operations beyond December 31, 2020, or, if available, that any such financing will be on terms acceptable to us.