On August 8, 2019 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), reported financial results for the second quarter ended June 30, 2019 and provided a summary of recent events (Press release, Regulus, AUG 8, 2019, View Source [SID1234538466]).

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"With the completed financing and restructuring of our term loan, we believe we are in a good position to work expeditiously to address the clear requirements outlined by FDA to reinitiate the MAD clinical study for RGLS4326," said Jay Hagan, CEO of Regulus. "We will also be evaluating potential options to initiate single dose studies in order to further characterize the molecule."

Second Quarter 2019 Corporate Highlights and Recent Updates

Private Financing: In May 2019, the Company closed the first tranche of its $41.8 million private placement of equity (the "Private Placement"). The Company received net proceeds of approximately $15.7 million from the first tranche, after deducting placement agent fees and other offering expenses. Subject to the Company’s public announcement on or before December 31, 2019 of its plan to recommence the Phase 1 multiple ascending dose ("MAD") clinical trial for RGLS4326 based upon correspondence from the United States Food and Drug Administration ("FDA"), the investors who purchased securities in the first tranche of the Private Placement have agreed to purchase shares of non-voting convertible preferred stock and accompanying warrants to purchase shares of common stock in a second closing (the "Milestone Closing"). If the Milestone Closing occurs, the gross proceeds to the Company from that closing will be approximately $25.1 million. The Company expects to use the proceeds from the Private Placement primarily to advance RGLS4326 for the treatment of autosomal dominant polycystic kidney disease ("ADPKD"), to advance select programs from its pipeline of microRNA therapies and for general corporate purposes. Excluding any potential proceeds from the Milestone Closing, the Company believes it has sufficient cash to fund operations into mid-2020.
Term Loan Amendments: In May 2019, and concurrently with the Private Placement, the Company amended its Term Loan with Oxford Finance to provide a new twelve-month period of interest-only payments, commencing May 2019, and a two-year extension of its maturity date from June 2020 to May 2022. Upon the closing of the second tranche of the Company’s Private Placement, the Company will receive an additional twelve-month period of interest-only payments, commencing May 2020.
RG-012 Transition to Sanofi: In November 2018, the Company and Sanofi agreed to transition further development activities of the miR-21 programs, including the Company’s RG-012 program, to Sanofi who will be responsible for all costs incurred in the development of these miR-21 programs (the "2018 Sanofi Amendment"). As of June 30, 2019, the transition activities, including the transfer of the investigational new drug application ("IND"), were complete. The Company received a total of $6.8 million in upfront and material transfer-related payments, which were recognized as revenue in the three months ended March 31, 2019. Regulus is also eligible to receive up to $40 million in clinical milestone payments.
Lease Agreement: In June 2019, the Company entered into an amendment of its lease (the "Lease Amendment") of 24,562 square feet located at 10628 Science Center Drive Suite 100, San Diego, California 92121. Under the terms of the Lease Amendment, the expiration of the lease was accelerated from June 30, 2023 to June 30, 2019, and the lease terminated on July 1, 2019. Concurrently with the Lease Amendment, the Company entered into a new lease agreement (the "New Lease") for 8,727 square feet located at 10628 Science Center Drive, Suite 225, San Diego, California, 92121, which it uses as its new principal offices and laboratory for research and development. This relocation reduced the Company’s facility size by approximately 65% and reduced its future contractual lease obligations by approximately 78%.
Management Transition: In July 2019, the Company appointed Cris Calsada as its new Chief Financial Officer, effective August 30, 2019. Ms. Calsada joins Regulus from Sanifit where she has served as Chief Financial Officer since December 2017. Ms. Calsada brings to Regulus’ senior management team a unique combination of financial, operational and managerial experience. She has over 20 years of leadership experience in the life sciences and technology industries. Prior to her employment with Sanifit, Ms. Calsada was self-employed as a finance consultant to various life sciences companies. From 2004 until its acquisition in 2015, she served in positions of increasing responsibility with Ambrx, most recently serving as its Chief Operating Officer and Vice President of Finance. Prior to Ambrx, she worked for Sony Online Entertainment as its Executive Director of Finance and Controller. Earlier in her career, she practiced as a certified public accountant. Ms. Calsada received a B.S. in Business Administration with emphasis in Accounting from San Diego State University and an M.B.A. from the University of Southern California Marshall School of Business. Ms. Calsada’s appointment follows the resignation of the Company’s previous Chief Financial Officer, Dan Chevallard, in July 2019.
Program Updates

RGLS4326 for ADPKD: In January 2019, the Company announced data from a planned interim analysis of a new mouse chronic toxicity study after 13 weeks of dosing in which no adverse or other significant findings across the range of doses tested were shown. In January 2019, the Company submitted a comprehensive data package for RGLS4326 to FDA that included the results from the planned 13-week interim analysis of the repeat mouse chronic toxicity study, as well as results from additional investigations, analytical testing, additional data from the previously terminated mouse chronic toxicity study, data from the completed Phase I single ascending dose ("SAD") study and data from the first cohort of the Phase I MAD study, to support its plan to resume the Phase I MAD study. After review of the requested submission, FDA notified the Company of additional nonclinical data requirements and placed the IND on a partial clinical hold, formalizing the specific requirements to initiate the MAD study and further proceed into chronic dosing in ADPKD patients. The additional data requirements have been outlined in two parts. In order to resume the MAD study, FDA has requested the final reports from the chronic toxicity studies in both mice and non-human primates and satisfactory related analyses to ensure subjects can be safely dosed. Additional data and analyses from new nonclinical studies, planned to be generated over the next several quarters, will be required for chronic dosing, and may also be used to support the resumption of the MAD study. Regulus is allowed to proceed with additional SAD clinical studies as part of the process to gather additional supporting information to guide the future development of the program.
Anti-miR-132 for Nonalcoholic Steatohepatitis (NASH): In April 2019, Regulus presented a late breaker poster at the EASL International Liver Congress describing the development of its lead anti-miR-132 for the treatment of NASH. Across multiple animal models of NASH, the lead candidate demonstrated improvement in key endpoints, including NAFLD Activity Score (NAS), liver transaminases, hyperglycemia, and disease-related gene expression. In the diet-induced NASH mouse model (Amylin model) after two to four weekly doses, early onset of improvement across multiple disease parameters including liver triglycerides and blood levels of transaminases was observed. After nine weeks of treatment, there was evidence of sustained benefit with significant improvement of liver fibrosis and hyperglycemia compared to control-treated animals. The Company believes that targeting dysregulated microRNA in a complex disease like NASH may offer a unique mechanism of action from other programs in development. The Company plans to seek a partner to further advance the development of this program.
Second Quarter 2019 Financial Results

Cash Position: As of June 30, 2019, Regulus had $19.6 million in cash and cash equivalents.

Revenue: Revenue was less than $0.1 million and $6.8 million for the three and six months ended June 30, 2019, respectively, compared to less than $0.1 million for each the three and six months ended June 30, 2018. The increase for the six months ended June 30, 2019 was attributable to revenue recognition of the upfront payments received under the 2018 Sanofi Amendment related to the transfer of RG-012.

Research and Development (R&D) Expenses: R&D expenses were $1.8 million and $7.8 million for the three and six months ended June 30, 2019, compared to $10.0 million and $21.8 million for the same periods in 2018. The decreases were driven by decreases in external development expenses, primarily attributable to the voluntary pause of the RGLS4326 Phase 1 MAD clinical study in the third quarter of 2018 and commencement of the transfer of the RG-012 program to Sanofi in the fourth quarter of 2018. Additionally, the decreases were driven by reductions in personnel and internal expenses, primarily attributable to a reduction in costs subsequent to our corporate restructuring in the third quarter of 2018.

General and Administrative (G&A) Expenses: G&A expenses were $2.9 million and $6.4 million for the three and six months ended June 30, 2019, compared to $3.3 million and $7.1 million for the same periods in 2018. These amounts reflect personnel-related and ongoing general business operating costs.

Net Loss: Net loss was $5.0 million, or $0.30 per share (basic and diluted), and $8.3 million, or $0.61 per share (basic and diluted), for the three and six months ended June 30, 2019, respectively, compared to $13.8 million, or $1.59 per share (basic and diluted), and $29.9 million, or $3.44 per share (basic and diluted), for the same periods in 2018. Historical and current period net loss per share values have been retroactively adjusted to reflect our October 2018 reverse stock split.

About Autosomal Dominant Polycystic Kidney Disease (ADPKD)

ADPKD, caused by the mutations in the PKD1 or PKD2 genes, is among the most common human monogenic disorders and a leading cause of end-stage renal disease. The disease is characterized by the development of multiple fluid filled cysts primarily in the kidneys, and to a lesser extent in the liver and other organs. Excessive kidney cyst cell proliferation, a central pathological feature, ultimately leads to end-stage renal disease in approximately 50% of ADPKD patients by age 60.

About RGLS4326

RGLS4326 is a novel oligonucleotide designed to inhibit miR-17 and designed to preferentially target the kidney. Preclinical studies with RGLS4326 have demonstrated direct regulation of PKD1 and PKD2 in human ADPKD cyst cells, a reduction in kidney cyst formation, improved kidney weight/body weight ratio, decreased cyst cell proliferation, and preserved kidney function in mouse models of ADPKD.

On August 8, 2019 Synthetic Biologics, Inc. (NYSE American: SYN), a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of patients, reported financial results for the three months ended June 30, 2019 (Press release, Synthetic Biologics, AUG 8, 2019, View Source [SID1234538465]). The Company also announced today a clinical trial agreement with Washington University School of Medicine in St. Louis ("Washington University") to conduct a Phase 1b/2a clinical trial of SYN-004 (ribaxamase), with enrollment expected to begin in the first quarter of 2020.

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"Our clinical trial collaboration with Washington University is an important step in our pursuit of a more cost-effective development strategy for SYN-004 targeting a more specialized patient population," stated Steven A. Shallcross, Chief Executive and Financial Officer. "SYN-004’s unique mechanism of action designed to degrade intravenous (IV) beta-lactam antibiotics and prevent dysbiosis of the gut microbiome has the potential to significantly improve outcomes for patients who undergo allogeneic hematopoietic cell transplantation (HCT), an area of significant unmet medical need."

"Prompt initiation of broad-spectrum IV beta-lactam antibiotics at onset of fever after conditioning chemotherapy for allogenic HCT is a life-saving intervention. However, this causes significant disruption of the microbiome, which places these patients at very high risk for infection due to some of our greatest antibiotic resistant threats, such as Clostridioides difficile, vancomycin-resistant Enterococci (VRE), and multidrug-resistant Gram-negative bacteria. We are seeking to determine if coadministration of SYN-004 while the patient is receiving IV beta-lactam antibiotics will preserve the microbiome and thus mitigate the risk from these threats," said Dr. Erik R. Dubberke Professor of Medicine and Clinical Director, Transplant Infectious Diseases at Washington University. "There are data to suggest preservation of the microbiome in allogeneic HCT recipients results in improved immune function after HCT as well. This would further enhance these patients’ outcomes and quality of life."

Mr. Shallcross continued, "During the second quarter, we remained focused on executing our strategy to advance our portfolio of gastrointestinal (GI) and microbiome-focused clinical programs. We held a highly informative pre-IND meeting with the U.S. Food and Drug Administration (FDA) for our SYN-020 intestinal alkaline phosphatase (IAP) program and clarified the parameters for IND-enabling toxicology studies. These activities are ongoing and will support our anticipated Investigational New Drug (IND) application which we intend to file promptly during the first quarter of 2020." Mr. Shallcross concluded, "Interest from prospective patients in our investigator-sponsored Phase 2b clinical trial of SYN-010 in breath-methane positive irritable bowel syndrome with constipation (IBS-C) patients remains strong. However, after consulting with the investigators at Cedars-Sinai Medical Center, the study sponsor, enrollment has been extended to accommodate higher than anticipated screen-fail rates. This is, in part, due to errant laxative use during the screening period that adversely impacts baseline measurements of IBS-C symptoms and breath-methane levels. Rigorous screening and reliable baseline parameters are critical to all IBS-C clinical trials in order to ensure the possibility of generating a meaningful data set of the highest quality. At this time, we are discussing with Cedars-Sinai the opportunity for a data read out in the first half of 2020, extending our previous guidance from the fourth quarter of 2019. We look forward to sharing important updates and progress for this and all our GI and microbiome-focused clinical programs."

Clinical Development and Operational Update

Entered into a Clinical Trial Agreement with Washington University School of Medicine in St. Louis to conduct a Phase 1b/2a clinical trial of SYN-004 (ribaxamase)
Under the terms of this agreement, Synthetic Biologics will serve as the sponsor of the study and supply SYN-004 (ribaxamase) and Dr. Dubberke will serve as the principal investigator along with his Washington University colleague Dr. Mark A. Schroeder, Associate Professor of Medicine, Division of Oncology, Bone Marrow Transplantation and Leukemia,
Enrollment is expected to begin during the first quarter of 2020, contingent upon review by the FDA and approval of the clinical study protocol by Washington University’s Institutional Review Board (IRB),
The proposed study is a Phase 1b/2a single-center, randomized, double-blinded, placebo-controlled clinical trial designed to evaluate the safety, tolerability and pharmacokinetics of oral SYN-004 (ribaxamase) in up to 36 adult allogeneic HCT recipients,
Study participants will be enrolled into three sequential cohorts that will be administered a different study-assigned IV beta-lactam antibiotic. Eight participants in each cohort will receive SYN-004 (ribaxamase) and four will receive placebo,
Safety and pharmacokinetic data for each cohort will be reviewed by an independent Data and Safety Monitoring Committee, which will make a recommendation on whether to proceed to the next IV beta-lactam antibiotic,
The proposed study will also evaluate potential protective effects of SYN-004 (ribaxamase) on the gut microbiome as well as generate preliminary information on potential therapeutic benefits and patient outcomes of SYN-004 (ribaxamase) in allogeneic HCT recipients;
Enrollment is ongoing in the Phase 2b investigator-sponsored clinical study of SYN-010, for the treatment of IBS-C
The Phase 2b clinical study is being conducted by the Medically Associated Science and Technology (MAST) Program at Cedars-Sinai Medical Center and is a 12-week, placebo-controlled, double-blind, randomized clinical trial evaluating two dose strengths of oral SYN-010 (21 mg and 42 mg) in approximately 150 patients diagnosed with IBS-C,
The primary objective for the study will be to determine the efficacy of SYN-010, measured as an improvement from baseline in the weekly average number of complete spontaneous bowel movements (CSBMs) during the 12-week treatment period for SYN-010 21 mg and 42 mg daily doses relative to placebo,
Secondary efficacy endpoints for both dose strengths of SYN-010 will measure changes from baseline in abdominal pain, bloating, stool frequency as well as the use of rescue medication relative to placebo,
A data readout is anticipated in 1H 2020,
Cedars-Sinai Medical Center and Synthetic Biologics are co-funding the study. The patent rights covering the use of SYN-010 are owned by Cedars-Sinai Medical Center and are exclusively licensed by Cedars-Sinai Medical Center to Synthetic Biologics;
Evaluated potential clinical development strategies to advance SYN-020 (intestinal alkaline phosphatase) to and through clinical trials targeting areas of significant unmet medical need, including enterocolitis associated with radiation therapy for cancer
Held Pre-IND meeting with FDA and clarified the requirements for IND-enabling toxicology studies
Exploratory study found SYN-020 enhanced 5-FU tumor treatment in a mouse ectopic colon cancer tumor model. A confirmatory study is ongoing with larger cohort sizes and additional mechanistic endpoints which, if repeated, may allow for further broadening of the clinical development strategy for this program,
Anticipate filing a US IND application in Q1 2020;
Continued to exercise prudent cash management and financial stewardship
Further reduced cash burn, extending projected cash runway to fund operations through at least the end of Q3 2020;
Quarter Ended June 30, 2019 Financial Results

General and administrative expenses decreased by 27% to $1.0 million for the three months ended June 30, 2019, from $1.4 million for the three months ended June 30, 2018. This decrease is primarily due to decreased stock-based compensation expense related to forfeitures and decreased options grants, along with the reduction of investor relations and consulting costs. The charge related to stock-based compensation expense was $59,000 for the three months ended June 30, 2019, compared to $264,000 the three months ended June 30, 2018.

Research and development expenses decreased by 27% to $2.6 million for the three months ended June 30, 2019, from $3.6 million for the three months ended June 30, 2018. This decrease is primarily the result of lower SYN-004 (ribaxamase) indirect program costs for the three months ended June 30, 2019, including salary and related expense reductions resulting from the 2018 restructuring and the fact that no clinical trial activity for SYN-004 (ribaxamase) was ongoing during the quarter, offset by an increase in manufacturing costs for SYN-020. The research and development costs incurred during the quarter were primarily related to the investigator-sponsored Phase 2b clinical study of SYN-010, a potential Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients, and the continued development of SYN-020. Research and development expenses also include a charge relating to stock-based compensation expense of $31,000 for the three months ended June 30, 2019, compared to $293,000 for the three months ended June 30, 2018.

Other income was $80,000 for the three months ended June 30, 2019, compared to other income of $789,000 for the three months ended June 30, 2018. Other income for the three months ended June 30, 2019 is primarily comprised of interest income while the three months ended June 30, 2018 is comprised of non-cash income of $783,000 from the change in fair value of warrants. The decrease in the fair value of the warrants was due to the decrease in our stock price.

Cash and cash equivalents as of June 30, 2019 was $21.7 million, a decrease of $7.2 million from December 31, 2018.

Conference Call

Synthetic Biologics will hold a conference call today, Thursday, August 8, 2019, at 4:30 p.m. (ET). The dial-in information for the call is as follows, U.S. toll free: +1 888-347-5280 or International: +1 412-902-4280. Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at View Source." target="_blank" title="View Source." rel="nofollow">View Source An archive of the call will be available for replay at the same URL, View Source, for 90 days after the call.

On August 8, 2019 Coordination Pharmaceuticals Inc. (CPI), a privately-held oncology drug development company reported that the first patient has been dosed in a Phase 1 study of CPI-200 in patients with advanced tumors (Press release, Coordination Pharmaceuticals, AUG 8, 2019, View Source [SID1234538464]). CPI-200 is a novel nanoscale coordination polymer (NCP) containing two new molecular entities (NMEs) with synergistic antitumor activities. In addition, CPI is also conducting Phase 1 studies of CPI-100 and RiMO-301 on patients with advanced tumors. CPI-100 is another NCP containing two synergistic NMEs to activate tumor microenvironments for combination therapy with an immune checkpoint inhibitor while RiMO-301 elicits unprecedented radiotherapy-radiodynamic therapy (RT-RDT) to enhance the efficacy of X-ray radiotherapy.

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"Initiation of this study represents a significant milestone for CPI as CPI-200 is the company’s third candidate to enter clinical studies in the past year," said Wenbin Lin, Ph.D., founder and chairman of RiMO and also the James Franck Professor of Chemistry, Radiation & Cellular Oncology, and the Ludwig Center for Metastasis Research at the University of Chicago. "We believe our two innovative technology platforms have the potential to change treatment paradigms for multiple cancer types and significantly benefit patients."

Dr. Lin and coworkers have pioneered the development of the NCP and RiMO technology platforms, publishing extensively on these novel nanotherapeutics. "We expect that this study will generate important insights about the safety and pharmacokinetics of CPI-200 and the synergistic actions of the two NMEs on patients’ tumors which no longer respond to standard therapies," said Everett Vokes, M.D., University of Chicago Medicine.

About the Studies

The Phase 1 study is a prospective, open-label, single-arm, non-randomized study of CPI-200 in patients with advanced tumors. The primary objectives in the study include determining maximum tolerated dose (MTD), pharmacokinetics and preliminary anti-tumor activity of CPI-200. For additional clinical trial details, please refer to View Source;rank=1.

For CPI-100 Phase I study: View Source;rank=1

For RiMO-301 Phase I study: View Source;rank=1

. CPI-200 is a novel nanoscale coordination polymer (NCP) containing two new molecular entities (NMEs) with synergistic antitumor activities. In addition, CPI is also conducting Phase 1 studies of CPI-100 and RiMO-301 on patients with advanced tumors. CPI-100 is another NCP containing two synergistic NMEs to activate tumor microenvironments for combination therapy with an immune checkpoint inhibitor while RiMO-301 elicits unprecedented radiotherapy-radiodynamic therapy (RT-RDT) to enhance the efficacy of X-ray radiotherapy.

"Initiation of this study represents a significant milestone for CPI as CPI-200 is the company’s third candidate to enter clinical studies in the past year," said Wenbin Lin, Ph.D., founder and chairman of RiMO and also the James Franck Professor of Chemistry, Radiation & Cellular Oncology, and the Ludwig Center for Metastasis Research at the University of Chicago. "We believe our two innovative technology platforms have the potential to change treatment paradigms for multiple cancer types and significantly benefit patients."

Dr. Lin and coworkers have pioneered the development of the NCP and RiMO technology platforms, publishing extensively on these novel nanotherapeutics. "We expect that this study will generate important insights about the safety and pharmacokinetics of CPI-200 and the synergistic actions of the two NMEs on patients’ tumors which no longer respond to standard therapies," said Everett Vokes, M.D., University of Chicago Medicine.

About the Studies

The Phase 1 study is a prospective, open-label, single-arm, non-randomized study of CPI-200 in patients with advanced tumors. The primary objectives in the study include determining maximum tolerated dose (MTD), pharmacokinetics and preliminary anti-tumor activity of CPI-200. For additional clinical trial details, please refer to View Source;rank=1.

For CPI-100 Phase I study: View Source;rank=1

For RiMO-301 Phase I study: View Source;rank=1

On August 8, 2019 Clovis Oncology, Inc. (NASDAQ: CLVS) reported the pricing of $250 million aggregate principal amount of its 4.50% convertible senior notes due 2024 (the "notes") in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Clovis Oncology, AUG 8, 2019, View Source [SID1234538463]). Clovis Oncology has also granted to the initial purchasers a 13-day option to purchase up to $37.5 million aggregate principal amount of additional notes on the same terms and conditions.

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The notes will bear interest at a rate of 4.50% per annum, payable semi-annually in arrears on February 1st and August 1st of each year. The notes will mature on August 1, 2024 unless earlier converted or repurchased. The holders of the notes may convert their notes at their option at any time prior to the close of business on the business day immediately preceding the maturity date at an initial conversion rate of 137.2213 shares of Clovis Oncology’s common stock per $1,000 principal amount of notes, which is equivalent to an initial conversion price of approximately $7.29 per share of common stock. The initial conversion price of the notes represents a premium of approximately 25% to the last reported sale price, $5.83 per share, of Clovis Oncology’s common stock on August 8, 2019.

Clovis Oncology will not have the right to redeem the notes prior to their maturity. Holders of the notes may require Clovis Oncology to repurchase for cash all or part of their notes upon certain fundamental changes at a repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. In addition, following certain corporate events that occur prior to the maturity date, Clovis Oncology will, in certain circumstances, increase the conversion rate for a holder who elects to convert its notes in connection with such corporate event.

The offering of the notes is expected to close on August 13, 2019, subject to customary closing conditions. Concurrently with the offering, in separate transactions, Clovis Oncology entered into privately negotiated transactions with a limited number of holders to repurchase, for settlement on or about August 13, 2019, approximately $190.3 million aggregate principal amount of its outstanding 2.50% Convertible Senior Notes due 2021 (the "2021 Notes"), for an aggregate repurchase price of approximately $171.8 million, including accrued interest. Clovis Oncology intends to use the net proceeds from the offering for these repurchases of the 2021 Notes. Any repurchase of the 2021 Notes could affect the market price of Clovis Oncology’s common stock. Clovis Oncology intends to use the remaining net proceeds from this offering for general corporate purposes, including sales and marketing expenses associated with Rubraca (rucaparib), funding of Clovis Oncology’s development programs, payment of milestones pursuant to Clovis Oncology’s license agreements, general and administrative expenses, acquisition or licensing of additional product candidates or businesses, repurchase or repayment of other debt obligations and working capital.

The offer and sale of the notes and the shares of common stock issuable upon conversion of the notes have not been registered under the Securities Act or any state securities laws and, unless so registered, the notes and any such shares may not be offered or sold in the United States except pursuant to an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. This press release does not constitute an offer to sell or the solicitation of an offer to buy the notes or any other securities, nor will there be any sale of notes or any other 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 August 8, 2019 IMV Inc. (TSX: IMV; NASDAQ: IMV), a clinical stage immunotherapy company, reported its financial and operational results for the second quarter ended June 30, 2019 (Press release, IMV, AUG 8, 2019, View Source [SID1234538462]).

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"At IMV, we are leveraging DPX, our no-release delivery technology that enables us to program immune cells in vivo. We continue to believe this mechanism offers potential to produce a new class of immunotherapies that elicit a more rapid, robust and sustained immune response," said Frederic Ors, IMV’s Chief Executive Officer. "In the second quarter, we reported important updates from two Phase 2 studies of our lead program, DPX-Survivac, our T cell-activating immunotherapy harnessing the power of this approach to target survivin, which is present in more than 20 solid and hematological tumor types. These results continue to validate our DPX platform and this novel target, with encouraging signs of anti-tumor activity contributing to the body of data we have accumulated to demonstrate DPX-Survivac’s potential in hard-to-treat cancers, both as a monotherapy and in combination with other agents. We look forward to providing additional data from this program by year-end, including top-line results from our Phase 2 study evaluating DPX-Survivac as a monotherapy in ovarian cancer and additional results from our Phase 2 r/r DLBCL and basket trial, evaluating DPX-Survivac in combination with Keytruda in multiple solid tumor indications."

DPX-Survivac Clinical Program Updates:

Phase 1b/2 DeCidE1 Clinical Study in Advanced Recurrent Ovarian Cancer

In June 2019, IMV presented new data at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting from DeCidE1, its ongoing Phase 1b/2 study evaluating the safety and efficacy of DPX-Survivac and intermittent low-dose cyclophosphamide (CPA), with and without epacadostat, in advanced recurrent ovarian cancer. These results expand on data previously reported from this study, which exhibited a durable response. Highlights of the new data from evaluable patients in the Phase 2 monotherapy arm of the trial include:

Five out of seven patients showed signs of treatment benefits, including reduction of target lesions in two patients;
Three out of four patients with low tumor burden showed stable disease, including two with tumour regression at first CT scan;
Of the five patients evaluable for T cell responses, all showed survivin-specific T cell activation in the blood; and
Treatments were well-tolerated supporting our views of the favourable safety profile of our approach.
Additionally, longer-term follow-up data from the Phase 1b portion of the study continued to demonstrate the prolonged duration of clinical benefits, surpassing two years of progression-free survival from previous treatments, including platinum-based chemotherapy.

We have enrolled 16 additional patients in the expanded monotherapy arm of the DeCidE1 trial. IMV expects to provide the top-line clinical results from this study before the end of 2019.

Phase 2 SPiReL Study of DPX-Survivac in Combination with KEYTRUDA in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

In June 2019, IMV reported updated data from SpiRel, its ongoing investigator-sponsored Phase 2 clinical trial assessing DPX-Survivac in combination with intermittent low dose cyclophosphamide and Merck’s checkpoint inhibitor Keytruda, linking antitumor activity with T cell responses that correlate with expression of survivin.

At the first "on treatment" interim assessment, five of the first six patients demonstrated clinical benefit, including four patients with tumor regressions. Two patients reached a complete radiological response, one exhibited a partial response and two reached stable disease while on the study. In addition, the study continued to demonstrate an acceptable safety profile for the two therapies in combination.

Based on these data, IMV agreed with the principal investigator to increase the number of sites recruiting patients from 5 to 9. As of August 8, 2019, investigators had enrolled 12 patients across four different clinical sites in Canada. Additional patients are being screened and IMV expects to give another update on this trial before the end of 2019 and report top-line clinical data from this study in the first half of 2020.

Phase 2 Basket Trial of DPX-Survivac in Combination with KEYTRUDA in Multiple Solid Tumor Indications

Fifteen patients have been enrolled to date, while screening and enrollment of patients is ongoing across nine clinical sites in the U.S. and Canada for five cohorts of patients with bladder, liver (hepatocellular carcinoma), ovarian, or non-small cell lung (NSCLC) cancers, as well as tumors shown to be positive for the microsatellite instability high (MSI-H) biomarker.

Patients have been treated in every cohort and IMV expects to report preliminary clinical results on several of the solid tumor indications included in this basket trial before the end of 2019.

Operational Highlights:

Modification of $5M loan agreement with the province of Nova Scotia. Previously, the entire loan was payable on August 9, 2020. Per this modification, the Corporation will now repay the loan over 60 months starting in January 2021. All the other terms remain the same. This revised repayment schedule will allow IMV to focus its cash resources towards developing its clinical programs.

Upcoming Milestones:

Milestones

Key dates

Preliminary clinical results from basket trial in 5 indications

H2 2019

Top-line monotherapy clinical results in ovarian cancer

H2 2019

Clinical results update in the DLBCL combination trial (investigator-sponsored)

H2 2019

Top-line clinical results in the DLBCL combination trial (investigator-sponsored)

H1 2020

Top-line clinical results from basket trial

H1 2020

Overview of Q2 2019 Financial Results

(In Canadian dollars)

At June 30, 2019, the Corporation had cash and cash equivalents of $26.9M and working capital of $28.3M, compared with $14.9M and $12.2M, respectively at December 31, 2018. Management believes that the Corporation’s cash resources of $26.9M and its additional potential cash resources of $3.1M will be sufficient to fund operations up to Q4-2020. For the six-month period ended June 30, 2019, IMV’s cash burn rate (defined as net loss and comprehensive loss adjusted for charges to operations not involving cash as described in the statement of cash flows) was $10.4 million. Based on the current business plan, the Corporation forecasts the quarterly cash burn rate to be between $5 million and $6 million for the remaining of 2019.

The net loss and comprehensive loss of $5.0M ($0.10 per share) for the three-month period ended June 30, 2019, was $0.2M lower than the net loss and comprehensive loss for three-month period ended June 30, 2018. This relates mainly to a $0.4M decrease in general and administrative expenses and a $0.9M increase in government assistance partly compensated by a $1.2M increase in research and development (R&D) expenses, in the three-month period ended June 30, 2019.

For the six-month period ended June 30, 2019, the net loss and comprehensive loss of $11.0M was $2.7M higher than the net loss and comprehensive loss for six-month period ended June 30, 2018. This relates mainly to a $3.3M increase in R&D expenses and a $0.2M increase in general and administrative expenses partly compensated by $1.0M increase in government assistance in the six-month period ended June 30, 2019. As of August 8, 2019, the number of issued and outstanding common shares was 50,612,125 and a total of 1,997,232 stock options, warrants, and deferred share units were outstanding at that date.

The Corporation’s unaudited interim condensed consolidated results of operations, financial condition and cash flows for the three and six-months ended June 30, 2019 and the related management’s discussion and analysis (MD&A) are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.

Conference Call and Webcast Information

IMV will host a conference call and webcast tomorrow at 8:00 am ET to discuss these results and provide an update on the company.

Financial analysts are invited to join the conference call by dialing (844) 461-9932 (U.S. and Canada) or (636) 812-6632 (international) using the conference ID: 7148568.

Other interested parties will be able to access the live audio webcast at this link: View Source The webcast will be recorded and available on the IMV website for 30 days following the call.

About IMV

IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies based on the Corporation’s proprietary drug delivery platform. This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac as a monotherapy in advanced ovarian cancer, as well as a combination therapy in multiple clinical studies with Merck. Connect at www.imv-inc.com