On August 11, 2022 Vyant Bio, Inc. ("Vyant Bio" or "Company") (Nasdaq: VYNT) is an innovative biotechnology company reported that reinventing drug discovery for complex neurodevelopmental and neurodegenerative disorders (Press release, Vyant Bio, AUG 11, 2022, View Source [SID1234618165]). The Company’s proprietary central nervous system ("CNS") drug discovery platform combines human-derived organoid models of brain disease, scaled biology, and machine learning. Today, Vyant Bio announced that it will release its financial results for the second quarter and first half ended June 30, 2022, on Monday, August 15, 2022. Vyant Bio will host an investor conference call and webcast on Monday, August 15, 2022 at 4:30 pm ET.

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Jay Roberts, Chief Executive Officer, Andy LaFrence, Chief Financial Officer, and Robert Fremeau, PhD, Chief Scientific Officer, of Vyant Bio will provide an update on the business, scientific, and financial progress made during the second quarter and first half of 2022. Management will also be taking audience questions that are submitted in advance only. Investors may submit written questions via e-mail to: [email protected]

Event: Vyant Bio Investor Conference Call and Webcast for the Second Quarter and First Half 2022
Date: Monday, August 15, 2022
Time: 4:30 pm ET
Dial In: Toll Free: 1.844.369.8770 Conference ID: 46372
Webcast: View Source
The event will be recorded and available for replay. The conference call and webcast details are also included inside the Investors section of the Vyant Bio corporate website at www.vyantbio.com.

On August 11, 2022 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, reported financial results for the second quarter ended June 30, 2022, and provided a corporate update (Press release, Synthetic Biologics, AUG 11, 2022, View Source [SID1234618164]).

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

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"We are pleased with the steady progress that continues to support the advancement of our novel OV platform and further underscores the potential value of our lead candidate, VCN-01, designed to address devastating cancers with high unmet need through a differentiated and potentially transformative mechanism of action," said Steven A. Shallcross, Chief Executive Officer of Synthetic Biologics. "We have made the strategic decision to rationalize our spend and prioritize our oncology program, which is expected to extend cash runway into the first quarter of 2024. We believe this sharpened approach has the potential to drive near-term value for our shareholders and propel us forward to key milestones, including the initiation of our Phase 2 study in patients with metastatic pancreatic adenocarcinoma in the fourth quarter of 2022 and our Phase 2/3 study in retinoblastoma in the second half of 2023."

Recent Program Developments:

The acquisition of VCN Biosciences transformed Synthetic Biologics’ pipeline with the addition of VCN’s lead clinical-stage drug candidate, VCN-01, an intravenous oncolytic adenovirus (OV), as well as preclinical stage VCN-11, which incorporates a proprietary albumin binding domain in the virus shell which is intended to improve systemic delivery by enabling the virus to coat itself in albumin and thereby evade neutralizing antibodies (NAbs).
Initiated the investigator sponsored Phase 1, open-label, non-randomized clinical trial evaluating VCN-01 in combination with mesothelin-directed lentiviral transduced human chimeric antigen receptor modified T cells (huCART-meso) for patients with pancreatic and serous epithelial ovarian cancers (NCT05057715).
Corporate Update:

On July 25, 2022, the Company’s common stock began trading on a split-adjusted basis. The Company’s common stock continues to trade on the NYSE American under the stock ticker "SYN" but under the new CUSIP number 87164U409.
Anticipated Milestones:
VCN-01

Initiation of VCN-01 dosing in an investigator sponsored study of brain tumors at the University of Leeds (H2 2022).
Data from the VCN-01 Phase 1 investigator sponsored study in and head and neck cancer to be presented at a major medical meeting (Q3 2022)
Initiation of a Phase 2 study of VCN-01 in combination with standard-of-care chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy in newly diagnosed metastatic PDAC patients (Q4 2022).
Initiation of a Phase 2/3 study of VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma (H2 2023).
SYN-004

Topline data read out from the first cohort of the SYN-004 study in allo-HCT patients (H2 2022) followed by initiation of the second cohort (Q4 2022).
Quarter Ended June 30, 2022 Financial Results

General and administrative expenses increased to $1.5 million for the three months ended June 30, 2022, from $1.3 million for the three months ended June 30, 2021. This increase of 19% primarily comprised of increased consulting and legal costs related to the VCN acquisition, higher insurance costs, audit fees, and public relations expenses and VCN administrative expenses not included in prior year. The charge related to stock-based compensation expense was $86,000 for the three months ended June 30, 2022, compared to $83,000 the three months ended June 30, 2021.

Research and development expenses increased to $3.5 million for the three months ended June 30, 2022, from approximately $1.9 million for the three months ended June 30, 2021. This increase of 80% is primarily the result of VCN research expenses related to VCN-01 not incurred in the prior year and to a lesser extent higher manufacturing expense for SYN-020, costs incurred related to our Phase 1a clinical trial of SYN-020 and expenses related to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients. We anticipate research and development expense to increase as we plan for and initiate enrollment for our phase 2 clinical trial for VCN-01 in PDAC, phase 2/3 clinical trial in retinoblastoma, expand GMP manufacturing activities for VCN-01, and continue with supporting our VCN-11 and other preclinical and discovery initiatives. The charge related to stock-based compensation expense was $27,000 for the three months ended June 30, 2022, compared to $19,000 related to stock-based compensation expense for the three months ended June 30, 2021.

Other income was $17,000 for the three months ended June 30, 2022 compared to other income of $2,000 for the three months ended June 30, 2021. Other income for the three months ended June 30, 2022 is primarily comprised of interest income of $26,000 offset by an exchange loss of $9,000. Other income for the three months ended June 30, 2021 is primarily comprised of interest income.

Cash and cash equivalents totaled $52.3 million as of June 30, 2022, compared to $67.3 million as of December 31, 2021. Cash and cash equivalents totaled approximately $53.5 million as of August 1, 2022.

On July 29, the company closed a private placement of Series C and Series D convertible preferred stock with MSD Credit Opportunity Master Fund, L.P. Total gross proceeds from the offerings, before deducting discounts, financial advisor fees and other estimated offering expenses, were $3 million.

Conference Call

Synthetic Biologics will host a conference call at 8:30 a.m. ET today to review second quarter 2022 operational highlights and financial results. Investors may participate in the live call via telephone by dialing (800) 289-0571 (domestic) or (929) 477-0324 (international) and using the conference ID: 7145566. Participants are asked to dial in 15 minutes before the start of the call to register. Investors and the public can access the live and archived webcast of this call via the "News & Media" section of the company’s website, View Source, under "Events" or by clicking here, for 90 days after the call.

On August 11, 2022 Knight Therapeutics Inc. (TSX: GUD) ("Knight" or "the Company"), a leading pan-American (ex-US) specialty pharmaceutical company, reported financial results for its second quarter ended June 30, 2022 (Press release, Knight Therapeutics, AUG 11, 2022, View Source [SID1234618163]). All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.

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Q2 2022 Highlights

Financials

Revenues were $75,820, an increase of $10,024 or 15% over the same period in prior year.
Gross margin of $38,295 or 51% compared to $28,871 or 44% in the same period in prior year.
Adjusted EBITDA1 was $17,890, an increase of $8,494 or 90% over the same period in prior year.
Net loss on financial assets measured at fair value through profit or loss of $7,692.
Net income was $2,516, compared to net income of $29,004 in the same period in prior year.
Cash inflow from operations was $11,521, compared to a cash inflow from operations of $12,409 in the same period in prior year.
Corporate Developments

Purchased 1,460,684 common shares through Knight’s normal course issuer bid ("NCIB") at an average price of $5.30 for an aggregate cash consideration of $7,739.
Shareholders re-elected Jonathan Ross Goodman, Samira Sakhia, James C. Gale, Robert N. Lande, Michael J. Tremblay, Nicolás Sujoy and Janice Murray on the Board of Directors.
Products

Entered into an exclusive license, distribution and supply agreement with Helsinn Healthcare SA ("Helsinn") for AKYNZEO oral/IV (netupitant/palonosetron/fosnetupitant/palonosetron) in Canada, Brazil and select LATAM countries and ALOXI oral/IV (palonosetron) in Canada.
Entered into exclusive license and supply agreements with Rigel Pharmaceuticals ("Rigel") to commercialize fostamatinib in LATAM.
Obtained marketing authorization transfer of Exelon from Novartis to Knight in Colombia, Brazil, and Mexico, and transferred Exelon’s commercial activities from Novartis to Knight’s affiliate in Colombia.
Subsequent Events

Relaunched AKYNZEO in Brazil in July 2022.
Transferred marketing authorization of Exelon from Novartis to Knight’s affiliate in Chile.
Executed a settlement agreement with former controlling shareholders of GBT and will receive US$4.6 million.
Launched a NCIB in July 2022 to purchase up to 7,988,986 common shares of the Company over the next 12 months.
"I am excited to announce that Knight achieved record quarterly revenues this quarter and see continuous growth in each of our key therapeutic categories primarily driven by the lifting of COVID-19 restrictions as well as the impact of the acquisition of Exelon. Almost one year after closing that transaction, we have completed the Exelon marketing authorization transfers to Knight in our key LATAM territories and have assumed Exelon commercial activities in Colombia. We also continued to execute on the business development front and entered into exclusive license, distribution and supply agreements with Helsinn and Rigel in our key territories,", said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics Inc.

__________
1 EBITDA and Adjusted EBITDA are a non-GAAP measures, refer to section "Non-GAAP measures" and "Reconciliation to adjusted EBITDA" for additional details

A positive variance represents a positive impact to net income (loss) and a negative variance represents a negative impact to net income (loss)
Percentage change is presented in absolute values
EBITDA and adjusted EBITDA are non-GAAP measures, refer to the definitions in section "Non-GAAP measures" for additional details
Operating expenses include selling and marketing expenses, general and administrative expenses, research and development expenses, amortization and impairment of intangible assets

Revenues: For the quarter ended June 30, 2022 revenues increased by $10,024 or 15% compared to the same period in prior year. The growth in revenues excluding the impact of hyperinflation was $9,836 or 15% and is explained by the following:

Knight recognized revenues of $12,390 for Exelon, an increase of $8,202 or 200% driven by the following factors:
The timing of the acquisition of Exelon executed on May 26, 2021
Estimated increase in revenues between $4,000 to $4,500 driven by the purchasing pattern of certain customers as well as higher sales in Brazil in anticipation of the transfer of commercial activities from Novartis to Knight
An increase in revenues of $1,634 driven by the growth of recently launched products including the Q1-22 launches of Lenvima, Rembre and Halaven in Colombia, an increase in patient treatments as our markets reduce COVID-19 restrictions and buying patterns offset by a decrease in revenues of certain of our oncology branded generics products due to market entrance of new competitors. In addition, revenues decreased by approximately $4,500 to $6,000 due to lower demand of certain of our infectious diseases products associated with COVID-19.
Gross margin: For the quarter ended June 30, 2022, gross margin increased from 44% to 51% explained by a change in product mix as well as the acquisition of Exelon. The revenues of Exelon is recorded as a net profit transfer from Novartis with the exception of revenues generated in Colombia upon the transfer of commercial activities to Knight in June 2022. The gross margin would have been 54% versus 51% (YTD-21: 44% to 46%) after excluding the adjustment of hyperinflation accounting in accordance with IAS 29.

Knight expects gross margin as a % of revenues to decline over the next quarters as the commercial activities of Exelon are transferred to Knight on a country-by-country basis and the Company records revenues with related cost of sales instead of a net profit transfer.

Selling and marketing: For the quarter ended June 30, 2022, S&M expenses were $10,926, an increase of $1,742 or 19%, compared to the same period in prior year due to an increase in compensation expenses, certain variable costs such as logistics fees as well as an increase in selling and marketing activities related to key promoted products and Exelon.

General and administrative: For the quarter ended June 30, 2022, G&A expenses were $10,566, an increased of $1,115 or 12%, compared to the same period in prior year due to an increase in compensation expense, certain consulting and professional fees partially offset by the lower costs of related to stock options

Research and development: For the quarter ended June 30, 2022, R&D expenses were $3,412, an increase of $827 or 32%, compared to the same period in prior year. The variance is not significant.

Amortization of intangible assets: For the quarter ended June 30, 2022, amortization of intangible assets was $11,055, an increase of $3,420 or 45%, compared to the same period in prior year driven by acquisition of Exelon.

Interest income: Interest income is the sum of interest income on financial instruments measured at amortized cost and other interest income. For the quarter ended June 30, 2022, interest income was $2,427, an increase of 36% or $641, compared to the same period in prior year due to higher interest rates.

Interest expense: For the quarter ended June 30, 2022, interest expense was $1,717, an increase of $1,049 or 157%, compared to the same period in prior year due to higher interest rates partially offset by a lower average bank loan balance.

Adjusted EBITDA: For the quarter ended June 30, 2022, adjusted EBITDA increased by $8,494 or 90%. The growth in adjusted EBITDA is driven by an increase in gross margin of $9,424, offset by an increase in operating expenses.

Net loss or income: For the quarter ended June 30, 2022, net income was $2,516 compared to net income of $29,004 for the same period in prior year. The variance mainly resulted from the above-mentioned items and (1) a net loss on the revaluation of financial assets measured at fair value through profit or loss of $7,692 versus a net gain of $28,472 in the same period in prior year, mainly due to unrealized revaluations of the strategic fund investments, offset by (2) a foreign exchange gain of $4,507 mainly due to the unrealized gains on intercompany balances driven by the appreciation of the USD compared to a foreign exchange loss of $3,194 in the same period in prior year mainly due to depreciation of the USD.

Cash, cash equivalents and marketable securities: As at June 30, 2022, Knight had $136,235 in cash, cash equivalents and marketable securities, a decrease of $13,267 or 9% as compared to December 31, 2021. The variance is primarily due to outflows related to due to upfront payments and certain milestones mainly related to in-licensing of AKYNZEO and ALOXI from Helsinn as well as fostamatinib from Rigel, shares repurchased through NCIB, partially offset by cash inflows from operating activities.

Financial assets: As at June 30, 2022, financial assets were at $162,306, a decrease of $30,137 or 16%, as compared to the prior year, mainly due to negative mark-to-market adjustments of $23,520 driven by the decline in the share prices of the publicly-traded equities of our strategic fund investments due to general market conditions and distributions of $4,336. Given the nature of the fund investments there could be significant fluctuations in the fair value of the underlying assets.

Bank Loans: As at June 30, 2022, bank loans were at $32,483, a decrease of $3,444 or 10% as compared to the prior period, due to loan repayments of $5,391, partially offset by the appreciation of BRL and accrued interest.

Product Updates

The marketing authorizations of Exelon for Colombia, Mexico, Chile and Brazil were transferred to Knight. The Company expects that remaining marketing authorizations will be transferred in the second half of 2022. Furthermore, Knight has assumed the commercial activities of Exelon in Colombia and expects to assume commercial activities in Brazil, Mexico and Chile in Q3-22.

Knight entered into an exclusive license, distribution and supply agreement with Helsinn for AKYNZEO oral/IV (netupitant/palonosetron / fosnetupitant/palonosetron) in Canada, Brazil and select LATAM countries and ALOXI oral/IV (palonosetron) in Canada. AKYNZEO oral is approved and marketed in Canada for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy and the prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy that is uncontrolled by a 5-HT3 receptor antagonist alone in adults. AKYNZEO oral is also approved and marketed in Argentina and Brazil for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults. ALOXI solution for injection is approved and marketed in Canada for the prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy and highly emetogenic cancer chemotherapy, including high dose cisplatin in adults. In Canada, the product is also indicated in pediatric patients aged 2 to 17 years for the prevention of acute nausea and vomiting associated with moderately and highly emetogenic cancer chemotherapy. ALOXI oral is approved in Canada for use in adults for the prevention of acute nausea and vomiting associated with moderately emetogenic cancer chemotherapy. According to IQVIA, sales of AKYNZEO in Canada and Brazil were approximately $7 million in 2021. Knight assumed commercial activities of AKYNZEO in Brazil and Argentina in July 2022 and will begin commercial activities following a transition period from Helsinn’s current licensees in Canada.

Knight entered into exclusive license and supply agreements with Rigel Pharmaceuticals for the exclusive rights to commercialize fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, in Latin America. Fostamatinib is commercially available in the United States under the brand name TAVALISSE and in Europe under the brand name TAVLESSE for the treatment of chronic immune thrombocytopenia. On June 8, 2022, Rigel announced topline efficacy and safety data from the Phase 3 clinical trial of fostamatinib in patients with warm autoimmune hemolytic anemia (wAIHA). The trial did not demonstrate statistical significance in the primary efficacy endpoint of durable hemoglobin response in the overall study population. The safety profile was consistent with prior clinical experience, and no new safety issues were identified. Rigel is conducting an in-depth analysis of this data to better understand differences in patient characteristics and outcomes and expects to discuss these findings with the FDA to determine the path forward in wAIHA. Fostamatinib is also in Phase 3 clinical trials for the treatment of hospitalized patients with COVID-191,2.

Corporate Updates

NCIB

On July 12, 2022, the Company announced that the Toronto Stock Exchange approved its notice of intention to launch a NCIB ("2022 NCIB"). Under the terms of the 2022 NCIB, Knight may purchase for cancellation up to 7,988,986 common shares of the Company which represented 10% of its public float as at June 30, 2022. The 2022 NCIB commenced on July 14, 2022 and will end on the earlier of July 13, 2023 or when the Company completes its maximum purchases under the NCIB. Furthermore, Knight entered into an agreement with a broker to facilitate purchases of its common shares under the NCIB. Under Knight’s automatic share purchase plan, the broker may purchase common shares which would ordinarily not be permitted due to regulatory restrictions or self-imposed blackout periods.

For the three-month period ended June 30, 2022, the Company purchased 1,460,684 common shares at an average price of $5.30 for an aggregate cash consideration of $7,739. The Company did not acquire any common shares subsequent to the quarter ended June 30, 2022.

Settlement Agreement

Knight executed a settlement agreement and general release ("Settlement Agreement") with the former shareholders of GBT. The Company made certain claims ("Claims") with respect to its indemnification rights under the purchase agreement for the acquisition of GBT. Under the Settlement Agreement, Knight will receive $5.9 million (US$4.6 million) as settlement for the Claims, which will be recorded in the Statement of Income.

Conference Call Notice

Knight will host a conference call and audio webcast to discuss its second quarter ended June 30, 2022, today at 8:30 am ET. Knight cordially invites all interested parties to participate in this call.

Replay: An archived replay will be available for 30 days at www.gud-knight.com

On August 11, 2022 IMV Inc. (Nasdaq: IMV; TSX: IMV) ("IMV" or the "Company"), a clinical-stage biopharmaceutical company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported its financial and operational results and provided an update for the second quarter ended June 30, 2022 (Press release, IMV, AUG 11, 2022, View Source [SID1234618162]).

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"We are excited to see that our lead immunotherapy, MVP-S, is progressing well in multi-center, company-sponsored, Phase 2B trials in both diffuse large B cell lymphoma (DLBCL) and ovarian cancer," said Andrew Hall, Chief Executive Officer of IMV. "Starting with an early look at our VITALIZE data in the third quarter of 2022 and continuing through mid-2023, we expect to communicate results and translational data from all our active clinical trials that, we believe, will further validate the efficacy and safety of MVP-S. These data should bolster the enthusiasm around the unique capabilities of our delivery platform to make cancer vaccines clinically viable."

Clinical Programs with Maveropepimut-S (MVP-S)

VITALIZE Phase 2B Study in Relapsed/Refractory DLBCL ("r/r DLBCL")

IMV continues to enroll patients in the VITALIZE Phase 2B clinical trial, advancing its lead compound, maveropepimut-S (MVP-S) in a global, multi-center confirmatory trial. The VITALIZE trial is designed to further evaluate the previously observed clinical benefit of MVP-S in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with r/r DLBCL. Activation of clinical sites in the EU, Australia and New Zealand is expected to accelerate recruitment that was initiated in North America earlier this year. IMV is on track to complete enrollment of the first stage of the study in H1 2023.

Matthew J. Matasar, MD has joined VITALIZE as principal investigator of the study. Dr. Matasar is the Section Head for Aggressive B-cell Lymphoma at Memorial Sloan Kettering Cancer Center in New York City. His expertise is well recognized in Hodgkin and non-Hodgkin lymphomas (including DLBCL), autologous stem cell transplantation, and cancer survivorship.

Details on the VITALIZE Phase 2B study will be presented in a poster session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 to take place September 9-13 in Paris (Poster #646TiP).

AVALON Phase 2B Trial in Platinum-Resistant Ovarian Cancer

The first patient has been dosed in the AVALON Phase 2B trial in ovarian cancer (NCT05243524). This is a single arm trial evaluating MVP-S and intermittent low-dose cyclophosphamide (CPA) in patients with recurrent, platinum-resistant ovarian cancer. The goal of the AVALON study is to further validate the encouraging data generated in the Phase 2 DeCidE trial, completed in 2021, wherein response rates doubled that of traditional chemotherapy and nearly half of patients survived 2 years.

Oliver Dorigo, M.D., Ph.D., Director and Associate Professor, Division Gynecologic Oncology, Department of Obstetrics and Gynecology at the Stanford University, CA, is the principal investigator of both the DeCidE and the AVALON studies.

Company is Exploring the Optimal Development Pathway for MVP-S in Bladder Cancer

Safety and preliminary efficacy data from the Phase 2 basket study of patients with advanced, metastatic bladder cancer utilizing a combination of MVP-S with pembrolizumab were presented by Jeremy R. Graff, Ph.D., IMV’s Chief Scientific Officer, at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting on April 12, 2022. The combination was well-tolerated and showed encouraging clinical activity, particularly in patients who had received prior immune checkpoint inhibitor therapy. IMV has convened a group of KOL advisors to identify the optimal design for the next trial to evaluate MVP-S in bladder cancer.

Corporate Update

$US10 Million Drawdown from Existing Long-Term Debt Facility

The company drew down the remaining US$10 million available under its existing US$25 million debt facility led by Horizon Technology Finance Corporation (Nasdaq: HRZN) ("Horizon"). This drawdown was made available as the Company achieved a predetermined milestone following site activation in its Phase 2B AVALON trial in platinum-resistant ovarian cancer.

Selected Upcoming Milestones

Maveropepimut-S (MVP-S)

Q3 2022: First results on early patients in VITALIZE study in r/r DLBCL
H2 2022: First results from the investigator-initiated neoadjuvant breast cancer trial
H2 2022: Preliminary data from the MVP-S arm of non-muscle invasive bladder cancer (NMIBC) neoadjuvant Phase 1 study
H1 2023: Complete enrollment of stage 1 in VITALIZE study and first scan data
Summer 2023: Complete enrollment of stage 1 in AVALON study and early data
DPX-SurMAGE

Q3 2022: Dose first patient with DPX-SurMAGE in second arm of NMIBC Phase 1 study
H1 2023: Initial data on DPX-SurMAGE arm in NMIBC trial
Overview of Second Quarter 2022 Financial Results

All dollar amounts noted herein are denominated in United States dollars (unless otherwise noted herein).

On June 30, 2022, the Company had cash and cash equivalents of $31.1 million and working capital of $27.7 million, compared with $38.6 million and $37.1 million, respectively at December 31, 2021. Based on its current plan, IMV expects its current cash position will be sufficient to fund operations into Q2 2023. Sources of cash from financing activities during the quarter primarily included the remaining $10 million under the Company’s venture debt facility with Horizon.

Research and development expenses were $6.0 million for the three months ended June 30, 2022, compared with $5.2 million for the three months ended June 30, 2021. This increase of $0.8 million was mainly due to an increase in costs for the DLBCL VITALIZE phase 2B trial and personnel costs as a result of increased headcount. This increase was partly offset by a decrease in basket trial costs, following the completion of enrollment in 2021.

General and administrative expenses were $4.6 million for the three months ended June 30, 2022, compared with $3.4 million for the three months ended June 30, 2021. This increase of $1.2 million was mainly attributable to loan interest associated with the Horizon venture debt facility, an increase in salaries and non-cash stock-based compensation, related to planned hiring and executive leadership changes.

The net loss and comprehensive loss of $9.9 million ($0.12 per share) for the three months ended June 30, 2022, was $2.5 million higher than the net loss and comprehensive loss of $7.4 million ($0.11 per share) for the three months ended June 30, 2021.

For the six-month period ended June 30, 2022, the net loss and comprehensive loss of $20.4 million ($0.25 per share) was $6.1 million higher than the net loss and comprehensive loss of $14.3 million ($0.21 per share) for the six-month period ended June 30, 2021.

As of August 10, 2022, the number of issued and outstanding common shares was 82,452,187 and a total of 16,101,369 stock options, warrants and deferred share units were outstanding.

The Corporation’s unaudited interim condensed consolidated results of operations, financial condition and cash flows for the quarter ended June 30, 2022, 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 as well as the Company’s website at www.imv-inc.com.

Conference Call and Webcast Information

Financial analysts are invited to join the conference call by registering at this link prior the call to receive their individual dial-in information.

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

On August 11, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported recent operational highlights and financial results for the second quarter ended June 30, 2022 (Press release, Oncolytics Biotech, AUG 11, 2022, View Source [SID1234618161]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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Oncolytics Biotech Inc. Logo (PRNewsfoto/Oncolytics Biotech Inc.)

"Recent clinical data in breast and pancreatic cancer highlight pelareorep’s multifaceted mechanism of action and the broad therapeutic benefits it confers," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "Results from AWARE-1 showed pelareorep activating cancer-killing T cells and modifying HR+/HER2- breast tumor microenvironments in ways that improve patient prognosis and long-term outlook. In the GOBLET trial’s pancreatic cancer cohort, we were thrilled to see objective responses in all phase 1b patients, suggesting pelareorep’s clinically demonstrated synergy with checkpoint inhibition in breast cancer extends into additional difficult-to-treat indications. Together, these findings further position pelareorep as an immune platform molecule that can enhance the efficacy of a variety of drug classes to improve treatment paradigms across a range of indications."

Dr. Coffey continued, "As we move forward, we are focused internally on pursuing strong signals of efficacy observed with pelareorep in breast and pancreatic cancer. With BRACELET-1 now fully enrolled, we are on a clear path towards a randomized phase 2 readout that is expected to validate prior positive survival data and catalyze our advancement into a registrational breast cancer study. If GOBLET’s initial results continue to show similar indications of efficacy, we will work to move expeditiously towards a late-stage pancreatic cancer trial that will de-risk our pipeline and provide additional opportunities to create stakeholder value. Alongside these internal programs, we continue to leverage preclinical data demonstrating pelareorep’s synergy with CAR T cells against solid tumors to advance business development efforts. We are fortunate to be supported in these various endeavors by a suite of top-flight biopharma collaborators, which allows us to execute on our objectives with a capital-efficient approach."

Second Quarter and Subsequent Highlights

Breast Cancer Program

Completed enrollment in phase 2 BRACELET-1 trial

BRACELET-1 is a randomized phase 2 trial in HR+/HER2- metastatic breast cancer that is being conducted under a co-development agreement with Pfizer Inc. and Merck KGaA (Darmstadt, Germany). Data from the trial represent the final confirmatory component of a data package Oncolytics intends to share with regulators to align on the best design for a registrational study. This package will also include the results of IND-213, a prior randomized phase 2 study in HR+/HER2- breast cancer that showed a statistically significant near doubling of median overall survival when pelareorep was combined with paclitaxel.

Following the completion of BRACELET-1’s 16-week patient monitoring period and database lock, Oncolytics will provide Pfizer and Merck KGaA with a study report. Delivery of the report will trigger a contractually-obligated 90-day exclusivity period during which the data cannot be publicly disclosed. Based on the expected timing of these steps, Oncolytics anticipates the public disclosure of BRACELET-1’s data to occur at a major oncology meeting in the first half of 2023. The change in the expected timing of the trial’s first data announcement will allow Oncolytics and its partners and collaborators to showcase not only top-line data on overall response rate, but also mature progression-free survival data, evolving overall survival data, and translational data. Oncolytics believes presenting this dataset as a whole will aid in its efforts to advance pelareorep towards registration as efficiently as possible. Oncolytics remains engaged with regulators and partners as it plans its registration program.

Biomarker data from AWARE-1 show pelareorep remodeling tumor microenvironments to improve prognosis and decrease the risk of recurrence in HR+/HER2- breast cancer patients

A poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Meeting featured data from AWARE-1’s first two cohorts, which evaluated changes in HR+/HER2- breast tumor microenvironments (TMEs) following treatment with pelareorep and letrozole without (cohort 1) or with (cohort 2) Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab. These data showed the prognosis of patients improving and their risk of cancer recurrence decreasing following treatment, as assessed by the well-validated PAM50 gene expression assay (link to PR, link to poster). All evaluable patients had a ‘low’ Risk of Recurrence Score after treatment compared to only 55% at baseline. Statistically significant increases in markers of tumor cell death and T cell activation were also observed. Together, these data further demonstrate pelareorep’s ability to activate the immune system and remodel TMEs in ways that improve the long-term outlook of cancer patients. Oncolytics anticipates presenting final AWARE-1 data in the fourth quarter of 2022.

Gastrointestinal Cancer Program

Achieved success criteria for efficacy in Stage 1 of the GOBLET trial’s pancreatic cancer cohort with partial responses in all phase 1b patients

Initial clinical data from the phase 1/2 GOBLET study’s pancreatic cancer cohort were featured in a poster at the ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer 2022 (link to PR, link to poster). These data revealed a strong efficacy signal with all phase 1b patients (n = 3) achieving a partial response following treatment with pelareorep in combination with atezolizumab and the chemotherapeutic agents gemcitabine and nab-paclitaxel. With these responses, the pancreatic cancer cohort has achieved the pre-specified success criteria for Stage 1. An independent safety review identified no safety concerns associated with the study treatment and recommended the study continue as planned. Collectively, these data suggest pelareorep synergizes with atezolizumab in pancreatic cancer and strongly support its continued evaluation in this highly challenging and prevalent indication. Oncolytics plans to report additional efficacy data on all evaluable patients in Stage 1 of GOBLET’s pancreatic cancer cohort at a major medical meeting in late 2022.

Additional Immunotherapeutic Opportunity

Science Translational Medicine paper provides external validation for the synergistic efficacy of pelareorep combined with chimeric antigen receptor (CAR) T cell therapy in murine solid tumor models

While long-term cures have been achieved with CAR T cell therapies in hematologic malignancies1, their efficacy against solid tumors has generally been poor. This severely limits the therapeutic and commercial potential of these therapies, as solid tumors represent the vast majority of cancer cases. A peer-reviewed preclinical study published in Science Translational Medicine suggests that pelareorep has the potential to realize the value of CAR T cells by enabling their success against solid tumors. In murine models of brain and skin cancer, loading CAR T cells with pelareorep led to statistically significant survival benefits compared to treatment with CAR T therapy alone (link to PR, link to the paper). The efficacy of pelareorep-loaded CAR T cells was augmented when mice received a subsequent intravenous dose (boost) of pelareorep, with results showing tumor cures in >80% of treated mice in each model. These impressive results were linked to the ability of pelareorep-loaded CAR T cells to overcome the three most significant barriers to effective CAR T therapy by dramatically increasing CAR T cell persistence, reversing immunosuppressive TMEs, and reducing antigen escape. Pelareorep’s ability to reduce antigen escape was due to the generation of dual-specific CAR T cells that targeted both tumor-derived and pelareorep proteins within the tumor. These immunotherapeutic effects position pelareorep to substantially expand the commercial potential presented by CAR T cell therapies since solid tumors offer a significant and unaddressed opportunity.

Corporate Updates

Elected James T. Parsons to the Board of Directors

Mr. Parsons has over twenty years of executive experience in the life sciences industry and served as Chief Financial Officer (CFO) of the immuno-oncology company Trillium Therapeutics Inc. through its acquisition by Pfizer for an aggregate purchase price of approximately US$2.2 billion.

Financial Highlights

As of June 30, 2022, the Company reported $33.7 million in cash and cash equivalents.
Operating expense for the second quarter of 2022 was $2.8 million, compared to $3.5 million for the second quarter of 2021.
R&D expense for the second quarter of 2022 was $3.2 million, compared to $3.2 million for the second quarter of 2021.
The net loss for the second quarter of 2022 was $5.1 million, compared to a net loss of $7.2 million in the second quarter of 2021. The basic and diluted loss per share was $0.09 in the second quarter of 2022, compared to a basic and diluted loss per share of $0.13 in the second quarter of 2021.
Net cash used in operating activities for the second quarter of 2022 was $6.9 million, compared to $6.8 million in the second quarter of 2021.
Anticipated Milestones and Catalysts

Additional efficacy data on all evaluable patients in Stage 1 of the phase 1/2 GOBLET study’s pancreatic cohort: Q4 2022
Final AWARE-1 study data: Q4 2022
Clinical data from Adlai Nortye’s bridging trial in HR+/HER2- metastatic breast cancer patients: Q4 2022
Overall response rate, progression-free survival, and evolving overall survival data from phase 2 BRACELET-1 metastatic breast cancer study: H1 2023
Webcast and Conference Call

Management will host a conference call for analysts and institutional investors at 8:30 a.m. ET today, August 11, 2022. To access the call, please dial (888) 220-8474 (North America) or (647) 484-0475 (International) and, if needed, provide confirmation number 8806-576. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 203-1112 (North America) or (647) 436-0148 (International) and using replay code: 8806-576#.