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.

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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#.

On August 11, 2022 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported financial results for the three and six months ended June 30, 2022, and provided a business update (Press release, Altimmune, AUG 11, 2022, View Source [SID1234618160]).

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"We continue to advance the development of pemvidutide, our GLP-1/glucagon dual receptor agonist, and look forward to reporting important readouts from our ongoing clinical trials during the coming months," said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. "We expect to announce top line data from our 12-week trial in subjects with obesity/overweight and NAFLD in mid-September 2022, followed by 24-week data from an extension of that trial in Q4 2022. Enrollment in our Phase 2 MOMENTUM obesity trial has been very robust. As of August 10, 167 subjects have been randomized, and approximately 25 additional subjects are being randomized each week. At this rate, we expect to complete the randomization of all 320 subjects in September 2022. We have also made the decision to conduct the interim analysis of this trial when approximately 50%, or 160 study participants, complete 24 weeks of treatment, which we expect will occur in Q1 2023. While we had planned to conduct an interim analysis on approximately 100 subjects at year end 2022, it is our current belief that an interim analysis on 50% of the subjects would be more meaningful."

"We believe that pemvidutide has the potential to deliver weight loss equaling or exceeding 20% after only 48 weeks of treatment. In addition, we believe that pemvidutide will have a highly differentiated product profile compared to other obesity products in development— including, no dose titration, faster weight loss and robust reductions in lipids. If achieved, we believe these features would translate into greater ease of administration, improved adherence to therapy, and greater potential for cardiovascular benefit," Dr. Garg added.

Recent Highlights and Anticipated Milestones:

Pemvidutide1 (ALT-801)

Topline data from 12-week Phase 1b trial in subjects with obesity/overweight and NAFLD expected mid-September 2022

This trial is being conducted in the U.S., with Dr. Stephen A. Harrison, Director, Pinnacle Research and University of Oxford, serving as Principal Investigator.
The trial is fully enrolled and has randomized and dosed a total of 94 subjects, of whom approximately 29% have type 2 diabetes. Treatments included 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo in a 1:1:1:1 ratio administered weekly for 12 weeks.
The topline data will include:
liver fat assessment by MRI-PDFF
weight loss
adverse events (AEs leading to discontinuation, rates of gastrointestinal AEs, severe and serious AEs)
laboratory parameters, including liver function tests and glucose
serum lipids
hemoglobin A1c
heart rate and blood pressure
Topline data from a 12-week extension to the Phase 1b trial expected in Q4 2022

This extension trial provides 12 weeks of additional treatment to subjects who completed the 12-week Phase 1b trial in subjects with obesity/overweight and NAFLD. This extension allows subjects to receive a total of 24 weeks of treatment.
The principal readouts are weight loss and the safety of pemvidutide at 24 weeks of treatment.
Enrollment is over 50% complete in 48-week Phase 2 MOMENTUM obesity trial – 24-week interim analysis of 160 subjects expected in Q1 2023

This Phase 2 trial is being conducted at approximately 25 sites in the U.S., with Dr. Lou Aronne, Professor of Clinical Medicine, Weill Cornell Medical College, a leading authority in obesity and obesity clinical trials, serving as the Principal Investigator.
The trial is expected to enroll approximately 320 non-diabetic subjects with obesity/overweight with at least one co-morbidity. Subjects are being randomized 1:1:1:1 to 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered weekly for 48 weeks in conjunction with diet and exercise.
The primary endpoint is the relative (percent) change in body weight at 48 weeks compared to baseline. Additional readouts include metabolic and lipid profiles, cardiovascular measures and glucose homeostasis.
As of August 10, 2022, 167 subjects have been randomized and approximately 25 additional subjects are being randomized each week. Based on the current rate of enrollment, Altimmune expects to complete the randomization of all 320 subjects in September 2022.
A 24-week interim analysis on approximately 50%, or 160 subjects, is planned in Q1 2023.

Enrollment ongoing in Phase 1b trial of diabetic subjects with obesity and overweight

This 12-week trial will evaluate the effects of pemvidutide on glucose control in approximately 48 subjects with type 2 diabetes.
Completion of enrollment is expected in September 2022, and data readout is expected in Q1 2023.
1proposed INN

HepTcell

Enrollment continuing in the Phase 2 clinical trial in chronic hepatitis B

Endpoints include virological markers of hepatitis B infection and functional cure.
Data readout is expected in H2 2023.
Financial Results for the Three Months Ended June 30, 2022

Altimmune had cash, cash equivalents and short-term investments totaling $184.8 million at June 30, 2022.
Revenue was minimal for the three months ended June 30, 2022 compared to $0.1 million in the same period in 2021. The change in revenue quarter over quarter was primarily due to the discontinuation of development activities for the T-COVID and NasoShield programs.
Research and development expenses were $16.0 million for the three months ended June 30, 2022, compared to $13.3 million in the same period in 2021. The expenses for the quarter ended June 30, 2022 included $8.7 million in direct costs related to development activities for pemvidutide and $1.4 million in direct costs related to development activities for HepTcell. In addition, approximately $1.9 million of expense was a non-cash expense associated with the achievement of the Phase 2 development milestone for pemvidutide.
General and administrative expenses were $4.4 million for the three months ended June 30, 2022, compared to $3.7 million in the same period in 2021. The change was primarily attributable to increased labor and labor-related expenses, including stock compensation.
Net loss for the three months ended June 30, 2022 was $20.1 million, or $0.42 net loss per share, compared to a net loss of $24.8 million, or $0.60 net loss per share, in the same period in 2021. Net loss for the three months ended June 30, 2021 included an $8.1 million impairment loss relating to a write-down of the construction-in-progress associated with the construction of the Lonza facility, which was to manufacture AdCOVID.
Conference Call Information:

Date: Thursday, August 11
Time: 8:30 am Eastern Time
Webcast: The conference call will be webcast live on Altimmune’s Investor Relations website at View Source
Dial-in: Participants who would like to join the call may register here to receive the dial-in numbers and unique PIN to access the call.
Following the conclusion of the call, the webcast will be available for replay on the Investor Relations page of the Company’s website at www.altimmune.com. The Company has used, and intends to continue to use, the IR portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

About Pemvidutide
Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and NASH. Activation of the GLP-1 and glucagon receptors is believed to mimic the complementary effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure. By combining GLP-1 and glucagon activity in a single peptide, pemvidutide has the potential to achieve weight loss equaling or exceeding 20% after only 48 weeks of treatment. Pemvidutide incorporates the EuPortTM domain, a proprietary technology that increases its serum half-life for weekly dosing while slowing the entry of pemvidutide into the bloodstream, which may improve its tolerability. In a 12-week Phase 1 clinical trial, pemvidutide-treated subjects demonstrated striking reductions in body weight, liver fat and serum lipids commonly associated with cardiovascular disease.

About HepTcell
HepTcell is a novel, investigational, immunotherapeutic comprised of nine synthetic peptides representing conserved hepatitis B (HBV) sequences formulated with IC31, a TLR9-based adjuvant from Valneva SE. The HBV-directed peptides are designed to drive T cell responses against all HBV genotypes towards a functional cure for chronic HBV in patients of diverse genetic backgrounds.

On August 11, 2022 Affimed N.V. (Nasdaq: AFMD) ("Affimed" or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported financial results for the second quarter ended June 30, 2022 and provided updates on preclinical, clinical and corporate progress (Press release, Affimed, AUG 11, 2022, View Source [SID1234618159]). "During the second quarter, we completed a public offering that enables Affimed to invest in its lead programs through key inflection points," said Dr. Adi Hoess, CEO of Affimed. "The second half of 2022 is shaping up to be very exciting with data updates from AFM13 monotherapy and combination studies and our AFM24 program at scientific conferences."

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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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CLINICAL STAGE PROGRAM UPDATES
AFM13 (CD30/CD16A)

The Company completed enrollment of its REDIRECT study (AFM13-202). REDIRECT is a phase 2, registration-directed study of AFM13 monotherapy in patients with relapsed/refractory CD30-positive peripheral T-cell lymphoma (PTCL).
Top-line data are expected to be reported in the fourth quarter of 2022. The focus of the initial data release will be on the overall response rate assessed by a blinded independent review committee and the preliminary assessment of response duration.

Enrollment continues in the phase 1/2 study in collaboration with The University of Texas MD Anderson Cancer Center (MD Anderson) evaluating cord-blood derived NK cells pre-complexed with AFM13 followed by single agent AFM13 in patients with relapsed/refractory CD30+ lymphomas.

Data presented at the 2022 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (AACR 2022) in the Clinical Trials Plenary Session by Dr. Yago Nieto, M.D., Ph.D., Professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson, reported that after a second cycle of treatment at the recommended phase 2 dose (RP2D), the complete response rate increased from 38% (5/13) as reported in December 2021 to 62% (8/13).

The overall objective response rate (ORR) remained at 100% and the treatment was safe and well tolerated by patients, enabling MD Anderson to continue treatment with up to four cycles as per the approved amended protocol. The main treatment- related side effect being infusion-related reactions. Investigators did not observe any cases of cytokine release syndrome (CRS), neurotoxicity or graft versus host disease often associated with T-cell therapies. In general, side effects observed in the trial were transient and did not lead to treatment delays or discontinuation.

Durability of response data presented at AACR (Free AACR Whitepaper) 2022 for patients treated at the RP2D was also promising. Of the eight patients who achieved a complete response (CR), seven remained in CR at median follow-up of 6.5 months, including two patients who remained in response after 10 months and two who received a consolidation autologous stem cell transplant (SCT).

The approved amendment to the AFM13-104 trial protocol allows for an increase in the number of CD30-positive lymphoma patients treated at the RP2D to 40 – including Hodgkin and non-Hodgkin’s lymphoma patients. Furthermore, under the amended protocol, patients can receive up to four cycles of treatment.

Enrollment continues to progress and as of July 31, 2022 30 patients have now been treated, including 24 at the RP2D. 11 additional patients have been treated at the RP2D since the AACR (Free AACR Whitepaper) 2022 data cutoff date.

The Company and MD Anderson expect to report updates on the study at a scientific conference in the fourth quarter of 2022.

The Company continues to make progress with third parties to ensure access to an off-the-shelf, cryopreserved NK cell product and expects to announce the development path for AFM13 with a specific NK cell in the second half of 2022.

Affimed is preparing for a meeting with the FDA later this year to discuss next development steps for this program and expects to provide an update once it receives feedback.

AFM24 (EGFR/CD16A)

The Company is continuing enrollment in the expansion phase of the monotherapy study at the RP2D (480 mg). The expansion cohorts include patients with renal cell carcinoma (clear cell), non-small cell lung cancer (EGFR mutant), and colorectal cancer (KRAS wild-type, MSS).

Enrollment also continues in two combination studies: a phase 1/2a combination study of AFM24 with the anti-PD-L1 checkpoint inhibitor atezolizumab (Tecentriq) (AFM24-102) and a phase 1/2a combination of AFM24 with SNK01, NKGen Biotech’s ex vivo expanded and activated autologous NK cell therapy (AFM24-103).

AFM24-102 is now enrolling patients at the 480 mg dose level of AFM24. The first cohort (160 mg) was completed successfully with no reports of dose limiting toxicities. AFM24-102 includes the treatment of patients with non-small cell lung cancer (EGFR wild-type), gastric and gastroesophageal junction adenocarcinoma and pancreatic/hepatocellular/biliary tract cancer. AFM24-103 is focused on the treatment of patients with non-small cell lung cancer (NSCLC, EGFR wild-type), squamous cell carcinoma of the head and neck, and colorectal cancer (KRAS wild-type/mutant, MSS).

Updates from the monotherapy study, including clinical data from the dose escalation phase will be shown at ESMO (Free ESMO Whitepaper) 2022. An additional update including correlative science data is expected to be presented at a scientific conference later this year. Affimed also expects to provide updates from the combination studies in the second half of 2022, including data from the dose escalation phase of AFM24-102 at a scientific conference in the fourth quarter of 2022.

PRECLINICAL PROGRAMS
AFM28 (CD123/CD16A)

As planned, the Company submitted an investigational new drug (IND) application to the FDA in June. Following feedback from the FDA related to the design of the dose escalation study, Affimed has made a strategic decision to voluntarily withdraw the IND. The Company plans to focus early clinical development of AFM28 in jurisdictions outside of the U.S.
The Company now anticipates initiating the phase 1 clinical study in the first half of 2023.
AFM28 is Affimed’s wholly-owned, bispecific, tetravalent innate cell engager (ICE) that targets CD16A on NK cells and macrophages, and CD123 on leukemic blasts and leukemic stem cells that are prevalent in acute myeloid leukemia (AML).

PRECLINICAL PIPELINE
Affimed is continuing to innovate and generate several novel ICE molecules derived from its proprietary ROCK platform.

PARTNERSHIPS AND COLLABORATIONS
Partnered programs with both Genentech and Roivant continue to progress according to plan. Affimed is eligible for additional proceeds from meeting pre-clinical and early regulatory achievement milestones.

SCIENTIFIC ADVISORY BOARD
During the quarter, the Company established an independent advisory panel made up of distinguished opinion leaders with scientific and clinical expertise in innate immunity and oncology. The Scientific Advisory Board (SAB) will provide guidance on the development strategy across preclinical and clinical development candidates as well as opportunities to apply our platform to cancer indications of high unmet need. All SAB members are leaders in a broad range of areas relevant to Affimed’s approach to developing cancer therapies including immuno-oncology, the biology of NK cells, lymphomas, leukemias, and solid tumors.

SECOND QUARTER 2022 FINANCIAL HIGHLIGHTS
Affimed’s consolidated financial statements are prepared in accordance with IFRS as issued by the International Accounting Standard Board (IASB). The consolidated financial statements are presented in euros, the Company’s functional and presentation currency.

As of June 30, 2022 cash and cash equivalents totaled €237.2 million compared to €197.6 million on December 31, 2021. Based on the Company’s current operating plan and assumptions, cash and cash equivalents are expected to support operations into mid-2024.

Net cash used in operating activities for the quarter ended June 30, 2022 was €26.5 million compared to €17.3 million for the quarter ended June 30, 2021.

Total revenue for the quarter ended June 30, 2022 was €7.3 million compared with €9.7 million for the quarter ended June 30, 2021. Revenue predominately relates to the Genentech and Roivant collaborations.

Research and development expenses decreased by 4% from €21.8 million in the quarter ended June 30, 2021 to €20.8 million for the quarter ended June 30, 2022. The decrease was primarily due to lower expenses associated with the development of the AFM13 and AFM24 programs, a result of a decrease in procurement of clinical trial material.

General and administrative expenses increased 54% from €5.4 million in the quarter ended June 30, 2021 to €8.4 million in the quarter ended June 30, 2022. The increase predominately relates to higher personnel, higher share-based payment expenses and increased insurance premiums.

Net finance income/(costs) increased from costs of €1.6 million for the quarter ended June 30, 2021 to income of €2.3 million for the quarter ended June 30, 2022. Net finance income/(cost) is largely made up of foreign exchange gains and losses related to assets denominated in U.S. dollars as a result of currency fluctuations between the U.S. dollar and the Euro during the year.

Net loss for the quarter ended June 30, 2022 was €19.4 million, or €0.13 loss per common share compared with a net loss of €18.8 million, or €0.16 loss per common share for the quarter ended June 30, 2021.

The weighted number of common shares outstanding for the quarter ended June 30, 2022 was 147.3 million.

Additional information regarding these results is included in the notes to the consolidated financial statements as of June 30, 2022 which will be included in Affimed’s filings with the U.S. Securities and Exchange Commission (SEC).

Note on International Financial Reporting Standards (IFRS)
Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles in the United States. Affimed maintains its books and records in Euro.

CONFERENCE CALL AND WEBCAST INFORMATION
Affimed will host a conference call and webcast on August 11, 2022 at 8:30 a.m. EDT / 14:30 CEST to discuss second quarter 2022 financial results and corporate developments. The conference call will be available via phone and webcast. To access the call, please dial +1 (866) 374-5140 for U.S. callers, or +1 (404) 400-0571 for international callers, and use PIN: 54780189# approximately 15 minutes prior to the call.
A live audio webcast of the conference call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source

A replay of the webcast will be accessible at the same link for 30 days following the call.