On May 7, 2020 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune diseases, reported financial results for the first quarter ended March 31, 2020 and provided a review of recent business and clinical highlights (Press release, Xencor, MAY 7, 2020, View Source [SID1234557262]).

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"Xencor’s XmAb technologies enable us, and our partners, to create antibodies and cytokines with enhanced properties and potential new mechanisms of therapeutic action. Today, our clinical-stage XmAb bispecific antibodies and cytokines include five wholly owned candidates, two being co-developed with partners and three being developed by our partners," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "Despite the challenges imposed by the COVID-19 pandemic, we are fortunate that our clinical trials and research activities continue to progress, with modest disruption to trial enrollment to date, and that we continue to enjoy a strong cash position. Our collaborations are also providing us with milestone payments and royalties, and we recently established new XmAb technology partnerships in viral infectious disease with Gilead Sciences and Vir Biotechnology, the latter of which is applying our Xtend Fc technology to antibodies in development for the treatment of patients with COVID-19."

Dr. Dahiyat continued, "Looking ahead, we continue to anticipate initial clinical results for our first two solid tumor programs in 2020, including initial Phase 1 data from XmAb20717, for which an abstract was accepted to the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program, and initial Phase 1 data from XmAb18087 later this year. Across our portfolio, we also look forward to initiating, subject to potential COVID-19 impacts, additional studies evaluating vibecotamab (XmAb14045) and plamotamab (XmAb13676), and we continue to enroll patients in the ongoing Phase 1 studies evaluating these programs. We are advancing research programs, as well, with preclinical data emerging from our first three internally developed 2+1 bispecific antibodies and an additional cytokine program."

Recent Business and Clinical Highlights

COVID-19 Business Update: Xencor is closely monitoring the pandemic caused by the novel coronavirus SARS-CoV-2, which causes the disease COVID-19.

Clinical Studies: The pandemic did not disrupt enrollment to Xencor’s six ongoing clinical studies during the first quarter of 2020. Clinical studies in oncology remain a high priority for patients, their families and their physicians; however, Xencor’s planned study initiations for vibecotamab and plamotamab and enrollment in its ongoing studies will likely be adversely affected in subsequent periods, as many clinical sites have delayed study initiations and have postponed enrollment in regions with significant numbers of COVID-19 cases.

Workforce and Research Operations: In mid-March, Xencor implemented measures to protect the health and safety of its employees, including a requirement for all non-laboratory employees to work remotely and a reduction of onsite laboratory staff density by implementing alternating shifts and reorganizing research facilities.

Licensing and Partnerships: Xencor is monitoring potential impacts to partnership revenues, which are primarily milestone payments and royalties. If the pandemic affects the sales or clinical and regulatory progress of partnered programs, Xencor’s revenue could be adversely affected in the future.

In addition, Xencor’s partners Alexion Pharmaceuticals and Vir Biotechnology each announced in April plans to initiate clinical studies evaluating antibodies that incorporate its Xtend Fc technology to treat patients with COVID-19.

XmAb20717: XmAb20717 is a PD-1 x CLTA-4 bispecific antibody targeting two immune checkpoint receptors and is engineered to selectively activate the tumor microenvironment (TME). XmAb20717 is being evaluated in an ongoing Phase 1 study, which is enrolling patients with advanced non-small cell lung cancer, renal cell carcinoma, prostate cancer and other cancers without approved checkpoint therapies to expansion cohorts, and the study continues to enroll patients in additional dose-escalation cohorts. An expansion cohort for patients with melanoma is fully enrolled. The American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) accepted an abstract (e15001) containing initial dose-escalation data to be published in the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program.

Phase 1 studies evaluating Xencor’s additional TME activators, XmAb22841 (CTLA-4 x LAG-3) and XmAb23104 (PD-1 x ICOS), are enrolling patients with select advanced solid tumors into dose-escalation cohorts.

XmAb24306: In March, Genentech dosed the first patient in a Phase 1 dose-escalation study to evaluate XmAb24306 as a single agent and in combination with atezolizumab. XmAb24306, Xencor’s first cytokine candidate, is an IL15/IL15Rα-Fc fusion protein that incorporates Xencor’s Xtend extended half-life technology. Xencor and Genentech are co-developing novel IL-15 cytokine therapeutics, including XmAb24306. The Phase 1 dose-escalation and expansion study, which is exploring XmAb24306 as a monotherapy and in combination with atezolizumab, will characterize the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity in patients with locally advanced or metastatic solid tumors.

Preclinical Programs: Xencor will present data from four preclinical-stage XmAb drug candidates, including three novel 2+1 bispecific antibodies targeting solid tumors and a novel cytokine, during Session II of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting to be held virtually June 22-24, 2020. CD3 bispecific antibodies engineered with a mixed valency format (e.g., two anti-tumor antigen binding domains and one CD3 binding domain) may potentially enhance redirected T-cell cytotoxicity (RTCC) of high antigen density tumor tissue versus low antigen density healthy tissue. The selectivity exhibited by the XmAb 2+1 bispecific antibody format potentially empowers CD3 bispecifics to address an expanded set of tumor antigens.

Select Partnered Programs: Xencor’s partners expand the use of XmAb technology by providing late-stage development capabilities, successful track records of developing or commercializing programs or have programs for potential combination with Xencor’s bispecific antibody or cytokine programs. Additionally, the plug-and-play nature of XmAb technologies enables selective access for licensees with limited effort or resources by Xencor.

Tafasitamab (MorphoSys): In March, MorphoSys announced that the U.S. Food and Drug Administration (FDA) accepted MorphoSys’ Biologics License Application (BLA) and granted priority review for tafasitamab in combination with lenalidomide for the treatment of patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL), and Xencor received a milestone payment of $12.5 million. Tafasitamab was initially developed by Xencor and incorporates an XmAb Cytotoxic Fc Domain to enhance its anti-tumor activity. The FDA has set a

Prescription Drug User Fee Act (PDUFA) goal date of August 30, 2020, and Xencor is eligible to receive an additional $25 million regulatory milestone payment related to DLBCL and royalties on net sales in the high-single to low-double digit percentages.

AMG 509 (Amgen): AMG 509 is Amgen’s STEAP1 x CD3 XmAb 2+1 bispecific antibody, developed under Xencor’s Amgen collaboration. Amgen is developing AMG 509 for patients with prostate cancer and Ewing sarcoma. Preclinical data were presented during Session I of the AACR (Free AACR Whitepaper) Virtual Annual Meeting in April. Amgen is recruiting patients in a Phase 1 study of AMG 509 in patients with metastatic castration-resistant prostate cancer (mCRPC).

Anti-HIV Antibodies (Gilead Sciences): In January, Xencor and Gilead Sciences entered into a license agreement under which Gilead has been granted access to Xencor’s Xtend extended half-life and Cytotoxic XmAb Fc technologies to develop and commercialize elipovimab (GS-9722), which is currently being evaluated in a Phase 1 clinical study for HIV, and options for up to three additional anti-HIV antibodies. Gilead has since exercised the three options. Xencor has received $13.5 million in upfront and option payments.

Anti-COVID-19 Antibodies (Vir Biotechnology): In March, Xencor and Vir Biotechnology entered into a second license agreement, under which Vir has non-exclusive access to Xencor’s Xtend Fc technology to extend the half-life of novel antibodies that Vir is investigating as potential treatments for patients with COVID-19. Vir has announced plans to proceed directly into a Phase 2 study within the coming months. Xencor is eligible to receive royalties on the net sales of approved products in the mid-single digit percent range.

First Quarter Ended March 31, 2020 Financial Results

Cash, cash equivalents and marketable securities totaled $609.9 million at March 31, 2020, compared to $601.3 million at December 31, 2019. The increase reflects upfront and milestone payments related to licensing agreements, net of cash used to fund operating activities in the first quarter of 2020.

Total revenue for the first quarter ended March 31, 2020 was $32.4 million, compared to $111.9 million for the same period in 2019. Revenues in the first quarter of 2020 included milestone revenue recognized from MorphoSys, royalty revenue recognized from Alexion and licensing revenue recognized from Aimmune and Gilead, compared to revenues from the same period in 2019, which primarily reflects licensing revenue from Genentech.

Research and development expenditures for the first quarter ended March 31, 2020 were $33.9 million, compared to $28.2 million for the same period in 2019. Additional spending on research and development expenses for the first quarter of 2020 reflects increased spending on the plamotamab and XmAb20717 programs, partially offset by reduced spending on the obexelimab program.

General and administrative expenses for the first quarter ended March 31, 2020 were $7.2 million, compared to $5.5 million in the same period in 2019. Additional spending on general and administrative expenses for the first quarter of 2020 reflects increased spending related to personnel and professional fees.

Non-cash, stock-based compensation expense for the first quarter ended March 31, 2020 was $6.5 million, compared to $5.9 million for same period in 2019.

Net loss for the first quarter ended March 31, 2020 was $8.1 million, or $(0.14) on a fully diluted per share basis, compared to net income of $80.0 million, or $1.38 on a fully diluted per share basis, for the same period in 2019. The net loss reported for first quarter of 2020 compared to the income for the same period in 2019 is primarily due to revenue recognized from Xencor’s Genentech collaboration in 2019.

The total shares outstanding were 57,001,253 as of March 31, 2020, compared to 56,349,389 as of March 31, 2019.

Financial Guidance

Based on current operating plans, Xencor expects to have cash to fund research and development programs and operations into 2024. Xencor expects to end 2020 with between $500 million and $550 million in cash, cash equivalents and marketable securities.

Conference Call and Webcast

Xencor will host a conference call today at 4:30 p.m. ET (1:30 p.m. PT) to discuss these first quarter 2020 financial results and provide a corporate update.

The live call may be accessed by dialing (877) 359-9508 for domestic callers or +1 (224) 357-2393 for international callers and referencing conference ID number 6686425. A live webcast of the conference call will be available online from the Investors section of Xencor’s website at www.xencor.com. The webcast will be archived on Xencor’s website for 30 days.

On May 7, 2020 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, reported that the company will hold a conference call and live webcast on Tuesday, May 19, 2020 at 4:30 p.m. Eastern Time (ET) to review its first quarter 2020 financial results and provide a business update (Press release, Ascendis Pharma, MAY 7, 2020, View Source [SID1234557261]).

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Conference Call Details

Date Tuesday, May 19, 2020
Time 4:30 p.m. ET/1:30 p.m. Pacific Time
Dial In (U.S.) 844-290-3904
Dial In (International) 574-990-1036
Access Code 8295749

A live webcast of the conference call will be available on the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will be available on this website shortly after conclusion of the event for 30 days.

On May 7, 2020 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, reported its financial results for the first quarter of 2020 and provided research and development (R&D) and business highlights (Press release, Aclaris Therapeutics, MAY 7, 2020, View Source [SID1234557260]).

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"In the first quarter, we borrowed $11 million from Silicon Valley Bank enabling us to extend our cash runway, and started enrolling subjects with moderate-to-severe rheumatoid arthritis in our Phase 2a trial of ATI-450. As a result of the COVID-19 pandemic and as a precautionary measure, we temporarily paused subject enrollment in this trial. At this time, we have decided to resume enrollment at one clinical trial site. We will continue to monitor the COVID-19 pandemic and engage additional clinical trial sites, as appropriate, based on our assessment of the impact on our trial. I’m proud of our team’s focus, dedication and resilience while navigating through the unique challenges that the COVID-19 pandemic has created," said Dr. Neal Walker, President and CEO of Aclaris.

R&D Highlights:
The global outbreak of COVID-19 continues to rapidly evolve and has caused and may continue to cause Aclaris to experience disruptions that could impact the timing of its regulatory and research and development activities listed below.

ATI-450:
ATI-450 is an investigational oral small molecule MK2 inhibitor.
ATI-450-RA-201: A Phase 2a trial to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ATI-450 in subjects with moderate-to-severe rheumatoid arthritis.
Aclaris started subject enrollment in the first quarter of 2020. Due to the COVID-19 pandemic, Aclaris temporarily paused enrollment of subjects in the trial. At this time, Aclaris has decided to resume enrolling subjects at one clinical trial site. The initiation of additional clinical trial sites will be determined on an ongoing basis as the COVID-19 pandemic evolves.
Aclaris previously anticipated reporting data from this trial in the second half of 2020; however, Aclaris expects that the data may be delayed and will provide an update, at a later date, regarding the timing of reporting data from this trial.
ATI-450-PKPD-101: This Phase 1 single and multiple ascending dose (SAD/MAD) trial evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered ATI-450 in 77 healthy subjects.
Final data from this trial demonstrated that ATI-450:
resulted in marked inhibition of TNFα, IL1β, IL8, and IL6;
was generally well-tolerated at all doses tested in the trial. The most common adverse events (reported by 2 or more subjects who received ATI-450) observed during the trial were dizziness, headache, upper respiratory tract infection, constipation, abdominal pain, and nausea;
had dose-proportional pharmacokinetics (PK) with a terminal half-life of 9-12 hours in the MAD cohort; and
had no meaningful food effect or drug-drug interaction with methotrexate.
Aclaris is also planning to initiate a Phase 2a clinical trial of ATI-450 in an additional immuno-inflammatory indication.

ATI-1777:
ATI-1777 is an investigational topical soft-Janus Kinase (JAK) inhibitor compound.
Aclaris expects to submit an IND for ATI-1777 for the treatment of atopic dermatitis in mid-2020.
If the IND is allowed, Aclaris expects to initiate a Phase 1/2 clinical trial in subjects with atopic dermatitis in the second half of 2020 evaluating ATI-1777 as a potential topical treatment for moderate-to-severe atopic dermatitis.

ATI-2138:
ATI-2138 is an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound that Aclaris is developing as a potential treatment for psoriasis and/or inflammatory bowel disease.
Aclaris expects to submit an IND for ATI-2138 in the fourth quarter of 2020 or the first quarter of 2021.
Business Development Highlights:

Aclaris continues to pursue strategic alternatives, including seeking partners for:
A-101 45% Topical Solution: to obtain regulatory approval and commercialize A-101 45% Topical Solution, an investigational compound, as a potential treatment for common warts (verruca vulgaris);
ATI-501 & ATI-502: to further develop, obtain regulatory approval and commercialize ATI-501 (oral) and ATI-502 (topical), investigational JAK 1/3 inhibitor compounds, as potential treatments for alopecia; and
ESKATA: to commercialize ESKATA (hydrogen peroxide) topical solution, 40% (w/w).
Financial Highlights:
Liquidity and Capital Resources

As of March 31, 2020, Aclaris had aggregate cash, cash equivalents and restricted cash and marketable securities of $79.0 million compared to $75.0 million as of December 31, 2019. For the quarter ended March 31, 2020, net cash used in operating activities was $6.8 million, which includes $5.2 million received from Allergan Sales, LLC on behalf of EPI Health, LLC for sales of RHOFADE (oxymetazoline hydrochloride) cream, 1%. On March 30, 2020, Aclaris entered into a loan and security agreement with Silicon Valley Bank pursuant to which Aclaris borrowed $11.0 million. As of March 31, 2020, Aclaris had approximately 41.8 million shares of common stock outstanding.

Aclaris anticipates that its cash, cash equivalents and marketable securities as of March 31, 2020, will be sufficient to fund its operations into the first quarter of 2022, without giving effect to any potential business development transactions or financing activities.

First Quarter 2020 Financial Results

The accompanying consolidated statements of operations and selected consolidated balance sheet data have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to Aclaris’ commercial products as discontinued operations. The accompanying financial statement data are generally presented in conformity with Aclaris’ historical format. Aclaris believes this format provides comparability with its previously filed financial statements.
Net loss was $15.6 million for the first quarter of 2020, compared to $37.6 million for the first quarter of 2019. Total costs and expenses from continuing operations for the first quarter of 2020 were $16.9 million, compared to $28.3 million for the first quarter of 2019.
Total costs and expenses in the first quarter of 2020 included non-cash stock-based compensation expense of $3.5 million, compared to $4.3 million in the prior year period.
R&D expenses were $9.4 million for the quarter ended March 31, 2020, compared to $19.6 million for the prior year period.
The quarter-over-quarter decrease of $10.2 million was primarily the result of the substantial completion of Aclaris’ various Phase 2 clinical trials of ATI-501 and ATI-502 and two pivotal Phase 3 clinical trials of A-101 45% Topical Solution in 2019, and the corresponding reduction in personnel costs to support these programs.
These reductions were offset by a $1.8 million non-cash charge for the change in the fair value of contingent consideration that was recorded in the first quarter of 2020.
General and administrative expenses were $6.2 million for the first quarter of 2020, compared to $7.5 million for the first quarter of 2019. The decrease was primarily the result of lower personnel and stock-based compensation related costs due to lower headcount.
Loss from continuing operations was $15.3 million for the first quarter of 2020 compared to $27.3 million for the first quarter of 2019, while our loss from discontinued operations was $0.3 million for the first quarter of 2020 compared to $10.3 million for the first quarter of 2019.

On May 7, 2020 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, financial results for the three-month period ended March 31, 2020 (Press release, Spectrum Pharmaceuticals, MAY 7, 2020, View Source [SID1234557259]).

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"The progress in our development pipeline speaks to the investigator interest and the commitment of our team during these unprecedented times," said Joe Turgeon, President and CEO, Spectrum Pharmaceuticals. "The PDUFA date for ROLONTIS remains October 24, 2020 and our updated poziotinib strategy is well under way. We continue to drive the business forward and remain focused on achieving our milestones this year."

Pipeline Updates

ROLONTIS (eflapegrastim), a novel long-acting G-CSF

FDA is actively reviewing the BLA for ROLONTIS for the treatment of chemotherapy-induced neutropenia. The PDUFA target action date for the ROLONTIS BLA is October 24, 2020.
Company-sponsored study evaluating the administration of ROLONTIS on the same day as chemotherapy, dosed its first patient. The trial will evaluate the duration of severe neutropenia when administered at three different time points on the same day following standard chemotherapy in patients with early stage breast cancer.
Poziotinib, an irreversible tyrosine kinase inhibitor targeting EGFR and HER2 mutations

Spectrum presented additional results for Cohort 1 from its Phase 2 clinical trial, ZENITH20, evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations at a plenary session of the virtual American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting on April 27, 2020. The podium presentation included additional safety and efficacy data. Although the results for Cohort 1 did not meet the primary endpoint, as previously announced, poziotinib demonstrated a 68.7% disease control rate.
Spectrum provided an update on its ZENITH20 trial evaluating poziotinib in NSCLC patients with EGFR and HER2 exon 20 insertion mutations. The protocol has been amended to explore additional dosing regimens and the earlier use of corticosteroids in an effort to increase drug compliance.
Cohort 2 of the ZENITH20 trial enrolling previously treated HER2 NSCLC patients is fully accrued as previously announced and is expected to have topline results released in mid-2020. Cohort 3 of the ZENITH20 trial enrolling first-line EGFR NSCLC patients is now fully enrolled and is expected to have topline results in the second half of 2020. Either cohort has the potential to support a future NDA submission.
Three-Month Period Ended March 31, 2020 (All numbers are from Continuing Operations and are approximate)

GAAP Results

Spectrum recorded a net loss of $40.6 million, or $0.36 loss per basic and diluted share, in the three-month period ended March 31, 2020, compared to net loss of $39.8 million, or $0.36 loss per basic and diluted share, in the comparable period in 2019. Total research and development expenses were $16.0 million in the quarter, as compared to $21.9 million in the same period in 2019. Selling, general and administrative expenses were $14.8 million in the quarter, compared to $16.0 million in the same period in 2019.

The company ended the quarter with cash, cash equivalents, and marketable securities of $177.8 million.

Non-GAAP Results

Spectrum recorded a non-GAAP net loss of $25.0 million, or $0.22 per basic and diluted share, in the three-month period ended March 31, 2020, compared to a non-GAAP net loss of $29.2 million, or $0.27 per basic and diluted share, in the comparable period in 2019. Non-GAAP research and development expenses were $14.6 million, as compared to $20.4 million in the same period of 2019. Non-GAAP selling, general and administrative expenses were $10.8 million, as compared to $10.7 million in the same period in 2019.

Conference Call and Webcast

Spectrum’s management will host a webcast and conference call today, May 7, 2020, at 4:30 p.m. ET / 1:30 p.m. PT to discuss the financial results and provide a corporate update. The live call may be accessed by dialing (877) 837-3910 for domestic callers and (973) 796-5077 for international callers and entering the conference ID#: 8470139. A live webcast of the call will be available from the Investor Relations section of the company’s website at View Source and will be archived there shortly after the live event.

On May 7, 2020 IMV Inc. ("IMV" or the "Company") (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines to fight against infectious diseases including COVID-19, reported that it has completed its previously announced non-brokered private placement (the "Private Placement") of 8,770,005 units of the Company (each, a "Unit") at Cdn$2.86 per Unit for gross proceeds of approximately Cdn$25.1 million (Press release, IMV, MAY 7, 2020, View Source [SID1234557258]). The size of the Private Placement has increased by approximately Cdn$2.8 million following our earlier announcement on April 30, 2020.

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Each Unit consists of one common share of the Company ("Common Share") and 0.35 of one common share purchase warrant (each whole common share purchase warrant, a "Warrant"). Each Warrant entitles its holder to purchase one Common Share at an exercise price of Cdn$3.72 per share and is exercisable until May 7, 2022.

The private placement is being co-led by Fonds de Solidarité FTQ, an existing investor, and Lumira Ventures, a new investor in the Company, along with participation by Altium Capital, also a new investor in IMV, together with incumbent investors.

The Company intends to use the net proceeds from the Private Placement for the clinical development of its lead candidate, DPX-Survivac, currently being assessed in advanced ovarian cancer, as well as in multiple clinical studies in combination with Merck’s Keytruda. The balance of the net proceeds will be used for general corporate purposes, including funding research and development, preclinical and clinical expenses, and corporate costs.

All securities issued pursuant to the Private Placement will be subject to a four month and one day hold period in Canada in accordance with applicable securities laws.

Fred Ors, President and CEO of IMV commented, "We are pleased to welcome both Lumira Ventures and Altium Capital as new investors and thank Fonds de Solidarité FTQ for their leadership in this round of financing. We greatly appreciate the confidence shown in the Company. We look forward to further advancing our existing clinical pipeline and leveraging our unique and proprietary delivery platform against other selected targets including COVID-19."

"Since 1989, the Fonds de Solidarité FTQ has supported the life sciences sector with direct investments in companies and in specialized funds which invest in Québec. More than ever, it is important to proactively support our portfolio companies like IMV that give hope to patients in particular and society in general, whether it be for the fight against cancer or COVID-19," said Didier Leconte, Vice-President for Investments, Life Sciences and Funds of Funds, at the Fonds de Solidarité FTQ.

"We believe that an effective immunotherapy treatment must be capable of eliciting rapid, robust, and long-lasting responses and we have been impressed with the ability of the DPX platform to produce clinical evidence of such type of immune responses. We are happy to support IMV in advancing such a differentiated immunotherapy approach to potentially provide a much needed new treatment ption for women with advanced ovarian cancer." said Daniel Hétu, Managing director at Lumira Ventures.