On March 27, 2019 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "ImmunoPrecise") (TSX VENTURE: IPA) (OTC PINK: IPATF) reported its financial results for Q3 ended January 31, 2019 (Press release, ModiQuest Therapeutics, MAR 27, 2019, View Source [SID1234534957]). The financial statements and related management’s discussion and analysis ("MD&A") can be viewed on SEDAR at www.sedar.com.

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Financial Highlights:

Revenue. During the three months ended January 31, 2019, the Company increased revenues to $2,695,583 from $1,723,308 in 2018. This represents a 56% increase in revenue and stems from the acquisitions of U-Protein and ModiQuest, the Company’s ability to grow its core business and expand its market share in Europe, and an increase in projects for the B-cell lab.
Gross Margin. During the three months ended January 31, 2019, the Company increased its gross margin to $1,568,055 from $989,203 in 2018. In percentage terms, the Company’s gross margin increased to 58% from 57% in 2018. The higher gross margin in 2019 was mostly attributable to the fact that the Company focused on higher margin projects at its new B-cell lab and introduced additional efficiencies into its operations. The Company anticipates that gross margin on a percentage basis will continue to be over 50% for the balance of fiscal 2019.
Net Loss. The Company recorded a net loss of $1,187,056 during the three months ended January 31, 2019, which is consistent with the net loss of $1,211,591 for three months ended January 31, 2018. $577,720 of the costs incurred during the three months ended January 31, 2019 were one-time costs which are not expected to be incurred again. These one-time costs included costs incurred to improve operational efficiency across all the divisions, to integrate U-Protein and ModiQuest into IPA’s global network, and to continue to establish a global structure for reporting and oversight. In the current period the Company also made investments that would enable its future growth, such as new management hires, more training programs, and additional space
Adjusted EBITDA. For the three and nine months ended January 31, 2019, excluding the one-time costs of $577,720 and $1,251,613, respectively, EBITDA would have been $116,367 and ($301,477), respectively.

Corporate:

On August 20, 2018, the Company announced that Mr. Guy Champagne resigned from his position as a Director of the Company, and joined the Company’s Advisory Board.

On November 21, 2018, the Company announced that Paul Andreola was appointed as a Director of the Company at its annual general meeting ("AGM") held in Vancouver, BC on November 20, 2018. Mr. Andreola has over 20 years of business development and financial markets experience including senior management, marketing, and communications roles for early stage companies. Previously in his career, Mr. Andreola was a licensed investment advisor for over 10 years and has facilitated multiple early stage private and public companies in the resource and technology sectors. Mr. Andreola is currently the CEO and Director of NameSilo Technologies Corp. (CSE: URL) and Ironwood Capital Corp. (TSXV: IRN.P).

On March 27, 2019 Elicio reported that it launched with $30 million in funding and an immunotherapy strategy aimed at getting cancer vaccines into the lymph nodes, a location that orchestrates immune responses but has been hard to target directly (Press release, Elicio Therapeutics, MAR 27, 2019, View Source [SID1234534871]).

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Elicio Therapeutics (Cambridge, Mass.) has exclusively licensed the Amphiphile platform from Darrell Irvine at the Koch Institute for Integrative Cancer Research at Massachusetts Institute of Technology. Irvine’s group figured out in 2014 how to ferry cancer vaccines into lymph nodes by tethering the vaccines to albumin to "hitchhike" on the carrier’s normal transportation route (see "Hitchhiker’s Guide to the Lymph Node").

Irvine’s group noticed that albumin effectively carried dyes and other compounds into the lymph nodes. In preclinical studies, the team showed that by conjugating vaccines to an albumin-binding lipid tail, tumor-targeting antigens and adjuvants elicited strong immune responses and slowed or reduced tumor growth in mice.

Elicio’s lead candidates from the Amphiphile platform will target pancreatic, colorectal and head and neck cancers. CEO Robert Connelly told BioCentury that Elicio is developing cancer vaccines with a range of different types of shared antigens, including viral antigens.

Connelly said the antigens Elicio is using "have only been delivered systemically, not directly to the lymph nodes," which results in weak immune responses and occasional systemic toxicity. "This is why cancer vaccines have been disappointing to date," he added.

Elicio plans to begin a Phase I/II trial in early 2020 of VED-002, a vaccine targeting KRAS mutations, to treat pancreatic cancer. Its second candidate, VED-001, is a vaccine targeting HPV E6 and E7 transforming proteins. It is set to enter the clinic in 2020 as a single agent and in combination with a checkpoint inhibitor for HPV-positive head and neck cancers.

Connelly declined to disclose the company’s investors.

Connelly was previously a venture partner at Flagship Pioneering and has served as CEO of multiple companies, including pulmonary disease company Pulmatrix Inc. (NASDAQ:PULM) from 2007 to 2012 and metabolic dysregulation company Axcella Health Inc. (Cambridge, Mass.) from 2013 to 2018.
Irvine is a professor of materials science and engineering and of biological engineering at MIT.

Targets: E6 transforming protein (Human papillomavirus-16) – HpV16gp1; E7 transforming protein (Human papillomavirus-16) – HpV16gp2; KRAS – K-Ras

On March 27, 2019 Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported that it has commenced an underwritten public offering of $300,000,000 in shares of its common stock (Press release, Blueprint Medicines, MAR 27, 2019, View Source [SID1234534711]). In addition, Blueprint Medicines expects to grant the underwriters a 30-day option to purchase up to an additional $45,000,000 in shares of its common stock in connection with the public offering. All shares of common stock will be offered by Blueprint Medicines.

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Blueprint Medicines expects to use the net proceeds of the offering to further build its commercial infrastructure and operations in support of one or more anticipated commercial launches of its drug candidates, including potential commercial launches of avapritinib in the United States and Europe, subject to regulatory approval; to fund clinical trials for avapritinib in gastrointestinal stromal tumors (GIST) and systemic mastocytosis (SM), including its planned registration-enabling Phase 3 COMPASS-2L clinical trial for second-line GIST and its ongoing registration-enabling Phase 2 PIONEER clinical trial for indolent and smoldering SM, as well as future indication expansion clinical trials; to fund clinical trials for BLU-667 in RET-driven cancers, including its planned Phase 3 clinical trial for BLU-667 in first-line RET-altered non-small cell lung cancer (NSCLC) and its planned Phase 2 clinical trial for BLU-667 in combination with osimertinib in treatment-resistant, EGFR-mutant NSCLC harboring an acquired RET alteration; to fund a planned Phase 2a clinical trial for BLU-782 in patients with fibrodysplasia ossificans progressiva; to fund manufacturing costs for ongoing and anticipated drug development efforts for its most advanced drug candidates, including a potential commercial launch of avapritinib; and the balance, if any, to fund additional discovery research efforts, its other ongoing and planned clinical trials, working capital requirements and other general corporate purposes.

Goldman Sachs & Co. LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering. Guggenheim Securities, LLC and Wedbush Securities Inc. are acting as co-lead managers for the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.

A registration statement on Form S-3 (File No. 333-216573) relating to these securities has been previously filed with the Securities and Exchange Commission (SEC) and has become effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

The offering will be made only by means of a prospectus. A copy of the prospectus supplement relating to the offering will be filed with the SEC and may be obtained, when available, from Goldman Sachs & Co. LLC by mail at Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, by fax at (212) 902-9316, or by email at [email protected], or from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (631) 274-2806, or by fax at (631) 254-7140

On March 27, 2019 Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported plans to expedite development of avapritinib, BLU-667 and BLU-782 based on recent clinical progress and interactions with regulatory authorities (Press release, Blueprint Medicines, MAR 27, 2019, View Source [SID1234534710]).

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"The updates we are announcing today for avapritinib, BLU-667 and BLU-782 represent the acceleration of multiple clinical-stage programs, including planned marketing applications for avapritinib and BLU-667, and highlight our commitment to executing a portfolio-based strategy," said Jeff Albers, Chief Executive Officer of Blueprint Medicines. "In addition, as we prepare to submit marketing applications for avapritinib for the treatment of PDGFRA-driven and fourth-line GIST in the United States in the second quarter and Europe in the third quarter, we are rapidly building global commercial capabilities to enable us to deliver this important new medicine, if approved, to patients in need."

Summary of Accelerated Regulatory Submission Plans and Recent Clinical Progress

Avapritinib: Gastrointestinal Stromal Tumors (GIST)

Blueprint Medicines now plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for avapritinib for the treatment of both PDGFRα D842V mutant GIST and fourth-line GIST in the third quarter of 2019.
Avapritinib: Advanced Systemic Mastocytosis (SM)

Blueprint Medicines now plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for avapritinib for the treatment of advanced SM in the first quarter of 2020, subject to continuing discussions with the FDA under its breakthrough therapy program to determine the required clinical data for an NDA submission.
BLU-667: RET-Altered Cancers

Top-line interim data from the Phase 1 ARROW clinical trial of BLU-667 for patients with RET-fusion non-small cell lung cancer (NSCLC) and RET-mutant medullary thyroid cancer (MTC) who were response evaluable and treated at the recommended Phase 2 dose of 400 mg once daily, as of November 14, 2018 with follow-up through a data cutoff date of March 1, 2019, showed the following:
In 34 patients with RET-fusion NSCLC previously treated with platinum-based chemotherapy, the overall response rate (ORR) was 62 percent.(1)
In 16 patients with RET-mutant MTC previously treated with the approved multi-kinase inhibitors cabozantinib and/or vandetanib, the ORR was 63 percent.(2)
BLU-667 was generally well-tolerated, and most adverse events (AEs) reported by investigators were mild or moderate (Grade 1 or 2). Across all doses and treatment cohorts (n=217), only eight patients discontinued treatment with BLU-667 due to treatment-related AEs, with one Grade 5 AE (pneumonia/lung infection) determined by the investigator to be possibly related to BLU-667.
Detailed clinical safety and efficacy data from the ARROW trial in RET-fusion NSCLC patients and RET-mutant MTC patients have been submitted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2019.
The enrollment target has been reached and patient screening is now closed for the registration-enabling ARROW trial cohort for patients with previously treated RET-fusion NSCLC. Blueprint Medicines anticipates reaching the enrollment target for the registration-enabling ARROW trial cohort for patients with previously treated MTC in the second quarter of 2019.
Based on the early achievement of the enrollment target for the RET-fusion NSCLC cohort, Blueprint Medicines now plans to submit an NDA to the FDA for BLU-667 for the treatment of patients with NSCLC previously treated with platinum-based chemotherapy in the first quarter of 2020. Blueprint Medicines continues to expect to submit an NDA to the FDA for BLU-667 for the treatment of patients with RET-mutant MTC previously treated with an approved multi-kinase inhibitor in the first half of 2020.
BLU-782: Fibrodysplasia Ossificans Progressiva (FOP)

Based on the progress of the ongoing Phase 1 clinical trial in healthy volunteers and input from clinical experts, Blueprint Medicines now plans to initiate a Phase 2a clinical trial of BLU-782 in patients with FOP in the fourth quarter of 2019.
Footnotes:
(1) 95 percent confidence interval (CI): 44-78 percent; five responses pending confirmation.
(2) 95 percent CI: 35-85 percent; three responses pending confirmation.

On March 27, 2019 Equillium, Inc. (Nasdaq: EQ), a biotechnology company leveraging deep understanding of immunobiology to develop products to treat severe autoimmune and inflammatory disorders with high unmet medical need, reported financial results for the fourth quarter and full-year ended December 31, 2018, and recent business highlights (Press release, Equillium, MAR 27, 2019, View Source [SID1234534706]).

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Business Highlights:

Completed a successful initial public offering in October 2018 resulting in gross proceeds of $71.6 million

Received FDA Fast Track designation and Orphan Drug designations for EQ001 for both the prevention and treatment of acute graft-versus-host disease (aGVHD)

Initiated the Phase 1b portion of the EQUATE trial for the frontline treatment of aGVHD

Announced plans to develop EQ001 for the treatment of lupus nephritis with a Phase 1b proof-of-concept clinical trial expected to commence in the second half of 2019

"The progress that we made during 2018, highlighted by our successful initial public offering in October, sets the stage for continued advancement of our pipeline this year with three clinical trials of our lead therapeutic candidate, EQ001, beginning with our EQUATE trial in aGVHD that commenced earlier this month," said Daniel Bradbury, chairman and chief executive officer of Equillium. "The recent announcement that we are exploring the clinical utility of EQ001 in lupus nephritis, in addition to aGVHD and uncontrolled moderate to severe asthma, leverages our research into the role of CD6-ALCAM pathway in immuno-inflammatory diseases, and represents a natural expansion of our pipeline targeting this potentially promising pathway. As we progress through 2019, we have line-of-sight to multiple potentially value-creating data catalysts beginning early next year, and believe we are well positioned to introduce a new class of therapeutic that can transform the lives of patients suffering from these serious and underserved medical conditions."

Upcoming Milestones:

Planned initiation of Phase 1b EQUIP proof-of-concept trial evaluating EQ001 for the treatment of uncontrolled moderate to severe asthma by the end of the second quarter of 2019

Planned initiation of Phase 1b proof-of-concept trial evaluating EQ001 for the treatment of lupus nephritis during the second half of 2019

Data from the Phase 1b portion of the EQUATE aGVHD trial expected during the first quarter of 2020, approximately 12 months following initiation

Fourth Quarter 2018 Financial Results

Research and development (R&D) expenses. Total R&D expenses for the three months ended December 31, 2018 were $2.5 million, compared with $0.5 million for the same period in 2017. The increase in R&D expenses was primarily driven by additional costs related to increased headcount, regulatory and clinical activity, and preclinical research activities to support Equillium’s clinical development program.

General and administrative (G&A) expenses. Total G&A expenses for the three months ended December 31, 2018 were $1.7 million, compared with $0.2 million for the same period in 2017. The increase in G&A expenses was primarily driven by increased headcount and other costs associated with supporting the increased level of clinical and corporate activities as Equillium transitioned to a public company.

Net loss. Total net loss for the three months ended December 31, 2018 was $5.0 million, compared with a net loss of $1.1 million for the same period in 2017.

Full-Year 2018 Financial Results

Research and development (R&D) expenses. Total R&D expenses for the year ended December 31, 2018 were $4.9 million, compared with approximately $1.3 million for the period March 16, 2017 (inception) through December 31, 2017. The increase in R&D expenses was primarily driven by additional costs related to increased headcount, regulatory and clinical activity, and preclinical research activities to support Equillium’s clinical development program.

General and administrative (G&A) expenses. Total G&A expenses for the year ended December 31, 2018 were $3.7 million, compared with $0.4 million for the period March 16, 2017 (inception) through December 31, 2017. The increase in G&A expenses was primarily driven by increased headcount and other costs incurred during the fourth quarter of 2018 associated with supporting the increased level of clinical and corporate activities as Equillium transitioned to a public company.

Net loss. Total net loss for the year ended December 31, 2018 was $13.3 million, compared with a net loss of $2.3 million for the period March 16, 2017 (inception) through December 31, 2017.

Cash, cash equivalents and short-term investments. Equillium held cash, cash equivalents and short-term investments totaling approximately $65.9 million at December 31, 2018, compared to $7.1 million at December 31, 2017. The increase was due to Equillium’s initial public offering in October 2018, partially offset by cash used in operations during 2018.