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Immunitas Therapeutics Completes $58 Million Series B Financing to Advance Pipeline into the Clinic and Expand Single Cell Analysis Drug Development Platform for Immuno-Oncology and Other Diseases

On August 18, 2021 Immunitas Therapeutics ("Immunitas"), a single cell genomics-based therapeutics company, reported the completion of a $58 million Series B financing led by Agent Capital with participation from Medical Excellence Capital (MEC), 120 Capital, Solasta Ventures, Mirae Asset, Ono Venture Investment, The Mark Foundation for Cancer Research, NS Investment, BrightEdge (American Cancer Society), and The Leukemia & Lymphoma Society Therapy Acceleration Program (LLS TAP) (Press release, Immunitas Therapeutics, AUG 18, 2021, View Source [SID1234586720]). Existing investors Alexandria Venture Investments, Evotec, Leaps by Bayer, M Ventures, Novartis Venture Fund (NVF), and founding investor Longwood Fund also joined the round. As part of the financing, Geeta Vemuri, PhD, MBA, Managing Partner and Founder of Agent Capital, and Brian Halak, PhD, on behalf of MEC will join the Immunitas Board of Directors.

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"Immunitas has made tremendous strides in the past year. This Series B financing is a key inflection point for the company and will enable us to drive IMT-009 rapidly into the clinic, while continuing to build and validate our pipeline of novel oncology programs," said Jeffrey Goldberg, Chief Executive Officer of Immunitas Therapeutics. "Our single cell technology platform allows our team to incorporate insights from human biology throughout the discovery and development process, enabling us to rapidly move towards serving patients in need."

The Series B funding will be used to advance Immunitas’ lead program, IMT-009, a CD161 inhibitor, into the clinic to treat both solid tumors and hematological malignancies. Both blockade and knockout of CD161 in preclinical systems have shown enhanced tumor-killing, increases in critical cytokines, and increased survival. The company expects to file its first Investigational New Drug application (IND) in 1H 2022 for IMT-009. This financing builds on the $39 million Series A financing secured in 2019. Immunitas Therapeutics was founded by Kai Wucherpfennig, MD, PhD, Dana-Farber Cancer Institute, K. Dane Wittrup, PhD, the Massachusetts Institute of Technology (MIT), Mario Suvà, MD, PhD, Massachusetts General Hospital (MGH), and Aviv Regev, PhD, MIT.

"Immunitas is focused on creating impactful therapies that modulate oncology targets, driven by a cross-functional platform that combines single cell analysis computation and molecular and cellular biology to rapidly identify and validate new targets," said Geeta Vemuri of Agent Capital. "This approach is well suited to provide powerful translational insights into biomarker and indication selection with long-term potential beyond IO."

In addition, Amanda Wagner, MBA, has been appointed Chief Business Officer in recognition of her significant contributions to the company’s business and corporate development. Ms. Wagner was one of the earliest employees of Immunitas, joining the company in October 2019 as Vice President of Strategy. Ms. Wagner has more than 15 years of experience in drug discovery, drug development, and medical technology, and has led teams to identify, research, and develop novel immune-modulating therapies. At Immunitas, Ms. Wagner has led the structuring and negotiation of multiple strategic collaborations and driven the progression of the lead program and pipeline. Prior to joining Immunitas, she was Vice President of Corporate Development at Q32 Bio, where she contributed to the company’s $46 million Series A. Previously, Ms. Wagner was at Concert Pharmaceuticals, where she managed a $250 million asset sale, directly contributed to the Initial Public Offering, and identified and led the development of a preclinical therapeutic for autoimmune disease, now in Phase 3. Prior to Concert, Ms. Wagner was an early member of the team at UpToDate, Inc. Ms. Wagner also sits on the Board of Directors of the National Alopecia Areata Foundation.

Anixa Biosciences Announces Issuance of U.S. Patent for Ovarian Cancer Vaccine Technology

On August 18, 2021 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that the U.S. Patent and Trademark Office has issued the first U.S. patent for its novel ovarian cancer vaccine technology (Press release, Anixa Biosciences, AUG 18, 2021, View Source [SID1234586719]). This technology was invented and developed at Cleveland Clinic and Anixa is the worldwide licensee. A European patent covering this technology was issued earlier this year.

The patent is titled, "Ovarian Cancer Vaccines," and the inventors are Drs. Vincent K. Tuohy, Suparna Mazumder, and Justin M. Johnson, all of Cleveland Clinic.

"The ovarian cancer vaccine targets a protein (the Extracellular Domain of the Anti-Mullerian Hormone Receptor 2, AMHR2-ED) that is normally expressed only in the ovaries of pre-menopausal women. After menopause, the target protein is no longer expressed in normal tissues and is only found again in ovarian cancer cells. Our vaccine targets the AMHR2-ED protein and trains the immune system to destroy ovarian cancer cells as they arise," said Dr. Tuohy of the Department of Inflammation and Immunity at Cleveland Clinic’s Lerner Research Institute. "We are looking forward to working together to further develop this technology."

Dr. Amit Kumar, President and CEO of Anixa Biosciences, said, "We are pleased that the U.S. Patent and Trademark Office has issued this patent. This technology is now patented in Europe and the U.S., and we continue to prosecute the intellectual property in other jurisdictions." Dr. Kumar continued, "This ovarian cancer vaccine has the potential to prevent one of the deadliest malignancies in women. Ovarian cancer is often diagnosed after it has reached stage 3 or 4, when it is difficult to effectively treat. Outcomes for ovarian cancer patients are poor, so if this vaccine is able to eliminate the onset of ovarian cancer, the impact for women and for our healthcare system would be significant. We are also pleased that the National Cancer Institute’s PREVENT program will collaborate and financially support the development of this vaccine."

PROMIS NEUROSCIENCES INC. ANNOUNCES PRICING OF US$15 MILLION PUBLIC OFFERING OF UNITS

On August 18, 2021 ProMIS Neurosciences Inc. ("ProMIS" or the "Company") (TSX: PMN), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported the pricing of its previously announced public offering (the "Offering") (Press release, ProMIS Neurosciences, AUG 18, 2021, View Source [SID1234586717]). Pursuant to the Offering, the Company will issue up to 93,750,000 units (the "Units") at a price of US$0.16 per Unit (the "Issue Price") for aggregate gross proceeds of US$15 million, exclusive of the Agent’s Option (as defined herein) and before deducting the Agent’s Cash Commission (as defined herein) and estimated Offering expenses payable by the Company. Each Unit consists of one common share of the Company (a "Common Share") and one quarter of one Common Share purchase warrant (each whole purchase warrant, a "Warrant"). Each Warrant will entitle the holder thereof to purchase one Common Share (each, a "Warrant Share") at a price of US$0.21 per Warrant Share at any time up to 60 months following the issuance date thereof, subject to acceleration.

The Offering will be conducted on a commercially reasonable efforts basis pursuant to the terms and conditions of an agency agreement to be entered into between the Company and Leede Jones Gable Inc. (the "Agent"). In connection with the Offering, the Agent will be paid a cash commission equal to 7.0% of the gross proceeds of the Offering (including any gross proceeds raised on exercise of the Agent’s Option) (the "Agent’s Cash Commission") and it will be issued that number of broker warrants exercisable for Common Shares (the "Compensation Warrant Shares") equal to 7.0% of the number of Units sold in the Offering (including any additional Units issued on exercise of the Agent’s Option). The Company will also grant the Agent an option (the "Agent’s Option"), exercisable, in whole or in part, at the sole discretion of the Agent, to increase the size of the Offering by up to 15%. The Agent’s Option is exercisable, in whole or in part, at any time until the date that is two business days prior to the Closing Date (as defined herein).

The Offering is expected to close on or about August 24, 2021, or such other date as may be mutually agreed to by the Company and the Agent (the "Closing Date"), subject to satisfaction of customary closing conditions, including the approval of the listing of the Common Shares, Warrant Shares and Compensation Warrant Shares on the Toronto Stock Exchange (the "TSX").

The Offering is being made pursuant to a prospectus supplement to the Company’s short form base shelf prospectus dated June 30, 2021 (the "Base Prospectus"), which the Company will file with the securities commissions or other security regulatory authorities in each of the provinces and territories of Canada (other than Québec). Additionally, the Offering is expected to be conducted by way of private placement in other jurisdictions where the Offering can lawfully be made.

The Company intends to use the net proceeds from the Offering (including additional proceeds from the possible exercise of the Agent’s Option) to advance its lead Alzheimer’s therapy PMN310 to the filing of an Investigational New Drug application to enable a first clinical trial, expanding the ProMIS portfolio of antibodies and patents, and general corporate purposes, as more fully described in the preliminary prospectus supplement of the Company dated August 17, 2021 (the "Preliminary Prospectus Supplement").

The securities referred to in this news release have not been, nor will they be, registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), or applicable state securities laws, and such securities may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons (as such terms are defined in Regulation S under the U.S. Securities Act) absent registration or an applicable exemption from such registration requirements. This news release does not constitute an offer for sale of securities nor a solicitation for offers to buy any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

BioLineRx Reports Second Quarter 2021 Financial Results and Provides Corporate Update

On August 18, 2021 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported its financial results for the quarter ended June 30, 2021 and provides a corporate update (Press release, BioLineRx, AUG 18, 2021, View Source [SID1234586716]).

Significant events and achievements during the second quarter 2021 and subsequent period:

Announced positive topline results from GENESIS Phase 3 trial of Motixafortide in stem-cell mobilization (SCM). The data demonstrate that the study successfully met all primary and secondary endpoints with an exceptionally high level of statistical significance (p<0.0001), including approximately 90% of patients who mobilized enough cells for transplantation with only one administration of Motixafortide and in only one apheresis session.
Based on the positive results from the GENESIS study, the Company is aggressively proceeding with activities in support of an NDA submission in stem cell mobilization anticipated in the first half of 2022, including a pre-NDA meeting with the FDA planned for the second half of this year. This is consistent with prior guidance.
Continued to advance a pharmacoeconomic cost effectiveness study of Motixafortide in SCM to establish Motixafortide as the new standard-of-care mobilization agent (in combination with G-CSF). The aim of the study is to demonstrate the cost benefits related to the use of Motixafortide, due to a reduction in the number of doses of G-CSF and apheresis sessions required, a reduction in the number of rescue therapies required, higher rates of transplantation, and quality-of-life benefits in Motixafortide-treated patients; initial data on track to be announced in the second half of this year.
Ended the second quarter on a solid financial footing, with cash and cash equivalents of $66 million.
"Following the overwhelmingly positive results from our Phase 3 GENESIS trial of Motixafortide in stem-cell mobilization that we announced in May, we are working vigorously to submit an NDA in the first half of next year," stated Philip Serlin, Chief Executive Officer of BioLineRx. "If approved, this would be transformative for BioLineRx as we would have a commercial-stage molecule in stem cell mobilization for transplantation in multiple myeloma, the standard of treatment for this disease, along with significant potential clinical utility in other cancer indications, most notably pancreatic cancer."

Mr. Serlin continued, "GENESIS has shown the ability of Motixafortide to mobilize substantially more than the target number of stem cells necessary for transplantation – in approximately 90% of cases with only one dose of Motixafortide and in one apheresis session – potentially resulting in significant clinical benefits for patients and cost savings for payers. We believe there is a compelling clinical and pharmacoeconomic case to be made for the use of Motixafortide as the new standard-of-care for all multiple myeloma patients. To that end, we are advancing a pharmacoeconomic cost effectiveness study that we believe will strongly support our case for the use of Motixafortide as the backbone of a new SCM treatment paradigm.

"In parallel with these activities, the versatility of Motixafortide demonstrated in studies to date has attracted interest from potential partners, and we continue to engage in productive discussions.

"We are very well financed with $66 million of cash, sufficient to bring Motixafortide through potential FDA approval in stem-cell mobilization, while continuing to advance our other clinical programs, including our second asset, AGI-134, a novel agent in immunotherapy currently being investigated in a Phase 1/2a study, with initial results expected by the end of this year," concluded Mr. Serlin.

Upcoming Significant Expected Milestones:

Results from pharmacoeconomic cost effectiveness study of Motixafortide in SCM in the second half of 2021;
Pre-NDA meeting with the FDA for SCM in the second half of 2021;
Initial results from Part 2 of the Phase 1/2a trial of AGI-134 in solid tumors in the second half of 2021;
NDA submission for SCM in the first half of 2022;
Presentation of additional data and analyses from Phase 3 GENESIS study at future medical meetings to be determined.
Financial Results for the Quarter Ended June 30, 2021

Research and development expenses for the three months ended June 30, 2021 were $5.1 million, an increase of $0.5 million, or 10.8%, compared to $4.6 million for the three months ended June 30, 2020. The increase resulted primarily from higher expenses related to NDA supporting activities for Motixafortide, an increase in payroll and related-expenses due to a company-wide salary reduction in connection with the COVID-19 pandemic in the 2020 comparable period, and an increase in expenses associated with the AGI-134 study; offset by a decrease in expenses related to the GENESIS and COMBAT clinical trials for Motixafortide, and a timing difference related to a tax credit received in respect of AGI-134. Research and development expenses for the six months ended June 30, 2021 were $9.4 million, a decrease of $0.6 million, or 6.4%, compared to $10.1 million for the six months ended June 30, 2020. The decrease resulted primarily from lower expenses associated with the Motixafortide GENESIS and COMBAT clinical trials and a timing difference related to a tax credit received in respect of AGI-134; offset by higher expenses related to Motixafortide NDA supporting activities and by an increase in payroll and related-expenses due to a company-wide salary reduction in connection with the COVID-19 pandemic in the 2020 comparable period.

Sales and marketing expenses for the three months ended June 30, 2021 were $0.3 million, an increase of $0.1 million, or 81.3%, compared to $0.2 million for the three months ended June 30, 2020. The increase resulted primarily from consultancy services related to Motixafortide. Sales and marketing expenses for the six months ended June 30, 2021 were $0.5 million, an increase of $0.1 million, or 35.6%, compared to $0.4 million for the six months ended June 30, 2020. The reason for the increase is similar to the aforementioned increase in the three-month period.

General and administrative expenses for the three months ended June 30, 2021 were $1.0 million, an increase of $0.3 million, or 40.3%, compared to $0.7 million for the three months ended June 30, 2020. The increase resulted primarily from an increase in directors’ and officers’ insurance. General and administrative expenses for the six months ended June 30, 2021 were $2.1 million, an increase of $0.1 million, or 3.7%, compared to $2.0 million for the six months ended June 30, 2020. The reason for the increase is similar to the aforementioned increase in the three-month period.

The Company’s operating loss for the three months ended June 30, 2021 amounted to $6.5 million, compared to an operating loss of $5.6 million for the comparable period in 2020. The Company’s operating loss for the six months ended June 30, 2021 was $12.0 million, compared to $12.4 million for the comparable period in 2020.

Non-operating expenses for the three and six months ended June 30, 2021 and for the three and six months ended June 30, 2020 primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet.

Net financial expenses for the three months ended June 30, 2021 amounted to $0.1 million compared to net ﬁnancial expenses of $0.4 million for the three months ended June 30, 2020. Net financial expenses for the six months ended June 30, 2021 amounted to $0.3 million compared to net financial expenses of $0.6 million for the six months ended June 30, 2020. Net financial expenses for all periods primarily relate to interest paid on loans, offset by investment income earned on bank deposits.

The Company’s net loss for the three months ended June 30, 2021 amounted to $6.8 million, similar to the comparable period in 2020. The Company’s net loss for the six months ended June 30, 2021 amounted to $17.0 million, compared with a net loss of $13.4 million for the comparable period in 2020. The increase in net loss between the six-month periods results from an increase in 2021 non-operating expenses in connection with fair-value adjustments of warrant liabilities on the Company’s balance sheet.

The Company held $66 million in cash, cash equivalents and short-term bank deposits as of June 30, 2021.

Net cash used in operating activities was $13.1 million for the six months ended June 30, 2021, compared with net cash used in operating activities of $12.3 million for the six months ended June 30, 2020. The $0.8 million increase in net cash used in operating activities between the two periods was primarily the result of changes in operating asset and liability items in the two periods, i.e., a larger increase in prepaid expenses and other receivables in 2021 versus 2020, as well as a larger decrease in accounts payable and accruals in 2021 versus 2020.

Net cash used in investing activities was $42.3 million for the six months ended June 30, 2021, compared to net cash provided by investing activities of $0.6 million for the six months ended June 30, 2020. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits.

Net cash provided by financing activities was $56.0 million for the six months ended June 30, 2021, compared to net cash provided by financing activities of $12.0 million for the six months ended June 30, 2020. The cash flows in 2021 primarily reflect an underwritten public offering of the Company’s ADSs in January 2021, warrant exercises, and net proceeds from an ATM facility, offset by repayments of a loan from Kreos Capital. The cash flows in 2020 primarily reflect two registered direct offerings to institutional investors, net proceeds from the ATM facility, offset by repayments of the loan from Kreos Capital.

Conference Call and Webcast Information

BioLineRx will hold a conference call today, Wednesday, August 18, 2021 at 10:00 a.m. EDT. To access the conference call, please dial +1-866-744-5399 from the US or +972-3-918-0644 internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until August 20, 2021; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

Alligator Bioscience announces Immuno-oncology Research Collaboration and License Agreement with Orion Corporation

On August 18, 2021 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that the company has entered into a research collaboration and license agreement with Orion Corporation, a global pharmaceutical company based in Finland, to discover and develop together new bispecific antibody cancer therapeutics (Press release, Alligator Bioscience, AUG 18, 2021, View Source [SID1234586715])

The research collaboration will focus on the discovery of novel bispecific antibodies directed towards immuno-oncology targets selected by Orion. The agreement covers an option to develop three bispecific antibodies. Under the agreement, Alligator Bioscience will employ its proprietary phage display libraries and RUBY bispecific platform to develop immuno-oncology product candidates based on design criteria identified by Orion.

During the initial research period of the collaboration, Alligator Bioscience will receive an upfront payment and research support payments. Additionally, as part of the agreement, Alligator Bioscience is eligible for development, approval and sales milestone payments of up to 469 million euros, in addition to royalties if Orion exercises its options to continue development and commercialization of the resulting product candidates.

Outi Vaarala, Senior Vice President, R&D, Orion, said: "We are particularly pleased with this collaboration with Alligator Bioscience to develop new immuno-oncology treatments mobilizing the immune system to eliminate cancer cells. Bispecific antibodies provide as a tool many advantages for the next generation immuno-oncology treatments with improved efficacy, particularly in the cancer patients who do not respond to the present available therapeutics."

"We are excited to enter into this collaborative research program which combines Alligator Bioscience’s expertise in antibody discovery and immuno-oncology development with Orion’s insights into novel immuno-oncology approaches and welcomed the opportunity to work with Orion," said Søren Bregenholt, CEO of Alligator Bioscience. Bregenholt continued, "This agreement validates that Alligator Bioscience’s extensive range of phage display libraries and our RUBY bispecific platform offer a solid foundation to identify and develop high quality first-in-class therapeutic antibodies with excellent manufacturability characteristics."

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:00 a.m. CEST on August 18, 2021.