Indi Molecular Closes Sale of PCC Technology Platform

On March Indi Molecular reported the successful close of the sale of its PCC technology platform (Press release, Indi Molecular, MAR 29, 2022, View Source [SID1234611266]). The company retains two powerful, advanced PCC molecules targeting ovarian and pancreatic cancer, respectively.

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PCC technology, originally developed with Caltech, allows for the rapid discovery and production of a synthetic class of binding agents with antibody-like properties. PCC molecule’s small size makes them a synthetic equivalent of a monoclonal antibody but with biophysical properties similar to a small molecule drug. PCCs offer the promise of superior performance, stability, lower cost and faster creation compared to monoclonal antibodies

IPA Announces Agreement to Acquire BioStrand BV – Revolutionizing Biotherapeutics with Methodology to Encode Omics and Power Drug Development with Advanced Artificial Intelligence

On March 29th, 2022 IPA (IMMUNOPRECISE ANTIBODIES LTD.) (the "Company" or "IPA") (NASDAQ: IPA) (TSXV: IPA) reported that it has entered into a definitive share purchase agreement (SPA) to acquire, through its wholly-owned subsidiary ImmunoPrecise Netherlands BV, control over BioStrand BV, BioKey BV, and BioClue BV (hereinafter collectively referred to as "BioStrand"), a group of Belgian biotech entities and pioneers in the field of bioinformatics and biotechnology (Press release, ImmunoPrecise Antibodies, MAR 29, 2022, View Source [SID1234611223]).

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This transaction is expected to create short and long-term commercialization opportunities with clients and partners by introducing a novel AI-powered protein-protein interactions prediction platform and fortifying IPA’s sequencing with massive throughput capabilities in omics (genomics, transcriptomics, proteomics, and metabolomics) interrogation. The Company anticipates that the transaction will not only attract new clients and partners but will also enable its subsidiary, Talem Therapeutics, to access unparalleled AI technologies to help power each stage of its therapeutic antibody development.

Transaction Highlights

• BioStrand offers a revolutionary, cloud-based solution to perform multi-omics research faster and more accurately, with more effective data analysis.

• The acquisition enhances IPA’s position as a leader in the field of biotherapeutics – BioStrand’s software and AI capabilities complement every sector of IPA’s business.

• BioStrand’s semantically driven natural language process (NLP) approach makes omics data research truly effective and differentiates IPA’s offerings to provide a powerful and unique opportunity for IPA’s clients.

• Total consideration of € 20 million, of which € 2 million will be paid in cash, subject to adjustments, and € 18 million will be paid in equity.

• Management and Board of Directors unanimously approved the Transaction.

Differentiating Technologies

BioStrand offers an AI-powered revolutionary methodology for rapidly analyzing and mining a broad range of biological data to identify patterns and variations in multi-omics data and detect structural anchor points that will drive innovation in numerous fields including precision medicine, drug and vaccine development, and target discovery. By detecting HYFTS, which are proprietary biological signature sequences, multiple layers of information in sequence and structural data are automatically integrated, resulting in a systems approach to omic analyses. These HYFTTM fingerprints connect sequences and literature analysis through a bottom-up NLP approach, by providing a universal syntax for the language of biology. This revolutionizing pattern and profile detection is critical in understanding diseases and biological processes. Multi-omics data integration typically requires quite considerable expertise in computational techniques with additional challenges in accuracy and reliability. With BioStrand’s revolutionary HYFT framework, all biological data is instantly computable.

Company Synergies

The acquisition of BioStrand expands IPA’s scientific capabilities to excel far beyond antibody discovery, expanding from the earliest stages of target identification to late-stage therapies. The transaction combines BioStrand’s computer-aided drug discovery capabilities with IPA’s best-in-class antibody discovery and development expertise to create an integrated, next-generation, end-to-end platform for target and therapeutic antibody discovery and development.

Dr. Jennifer Bath, President and Chief Executive Officer of ImmunoPrecise Antibodies, commented, "The addition of BioStrand’s next-generation capabilities in systems omics analysis further enhances IPA’s unique ability to serve as a single-source partner to support our clients’ in silico, in vitro and in vivo research, further solidifying our position as the leading, early-stage antibody discovery contract research organization. A previously undisclosed collaboration with BioStrand has already generated unique and intriguing data and we are confident that our clients and partners will find the addition of BioStrand’s offerings both advantageous and transformational for their research programs. We believe the acquisition of BioStrand, recently referred to as the "Google of Genomics", is a blockbuster move, brings together a revolutionary combination that will change the way researchers approach and complete target and antibody discovery, and that our combined platforms, once integrated, will attract new business opportunities at an accelerated rate. We are excited to add BioStrand to the IPA family."

The Transaction

Pursuant to the SPA, ImmunoPrecise Netherlands B.V. will acquire i) all of the issued and outstanding shares of Idea Family BV, a private limited liability company holding 75.01% of the issued and outstanding shares of BioStrand and ii) the remaining 24.99% of the issued and outstanding shares of BioStrand, the whole for a total consideration of approximately € 20 million, plus a potential earnout consideration. The purchase price will be satisfied as follows:

• Approximately € 2 million payable in cash, of which € 1 million will be subject to holdback. A sum of € 500,000 will be held back for a period of 90 days after closing of the transaction for adjustment purposes and € 500,000 of the cash consideration will be held back and progressively released over a 3-year period to guarantee the obligations of the vendors under the SPA;

• A number of common shares of IPA to be issued at closing, the value per common share to be determined based on the 30-day volume-weighted average price of the common shares (VWAP) ending on the trading day immediately prior to the date of closing, representing no greater than 19.99% of the issued and outstanding common shares of IPA immediately prior to closing, for an aggregate deemed value of € 18 million. In the event the issuance cap is reached, IPA will make a cash payment to the vendors equal to the value of the common shares that were not issued as a result of the issuance cap, based on the VWAP of the common shares as of the closing date; and

• A contingent earnout payment based on the profitability of BioStrand over a 7-year period, which shall not exceed in total € 12 million.

Other Key Deal Terms

• BioStrand is being acquired on a debt-free, cash-free basis;
• Investment consideration provided by IPA to BioStrand of aggregate amount of € 6 million in the form of a loan or in the form of equity over a period of 3 years for operation expenses, development of BioStrand’s platform, and correction of deficiencies;

• Customary representations and warranties in the SPA;

• Customary indemnities for breaches of representations and warranties and breaches of covenants in the SPA;

• The equity consideration will be subject to a 4-month statutory resale restriction period pursuant to Canadian securities laws, as well as a contractual escrow agreement to be entered into at closing between the vendors, IPA, and an escrow agent, providing for the gradual release of the common shares over a 3-year period.

• Key personnel, including the founders of BioStrand and other members of the executive team of BioStrand, will continue their employment with updated management agreements;

• Non-competition and non-solicitation agreements will be entered into, as a condition of closing, with certain principals of BioStrand;

• Each of BioStrand and the BioStrand shareholders are arm’s length parties to the Company;

• The purchase price is subject to working capital and other adjustments;

• Closing of the Transaction is expected to occur on or before April 15, 2022, subject to receipt of all applicable approvals and the satisfaction of applicable conditions to closing;

• The other closing conditions in the SPA are customary, including, but not limited to, the receipt of all necessary regulatory approvals and the required notifications to NASDAQ with respect to the issuance of IPA’s common shares; and

• The Transaction is an "expedited acquisition" under Policy 5.3 of the TSX Venture Exchange.

Entry into a Material Definitive Agreement

On March 29, 2022, Geron Corporation (the "Company") reported that entered into an underwriting agreement (the "Underwriting Agreement") with Stifel, Nicolaus & Company, Incorporated and Robert W. Baird & Co. Incorporated, as representatives of the several underwriters named therein (collectively, the "Underwriters"), relating to the issuance and sale (the "Offering") of 53,333,334 shares of the Company’s common stock ("Common Stock"), and pre-funded warrants to purchase 18,095,238 shares of Common Stock (the "Pre-Funded Warrants"), together with accompanying warrants to purchase 35,714,286 shares of Common Stock (the "Purchase Warrants", and together with the Pre-Funded Warrants, the "Warrants") (Press release, Geron, MAR 29, 2022, View Source [SID1234611222]). The combined offering price to the public of each share of Common Stock and accompanying Purchase Warrant is $1.05. The combined offering price to the public of each Pre-Funded Warrant and accompanying Purchase Warrant is $1.049. The gross proceeds to the Company from the Offering are expected to be approximately $75.0 million, before deducting underwriting discounts and estimated offering expenses. All of the securities in the Offering are being sold by the Company. The Offering is expected to close on April 1, 2022, subject to satisfaction of customary closing conditions.

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Each Pre-Funded Warrant will have an initial exercise price per share of $0.001, subject to certain adjustments. The Pre-Funded Warrants will be exercisable immediately and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full. A holder (together with its affiliates and other attribution parties) may not exercise any portion of a Pre-Funded Warrant to the extent that immediately prior to or after giving effect to such exercise the holder would own more than 9.99% of the Company’s outstanding Common Stock immediately after exercise, which percentage may be changed at the holder’s election to a lower or higher percentage not in excess of 19.99% (if exceeding such percentage would result in a change of control under Nasdaq Listing Rule 5635(b) or any successor rule) upon 61 days’ notice to the Company subject to the terms of the Pre-Funded Warrants.

Each Purchase Warrant will have an initial exercise price per share of $1.45, subject to certain adjustments. The Purchase Warrants will be exercisable immediately and will expire on the earlier to occur of (a) the date that is 30 business days following the date on which the Company first issues a press release announcing, if applicable, that the United States Food and Drug Administration (the "FDA") has accepted for filing a New Drug Application submitted to the FDA for imetelstat in Low or Intermerdiate-1 risk myelodysplastic syndromes (or, if such date is not a business day, then the next business day following such date) and (b) April 1, 2027. A holder (together with its affiliates and other attribution parties) may not exercise any portion of a Purchase Warrant to the extent that immediately prior to or after giving effect to such exercise the holder would own more than 9.99% of the Company’s outstanding Common Stock immediately after exercise, which percentage may be changed at the holder’s election to a lower or higher percentage not in excess of 19.99% (if exceeding such percentage would result in a change of control under Nasdaq Listing Rule 5635(b) or any successor rule) upon 61 days’ notice to the Company subject to the terms of the Purchase Warrants.

The Offering is being made pursuant to the Company’s shelf registration statement on Form S-3 filed with the Securities and Exchange Commission (the "SEC") on September 4, 2020, which became effective on November 6, 2020 (Registration Statement No. 333-248637), and a prospectus supplement thereunder (the "Prospectus Supplement").

The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities arising under the Securities Act other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Underwriting Agreement were made only for the purposes of such agreement and as of specific dates, and were solely for the benefit of the parties to such agreement.

The foregoing descriptions of the terms of the Underwriting Agreement, Pre-Funded Warrants and Purchase Warrants are each qualified in their entirety by reference to the Underwriting Agreement, form of Pre-Funded Warrant and form of Purchase Warrant, respectively, which are attached as Exhibit 1.1, Exhibit 4.1 and Exhibit 4.2 hereto, respectively, and incorporated by reference herein.

VYANT BIO AND ORGANOTHERAPEUTICS ANNOUNCE STRATEGIC COLLABORATION TO DISCOVER THERAPEUTICS TO TREAT PARKINSON’S DISEASE

On March 29, 2022 Vyant Bio, Inc. ("Vyant Bio", "Company") (Nasdaq: VYNT), an innovative biotechnology company reinventing drug discovery for complex neurodevelopmental and neurodegenerative disorders and OrganoTherapeutics, a developer of proprietary patient-specific organoids that recapitulate Parkinson’s Disease (PD) pathology, reported they have entered into a collaboration agreement to work toward accelerating the discovery of drugs for the treatment of Parkinson’s Disease (Press release, Vyant Bio, MAR 29, 2022, View Source [SID1234611213]).

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The collaboration brings together the respective teams’ expertise in drug discovery using human-derived cells, high-throughput biology and chemistry, and machine learning-based therapeutic design to identify potential PD drugs. Together, they will focus on the identification of drug candidates that rescue the PD phenotype through the development of disease-linked, clinically- translatable assays and biomarkers through multiple molecular, biochemical, and cellular methods. This approach will integrate and leverage OrganoTherapeutic’s complex, patient-derived, 3D-organoid disease models derived from induced pluripotent stem cells (iPSCs), and Vyant Bio’s iPSC expertise and its AnalytiXTM machine learning technology.

OrganoTherapeutics has developed Parkinson’s Disease-specific midbrain organoids from multiple PD patients, providing the ability to more fully understand drug response based on genetic differences. Robert Fremeau, PhD, Vyant Bio’s Chief Scientific Officer, states "This collaboration with OrganoTherapeutics is another example of Vyant Bio’s commitment to accelerate the discovery and development of transformative therapies for patients living with severe CNS diseases. We are pleased to announce this collaboration with OrganoTherapeutics as they bring deep knowledge and innovative approaches to Parkinson’s Disease-based drug discovery. Together, we will expand our human-first platform in neurodevelopmental disorders such as Rett Syndrome and CDKL5 deficiency disorder into Parkinson’s Disease and ultimately other neurodegenerative disorders."

Jens Schwamborn, PhD, OrganoTherapeutics Co-Founder and CEO, confirms the anticipated benefits of the collaboration, "The specific genetic and environmental causes in most Parkinson’s patients are unknown. By focusing initially on disease-linked genetic mutations, we plan to identify common causes and potential therapeutic approaches that can be expanded into the much larger patient population. We look forward to integrating our approaches with Vyant Bio."

"We know that therapies for diseases that affect the CNS are difficult to discover: it requires meaningful innovation and exceptional scientific expertise to tackle," said Jay Roberts, CEO of Vyant Bio. "This collaboration is another in a series of strategic moves to focus our efforts while accelerating our position in drug discovery through the use of technologies that allow insight into human biology early in the discovery of CNS drugs."

Checkmate Pharmaceuticals Announces Full Year 2021 Financial Results and Provides Business Update

On March 29, 2022 Checkmate Pharmaceuticals, Inc. (Nasdaq: CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported full year 2021 financial results and provided a business update (Press release, Checkmate Pharmaceuticals, MAR 29, 2022, View Source [SID1234611187]).

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"Our vidutolimod program continued to advance in 2021 and expand into multiple cancer indications," said Alan Bash, President and Chief Executive Officer of Checkmate. "Driving vidutolimod forward to multiple clinical data readouts and towards registration in refractory melanoma remains our top strategic priority. I look forward to advancing our leadership in innate immunity and driving the success of Checkmate with our highly talented executive team and Board of Directors."

Recent Business Updates

Alan Bash, accomplished global biopharmaceutical executive with over 20 years of strategic and operational leadership at Bristol Myers Squibb, was appointed President and CEO. Mr. Bash also joined the Board of Directors.

Jon Wigginton, M.D. and Joy Yan, M.D., Ph.D., both industry leaders in immuno-oncology clinical development, joined the Board of Directors.

Patient dosing was initiated in a Phase 2 multi-indication study evaluating the efficacy and safety of vidutolimod in combination with cemiplimab supported by a clinical collaboration with Regeneron; cohorts focused on anti-PD-1 refractory cutaneous squamous cell carcinoma and Merkel cell carcinoma are currently enrolling.

Patient recruitment activities and enrollment continue across our other ongoing clinical trials evaluating vidutolimod, including:

A Phase 2 trial of vidutolimod in combination with nivolumab in anti-PD-1 refractory advanced melanoma, supported by a clinical collaboration with Bristol Myers Squibb.

A randomized Phase 2/3 trial of vidutolimod in combination with nivolumab vs. nivolumab monotherapy in first-line metastatic or unresectable melanoma, also supported by the clinical collaboration with Bristol Myers Squibb.

A Phase 2 trial of vidutolimod in combination with pembrolizumab in recurrent or metastatic squamous cell head and neck cancer.

Vidutolimod Anticipated 2022 Milestones

Phase 2 head and neck cancer trial—preliminary data on a subset of patients are anticipated in the second half of 2022.

Phase 2 non-melanoma skin cancer trial cohorts—preliminary data on a subset of patients are anticipated in the second half of 2022.

Full Year 2021 Financial Results

Research and development expenses (R&D): R&D expenses for the full year 2021 were $45.8 million, compared to $26.7 million for the same period in the prior year. This increase reflects a combined $6 million in milestone payments to Kuros Biosciences AG for achievement of patient dosing milestones in our trials, higher third-party CRO and manufacturing costs directly related to the vidutolimod clinical trials, and additional personnel and consulting costs associated with execution of the clinical trials.

General and administration expenses (G&A): G&A expenses for the full year 2021 were $15.7 million, compared to $10.2 million for the same period in the prior year. This increase was primarily attributable to increases in personnel and operating expense to support Checkmate operating for a full year in 2021 as a publicly traded company.

Net loss: Net loss for the full year 2021 was $61.4 million, compared to $36.9 million for the prior year.

Cash, cash equivalents and investments: Cash, cash equivalents and available-for-sale investments were $70.9 million as of December 31, 2021.