On February 9, 2020 Oncoheroes Biosciences Inc. ("Oncoheroes"), a biotech company exclusively focused on the development of innovative medicines to treat cancer in children and adolescents, reported that it has closed the first investment with Dreamers Startup Ventures (Press release, Oncoheroes Biosciences, FEB 9, 2020, View Source [SID1234568290]). Under the terms of the agreement, Dreamers Startup Ventures has committed to invest up to $1.1M, disbursed in installments subject to Oncoheroes milestone achievements in the coming months.

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The agreement goes beyond a traditional VC investment. Ricardo Garcia, Oncoheroes’ CEO, stated: "This is a great opportunity for Oncoheroes to take advantage of Dreamers Startup Ventures hands-on approach to support our efforts in all directions. We feel honored and acknowledge the responsibility of being the first investment of Dreamers Startup Ventures in the biotech sector."

Cesare Spadoni, Oncoheroes’ Chief Operations Officer added: "This funding is an important financial achievement for Oncoheroes and enables us to focus on continue working on the clinical development plan for volasertib, our first asset in-licensed from Boehringer Ingelheim, and identify two new assets and complete our pipeline".

Gorka Fius, cofounder of Dreamers Startup Ventures further notes: "From the beginning, we realized that Oncoheroes holds great potential as a biotech company, which made it a very strategic investment for us. The first reason that led us to invest in Oncoheroes is the uniqueness of being 100% focused on developing drugs for pediatric cancer, an estimated niche market of $5-10B/year. We also value the multi-asset portfolio strategy that contributes to diversifying our investment risk and the fact they already have volasertib, a very strong drug candidate in their pipeline. Moreover, Oncoheroes’ first-class team has wide expertise over all of the drug development spectrum, a clear strategy, and a very well-defined road map. Finally, we are confident that we are diminishing the risk of our first operation in the biotech sector by investing in the rare disease space, where normally the cost to develop a drug is lower and the time to reach the market is faster."

On February 9, 2020 KSQ Therapeutics, a biotechnology company using its proprietary CRISPRomics discovery platform to systematically screen the whole genome to identify optimal gene targets for oncology and autoimmune disease, reported the identification and validation of a novel target, CT-1, for the development of engineered tumor infiltrating lymphocyte (eTIL) therapies for refractory solid tumors. Data from two large-scale CRISPR-Cas9 functional screens using the company’s novel CRISPRomics platform and in vivo validation data will be presented at the Engineering the Genome conference, which takes place in Banff, Alberta, Canada (Press release, KSQ Therapeutics, FEB 9, 2020, View Source [SID1234554056]).

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"Adoptive cell therapies have long been hypothesized to be potentially curative treatments for refractory solid tumors, but their efficacy has been limited by the immunosuppressive tumor microenvironment," said Frank Stegmeier, Chief Scientific Officer of KSQ Therapeutics. "Our CRISPRomics platform enables us to identify gene targets that improve the ability of the T cell to function in this hostile tumor microenvironment. These insights allowed us to develop a pipeline of CRISPR/Cas9 eTIL programs that have the potential to unlock adoptive cell therapy in PD-1 refractory solid tumors."

KSQ’s proprietary CRISPRomics platform was used to identify the top targets across the T- cell genome that increase the efficacy of adoptive T cell transfer therapy (ACT) in PD-1 refractory mouse solid tumor models. CT-1, an undisclosed target identified by KSQ, emerged as a top target from these screens. CT-1-edited T cells produced a 10-fold increase in anti-tumor activity in vivo, and CT-1 edited human TILs exhibit an enhanced cytokine production profile. The data presented support the development of eTIL products with the potential to increase the efficacy of TIL adoptive cell therapy.

On February 7, 2020 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage oncology company targeting the epigenetic causes of cancer, reported the pricing of an underwritten public offering for gross proceeds of approximately $9.6 million, prior to deducting underwriting discounts and commissions and offering expenses payable by Salarius (Press release, Salarius Pharmaceuticals, FEB 7, 2020, View Source [SID1234554214]).

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The offering is comprised of 7,101,307 Class A Units, priced at a public offering price of $1.15 per unit, with each unit consisting of one share of common stock and a five-year warrant to purchase one share of common stock at an exercise price of $1.15 per share, and 1,246,519 Class B Units, priced at a public offering price of $1.15 per unit, with each unit consisting of one share of Series A convertible preferred stock and a five-year warrant to purchase one share of common stock with an exercise price of $1.15 per share. The convertible preferred stock issued in this transaction includes a beneficial ownership limitation on conversion, but has no dividend rights (except to the extent that dividends are also paid on the common stock), liquidation preference or other preferences over common stock, and has no voting rights. The conversion price of the Series A convertible preferred stock in the offering as well as the exercise price of the warrants are fixed and do not contain any variable pricing features or any price-based anti-dilutive features. The securities comprising the units are immediately separable and will be issued separately.

The closing of the offering is expected to take place on or about February 11, 2020, subject to the satisfaction or waiver of customary closing conditions. In addition, Salarius has granted the underwriter a 45-day option to purchase up to 1,252,173 additional shares of common stock and/or warrants to purchase up to 1,252,173 shares of common stock at the public offering price per share and per warrant, less underwriting discounts and commissions.

Salarius intends to use the net proceeds from this offering for general corporate purposes, including working capital.

Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (NYSE American: LTS), is acting as sole book-running manager in connection with the public offering.

The securities were offered pursuant to a registration statement on Form S-1 (File No. 333-235879), which was declared effective by the United States Securities and Exchange Commission ("SEC") on February 6, 2020, and an additional registration statement filed pursuant to Rule 462(b), which became effective on February 7, 2020.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A final prospectus relating to this offering will be filed by Salarius with the SEC. When available, copies of the final prospectus can be obtained at the SEC’s website at www.sec.gov or from Ladenburg Thalmann & Co. Inc., Attn: Prospectus Department, 277 Park Avenue, 26th Floor, New York, New York 10172, by calling (212) 409-2000.

On February 7, 2020, Syndax Pharmaceuticals, Inc. (the "Company") reported that it has entered into a loan and security agreement (the "Loan Agreement") with Hercules Capital, Inc. ("Hercules"), which provided for aggregate maximum borrowings of up to $30.0 million, consisting of (i) a term loan of up to $20.0 million, which was funded on February 7, 2020, and (ii) subject to Hercules’ investment committee approval, an additional term loan of up to $10.0 million, available for borrowing from February 7, 2020 to December 15, 2020 (the "Tranche 2 Advance") (Filing, 8-K, Syndax, FEB 7, 2020, View Source [SID1234554092]). Borrowings under the Loan Agreement bear interest at an annual rate equal to the greater of (i) 9.5% or (ii) 5.10% plus the Wall Street Journal prime rate.

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Borrowings under the Loan Agreement are repayable in monthly interest-only payments through October 1, 2021, or April 1, 2022 if the Phase 3 clinical trial of entinostat (E2112) in patients with advanced hormone receptor positive, human epidermal growth factor receptor 2 negative, breast cancer has achieved the primary efficacy endpoint sufficient to file an NDA as the next step in clinical development ("Performance Milestone"). After the interest-only payment period, borrowings under the Loan Agreement are repayable in equal monthly payments of principal and accrued interest until the maturity date of the loan, which is either (i) September 1, 2023, or (ii) March 1, 2024 upon achievement of the Performance Milestone (the "Maturity Date"). At the Company’s option, the Company may prepay all, but not less than all, of the outstanding borrowings, subject to a prepayment premium equal to (i) 2.0% of the principal amount outstanding if the prepayment occurs during the first year following the applicable loan being funded, (ii) 1.5% of the principal amount outstanding if the prepayment occurs during the second year following the applicable loan being funded, and (iii) 1.0% of the principal amount outstanding at any time thereafter but prior to the Maturity Date. In addition, the Company paid a $100,000 facility charge upon closing and will pay a $50,000 facility charge in connection with the Tranche 2 Advance. The Loan Agreement also provides for a final payment, payable upon maturity or the repayment in full of all obligations under the agreement, of up to $998,000.

Borrowings under the Loan Agreement are collateralized by substantially all of the Company’s and its subsidiaries personal property and other assets, other than its intellectual property. The Loan Agreement includes a minimum cash covenant of $12.5 million that applies commencing on September 30, 2020, subject to reduction upon satisfaction of certain conditions as set forth in the Loan Agreement. In addition, the Loan Agreement includes customary affirmative and restrictive covenants and representations and warranties, including a covenant against the occurrence of a "change in control," financial reporting obligations, and certain limitations on indebtedness, liens (including a negative pledge on intellectual property and other assets), investments, distributions (including dividends), collateral, investments, distributions, transfers, mergers or acquisitions, taxes, corporate changes, and deposit accounts. The Loan Agreement also includes customary events of default, including payment defaults, breaches of covenants following any applicable cure period, the occurrence of certain events that could reasonably be expected to have a "material adverse effect" as set forth in the Loan Agreement, cross acceleration to third-party indebtedness and certain events relating to bankruptcy or insolvency. Upon the occurrence of an event of default, a default interest rate of an additional 5.0% may be applied to the outstanding principal balance, and Hercules may declare all outstanding obligations immediately due and payable and take such other actions as set forth in the Loan Agreement.

On February 7, 2020 BMS reported completed its merger with Celgene in November, enough time to help its revenues rise 33% to $7.95bn for the period, up from just under $6bn a year earlier, thanks to the contribution of drugs like blockbuster blood cancer drug Revlimid (lenalidomide) (Press release, Celgene, FEB 7, 2020, View Source,_but_opdivo_stalls_1324495 [SID1234554064]).

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Investors responded warmly to the figures, sending BMS’ share price up 3%, though it would likely have been a different story if the Celgene deal hadn’t come through in time.

Opdivo (nivolumab) grew modestly for the full-year, but declined 2% in the fourth quarter to $1.76bn after a slowdown throughout the year that BMS said stemmed largely from reduced sales in second-line non-small lung cancer (NSCLC).

The reason? First-line use of rival checkpoint inhibitors – mainly Merck & Co’s Keytruda (pembrolizumab) – have reduced the opportunity for later-line chemotherapies in this form of cancer, as well as some other tumours like small cell lung cancer and head and neck cancer.

BMS chief executive Giovanni Caforio said on a conference call that he expects Opdivo to return to growth in 2020, providing it gets additional launches in new indications, including first-line NSCLC.

That hinges on two studies – CheckMate-227 and CheckMate-9LA – which involved a combination of Opdivo with low-dose Yervoy (ipilimumab), its CTLA4 inhibitor.

BMS was forced to withdraw its filing in the EU based on the CheckMate-227 trial after the EMA said protocol changes had made the data uninterpretable, but its still under review in the US with an FDA verdict due in May.

Full data from CheckMate-9LA is due for presentation later this year, but BMS said in October it had met its main objective of improving overall survival.

"While we’re disappointed by the position taken by the CHMP, we continue to view the combination of Opdivo and Yervoy as a differentiated regimen with the potential for long-term survival and one that should be available to patients globally," said Caforio on the call.

Revlimid brought in almost $1.3bn between 20 November – when the takeover completed – and the end of the year, but it is facing the loss of patent protection in the US in 2023 and generics are already being launched in Europe.

Thankfully for BMS, it wasn’t only Celgene’s drugs that caused the revenue surge. BMS’ well-established anticoagulant Eliquis (apixaban) had another strong quarter with a 19% rise to just over $2bn, while multiple myeloma drug Empliciti (elotuzumab) grew by more than a third to $94m.

Meanwhile, Caforio is confident that Opdivo’s expected return to growth – plus a series of upcoming launches like multiple sclerosis drug ozanimod, Reblozyl (luspatercept) in myelodysplastic syndrome (MDS) and its CAR-T therapy franchise headed by liso-cel for B-cell lymphomas – sets the company up well for the future.

"The company is in a strong position and this is reflected in the performance of our business and the outlook we are providing today," he said. The company is predicting that full-year 2020 revenues will be between $40.5bn and $42.5bn.