Bicycle Therapeutics to Present on BT5528, a Bicycle Toxin Conjugate Targeting EphA2 for the Treatment of Solid Tumours, at World ADC 2019

On March 5, 2019 Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle) product platform, reported that Gavin Bennett, Ph.D., Bicycle’s Director of Preclinical Development and Project leader for BT5528, will present at the 9th Annual World ADC Conference in London (Press release, Bicycle Therapeutics, MAR 5, 2019, View Source [SID1234533971]). The presentation, focused on Bicycle’s pre-clinical BT5528 program for the treatment of solid tumours, will take place at 11:30 a.m. GMT on Wednesday, March 6.

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"We expect BT5528 to be Bicycle’s second clinical oncology product candidate and will build on the ongoing Phase I/IIa clinical study with BT1718. We are very excited about its potential to treat solid tumours," said Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics. "Preclinical data from our BT5528 program shows target-dependent anti-tumour activity across a range of EphA2-expressing tumour models without evidence of the profound toxicity seen with previous clinical-stage antibody drug conjugates targeting EphA2."

Dr. Bennett has also been invited to chair the "Discovery" track sessions at the conference.

Erasca Announces Series A Extension, Bringing Total Round to $64 Million

On March 5, 2019 Erasca, a company dedicated to advancing exceptional scientific approaches to erase cancer, reported that it has closed an extension to its Series A financing round, bringing the total raised to $64 million (Press release, Erasca, MAR 5, 2019, View Source [SID1234534178]). New investors in the Series A round include ARCH Venture Partners, Andreessen Horowitz, Reneo Capital, and other private and strategic investors. Proceeds of the financing will support the company’s efforts to potentially in-license new investigational compounds in development, while also accelerating the buildout of Erasca’s artificial intelligence (AI) platform that will drive discovery and development of a new generation of oncology drugs designed to not just treat, but actually cure, cancer.

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"Because cancer is such a formidable foe, we are committed to leveraging all available tools to beat it, including supplementing our in-house efforts with both external innovation and in silico approaches like machine learning," said Jonathan E. Lim, M.D., Erasca’s executive chairman and co-founder. "The support of world-class life science investors, as well as Silicon Valley-based investors with expertise in machine learning, will augment both our corporate development efforts and our rapid development of an AI platform we call OPRA, which aims to transform how drugs are discovered and developed."

Erasca has multiple discovery programs underway for undisclosed targets that are biological drivers of cancer.

"I feel confident in Erasca’s potential to make a significant impact on patient outcomes with their corporate development capabilities, cutting-edge drug discovery platform, and highly capable team that Jonathan has assembled," said Kristina Burow, managing director at ARCH Venture Partners.

Jorge Conde, general partner at Andreessen Horowitz, added, "Technology has transformed virtually every aspect of our lives, but the drug discovery process remains incredibly difficult, expensive and failure-prone. The combination of Erasca’s seasoned team, powered by the application of the latest advances in artificial intelligence, will allow them to develop strategies to attack cancer at its core and dare to pursue the prospect of cures for patients."

About OPRA

OPRA (Oncology Pattern Recognition Algorithm) is Erasca’s proprietary artificial intelligence drug discovery platform that leverages advanced computational tools like machine learning to accelerate drug discovery by elucidating novel tumor biology and innovative strategies that shut down key cancer pathways, both with single agent and combination approaches. OPRA analyzes large-scale data sets, generated in-house and by our collaborators, to provide insights that focus Erasca scientists on the most promising strategies to tackle essential oncogenes within the vast landscape of cancer biology.

OPRA’s data-to-medicine approach is flexible and scalable, enabling deployment across multiple programs in parallel. OPRA overlays onto Erasca’s established drug discovery workflows, allowing both scientist- and AI-driven insights to disrupt the discovery process, accelerating the development of therapies with maximal potency to achieve our ultimate aim of erasing cancer.

CymaBay Announces Proposed Public Offering of Common Stock

On March 5, 2019 CymaBay Therapeutics, Inc. (Nasdaq: CBAY), a clinical-stage biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases with high unmet medical need, reported that it has commenced an underwritten public offering of its common stock (Press release, CymaBay Therapeutics, MAR 5, 2019, View Source [SID1234533956]). All shares of common stock to be sold in the offering will be offered by CymaBay. CymaBay intends to grant the underwriters a 30-day option to purchase up to an aggregate of an additional 15% of the shares of its common stock offered in the public 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. CymaBay anticipates using the net proceeds from the offering to fund ongoing development of seladelpar and for working capital and general corporate purposes.

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Citigroup, Evercore ISI and Cantor Fitzgerald & Co. are acting as the joint book-running managers for the offering. Oppenheimer & Co. Inc. and Roth Capital Partners are acting as co-managers for the offering.

The securities described above are being offered by CymaBay pursuant to a shelf registration statement previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, from: Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or telephone: 1-800-831-9146; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, New York, NY 10055, or by telephone at (888) 474-0200, or by email at [email protected]; or Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by email at [email protected].

This press release shall not constitute an offer to sell or the 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.

Epizyme Announces Presentations at Upcoming March Investor Conferences

On March 5, 2019 Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapies, reported that management will present at the following March investor conferences (Press release, Epizyme, MAR 5, 2019, View Source [SID1234533972]):

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Cowen 39th Annual Health Care Conference on Tuesday, March 12, 2019 at 11:20 a.m. ET in Boston; and,
Oppenheimer & Co. 29th Annual Healthcare Conference at 11:00 a.m. ET on March 20, 2019 in New York City.
Live webcasts will be available in the investor section of the company’s website at www.epizyme.com. The webcasts also will be archived for 60 days following the call and presentation.

Entry into a Material Definitive Agreement

On March 1, 2019, TG Therapeutics, Inc. ("TG" or the "Company") entered into an underwriting agreement (the "Underwriting Agreement") with Cantor Fitzgerald & Co. (the "Underwriter"). Pursuant to the Underwriting Agreement, the Company agreed to sell to the Underwriter, in a firm commitment underwritten public offering, 4,100,000 shares (the "Firm Shares") of the Company’s common stock, $0.001 par value per share ("Common Stock") and 615,000 shares of the Company’s common stock, par value $0.001 per share (the "Option Shares" and together with the Firm Shares, the "Shares"), less underwriting discounts and commissions. The transactions contemplated by the Underwriting Agreement are expected to close on March 5, 2019, subject to the satisfaction of customary closing conditions (Filing, 8-K, TG Therapeutics, MAR 5, 2019, View Source [SID1234533989]). A copy of the Underwriting Agreement is attached hereto as Exhibit 1.1 and is incorporated by reference herein.

Cantor Fitzgerald & Co. is acting as sole book-running manager for the offering.

The gross proceeds to the Company are expected to be approximately $27.7 million before deducting estimated expenses payable by the Company associated with the offering.

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 under the Securities Act of 1933, as amended (the "Securities Act"), other obligations of the parties and termination provisions.

The offering is being made pursuant to the Company’s effective "shelf" registration statement on Form S-3 (File No. 333-218293) (the "Registration Statement") filed with the Securities and Exchange Commission (the "SEC") on May 26, 2017, which was declared effective by the SEC on June 13, 2017, as supplemented by a preliminary prospectus supplement filed with the SEC on February 28, 2019 and a final prospectus supplement filed with the SEC on March 5, 2019, pursuant to Rule 424(b) under the Securities Act.

Alston & Bird LLP, counsel to the Company, delivered an opinion as to the validity of the Shares, a copy of which is attached hereto as Exhibit 5.1 and is incorporated by reference herein.

This Current Report on Form 8-K is being filed to incorporate the Underwriting Agreement and opinion by reference into such Registration Statement. The foregoing summary description of the offering and the documentation related thereto, including without limitation, the Underwriting Agreement, does not purport to be complete and is qualified in its entirety by reference to such Exhibits.

The Underwriting Agreement has been included to provide investors and security holders with information regarding its terms. It is not intended to provide any other factual information about the Company. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties, including being qualified by confidential disclosures exchanged between the parties in connection with the execution of the Underwriting Agreement. The representations and warranties may have been made for the purposes of allocating contractual risk between the parties to the agreement instead of establishing these matters as facts, and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors. Investors are not third-party beneficiaries under the Underwriting Agreement and should not rely on the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the Company or any of its subsidiaries or affiliates. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the Underwriting Agreement, and this subsequent information may or may not be fully reflected in the Company’s public disclosures.

Debt Financing

On February 28, 2019 (the "Closing Date"), the Company ("Borrower") entered into a term loan facility of up to $60.0 million ("Term Loan") with Hercules Capital, Inc., ("Hercules"), the proceeds of which will be used for its ongoing research and development programs and for general corporate purposes. The Term Loan is governed by a loan and security agreement, dated February 28, 2019 (the "Loan Agreement"), which provides for up to four separate advances. The first advance of $30.0 million was drawn on the Closing Date. Two additional advances of $10.0 million may be drawn at the Borrower’s option but subject to the clinical trial milestones, and the fourth advance of $10.0 million, available in minimum increments of $5.0 million, is available through December 15, 2020 subject to the approval of Hercules’ investment committee.

The Term Loan will mature on March 1, 2022 (the "Loan Maturity Date"). Each advance accrues interest at a per annum rate of interest equal to the greater of either (i) the "prime rate" as reported in The Wall Street Journal plus 4.75%, and (ii) 10.25%. The Term Loan provides for interest-only payments until October 1, 2020. The interest-only period may be extended to April 1, 2021 if the Borrower, on or before September 30, 2020, achieves either the third milestone or the Company has raised at least an amount equal to $150.0 million in unrestricted net cash proceeds from one or more equity financings, subordinated indebtedness and/or upfront proceeds from business development transactions permitted under the Loan Agreement, in each case after February 7, 2019, and prior to September 30, 2020. Thereafter, amortization payments will be payable monthly in eighteen installments (or, if the period requiring interest-only payments has been extended to April 1, 2021, in twelve installments) of principal and interest (subject to recalculation upon a change in prime rates). At its option upon seven business days’ prior written notice to Hercules, the Company may prepay all or any portion greater than or equal to $5.0 million of the outstanding advances by paying the entire principal balance (or portion thereof), all accrued and unpaid interest, subject to a prepayment charge of 3.0%, if such advance is prepaid in any of the first twelve months following the Closing Date, 1.5%, if such advance is prepaid after twelve months following the Closing Date but on or prior to twenty-four months following the Closing Date, and 0% thereafter. In addition, a final payment equal to 3.5% of the aggregate principal amount of the loan extended by Hercules is due on the maturity date. Amounts outstanding during an event of default shall be payable on demand and shall accrue interest at an additional rate of 4.0% per annum of the past due amount outstanding.

The Term Loan is secured by a lien on substantially all of the assets of the Borrower, other than intellectual property and contains customary covenants and representations, including a liquidity covenant, financial reporting covenant and limitations on dividends, indebtedness, collateral, investments, distributions, transfers, mergers or acquisitions, taxes, corporate changes, deposit accounts, and subsidiaries.

The events of default under the Loan Agreement include, without limitation, and subject to customary grace periods, (1) the Borrower’s failure to make any payments of principal or interest under the Loan Agreement, promissory notes or other loan documents, (2) the Borrower’s breach or default in the performance of any covenant under the Loan Agreement, (3) the occurrence of a material adverse effect, (4) the Borrower making a false or misleading representation or warranty in any material respect, (5) the Borrower’s insolvency or bankruptcy, (6) certain attachments or judgments on the Borrower’s assets, or (7) the occurrence of any material default under certain agreements or obligations of the Borrower involving indebtedness in excess of $750,000. If an event of default occurs, Hercules is entitled to take enforcement action, including acceleration of amounts due under the Loan Agreement.

The Loan Agreement also contains warrant coverage of 2% of the total amount funded. A warrant (the "Warrant") was issued by Borrower to Hercules to purchase 147,058 shares of common stock with an exercise price of $4.08. The Warrant shall be exercisable for seven years from the date of issuance. Hercules may exercise the Warrant either by (a) cash or check or (b) through a net issuance conversion. The shares will be registered and freely tradeable within six months of issuance.

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