On June 29, 2022, Exact Sciences Corporation (the "Company"), reported that through a wholly-owned special purpose entity, Exact Receivables LLC ("Exact Receivables"), entered into an accounts receivable securitization program (the "Securitization Facility") with PNC Bank, National Association ("PNC"), as administrative agent, with a scheduled maturity date of June 29, 2024 (Filing, 8-K, Exact Sciences, JUN 29, 2022, View Source [SID1234616407]). The Securitization Facility provides Exact Receivables with up to $150.0 million of borrowing capacity, subject to maintaining certain borrowing base requirements, by collateralizing the customer accounts receivable of Exact Sciences Laboratories, LLC and Genomic Health, Inc.

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PNC serves as the lender pursuant to a Loan Agreement with the Company dated November 5, 2021, under which a revolving line of credit of up to $150.0 million is available to the Company, until a scheduled termination date of November 5, 2023.

On June 29, 2022, Exact Receivables borrowed $50.0 million under the Securitization Facility.

Outstanding loans under the Securitization Facility accrue interest at a rate equal to a daily SOFR rate, a term SOFR rate or a base rate, in any case, plus an applicable margin. Additionally, Exact Receivables will pay certain fees to the agents and the lenders under the Securitization Facility.

The Securitization Facility contains certain customary representations, warranties, affirmative covenants and negative covenants, subject to certain cure periods in some cases, including the eligibility of the receivables, as well as customary reserve requirements, events of default, termination events, and servicer defaults. The Securitization Facility termination events permit the lenders to terminate the Receivables Financing Agreement upon the occurrence of certain specified events, including, among others, failure by Exact Receivables to pay amounts when due, certain defaults on other material indebtedness, certain judgments, a change of control, certain events negatively affecting the overall credit quality of transferred receivables and bankruptcy and insolvency events.

The Securitization Facility consists of, among other agreements, (i) a Receivables Financing Agreement (the "Receivables Financing Agreement") among Exact Receivables, PNC, as administrative agent, and the lenders and other parties party thereto, (ii) a Receivables Purchase Agreement (the "Company Purchase Agreement") among the Company and certain subsidiaries of the Company and (iii) a Receivables Purchase Agreement (the "Borrower Purchase Agreement") among Exact Receivables and the Company. The foregoing descriptions of the Receivables Financing Agreement, the Company Purchase Agreement and the Borrower Purchase Agreement do not purport to be complete and are qualified in their entirety by reference to the full text of such agreements, copies of which are filed herewith as Exhibit 10.1, Exhibit 10.2, and Exhibit 10.3, respectively, and the terms of which are incorporated herein by reference.

On June 29, 2022, Seres Therapeutics, Inc. (the "Company") reported that entered into a Securities Purchase Agreement with certain institutional accredited investors (the "IAIs") named therein (the "Non-Affiliate Purchase Agreement") and a Securities Purchase Agreement with certain directors and officers of the Company (the "Affiliates", and collectively with the IAIs, the "Purchasers") named therein (the "Affiliate Purchase Agreement" and, together with the Non-Affiliate Purchase Agreement, the "Purchase Agreements") (Filing, 8-K, Seres Therapeutics, JUN 29, 2022, View Source [SID1234616399]). Pursuant to the Purchase Agreements, the Company agreed to issue and sell in a registered direct offering (the "Offering") (i) an aggregate of 31,238,094 shares of the Company’s common stock, par value $0.001 per share (the "Common Stock"), at a purchase price of $3.15 per share (the "Purchase Price") to the IAIs, for aggregate gross proceeds to the Company of $98.4 million, and (ii) an aggregate of 507,936 shares of Common Stock at the Purchase Price to the Affiliates, for aggregate gross proceeds to the Company of $1.6 million, in each case pursuant to an effective shelf registration statement on Form S-3, as amended (File No. 333-244401) and a related prospectus supplement filed with the Securities and Exchange Commission. The closing of the Offering is expected to occur on or about July 5, 2022, subject to the satisfaction of customary closing conditions.

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The Company expects to receive net proceeds from the Offering of approximately $96.8 million, after deducting the placement agent’s fees and estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the Offering for commercial readiness and manufacture of SER-109 for the U.S. market, including expanding longer-term commercial manufacturing capacity, advancing the clinical development of SER-109 for the EU market, and other general corporate and working capital purposes. The Company believes that its existing cash, cash equivalents and investments, together with the net proceeds from the Offering, will fund its operations for at least 12 months from the date of the prospectus related to the Offering filed with the Securities and Exchange Commission (the "SEC") on June 30, 2022. This evaluation does not take into consideration contingent payments associated with SER-109 FDA approval, which the Company anticipates in the first half of 2023, as these are uncertain and there is no assurance the Company will receive them. These contingent payments include the potential to receive a $125 million milestone payment pursuant to the Company’s collaboration and license agreement with NHSc Pharma Partners upon SER-109 FDA approval and a $25 million tranche under its existing term loan with Hercules Capital, Inc., which becomes available upon the satisfaction of certain conditions, including FDA approval of SER-109.

The Purchase Agreements contain customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Purchasers, including for liabilities under the Securities Act of 1933, as amended (the "Securities Act"), other obligations of the parties and termination provisions.

The foregoing description of the Purchase Agreements is not complete and is qualified in its entirety by reference to the full text of the Non-Affiliate Purchase Agreement and Affiliate Purchase Agreement, forms of which are filed as Exhibits 10.1 and 10.2, respectively, to this Current Report on Form 8-K and are incorporated by reference herein.

On June 29, 2022 Exicure, Inc. (NASDAQ: XCUR), an early-stage biotechnology company focused on the development of next generation nucleic acid therapies targeting RNA to address both genetic and non-genetic neurological disorders and hair loss disorders, reported that, following the implementation of a one-for-thirty reverse stock split at 5:00 p.m. EDT today, the Company’s common stock will begin trading on a split-adjusted basis on Nasdaq effective with the open of business tomorrow, Thursday, June 30, 2022 (Press release, Exicure, JUN 29, 2022, View Source [SID1234616394]). The Company’s common stock will continue to trade under the ticker symbol "XCUR". The new CUSIP number for the post-reverse split common shares is 30205M 200. The Company is implementing the reverse stock split in an effort to regain compliance with Nasdaq’s minimum bid price requirement of $1.00 per share.

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As a result of the reverse stock split, every thirty pre-split shares of common stock outstanding will be automatically combined and converted into one issued and outstanding share of common stock, without any change in the par value per share. No fractional shares of the Company’s common stock will be issued to any stockholders in connection with the reverse stock split. Holders of record will receive a cash payment in lieu of fractional shares.

Stockholders of record will receive information regarding their share ownership from the Company’s transfer agent, American Stock Transfer & Trust Company, LLC. AST can be reached at (877) 248-6417 or (718) 921-8337.

As previously disclosed, on December 30, 2021, Nasdaq notified the Company that it no longer satisfied the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2), as the bid price for the Company’s common stock had closed below $1.00 per share for the previous thirty consecutive business days (the "Bid Price Requirement"). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was granted a 180-calendar day compliance period, through June 28, 2022, to regain compliance with the Bid Price Requirement. The Company did not do so within the time provided and, on June 29, 2022, was notified that the Company’s securities were subject to delisting unless the Company timely requested a hearing before the Nasdaq Hearings Panel (the "Panel"). The Company plans to timely request a hearing before the Panel, which will stay any further action by Nasdaq at least until the conclusion of the hearing process.

In any event, should the Company evidence compliance with the Bid Price Requirement for the requisite minimum ten-consecutive business day period prior to or following the hearing, the Company will request that Nasdaq issue a compliance determination, in which case the listing matter will be closed.

On June 29, 2022 Generian Pharmaceuticals, Inc. ("Generian") and Mitobridge, Inc. (a wholly owned subsidiary of Astellas Pharma Inc.) reported that they have entered into a collaboration and exclusive license agreement to discover and develop novel small molecules for undruggable therapeutic targets by using a proprietary drug discovery platform for diseases that have limited treatment options (Press release, Astellas Pharma, JUN 29, 2022, View Source [SID1234616391]).

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Under the terms of the agreement, the companies will jointly conduct research and preclinical development activities to identify novel monovalent small molecules that modulate target proteins through activation, stabilization or degradation as potential development candidates. Astellas will be solely responsible for clinical development, manufacturing and commercialization of all products arising from the joint research activities. Generian will receive an upfront payment and is eligible to receive success-based milestone payments that could result in payments of over $180 million, along with single digit royalties on global net sales of those products.

"We are excited to collaborate with Astellas and believe our strategy can successfully mine for candidate drugs for therapeutically relevant targets that are currently considered undruggable," said Hank Safferstein, PhD, JD, Chief Executive Officer of Generian. "Our small molecule discovery approach allows us to rapidly screen and identify potential drug candidates in an entirely new way in order to develop first-in-class medicines."

"Our collaboration with Generian is an exciting and transformative opportunity to accelerate our drug discovery activities in the area of undruggable target space," said David Barrett, Ph.D., Division Head and President of Mitobridge. "We are very excited to work with a world-class team of collaborators to deliver significant new treatment options for patients suffering from currently intractable or poorly served diseases."

On June 29, 2022 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for talquetamab for the treatment of adult patients with relapsed or refractory multiple myeloma, who have previously received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody (Press release, Johnson & Johnson, JUN 29, 2022, View Source [SID1234616390]). Talquetamab is an investigational, off-the-shelf, T-cell redirecting bispecific antibody targeting both GPRC5D, a novel drug target, on multiple myeloma cells and CD3 on T-cells. This distinction for talquetamab follows a PRIME (PRIority MEdicines) designation from the European Medicines Agency (EMA) on January 29, 2021, and an Orphan Drug Designation (ODD) from the FDA on May 3, 2021. Today’s milestone marks the 12th BTD received by Janssen in oncology and the third such designation for the company’s portfolio of bispecific antibodies.

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"This Breakthrough Therapy Designation marks an important step in the continued development of talquetamab, a first-in-class bispecific antibody T-cell engager using GPRC5D, a novel target for the treatment of patients with relapsed or refractory multiple myeloma," said Sen Zhuang, M.D., Ph.D., Vice President, Clinical Research and Development, Janssen Research & Development, LLC. "Despite the therapies available for patients with relapsed or refractory multiple myeloma, new targets and treatments are needed because of the heterogeneity of the disease, which can impact a patient’s response to treatment. We are resolute in our commitment to advance science and develop new therapies and regimens for patients with the goal of delivering the best possible outcomes while driving toward cures."

The Breakthrough Therapy Designation is supported by data from the Phase 1/2, first-in-human dose-escalation MonumenTAL-1 study of talquetamab (Phase 1: NCT03399799; Phase 2: NCT04634552) for the treatment of heavily pretreated patients with relapsed or refractory multiple myeloma.1

Data from the MonumenTAL-1 study were featured during the 2022 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress as an oral presentation (Abstract #S182)2 and were presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Abstract #8015).3

The FDA grants BTD to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition and is based on preliminary clinical evidence that demonstrates the drug may have substantial improvement in at least one clinically significant endpoint over available therapy.4

About Talquetamab
Talquetamab is a potential first-in-class, investigational T-cell redirecting bispecific antibody targeting both GPRC5D, a novel multiple myeloma target that does not shed over time, and CD3, a component of the T-cell receptor.1 CD3 is involved in activating T-cells, and GPRC5D is highly expressed on multiple myeloma cells.5,6 Results from preclinical studies in mouse models demonstrate that talquetamab induces T-cell-mediated killing of GPRC5D-expressing multiple myeloma cells through the recruitment and activation of CD3-positive T-cells and inhibits tumor formation and growth.7

Talquetamab is currently being evaluated in a Phase 1/2 clinical study for the treatment of relapsed or refractory multiple myeloma (NCT03399799) and is also being explored in combination studies (NCT04586426).

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that affects white blood cells called plasma cells, which are found in the bone marrow.8 When malignant, these plasma cells rapidly spread and replace normal cells in the bone marrow. In 2020, an estimated 176,000 people worldwide were diagnosed with multiple myeloma.9 In 2022, it is estimated that more than 34,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the U.S.10 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems or infections.11