On March 20, 2020, OncoCyte Corporation (the "Company") reported that it has entered into an equity distribution agreement (the "Agreement") with Piper Sandler & Co. (the "Agent") to create an at-the-market equity program under which it may sell up to an aggregate of $25,000,000 of shares of the Company’s common stock (the "Shares") from time to time through the Agent, as sales agent (the "ATM Offering") (Filing, 8-K, Oncocyte, MAR 20, 2020, View Source [SID1234555727]).

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Under the Agreement, the Company will set the parameters for the sale of Shares, including the number of Shares to be issued, the time period during which sales are requested to be made, limitations on the number of Shares that may be sold in any one trading day and any minimum price below which sales may not be made. Sales of the Shares, if any, under the Agreement may be made in transactions that are deemed to be "at-the-market equity offerings" as defined in Rule 415 under the Securities Act of 1933, as amended. The Company will pay the Agent a commission equal to up to 3.0% of the gross proceeds of any Shares sold through the Agent under the Agreement. The Agreement contains customary representations, warranties and agreements by the Company, indemnification obligations of the Company and the Agent, other obligations of the parties and termination provisions. The Company has no obligation to sell any of the Shares, and may at any time suspend offers under the Agreement.

The Shares will be issued pursuant to the Company’s previously filed Registration Statement on Form S-3 (File No. 333-231980) that was declared effective on June 18, 2019. On March 20, 2020, the Company filed a prospectus supplement relating to the ATM Offering with the Securities and Exchange Commission.

The Agreement is filed as Exhibit 10.1 to this Report. The description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the Agreement filed herewith as an exhibit to this Report.

Attached as Exhibit 5.1 to this Report is the opinion of Ellenoff Grossman & Schole LLP relating to the legality of the issuance and sale of the shares.

On March 20, 2020 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported plans to host a live conference call and webcast on Monday, March 30, 2020 at 5:00 p.m. ET to report updated data from the ongoing XMT-1536 Phase 1 dose escalation study (Press release, Mersana Therapeutics, MAR 20, 2020, View Source [SID1234555726]). Members of the Mersana executive team will be joined by investigator, Debra L. Richardson, MD, Associate Professor of Gynecologic Oncology at the Stephenson Cancer Center at the University of Oklahoma Health Sciences Center and the Sarah Cannon Research Institute in Nashville, TN.

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Mersana Therapeutics had previously announced plans to present the updated XMT-1536 Phase 1 dose escalation data in a late-breaking oral presentation at the now cancelled Society of Gynecologic Oncology 2020 Annual Meeting on Women’s Cancer in Toronto, Canada.

Conference Call Details

To access the call, please dial 877-303-9226 (domestic) or 409-981-0870 (international) and provide the Conference ID 2889994. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com.

On March 20, 2020 Merck & Co., Inc. (NYSE:MRK), known as MSD outside the United States and Canada, reported that it has been notified that TRC Capital Investment Corporation (TRC Capital) has commenced an unsolicited "mini-tender" offer, dated March 26, 2020, to purchase up to 1,500,000 shares of Merck common stock at $73.35 per share (Press release, Merck & Co, MAR 20, 2020, View Source [SID1234555725]). The offer price is approximately 4.4% below the closing price of the Merck common stock on March 13, 2020 ($76.75), the last trading day before the date of the offer, but approximately 2.8% above the closing price of the Merck common stock today March 20, 2020 ($71.36).

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Merck does not endorse TRC Capital’s offer and recommends that Merck shareholders reject the offer and not tender their shares in response to TRC Capital’s unsolicited mini-tender offer. This mini-tender offer is at a price below the closing price for Merck’s shares (as of the day prior to the offer) and is subject to numerous conditions, including TRC Capital’s ability to obtain financing, there being no decrease to the market price of the Merck common stock since March 16, 2020, and no material worsening of the COVID-19 pandemic since March 13, 2020. Merck is not associated in any way with TRC Capital, its mini-tender offer or the offer documentation.

TRC Capital has made similar, unsolicited mini-tender offers for shares of other publicly traded companies. Mini-tender offers seek to acquire less than five percent of a company’s outstanding shares. This lets the offering company avoid many of the disclosure and procedural requirements the U.S. Securities and Exchange Commission (SEC) requires for tender offers. As a result, mini-tender offers do not provide investors with the same level of protections as provided by larger tender offers under the U.S. federal securities laws.

On its website, the SEC advises that the people behind mini tender-offers "frequently use mini-tender offers to catch shareholders off guard" and that investors "may end up selling at below-market prices." The SEC’s website also contains important tips for investors regarding mini-tender offers.

Like TRC Capital’s other offers, this one puts individual investors at risk because they may sell their shares at a discount without so realizing. Merck urges shareholders to obtain current stock quotes for their shares of Merck common stock, review the terms and conditions to the offer, consult with their broker or financial adviser and exercise caution with respect to TRC Capital’s mini-tender offer.

Merck shareholders who have already tendered are advised that they may withdraw their shares by providing the written notice described in the TRC Capital offering documents prior to the expiration of the offer, which is currently scheduled at 12:01 a.m. New York City time on Wednesday, April 15, 2020.

Merck encourages brokers, dealers, and other investors to review the SEC’s letter regarding broker-dealer mini-tender offer dissemination and disclosure.

Merck requests that a copy of this news release be included with all distribution of materials related to TRC Capital’s offer for shares of Merck common stock.

On March 20, 2020 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that on March 17, 2020 the U.S. Patent and Trademark Office ("USPTO") issued a Certificate to extend the duration of U.S. patent 6,409,990 for an additional five years through May 12, 2025 (Press release, Navidea Biopharmaceuticals, MAR 20, 2020, View Source [SID1234555723]). This Certificate was based on the U.S. Food and Drug Administration’s ("FDA") recommendation for a five-year extension under the Hatch-Waxman Act for patent term lost in regulatory review.

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This patent claims and protects Lymphoseek (technetium [Tc 99m] tilmanocept) and has been exclusively licensed with varying geographical and medical indication coverages to Cardinal Health and Navidea. Allowance of this patent extension will permit Cardinal Health and Navidea to extend their exclusive rights to manufacture and commercialize Lymphoseek until the end of the extended patent term in 2025.

"I am pleased the USPTO has taken positive action and extended the Lymphoseek patent until May 12, 2025," said Jed Latkin, CEO of Navidea. "This is an exciting time for Navidea as this extension is just the first of several IP related announcements that we expect to have over the next several quarters."

On March 19, 2020 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported highly encouraging initial clinical data from the first 15 patients enrolled in the ongoing Phase I/II OVATION 2 Study for patients newly diagnosed with Stage III and IV ovarian cancer (Press release, Celsion, MAR 19, 2020, View Source [SID1234555709]). The OVATION 2 Study combines GEN-1, the Company’s IL-12 gene-mediated immunotherapy, with standard-of-care neoadjuvant chemotherapy (NACT). Following NACT, patients undergo interval debulking surgery (IDS), followed by three additional cycles of chemotherapy.

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GEN-1 plus standard NACT produced positive dose-dependent efficacy results, with no dose-limiting toxicities, which correlates well with successful surgical outcomes as summarized below:

Of the 15 patients treated in the Phase I portion of the OVATION 2 Study, nine patients were treated with GEN-1 at a dose of 100 mg/m² plus NACT and six patients were treated with NACT only. All 15 patients had successful resections of their tumors, with seven out of nine patients (78%) in the GEN-1 treatment arm having an R0 resection, which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. Only three out of six patients (50%) in the NACT only treatment arm had a R0 resection.

When combining these results with the surgical resection rates observed in the Company’s prior Phase Ib dose-escalation trial (the OVATION 1 Study), a population of patients with inclusion criteria identical to the OVATION 2 Study, the data reflect the strong dose-dependent efficacy of adding GEN-1 to the current standard of care NACT:
% of Patients with
R0 Resections
0, 36, 47 mg/m² of GEN-1 plus NACT n=12 42%
61, 79, 100 mg/m² of GEN-1 plus NACT n=17 82%
The objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria for the 0, 36, 47 mg/m² dose GEN-1 patients were comparable, as expected, to the higher (61, 79, 100 mg/m²) dose GEN-1 patients, with both groups demonstrating an approximate 80% ORR.
As previously reported, the independent Data Safety Monitoring Board (DSMB) for the OVATION 2 Study completed its initial safety review of data from the first 15 patients treated with the first four weekly doses of GEN-1 at 100 mg/m², and confirmed that there were no apparent dose-limiting toxicities in any of the six evaluable patients (those patients who received at least four weekly doses of GEN-1) and that intraperitoneal administration of GEN-1 is well tolerated even when given with standard NACT.

The OVATION 2 Study is an open-label, 130-patient, 1-to-1 randomized Phase I/II trial, 80% powered to show the equivalent of a 33% improvement in progression-free survival (PFS), the primary endpoint, when comparing the treatment arm (NACT + GEN-1) with the control arm (NACT alone). GEN-1 is a formulation of Celsion’s proprietary, synthetic, non-viral cell transfection platform TheraPlas, which incorporates DNA plasmids coded for the inflammatory protein interleukin-12 (IL-12). Cell transfection is followed by persistent, local secretion of the IL-12 protein at therapeutic levels.

The OVATION 2 Study builds on encouraging clinical and translational research data from the Phase Ib OVATION 1 Study, in which enrolled patients received escalating weekly doses of GEN-1 up to 79 mg/m² for a total of eight treatments in combination with NACT, followed by IDS. These data from the OVATION 1 Study were presented at the ASCO (Free ASCO Whitepaper)-SITC Clinical-Oncology Symposium by Dr. Premal H. Thaker on May 4, 2019 and can be reviewed here. In addition to exploring a higher dose of GEN-1 in the OVATION 2 Study, patients will continue to receive GEN-1 after their IDS in combination with adjuvant chemotherapy.

"Of the nine patients treated with GEN-1 at 100 mg/m² plus NACT in the Phase I portion of the OVATION 2 Study, seven patients had an R0 resection at the time of their interval debulking surgery. A recent article published in the European Journal of Obstetrics & Gynecology and Reproductive Biology1 confirms the importance of complete tumor resection to improved survival outcome," said Nicholas Borys, M.D., executive vice president and chief medical officer of Celsion. "The combined data from our previous Phase Ib dose-escalating trial (OVATION 1 Study) plus this latest data from the Phase I portion of the OVATION 2 Study further confirms the encouraging dose-dependent efficacy of GEN-1 plus NACT. The clinical data at the three highest doses of GEN-1 showed an 82% R0 resection rate, compared with a 50% R0 resection rate for the NACT only control arm of the OVATION 2 Study. Historical levels of R0 resections after interval debulking surgery range from 40% to 60%."

1219 (2017) 100-105

"These data provide an early, but highly encouraging trend in both Phase I studies, and even more so when the study populations are combined to provide a larger ‘n’," stated Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "Confirmation that the 100 mg/m² dose is effective as a treatment for newly diagnosed ovarian cancer will be determined in the Phase II portion of the OVATION 2 Study, which is expected to begin enrollment in the 2nd half of 2020. As an open label randomized trial, we expect to report patient data and trends over the course of 2021, as it becomes available, with final PFS data expected to be reported 12 months following full patient enrollment."

About GEN-1 Immunotherapy

GEN-1, designed using Celsion’s proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation. The Company has previously reported positive safety and encouraging Phase I results with GEN-1 given as monotherapy in patients with peritoneally metastasized ovarian cancer, and recently completed a Phase Ib trial of GEN-1 in combination with PEGylated doxorubicin in patients with platinum-resistant ovarian cancer.