On March 9, 2021 Jounce Therapeutics, Inc. (Nasdaq: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that it is offering to sell shares of its common stock in an underwritten public offering (Press release, Jounce Therapeutics, MAR 9, 2021, View Source [SID1234576313]).

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The proceeds of the offering are expected to be used to fund ongoing and planned clinical trials, including the INNATE trial for JTX-8064, to fund research and development to advance Jounce’s pipeline, and for working capital and other general corporate purposes. All of the shares in the offering are to be sold by Jounce. 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. Jounce also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock sold in the offering on the same terms and conditions.

Cowen and Piper Sandler are acting as joint book-running managers for the offering.

The proposed offering is being made pursuant to a shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on March 8, 2018 and declared effective by the SEC on May 1, 2018. The offering will be made only by means of the prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to, and describing the terms of, the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov.

Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering can be obtained from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by telephone at 833-297-2926; or from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release does 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.

On March 9, 2021 GeneCentric Therapeutics, a company making precision medicine more precise, reported the granting of Patent No. 10,934,595 by the United States Patent and Trademark Office (USPTO), protecting another one of its novel RNA-based lung cancer gene signatures (Press release, GeneCentric Therapeutics, MAR 9, 2021, View Source [SID1234576311]). This new patent provides further demonstration of the novel RNA-based technology achievements of the GeneCentric team and its growing pipeline of predictive response signatures developed using its Tumor and Immune Micro-Environment (T(I)ME) Explorer platform.

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The patent covers the use of reduced RNA gene sets to characterize tumors from patients diagnosed with non-squamous non-small cell lung cancer (NSCLC), which are foundational to the development of the company’s predictive response signatures and diagnostics for this important patient population. The use of RNA-based gene signatures allows for a deeper understanding of the T(I)ME than DNA mutations alone, often allowing for the identification of a broader patient population that may benefit from targeted therapy compared to use of traditional DNA mutation analysis.

"Those of us who study the genomics of lung cancer have known for more than a decade that there is a rich and reproducible story to be told though gene expression assays," said Neil Hayes, MD, GeneCentric co-founder, and Scientific Director, University of Tennessee West Institute for Cancer Research. "The signatures inherent to clinically relevant subgroups are opaque to the microscope but revealed through the genome. We are thrilled to open the door to applications applicable to prognosis and response for traditional cytotoxic chemotherapy, targeted therapies, and emerging immune-oncologic approaches."

GeneCentric continues to make significant progress with its growing pipeline of RNA-based predictive response signatures and molecular diagnostics, with the lung cancer program as its cornerstone. Further updates will be provided as the company presents additional data validating its novel RNA-based signatures and diagnostic tests across multiple tumor types at upcoming scientific meetings and in peer-reviewed publications.

"This is an important time for GeneCentric as we clinically validate and prepare to launch this diagnostic test," said Dr. Mike Milburn, President, and CEO of GeneCentric Therapeutics. "The granting of this latest lung cancer patent by the USPTO demonstrates the utility and uniqueness of our growing pipeline of RNA-based diagnostics,"

On March 9, 2021 Five Prime Therapeutics, Inc. (NASDAQ: FPRX) reported that it has canceled its fourth quarter and full year 2020 earnings conference call, which was previously scheduled for Wednesday, March 10, 2021 at 1:30 p.m. PT / 4:30 p.m. ET (Press release, Five Prime Therapeutics, MAR 9, 2021, View Source [SID1234576310]).

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The cancellation is the result of the company’s announcement on March 4, 2021 that it has entered into an agreement under which Amgen Inc. will acquire Five Prime Therapeutics. Five Prime will issue its fourth quarter and full-year 2020 financial results in its Form 10-K that it will file with the Securities and Exchange Commission.

On March 9, 2021 Evelo Biosciences, Inc. (Nasdaq: EVLO), a clinical stage biotechnology company developing a new modality of orally delivered medicines, reported financial results and business highlights for the fourth quarter and full year 2020 (Press release, Evelo Biosciences, MAR 9, 2021, View Source [SID1234576309]).

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"Building on a series of positive clinical data announcements and strong progress in 2020, we are pleased to begin 2021 by announcing a further positive clinical data readout with EDP1815. We have now shown positive clinical data with EDP1815 in five separate cohorts across psoriasis, atopic dermatitis, and a human experimental model of inflammation. EDP1815’s observed profile of broad inflammation resolving effects and tolerability is highly differentiated and supports the potential of EDP1815 as a foundational treatment for all stages of inflammatory disease," said Simba Gill, Ph.D., Chief Executive Officer of Evelo. "The new EDP1815 data we are reporting today is from a healthy volunteer experimental model of inflammation. This study showed that an increase in the concentration of drug in a capsule resulted in enhanced effect for the same overall dose. We are also pleased with the accelerated recruitment of the Phase 2b trial of EDP1815 in psoriasis, and we will now report top-line data for the full cohort of patients in the third quarter of this year."

Dr. Gill continued, "The results we have observed with EDP1815 provide evidence for the entire SINTAX platform and support the potential of our investigational medicines to control systemic inflammation and immunity. EDP1815 and dermatological diseases are only the beginning. In February, we initiated the first clinical trial of our next anti-inflammatory candidate, EDP1867. We are progressing our two extracellular vesicle candidates, EDP2939 for inflammatory diseases and EDP1908 for oncology. In addition, we have strengthened our balance sheet with $88 million in net proceeds from recent sales of our common stock and have expanded our team with the appointments of Jonathan Zung, Ph.D., as Chief Development Officer, and John Hohneker, M.D., to our Board of Directors. We now have the resources and team in place to advance our broad portfolio to later-stage development."

Fourth Quarter/Full Year 2020 Highlights and Recent Progress

EDP1815 in Human Experimental Model of Inflammation

Evelo reported positive data from a healthy volunteer experimental model of inflammation with EDP1815.
○ A total of 32 healthy volunteers were dosed daily for 28 days with either of two concentrations of EDP1815, or placebo.

○ The study was designed to investigate the relative effectiveness of two different concentrations of EDP1815 in capsules.

○ The increased concentration of drug results from improvements made in the commercial-scale manufacturing process (referred to as A2). This is the same active drug at four times the concentration compared to a prior manufacturing process (referred to as A’).

○ Healthy volunteers were immunized with the same antigen used in preclinical inflammation experiments. After 28 days of daily oral treatment with EDP1815 or placebo, subjects were given a skin challenge with the antigen which causes measurable skin inflammation a day later. 12 subjects were given A’ EDP1815. Another 12 subjects were given the higher concentration A2. The 8 subjects who received a placebo were divided between the two treatment groups.

○ As shown in the figure below, the higher concentration A2, given in fewer capsules, resulted in numerically superior reductions across the full range of skin evaluation scores compared to A’ and to placebo. A2 and A’ were given at the same total daily dose of drug.

○ These results are consistent with preclinical data showing that increased drug concentration resulted in increased effects.

○ This is a key advancement in Evelo’s understanding of how to get even more benefit from SINTAX medicine candidates.

A figure accompanying this announcement is available at: View Source

Based on these data, Evelo is expanding its ongoing Phase 1b clinical trial to include additional cohorts evaluating the higher concentration A2 in both tablet and capsule formulations. Results from the Phase 1b trial and ongoing Phase 2b trial together will position the Company to go forward into Phase 3 trials with an optimized dose and formulation of EDP1815 which may further improve on the positive results already seen.
EDP1815 in Psoriasis

Evelo has completed enrollment in its ongoing Phase 2b dose-ranging trial using A’ EDP1815. Given accelerated recruitment, the Company now plans to report top-line data for all patients in the study in the third quarter of this year in place of an interim data readout on the first 113 patients.
EDP1815 in Atopic Dermatitis

In December and January, Evelo announced positive clinical data from a cohort of patients with mild and moderate atopic dermatitis in its Phase 1b clinical trial.
In addition to being well tolerated with no treatment-related adverse events of moderate or severe intensity and no serious adverse events, the data showed consistent improvements in percentage change from baseline compared to placebo for Eczema Area and Severity Index (EASI), Investigator’s Global Assessment and Body Surface Area (IGA*BSA) and SCORing Atopic Dermatitis (SCORAD). Treatment with EDP1815 also resulted in clinically meaningful improvement in the patient-reported outcomes of Dermatology Life Quality Index (DLQI) and Patient-Oriented Eczema Measure (POEM).
EDP1867 in Atopic Dermatitis

In February, Evelo initiated a Phase 1b trial of EDP1867 in healthy volunteers and patients with moderate atopic dermatitis.
EDP1908 in Oncology

In November, Evelo presented preclinical data for EDP1908 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting. The data showed that orally administered EDP1908, an extracellular vesicle, resulted in superior tumor growth control versus either the parental microbial strain or anti-PD-1 therapy, with an observed dose-dependent reduction of tumor growth. The observed effects were comparable to those reported in the literature for intratumorally administered immune stimulators. Evelo subsequently announced the decision to prioritize EDP1908 as its lead clinical candidate in oncology.
Business Highlights

In December 2020, Evelo announced the appointment of Jonathan Zung, Ph.D., as Chief Development Officer and a member of the Evelo Executive Team. Dr. Zung brings more than 25 years of global pharmaceutical development and commercialization experience to Evelo.
In February 2021, Evelo closed an underwritten public offering of shares of its common stock at a public offering price of $15.00 per share, and a private placement of shares of its common stock at an offering price of $15.00 per share, resulting in gross proceeds of approximately $85.1 million, before underwriting discounts and commissions.
In February 2021, Evelo announced the appointment of John A. Hohneker, M.D., to its Board of Directors.
Upcoming Key Milestones

EDP1815 – Psoriasis; all data anticipated to be reported in 3Q 2021

Data from Phase 1b cohorts with A2 tablets and A2 capsules
Full data from Phase 2b dose-ranging trial
EDP1815 – Atopic Dermatitis

Subject to regulatory approval, initiation of Phase 2 trial in 3Q 2021
EDP1815 – COVID-19

Data from Phase 2 trial with Rutgers University in 2Q 2021
Interim safety and futility analysis from Phase 2/3 TACTIC-E trial in 2Q 2021
EDP1867 – Atopic Dermatitis

Interim data from Phase 1b trial expected in 4Q 2021
EDP2939 – Inflammation

Initiation of clinical development in 2022
EDP1908 – Oncology

Initiation of clinical development in 2022
Fourth Quarter and Full Year 2020 Financial Results

Cash Position: As of December 31, 2020, cash and cash equivalents were $68.9 million, as compared to cash and cash equivalents of $77.8 million as of December 31, 2019. This decrease was primarily due to cash used in operating activities, partially offset by $48.4 million in net proceeds from the Company’s June 2020 follow-on offering of common stock and draw down of an additional $10 million under its existing debt facility in July 2020. During the first quarter of 2021, the Company raised net proceeds of $82.2 million from the issuance of common stock exclusive of certain other fees payable by the Company.
Research and Development Expenses: R&D expenses were $22.1 million for the three months ended December 31, 2020 and $69.6 million for the full year ended December 31, 2020, compared to $16.4 million for the three months ended December 31, 2019, and $63.1 million for the full year ended December 31, 2019. The increase of $6.5 million year over year was primarily due to increased costs related to Evelo’s inflammation clinical development programs, clinical development and technical operations headcount growth and platform investment, partially offset by lower oncology spend.
General and Administrative Expenses: G&A expenses were $6.1 million for the three months ended December 31, 2020 and $22.3 million for the full year ended December 31, 2020, compared to $6.3 million for the three months ended December 31, 2019 and $23.2 million for the full year ended December 31, 2019. The decrease of $1.0 million year over year was primarily due to lower cost associated with legal, consulting and other professional fees, partially offset by higher IT and other office expense costs.
Net Loss: Net loss was $29.1 million for the three months ended December 31, 2020 and $93.7 million for the full year ended December 31, 2020, or $(0.62) and $(2.37) per basic and diluted share, respectively, as compared to a net loss of $22.6 million for the three months ended December 31, 2019 and $85.5 million for the full year ended December 31, 2019, or $(0.70) and $(2.67) per basic and diluted share, respectively.
Conference Call

Evelo will host a conference call and webcast at 8:30 a.m. ET today to review fourth quarter and full year 2020 highlights. To access the call, please dial (866) 795-3242 (domestic) or (409) 937-8909 (international) and refer to conference ID 3094547. A live webcast of the event will also be available under "News and Events" in the Investors section of Evelo’s website at View Source The archived webcast will be available on Evelo’s website approximately two hours after the completion of the event and will be available for 30 days following the call.

On March 9, 2021 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the Company will release its fourth quarter 2020 financial results on Tuesday, March 16, 2021, after the close of US markets (Press release, Curis, MAR 9, 2021, View Source [SID1234576308]). Management will host a conference call on the same day at 4:30 pm ET.

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To access the live conference call, please dial (888) 346-6389 from the United States or (412) 317-5252 from other locations, shortly before 4:30 pm ET. The conference call can also be accessed on the Curis website at www.curis.com in the ‘Investors’ section. A replay of the financial results conference call will be available on the Curis website shortly after completion of the call.