On August 11, 2020, Replimune Group, Inc. (the "Company") reported that it entered into a Sales Agreement (the "Sales Agreement") with SVB Leerink LLC (the "Agent"), pursuant to which the Company may sell, from time to time, at its option, up to an aggregate of $75,000,000 of shares of the Company’s common stock, $0.001 par value per share (the "Shares"), through the Agent, as the Company’s sales agent (Filing, 8-K, Replimune, AUG 11, 2020, View Source [SID1234563435]).

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Any Shares to be offered and sold under the Sales Agreement will be issued and sold (i) by methods deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended or in negotiated transactions, if authorized by the Company and (ii) pursuant to, and only upon the effectiveness of, a registration statement on Form S-3 filed by the Company with the Securities and Exchange Commission on August 11, 2020 for an offering of up to $350,000,000 of various securities, including shares of the Company’s common stock, preferred stock, debt securities, warrants and/or units for sale to the public in one or more public offerings.

Subject to the terms of the Sales Agreement, the Agent will use reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company cannot provide any assurances that it will issue any Shares pursuant to the Sales Agreement. The Company will pay the Agent a commission of up to 3.0% of the gross proceeds from the sale of the Shares, if any. The Company has also agreed to provide the Agent with customary indemnification rights.

Pursuant to the Sales Agreement, the parties mutually agreed to terminate that certain sales agreement, dated August 8, 2019, by and between the Company and the Agent (as amended, the "2019 Sales Agreement") with respect to the Company’s previous at-the-market offering program (the "2019 ATM Program").

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Shares nor shall there be any sale of the Shares in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

The foregoing description of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Sales Agreement, which is attached hereto as Exhibit 1.1 and is incorporated by reference herein.

On August 11, 2020 Quanterix Corporation (Nasdaq: QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported the closing of its previously announced underwritten public offering of 3,048,774 shares of its common stock at a public offering price of $32.00 per share, including 397,666 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares (Press release, Quanterix, AUG 11, 2020, View Source [SID1234563434]). Gross proceeds from the sale of the shares, before deducting underwriting discounts and commissions and offering expenses, were approximately $97.6 million.

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SVB Leerink and Cowen acted as joint bookrunning managers for the offering. Canaccord Genuity acted as co-manager for the offering.

The public offering was made pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the Securities and Exchange Commission ("SEC"), as well as a related registration statement on Form S-3MEF filed with the SEC pursuant to Rule 462(b) under the Securities Act of 1933, as amended. The final prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website located at View Source, and copies of which can be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by telephone at (800) 808-7525, ext. 6218 or by e-mail at [email protected], or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at [email protected].

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On August 11, 2020 Context Therapeutics, a clinical-stage biopharmaceutical company dedicated to advancing medicines for hormone driven cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for onapristone extended release (ONA-XR), for the treatment of patients with progesterone receptor positive (PR+) ovarian cancer (Press release, Context Therapeutics, AUG 11, 2020, View Source [SID1234563433]).

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"We are very encouraged by the FDA’s decision to grant us Fast Track Designation for our lead program ONA-XR, which has shown very encouraging activity and tolerability in our ongoing Phase 2 study in advanced PR+ ovarian cancers. We believe this recognition underscores the high unmet medical need for a treatment for patients with PR+ ovarian cancer," said Martin Lehr, Chief Executive Officer of ContextTherapeutics. "With this designation in hand, we plan to be able to quickly advance through the administrative steps of ONA-XR’s development and bring forth a therapy for these patients as soon as possible."

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill unmet medical needs. A drug granted Fast Track Designation may be eligible for several benefits, including more frequent meetings and communications with the FDA and, if certain criteria are met, the potential for Accelerated Approval, Priority Review or Rolling Review of a New Drug Application (NDA).

About Onapristone Extended Release
ONA-XR (onapristone extended release) is a potent and specific antagonist of the progesterone receptor that is orally administered. Currently, there are no approved therapies that selectively target PR+ cancers. Preliminary preclinical and clinical data suggest that ONA-XR has anticancer activity by inhibiting progesterone receptor binding to chromatin, downregulating cancer stem cell mobilization and blocking immune evasion. ONA-XR is currently the subject of an ongoing Phase 2 clinical trial in progesterone receptor positive ovarian cancer. Additional Phase 2 clinical trials in breast and endometrial cancers will initiate in 2020. ONA-XR is an investigational drug that has not been approved for marketing by any regulatory authority.

On August 11, 2020 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported its financial results for the second quarter 2020 and provided a corporate update (Press release, Gossamer Bio, AUG 11, 2020, View Source [SID1234563432]).

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"I hold tremendous pride in the progress made by the Gossamer team to date," said Sheila Gujrathi, M.D., Co-Founder and Chief Executive Officer of Gossamer. "We look forward to the continued advancement of our product candidates, and before year end, we are excited for the achievement of milestones across all four of our clinical programs."

Clinical-Stage Product Candidate Updates

GB001: Oral DP2 Antagonist for Eosinophilic Asthma and Chronic Rhinosinusitis (CRS)

Phase 2b LEDA study in patients with moderate-to-severe eosinophilic asthma is on track to report topline data in the second half 2020.
Phase 2 TITAN study in patients with chronic rhinosinusitis, both with and without nasal polyps, is also on track to report topline data in the second half 2020.
GB002: Inhaled PDGFR Inhibitor for Pulmonary Arterial Hypertension (PAH)

GB002 is currently being evaluated in an ongoing Phase 1b study in PAH. Given COVID-19 related delays in study enrollment, Gossamer anticipates reporting initial results from this study in the second half of this year.
Subject to developments in the ongoing COVID-19 pandemic, Gossamer plans to commence TORREY, a Phase 2 study in functional class II and III PAH patients in the second half of 2020. The primary endpoint for this 24-week study will be change in pulmonary vascular resistance (PVR) from baseline. The key secondary endpoint will be change from baseline in 6-minute walk distance at week 24.
GB004: Oral HIF-1α Stabilizer for Inflammatory Bowel Disease

Gossamer to present data from its completed Phase 1b study in patients with active mild-to-moderate ulcerative colitis (UC) at UEG Week Virtual 2020, which will take place October 11-13. Gossamer previously announced topline data from its completed Phase 1b study on May 12, 2020.
Subject to developments in the ongoing COVID-19 pandemic, Gossamer plans to initiate SHIFT-UC, a 12-week Phase 2 study of GB004 in patients with mild-to-moderate UC in the second half of 2020.
GB1275: Oral CD11b Modulator for Oncology Indications

Further Phase 1 data from KEYNOTE-A36, a Phase 1/2 study to evaluate GB1275 as a monotherapy and in combination with either KEYTRUDA (pembrolizumab) or chemotherapy in patients with selected solid tumors, are expected to be announced in the fourth quarter of 2020.
Financial Results for the Quarter Ended June 30, 2020

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of June 30, 2020, were $600.4 million. The Company expects the combination of current cash, cash equivalents and marketable securities, and access to our debt facility will be sufficient to fund its operating and capital expenditures into 2024.
Research and Development (R&D) Expenses: For the quarter ended June 30, 2020, R&D expenses were $38.7 million, compared to R&D expenses of $35.7 million for the same period in 2019.
In Process Research and Development (IPR&D) Expenses: For the quarter ended June 30, 2020, IPR&D expenses were $15.0 million, compared to $1.0 million for the same period in 2019. This increase reflects a $15.0 million upfront payment to Aerpio Pharmaceuticals, Inc. for the amendment to the in-license of GB004.
General and Administrative (G&A) Expenses: For the quarter ended June 30, 2020, G&A expenses were $11.7 million, compared to $9.7 million for the same period in 2019.
Net Loss: Net loss for the quarter ended June 30, 2020, was $66.9 million, or $1.00 per share, compared to a net loss of $44.5 million, or $0.74 per share, for the same period in 2019.

On August 11, 2020 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported preliminary, unaudited revenue and net product sales for the second quarter of 2020 (Press release, Supernus, AUG 11, 2020, View Source [SID1234563431]).

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Preliminary second quarter 2020 revenue consisted of net product sales of $124.0 million and royalty revenue of $2.7 million. Preliminary second quarter 2020 net product sales of $124.0 million increased 21% compared to the same period in 2019 due to higher net product sales of Trokendi XR and Oxtellar XR and the addition of $10.6 million of net product sales from the acquisition of the CNS portfolio of US WorldMeds, which closed on June 9, 2020.

The second quarter 2020 revenue results included herein are preliminary and are therefore subject to change.

Conference Call Details

The Company expects to report full second quarter 2020 results after 5:00 p.m. ET on Tuesday, August 18, 2020. The Company will hold a conference call hosted by Jack Khattar, President and Chief Executive Officer, and Greg Patrick, Senior Vice President and Chief Financial Officer, to discuss these results at 9:00 a.m. Eastern Time, on Wednesday, August 19, 2020. Please refer to the information below for conference call dial-in information and webcast registration. Callers should dial in approximately 10 minutes prior to the start of the call.

Conference dial-in: (877) 288-1043
International dial-in: (970) 315-0267
Conference ID: 5175177
Conference Call Name: Supernus Pharmaceuticals Second Quarter 2020 Earnings Conference Call
Following the live call, a replay will be available on the Company’s website, www.supernus.com, under "Investor Relations".