On November 4, 2021, Fate Therapeutics, Inc. (the "Company") reported that filed a registration statement on Form S-3ASR (the "Registration Statement") under Rule 415 of the Securities Act of 1933, as amended (the "Securities Act") (Press release, Fate Therapeutics, NOV 4, 2021, View Source [SID1234594445]). Pursuant to such Registration Statement, the Company may issue and sell from time to time securities consisting of (i) the Company’s common stock, par value $0.001 per share (the "Common Stock"), (ii) the Company’s preferred stock, par value $0.001 per share (the "Preferred Stock" together with the Common Stock, the "Equity Securities"), (iii) debt securities ("Debt Securities"), which may be either senior debt securities, subordinated debt securities, senior convertible debt securities or subordinated convertible debt securities, (iv) warrants or other rights to purchase Common Stock ("Warrants"), and (v) units comprised of shares of Common Stock, shares of Preferred Stock, Debt Securities and Warrants in any combination.

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In addition, on November 4, 2021, the Company entered into an Open Market Sale AgreementSM (the "Agreement") with Jefferies LLC ("Jefferies") with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of its Common Stock having an aggregate offering price of up to $350,000,000 (the "Placement Shares"), through Jefferies as its sales agent. The issuance and sale, if any, of the Placement Shares may be by any method permitted by law deemed to be an "at-the-market offering" as defined in Rule 415 of the Securities Act, including, without limitation, sales made directly on the Nasdaq Global Market ("Nasdaq"), or on any other existing trading market for the Common Stock.

The Company is not obligated to make any sales of Common Stock, and Jefferies is not required to sell any specific number or dollar amount of shares of the Common Stock, under the Agreement. The Company or Jefferies may suspend or terminate the offering of Placement Shares upon notice to the other party and subject to other conditions.

Subject to the Company’s request to sell Placement Shares, Jefferies will act as the Company’s sales agent on a best efforts basis and use commercially reasonable efforts to sell on the Company’s behalf, from time to time consistent with its normal sales practices and applicable state and federal laws, rules and regulations and Nasdaq rules, such Placement Shares based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay Jefferies a commission equal to 3.0 percent (3.0%) of the gross proceeds of any Placement Shares sold through Jefferies under the Agreement, and also has provided Jefferies with customary indemnification and contribution rights.

The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is filed herewith and incorporated herein by reference.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities 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.

On November 4, 2021, Neoleukin Therapeutics, Inc. (the "Company"), reported that entered into an ATM Equity Offering Sales AgreementSM (the "Sales Agreement") with BofA Securities, Inc., as agent ("BofA"), pursuant to which the Company may offer and sell, from time to time through BofA, shares of the Company’s common stock, par value $0.000001 per share (the "Common Stock"), having an aggregate offering price of up to $40.0 million (the "Shares") (Filing, 8-K, Neoleukin Therapeutics, NOV 4, 2021, View Source [SID1234594444]).

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The offer and sale of the Shares will be made pursuant to a shelf registration statement on Form S-3 and the related prospectus (File No. 333-251294) filed by the Company with the Securities and Exchange Commission (the "SEC") on December 11, 2020 and declared effective by the SEC on December 21, 2020, as supplemented by a prospectus supplement dated November 4, 2021 and filed with the SEC pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the "Securities Act").

Pursuant to the Sales Agreement, BofA may sell the Shares by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415 of the Securities Act, including sales made by means of ordinary brokers’ transactions, including on the Nasdaq Global Market, at market prices or as otherwise agreed with BofA. BofA will use commercially reasonable efforts consistent with its normal trading and sales practices to sell the Shares from time to time, based upon instructions from the Company, including any price or size limits or other customary parameters or conditions the Company may impose.

The Company is not obligated to make any sales of the Shares under the Sales Agreement. The offering of Shares pursuant to the Sales Agreement will terminate upon the earliest of (a) the sale of all of the Shares subject to the Sales Agreement or (b) the termination of the Sales Agreement by BofA or the Company, as permitted therein.

The Company will pay BofA a commission rate of up to 3.0% of the aggregate gross proceeds from each sale of Shares and has agreed to provide BofA with customary indemnification and contribution rights. The Company will also reimburse BofA for certain specified expenses in connection with entering into the Sales Agreement. The Sales Agreement contains customary representations and warranties and conditions to the placements of the Shares pursuant thereto.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. The opinion of the Company’s counsel regarding the validity of the Shares that will be issued pursuant to the Sales Agreement is also filed herewith as Exhibit 5.1.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Common Stock discussed herein, nor shall there be any offer, solicitation, or sale of common stock 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.

On November 4, 2021 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) ("Merrimack" or the "Company") reported its third quarter 2021 financial results for the period ended September 30, 2021 (Press release, Merrimack, NOV 4, 2021, View Source [SID1234594443]).

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"Both Ipsen Pharmaceuticals and Elevation Oncology publicly announced updates during the last three months that indicate that the clinical programs that may result in milestone payments to Merrimack continue to move forward", said Gary Crocker, CEO and Chairman of Merrimack’s Board of Directors. "In addition, we are pleased that our sustained focus on streamlining operational expenses continues to result in overhead cost reductions."

Third Quarter 2021 Financial Results

Merrimack reported net loss of $0.5 million for the third quarter ended September 30, 2021, or $0.04 per basic share, compared to a net loss of $1.0 million, or $0.08 per basic share, for the same period in 2020.

General and administrative expenses for the third quarter ended September 30, 2021 were $0.6 million, compared to $1.0 million for the same period in 2020.

As of September 30, 2021, Merrimack had cash and cash equivalents of $14.6 million, compared to $14.0 million as of December 31, 2020. The increase in cash position was due to a decrease of $2.0 million in prepaid expense and other assets including the receipt of our federal tax refund in April 2021, as well as $0.2 million from the exercise of stock options.

As of September 30, 2021, Merrimack had 13.4 million shares of common stock outstanding.

Updates on Programs Underlying Potential Milestone Payments

Ipsen Pharmaceuticals

On October 21, 2021, as part of its Q3 2021 Results Presentation, Ipsen provided to the public an update on the RESILIENT trial of ONIVYDE as a second line treatment for Small Cell Lung Cancer, indicating that clinical data from this trial are anticipated in the second half of 2022. Ipsen also provided an update on the NAPOLI 3 trial of ONIVYDE as a first line treatment for pancreatic cancer. Enrollment is completed in this trial and Ipsen indicated that clinical data are expected in 2023.

Elevation Oncology

Elevation Oncology licensed an anti-HER3 program from Merrimack in 2019. In its September 2021 investor presentation, Elevation communicated that the ongoing CRESTONE trial is intended to be a registrational trial pending continued discussions with the FDA and that top line results from this trial will be available in H1 2023. The anti-HER3 program licensed from Merrimack continues to be Elevation’s lead clinical asset.

On November 4, 2021 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the third quarter ended September 30, 2021 (Press release, Checkpoint Therapeutics, NOV 4, 2021, View Source [SID1234594442]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, stated, "The third quarter brought a marked increase in our preparation activities for a potential Biologics License Application submission for cosibelimab next year, as we eagerly await the top-line results from our registration-enabling study in metastatic cutaneous squamous cell carcinoma. Additionally, during the quarter we made substantial progress towards the near-term initiation of our Phase 3 registration-enabling trial for cosibelimab in first-line metastatic non-small cell lung cancer." Mr. Oliviero continued, "We believe the coming months could be transformational for our company, as we continue to hire the key personnel to position us favorably for the transition into a fully-integrated biopharmaceutical company focused on the goal of offering cancer therapies that provide better patient outcomes while delivering significant value to the future of healthcare."

Financial Results:

●Cash Position: As of September 30, 2021, Checkpoint’s cash and cash equivalents totaled $60.2 million, compared to $65.1 million at June 30, 2021 and $40.8 million at December 31, 2020, a decrease of $4.9 million for the quarter and an increase of $19.4 million year-to-date.
●R&D Expenses: Research and development expenses for the third quarter of 2021 were $9.4 million, compared to $2.5 million for the third quarter of 2020, an increase of $6.9 million. The increase in research and development expenses is primarily attributable to an increase in clinical trial and manufacturing related expenses for cosibelimab. Research and development expenses for the third quarters of 2021 and 2020 each included $0.2 million of non-cash stock expenses.
●G&A Expenses: General and administrative expenses for the third quarter of 2021 were $1.9 million, compared to $2.4 million for the third quarter of 2020, a decrease of $0.5 million. General and administrative expenses for the third quarter of 2021 included $0.6 million of non-cash stock expenses, compared to $1.3 million for the third quarter of 2020.
●Net Loss: Net loss attributable to common stockholders for the third quarter of 2021 was $11.3 million, or $0.14 per share, compared to a net loss of $4.9 million, or $0.09 per share, in the third quarter of 2020. Net loss for the third quarter of 2021 included $0.8 million of non-cash stock expenses, compared to $1.5 million for the third quarter of 2020.

On November 4, 2021 Genmab A/S (Nasdaq: GMAB) reported that it is improving its 2021 financial guidance published on August 11, 2021 (Press release, Genmab, NOV 4, 2021, View Source [SID1234594441]). The improved guidance is driven primarily by increased royalty revenue related to the net sales of DARZALEX (daratumumab), both intravenous and subcutaneous formulations, and lower operating expense resulting from timing of investments for R&D activities and organizational capability build.

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Genmab’s projected revenue for 2021 primarily consists of DARZALEX royalties. Such royalties are based on Genmab’s revised estimate of DARZALEX 2021 net sales of USD 5.9–6.2 billion compared to Genmab’s previous estimate of USD 5.6-5.9 billion.

Genmab’s financial results for the first nine months of 2021 will be published on November 10, 2021.

The above expectations are based on assumptions including those described on pages 5 and 6 of the Interim Report for the First Half of 2021 (Company Announcement No. 60 / 2021).