On February 3, 2023, DURECT Corporation ("DURECT"), reported that it has entered into a securities purchase agreement (the "Purchase Agreement"), with two institutional healthcare investors (the "Purchasers"), relating to the purchase and sale of an aggregate of (i) 1,700,000 shares (the "Shares") of its common stock, par value $0.0001 per share ("Common Stock"), (ii) pre-funded warrants to purchase 300,000 shares of Common Stock, and (iii) accompanying common warrants, to purchase an aggregate of 2,000,000 shares of Common Stock in a registered direct offering (the "Offering") (Filing, 8-K, DURECT, FEB 7, 2023, View Source [SID1234626913]). The aggregate gross proceeds to DURECT from the Offering were $10.0 million before deducting placement agent fees and other estimated offering expenses payable by DURECT and excluding the proceeds, if any, from the exercise of the pre-funded warrants and common warrants issued in the Offering.

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The pre-funded warrants are exercisable immediately following the closing date of the Offering and have an unlimited term and an initial exercise price of $0.00001 per share. The common warrants will be immediately exercisable and have a five year term and an initial exercise price of $5.00 per share. The combined offering price is $5.00 per Share and accompanying common warrant, or in the case of pre-funded warrants, $4.99999 per pre-funded warrant and accompanying common warrant. A holder (together with its affiliates) may not exercise any portion of a pre-funded warrant or common warrant to the extent that the holder would own more than 4.99% (or, at the election of the holder 9.99%) of DURECT’s outstanding Common Stock immediately after exercise.

The common warrants include full ratchet anti-dilutive adjustment rights in the event DURECT issues shares of Common Stock or Common Stock equivalents in the future with a value less than the then effective exercise price of such common warrants subject to certain customary exceptions. The common warrants also include certain rights upon "fundamental transactions" as described in the common warrants, including the right of the holders thereof to receive from DURECT or a successor entity the same type or form of consideration (and in the same proportion) that is being offered and paid to the holders of Common Stock in such fundamental transaction in the amount of the Black Scholes value (as described in such common warrants) of the unexercised portion of the applicable common warrants on the date of the consummation of such fundamental transaction. In addition, a holder of a common warrant may also effect an "alternative cashless exercise" on or prior to the six (6) month anniversary of the original issuance date. In such event, the aggregate number of shares of our Common Stock issuable in such alternative cashless exercise shall equal the product of (x) the aggregate number of shares of our Common Stock that would be issuable upon exercise of the common warrant in accordance with the terms of such common warrant if such exercise were by means of a cash exercise rather than a cashless exercise and (y) 0.66.

The Purchase Agreement contains customary representations, warranties and agreements by DURECT, customary conditions to closing, and indemnification obligations of DURECT and the Purchasers. The representations, warranties and covenants contained in the Purchase Agreement were made only for purposes of the Purchase Agreement and as of a specific date, were solely for the benefit of the parties to the Purchase Agreement, and may be subject to limitations agreed upon by the contracting parties.

DURECT engaged Cantor Fitzgerald & Co. and Oppenheimer & Co. Inc. to act as lead placement agents in the Offering. DURECT has agreed to pay the placement agents a cash fee equal to 6.0% of the aggregate gross proceeds generated from the Offering and to reimburse certain expenses of the placement agents in connection with the Offering in an amount not to exceed $150,000.

DURECT intends to use the proceeds from the Offering primarily for general corporate purposes, which may include clinical trials, research and development activities, capital expenditures, and selling, general and administrative costs, facilities expansion, and to meet working capital needs. The closing of the Offering is expected to occur on February 8, 2023, subject to customary closing conditions.

The Offering is being made pursuant to DURECT’s registration statement on Form S-3 (File No. 333-258333), previously filed with the U.S. Securities and Exchange Commission ("SEC") on July 30, 2021, and declared effective by the SEC on August 16, 2021, and a prospectus supplement thereunder.

A copy of the form of common warrant is filed as Exhibit 4.1 hereto, a copy of the form of pre-funded warrant is filed as Exhibit 4.2 hereto and the Purchase Agreement is filed as Exhibit 10.1 hereto. The foregoing descriptions of the terms of the Purchase Agreement and the pre-funded and common warrants are qualified in their entirety by reference to such exhibits. A copy of the opinion of Orrick, Herrington & Sutcliffe LLP relating to the legality of the issuance and sale of the Common Stock and pre-funded and common warrants in the Offering is attached to this Current Report on Form 8-K as Exhibit 5.1.

On February 7, 2023 Derm-Biome Pharmaceuticals, Inc, a Vancouver based biopharmaceutical company focused on skin health, ireported that it has been invited to present at the 2023 OBIO Investment Summit (OIS) in Toronto on Friday, February 10th at 11:51am EST (Press release, Derm-Biome Pharmaceuticals, FEB 7, 2023, View Source;utm_medium=rss&utm_campaign=derm-biome-pharmaceuticals-to-present-at-the-2023-obio-investment-summit-on-february-10-2023 [SID1234626912]). The Summit is Canada’s premier health science investment event, a forum that connects global investors with Canada’s best technology innovators. Since 2018 summit companies have raised $1.3 billion.

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Derm-Biome CEO Gordon Eberwein: "The OBIO Investment Summit will be the kick off to a seed round that will fund the advancement of our topical skin disease drug through a phase I clinical trial, a significant milestone for our company. We look forward to presenting our exciting technology and meeting people from the life sciences investment community."

On February 7, 2023 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, reported financial results for the fourth quarter and year ended December 31, 2022 and provided a corporate update (Press release, Deciphera Pharmaceuticals, FEB 7, 2023, View Source [SID1234626911]).

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"We are exceptionally proud of the progress we made across our pipeline in 2022, which has set the stage for continued growth and momentum in 2023 for our commercial, clinical, and preclinical programs. We are well positioned to achieve our goals thanks to our strong balance street, which was bolstered by our recent financing that extended our cash runway into 2026," said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. "As QINLOCK continues to become the standard-of-care treatment for fourth-line GIST around the world, we are excited to initiate the INSIGHT pivotal Phase 3 study later this year, which seeks to build upon the substantial clinical benefit in second-line GIST patients harboring mutations in KIT exon 11 and 17/18 that we observed in the ctDNA analysis from our INTRIGUE study. We believe that with an expanded indication in the second-line setting, QINLOCK and vimseltinib in TGCT combined represent a peak global revenue opportunity of over one billion dollars. We now expect to complete enrollment in vimseltinib’s MOTION pivotal Phase 3 study in the first quarter of 2023, bringing us one step closer to becoming a company with multiple approved medicines."

Fourth Quarter 2022 and Early 2023 Highlights and Upcoming Milestones

QINLOCK (ripretinib)

Recorded $32.9 million in QINLOCK net product revenue in the fourth quarter of 2022, including $25.6 million in U.S. net product revenue and $7.3 million in international net product revenue, an increase of 39% from net product revenue of $23.7 million in the fourth quarter of 2021.
Included in the National Reimbursement Drug List (NRDL) by China’s National Healthcare Security Administration (NHSA) for advanced gastrointestinal stromal tumor (GIST) patients who have received prior treatment with three or more kinase inhibitors in the all-comer setting.
Received approval in New Zealand in December 2022 and in Israel and Macau in January 2023 for the treatment of adult patients with GIST who have received prior treatment with three or more kinase inhibitors, including imatinib.
Presented data from the INTRIGUE Phase 3 exploratory circulating tumor DNA (ctDNA) analysis at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Series Session on January 24, 2023, which followed the announcement of top-line results earlier that month.
Patients with mutations in KIT exon 11 and 17/18 derived substantially improved clinical benefit with QINLOCK versus sunitinib.
QINLOCK demonstrated a median progression free survival (mPFS) of 14.2 months compared to 1.5 months for the sunitinib arm (hazard ratio [HR] 0.22, nominal p value <0.0001).
QINLOCK demonstrated a confirmed objective response rate (ORR) of 44.4% (n=12 of 27) compared to 0% for sunitinib (nominal p value 0.0001).
Overall survival (OS) for the QINLOCK arm has not reached a median, while patients randomized to the sunitinib arm had a median OS (mOS) of 17.5 months (HR 0.34, nominal p value 0.0061).
Expects to initiate the INSIGHT pivotal Phase 3 study of QINLOCK versus sunitinib in second-line GIST patients with mutations in KIT exon 11 and 17 and/or 18 and the absence of mutations in KIT exon 9, 13, and/or 14 (also referred to as patients with mutations in KIT exon 11 and 17/18) in the second half of 2023.
Vimseltinib

Expects to complete enrollment for the MOTION pivotal Phase 3 study of vimseltinib, an investigational, orally administered, potent, and highly selective switch-control kinase inhibitor of CSF1R for the potential treatment of tenosynovial giant cell tumor (TGCT), in the first quarter of 2023 and announce top-line results from the study in the fourth quarter of 2023.
Expects to present updated data from the Phase 1/2 study of vimseltinib in the second half of 2023.
DCC-3116

Expects to initiate a new combination study evaluating DCC-3116, an investigational switch-control kinase inhibitor of ULK1/2 designed to inhibit autophagy, in combination with encorafenib and cetuximab in patients with colorectal cancer in the second half of 2023. Under the terms of the clinical trial collaboration and supply agreement with Pfizer, Inc., Deciphera will sponsor the study and Pfizer will supply encorafenib at no cost.
Opened enrollment in three Phase 1b combination dose escalation cohorts and treated the first patient in the fourth quarter of 2022:
In combination with trametinib, a Food and Drug Administration (FDA)-approved MEK inhibitor, in patients with advanced or metastatic solid tumors with RAS, NF1, or RAF mutations.
In combination with binimetinib, an FDA-approved MEK inhibitor, in patients with advanced or metastatic solid tumors with RAS, NF1, or RAF mutations.

In combination with sotorasib, an FDA-approved KRASG12C inhibitor, in patients with advanced or metastatic solid tumors with KRASG12C mutations.
Expects to present updated data from the single agent dose escalation phase and initial data from the combination dose escalation cohorts of the Phase 1/2 study of DCC-3116 in the second half of 2023.
Expects to initiate one or more expansion cohorts in the ongoing Phase 1/2 study of DCC-3116 in the second half of 2023 in combination with the MEK inhibitors trametinib or binimetinib, or the KRASG12C inhibitor sotorasib.
Expects to present preclinical data on new clinical combinations with DCC-3116 in the first half of 2023.
DCC-3084

Expects to submit an investigational new drug (IND) application with the FDA for DCC-3084, a potential best-in-class pan-RAF inhibitor, in the second half of 2023.
Expects to present in vitro and in vivo data demonstrating its preclinical profile as a potent and selective inhibitor of BRAF/CRAF kinases, with optimized pharmaceutical properties for development in both single-agent and combination opportunities, in the first half of 2023.
Kinase Switch-Control Research Engine

Expects to nominate a new development candidate from Deciphera’s proprietary discovery engine of novel switch-control inhibitors in the first half of 2023.
Expects to present new preclinical data from research programs at a medical meeting in the first half of 2023.
Corporate Update

Announced the closing of its underwritten public offering of 7,986,111 shares of its common stock, including 1,041,666 shares pursuant to the option granted by Deciphera to the underwriters, which option was exercised in full. The public offering price of each share of common stock was $18.00. The aggregate gross proceeds to Deciphera from this offering were approximately $143.7 million, before deducting underwriting discounts and commissions and other estimated offering expenses.
Fourth Quarter and Full Year 2022 Financial Results

Revenue: Total revenue for the fourth quarter of 2022 was $36.3 million, which includes $32.9 million of net product revenue of QINLOCK and $3.4 million of collaboration revenue compared to $24.2 million of total revenue, including $23.7 million of net product revenue of QINLOCK and $0.5 million of collaboration revenue, for the same period in 2021. Total revenue for the year ended December 31, 2022 was $134.0 million, which includes $125.5 million of net product revenue of QINLOCK and $8.5 million of collaboration revenue compared to $96.1 million of total revenue, including $87.4 million of net product revenue of QINLOCK and $8.8 million of collaboration revenue, for the same period in 2021. International and total net product revenue for the fourth quarter includes a one-time reserve for QINLOCK product sales in Germany due to a change in German law effective as of November 2022 shortening the free pricing period retroactively to six months from twelve months.

Cost of Sales: Cost of sales were $3.2 million in the fourth quarter of 2022, which includes $0.7 million in cost of product sales, compared to cost of product sales of $0.5 million for the fourth quarter of 2021. For the year ended December 31, 2022, cost of sales were $8.7 million, including $2.7 million in cost of product sales, compared to cost of sales of $2.9 million in 2021, including cost of product sales of $1.3 million. In the third quarter of 2022, the Company completed the sales of zero cost inventories of QINLOCK that had been expensed prior to FDA approval.
R&D Expenses: Research and development expenses for the fourth quarter of 2022 were $48.1 million, compared to $74.9 million for the same period in 2021, and $187.8 million for the year ended December 31, 2022 compared to $257.0 million for the same period in 2021. The decrease was primarily due to lower clinical study costs related to QINLOCK, including the Phase 3 INTRIGUE study and the Phase 1 study, the discontinuation of the rebastinib program following the corporate restructuring implemented in the fourth quarter of 2021, partially offset by an increase in clinical study costs related to the Phase 3 study of vimseltinib and the Phase 1/2 study of DCC-3116. Non-cash, stock-based compensation was $22.2 million and $20.7 million for the year ended December 31, 2022 and 2021, respectively.

SG&A Expenses: Selling, general, and administrative expenses for the fourth quarter of 2022 were $32.2 million, compared to $37.2 million for the same period in 2021 and $120.2 million for the year ended December 31, 2022, compared to $136.3 million for the same period in 2021. The decrease was primarily due to a decrease in personnel-related costs and professional and consultant fees. Non-cash, stock-based compensation was $29.7 million and $25.4 million for the year ended December 31, 2022 and 2021, respectively.
Net Loss: For the fourth quarter of 2022, Deciphera reported a net loss of $45.9 million, or $0.60 per share, compared with a net loss of $88.4 million, or $1.51 per share, for the same period in 2021. Net loss for the year ended December 31, 2022 was $178.9 million, or $2.37 per share, compared with a net loss of $300.0 million, or $5.16 per share, for the year ended December 31, 2021.

Cash Position: As of December 31, 2022, cash, cash equivalents, and marketable securities were $339.0 million, compared to $327.6 million as of December 31, 2021. Based on its current operating plans, Deciphera expects its current cash, cash equivalents, and marketable securities together with anticipated product, royalty, and supply revenues, and the net proceeds from our underwritten public offering completed in January 2023, but excluding any potential future milestone payments under its collaboration or license agreements, will enable the Company to fund its operating and capital expenditures into 2026.
Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, February 7, 2023, at 8:00 AM ET. The conference call may be accessed via this link: https://register.vevent.com/register/BId831b7236a304519833842d99a13487f. A live webcast of the conference call will be available in the "Events and Presentations" page in the "Investors & News" section of the Company’s website at View Source A replay will be available on the Company’s website approximately two hours after the conference call and will be available for 30 days following the call.

On February 7, 2023 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported that Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin, will host a conference call and webcast on Monday, February 27, at 4:30 p.m. ET to discuss fourth quarter and full-year 2022 financial results and provide a general business update (Press release, BioMarin, FEB 7, 2023, View Source,-February-27,-at-4-30-p-m-ET [SID1234626909]).

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Dial-in Number
U.S. / Canada Dial-in Number: 800-831-4163
International Dial-in Number: 213-992-4616

U.S. / Canada Replay Dial-in Number: 800-645-7964
International Replay Dial-in Number: 757-849-6722
Playback ID: 9184#

Interested parties may access a live audio webcast of the conference call via the investor section of the BioMarin website, www.biomarin.com. A replay of the call will be archived on the site for one week following the call.

On February 7, 2023 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company will report its fourth quarter 2022 financial results on Tuesday, February 21, 2023 (Press release, BioCryst Pharmaceuticals, FEB 7, 2023, View Source [SID1234626908]).

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BioCryst management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing 1-866-777-2509 for domestic callers and 1-412-317-5413 for international callers. A live webcast and replay of the call will be available online at the investors section of the company website at www.biocryst.com.