On November 16, 2020 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, reported financial results for the third quarter ended September 30, 2020 and provided an update on recent operational and business progress (Press release, RAPT Therapeutics, NOV 16, 2020, View Source [SID1234571104]).

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"Earlier today, we reported positive initial data from our ongoing Phase 1/2 clinical trial evaluating FLX475 in multiple cancer indications," said Brian Wong, M.D., Ph.D., President and CEO of RAPT Therapeutics. "With the advancement of this program and continued enrollment for our ongoing Phase 1b study of RPT193 in atopic dermatitis, which we now expect to read out in the first half of 2021, we are well positioned for multiple catalysts in 2021."

Financial Results for the Third Quarter and Nine Months Ended September 30, 2020

Third Quarter Ended September 30, 2020

Net loss for the third quarter of 2020 was $14.6 million, compared to $10.0 million for the third quarter of 2019.

Research and development expenses for the third quarter of 2020 were $12.9 million, compared to $8.6 million for the same period in 2019 due to increased clinical costs for FLX475 and RPT193, increased personnel costs and stock-based compensation expense, an increase in preclinical program costs and laboratory supplies.

General and administrative expenses for the third quarter of 2020 were $3.2 million, compared to $1.7 million for the same period of 2019. The increase was primarily due to an increase in stock-based compensation expense, personnel costs, legal and accounting fees and insurance expense offset by a decrease in consulting costs.

Nine Months Ended September 30, 2020

Net loss for the nine months ended September 30, 2020 was $40.2 million, compared to $29.8 million for the same period in 2019.

Research and development expenses for the nine months ended September 30, 2020 were $34.6 million, compared to $24.7 million for the same period in 2019. The increase was primarily due to an increase in clinical costs relating to FLX475 and RPT193, increased preclinical program costs as well as increased stock-based compensation and personnel expenses, offset by decreases in lab supplies and travel costs.

General and administrative expenses for the nine months ended September 30, 2020 were $9.3 million, compared to $6.1 million for the same period of 2019. The increase in general and administrative expenses was primarily due to increased stock-based compensation expense, increased personnel costs, an increase in legal and accounting fees as well as insurance expense offset by a decrease in travel and consulting costs.

As of September 30, 2020, we had cash and cash equivalents and marketable securities of $122.8 million.

On November 16, 2020 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported the company will participate in a fireside chat at the Piper Sandler 32nd Annual Virtual Healthcare Conference (Press release, Alpine Immune Sciences, NOV 16, 2020, View Source [SID1234571135]).

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The fireside chat will be available online during the week of November 23 in the investor relations section of the company’s website at View Source The virtual conference will be held from December 1-3, 2020.

On November 16, 2020 Guardant Health, Inc. (Nasdaq: GH) reported its intention to offer, subject to market and other conditions, $1,000,000,000 aggregate principal amount of convertible senior notes due 2027 (the "notes") in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Guardant Health, NOV 16, 2020, View Source [SID1234571156]). Guardant Health also expects to grant the initial purchasers of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date notes are first issued, up to an additional $150,000,000 principal amount of notes.

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The notes will be senior, unsecured obligations of Guardant Health, will accrue interest payable semi-annually in arrears and will mature on November 15, 2027, unless earlier repurchased, redeemed or converted. Noteholders will have the right to convert their notes in certain circumstances and during specified periods. Guardant Health will settle conversions by paying or delivering, as applicable, cash, shares of its common stock or a combination of cash and shares of its common stock, at Guardant Health’s election. The notes will be redeemable, in whole or in part, for cash at Guardant Health’s option at any time, and from time to time, on or after November 20, 2024 and on or before the 25th scheduled trading day immediately before the maturity date, but only if the last reported sale price per share of Guardant Health’s common stock exceeds 130% of the conversion price for a specified period of time. The interest rate, initial conversion rate and other terms of the notes will be determined at the pricing of the offering.

Guardant Health intends to use a portion of the net proceeds from the offering to fund the cost of entering into the capped call transactions described below. Guardant Health intends to use the remainder of the net proceeds from the offering for general corporate purposes and working capital, including increasing investment in research and development and sales and marketing activities to expand its business, as well as general and administrative matters. Guardant Health may also use a portion of the net proceeds to acquire complementary products, technologies, intellectual property or businesses as part of its growth strategy; however, Guardant Health currently does not have any agreements or commitments to complete any such transactions and is not involved in negotiations regarding such transactions. If the initial purchasers exercise their option to purchase additional notes, then Guardant Health intends to use a portion of the additional net proceeds to fund the cost of entering into additional capped call transactions as described below.

In connection with the pricing of the notes, Guardant Health expects to enter into privately negotiated capped call transactions with one or more of the initial purchasers and/or their respective affiliates and/or other financial institutions (the "option counterparties"). The capped call transactions will cover, subject to customary adjustments, the number of shares of common stock initially underlying the notes. The capped call transactions are expected generally to reduce potential dilution to Guardant Health’s common stock upon conversion of the notes or at Guardant Health’s election (subject to certain conditions) offset any cash payments Guardant Health is required to make in excess of the aggregate principal amount of converted notes, as the case may be, with such reduction or offset subject to a cap.

In connection with establishing their initial hedges of the capped call transactions, the option counterparties or their respective affiliates expect to purchase shares of Guardant Health’s common stock and/or enter into various derivative transactions with respect to Guardant Health’s common stock concurrently with or shortly after the pricing of the notes. This activity could increase (or reduce the size of any decrease in) the market price of Guardant Health’s common stock or the notes at that time. In addition, the option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Guardant Health’s common stock and/or purchasing or selling Guardant Health’s common stock or other securities issued by Guardant Health in secondary market transactions following the pricing of the notes and prior to the maturity of the notes (and are likely to do so on each exercise date of the capped call transactions, which are expected to occur during the 25 trading day period beginning on the 26th scheduled trading day prior to the maturity date of the notes, or following any termination of any portion of the capped call transactions in connection with any repurchase, redemption or early conversion of the notes). This activity could also cause or avoid an increase or a decrease in the market price of Guardant Health’s common stock or the notes, which could affect a noteholder’s ability to convert the notes and, to the extent the activity occurs during any observation period related to a conversion of the notes, it could affect the number of shares and value of the consideration that a noteholder will receive upon conversion of the notes.

In addition, if any such capped call transaction fails to become effective, whether or not this offering of the notes is completed, the option counterparty party thereto may unwind its hedge positions with respect to Guardant Health’s common stock, which could adversely affect the value of Guardant Health’s common stock and, if the notes have been issued, the value of the notes.

The offer and sale of the notes and any shares of common stock issuable upon conversion of the notes have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes and any such shares cannot be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the notes or any shares of common stock issuable upon conversion of the notes, nor will there be any sale of the notes or any such shares, in any state or other jurisdiction in which such offer, sale or solicitation would be unlawful.

On November 16, 2020 Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) ("Titan" or the "Company") reported financial results for the third quarter ended September 30, 2020 and provided an update on its business (Press release, Titan Pharmaceuticals, NOV 16, 2020, View Source [SID1234571179]).

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Third Quarter 2020 and Recent Highlights

In September 2020, the Company completed a registered direct offering, resulting in net cash proceeds of approximately $2.4 million.
In October 2020, Titan announced a strategic restructuring, where it will focus on ProNeura-based product development; and discontinue its U.S. Probuphine implant sales and wind down Probuphine commercialization activities.
In October 2020, Kate DeVarney, Ph.D., was promoted from the position of Executive Vice President and Chief Scientific Officer to President and Chief Operating Officer. In addition, Sunil Bhonsle stepped down from his executive role. Dr. Marc Rubin, Titan’s Executive Chairman, together with Dr. DeVarney, will oversee the Company’s product development activities.
In October 2020, Titan completed a public offering resulting in net cash proceeds of approximately $5.7 million.
In October 2020, the Company settled all of its debt obligations with Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A and Horizon Credit LLC II.
In October 2020, Titan acquired JT Pharmaceuticals, Inc.’s kappa opioid agonist peptide, JT-09, for use in combination with Titan’s ProNeura long-term, continuous drug delivery technology, for the treatment of chronic pruritus.
"Subsequent to the end of the third quarter, Titan began an important, focused restructuring to position the Company for future growth," said Dr. DeVarney. "We believe that our ProNeura platform, which has the potential to provide continuous drug delivery over extended periods of up to six to 12 months, offers potential key value-generating opportunities. These include the platform’s application to the recently-acquired JT-09, for which we plan to establish proof-of-concept as a treatment of chronic pruritus in the first half of next year. In addition, we remain committed to helping individuals impacted by the opioid epidemic through our ongoing, National Institute on Drug Abuse-funded nalmefene implant development program, with plans to file an investigational New Drug Application with the U.S. Food and Drug Administration in the first half of 2021."

"In addition to refocusing our efforts on the ProNeura platform, our recent restructuring significantly reduced operating expenses, while our debt settlements restored our ability to fully capitalize on our IP," said Dr. Rubin. "These, combined with the recent completion of two financings, positions Titan to execute on our new strategy."

Third Quarter 2020 Financial Results

For the three months ended September 30, 2020, Titan reported approximately $1.1 million in revenue, which reflects approximately $0.1 million in product sales and approximately $1.0 million related to the Company’s National Institute on Drug Abuse ("NIDA") grant. This compared with revenues of approximately $0.9 million in the same period in 2019, which was comprised of $0.2 million in product sales and $0.8 million related to the NIDA grant. Product revenue during the three month period ended September 30, 2020 declined from the comparable periods in 2019 due to a substantial decrease in unit sales volumes; increased utilization of patient assistance programs; and the effects of the COVID-19 pandemic and the related shelter-in-place restrictions and clinic closures.

Total operating expenses for the third quarter of 2020 were approximately $5.8 million, compared with approximately $4.8 million from the same quarter in 2019, and consisted primarily of research and development ("R&D") and selling, general and administrative ("SG&A") expenses and costs of goods sold, inclusive of distribution expenses. R&D expenses for the quarter ended September 30, 2020 were approximately $1.6 million, consistent with the same three month period in 2019. SG&A expenses for the 2020 third quarter were approximately $3.5 million, compared with approximately $3.0 million in the same quarter a year ago. Costs of goods sold for the third quarter of 2020 were approximately $0.7 million, compared with approximately $0.2 million the 2019 third quarter.

Net other expense, consisting primarily of interest expense, was approximately $0.3 million in the third quarter of 2020, compared with net other income of approximately $1.1 million in the third quarter of 2019. The increase in other expense, net for the three months ended September 30, 2020 was primarily due to an approximately $1.0 million non-cash gain on changes in the fair value of warrants issued in connection with Titan’s August 2019 offering and an approximately $0.3 million non-cash gain on debt extinguishment related to the modification of Titan’s loan from Molteni.

Net loss applicable to common stockholders in the third quarter of 2020 was approximately $4.9 million, or approximately $0.05 per share, compared with a net loss applicable to common stockholders of approximately $2.8 million, or approximately $0.18 per share, in the same quarter in 2019.

As of September 30, 2020, Titan had cash and cash equivalents of approximately $4.1 million, which the Company believes, along with the proceeds of public offering, is sufficient to fund planned operations into the third quarter of 2021.

Conference Call Details

Titan management will host a conference call today at 12:00 p.m. ET / 9:00 a.m. PT to discuss business developments in the period. The conference call will be hosted by Marc Rubin, M.D., Executive Chairman, and Kate DeVarney, Ph.D., President and Chief Operating Officer.

The live conference call may be accessed by dialing 1-888-317-6003 (U.S.) or 1-412-317-6061 (international) and providing passcode 9502574. The call will also be broadcast live at View Source, and archived on Titan’s website at www.titanpharm.com/news/events.

On November 16, 2020 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, reported financial results for the third quarter ended September 30, 2020 and provided an update on recent operational and business progress (Press release, RAPT Therapeutics, NOV 16, 2020, View Source [SID1234571104]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Earlier today, we reported positive initial data from our ongoing Phase 1/2 clinical trial evaluating FLX475 in multiple cancer indications," said Brian Wong, M.D., Ph.D., President and CEO of RAPT Therapeutics. "With the advancement of this program and continued enrollment for our ongoing Phase 1b study of RPT193 in atopic dermatitis, which we now expect to read out in the first half of 2021, we are well positioned for multiple catalysts in 2021."

Financial Results for the Third Quarter and Nine Months Ended September 30, 2020

Third Quarter Ended September 30, 2020

Net loss for the third quarter of 2020 was $14.6 million, compared to $10.0 million for the third quarter of 2019.

Research and development expenses for the third quarter of 2020 were $12.9 million, compared to $8.6 million for the same period in 2019 due to increased clinical costs for FLX475 and RPT193, increased personnel costs and stock-based compensation expense, an increase in preclinical program costs and laboratory supplies.

General and administrative expenses for the third quarter of 2020 were $3.2 million, compared to $1.7 million for the same period of 2019. The increase was primarily due to an increase in stock-based compensation expense, personnel costs, legal and accounting fees and insurance expense offset by a decrease in consulting costs.

Nine Months Ended September 30, 2020

Net loss for the nine months ended September 30, 2020 was $40.2 million, compared to $29.8 million for the same period in 2019.

Research and development expenses for the nine months ended September 30, 2020 were $34.6 million, compared to $24.7 million for the same period in 2019. The increase was primarily due to an increase in clinical costs relating to FLX475 and RPT193, increased preclinical program costs as well as increased stock-based compensation and personnel expenses, offset by decreases in lab supplies and travel costs.

General and administrative expenses for the nine months ended September 30, 2020 were $9.3 million, compared to $6.1 million for the same period of 2019. The increase in general and administrative expenses was primarily due to increased stock-based compensation expense, increased personnel costs, an increase in legal and accounting fees as well as insurance expense offset by a decrease in travel and consulting costs.

As of September 30, 2020, we had cash and cash equivalents and marketable securities of $122.8 million.