On November 10, 2021 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported financial results for the third quarter ended September 30, 2021 (Press release, Alpine Immune Sciences, NOV 10, 2021, View Source [SID1234595087]).

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"We continue to make considerable progress across our portfolio and anticipate opportunities to share clinical updates for both ALPN-202 and ALPN-303 in the first half of 2022," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "Importantly, the recently completed private placement will enable us to accelerate and expand development plans for both of these molecules, as well as our discovery pipeline, as we work to advance innovative therapies to treat cancer, autoimmune and inflammatory diseases."

Third Quarter 2021 and Recent Corporate and Clinical Updates

ALPN-303: Dual APRIL/BAFF inhibitor (autoimmune/inflammation)
Data demonstrating the superior efficacy of ALPN-303 in preclinical models was shared in an oral presentation in the Plenary III session of the American College of Rheumatology (ACR) Convergence 2021 Annual Meeting.
A first-in-human, phase 1 study of ALPN-303 is expected to begin enrolling in the fourth quarter of 2021 with topline results expected in the first half of 2022. The randomized, placebo-controlled study in healthy adult participants will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenously and subcutaneously administered ALPN-303.
ALPN-202: Conditional CD28 co-stimulator and dual checkpoint inhibitor (oncology)
A trial-in-progress presentation on NEON-2, a phase 1 study of ALPN-202 in combination with KEYTRUDA (pembrolizumab) in patients with advanced malignancies, will be shared at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting on Friday, November 12, 2021. The poster (#497) will be available both on site and as an ePoster.
NEON-1, a phase 1 study of ALPN-202 monotherapy in patients with advanced malignancies, continues to proceed, with completion of dose escalation anticipated in the fourth quarter of 2021. Further updates are anticipated for the first half of 2022.
Corporate: $91M securities offering completed September 2021
Completed a private placement of common stock and prefunded warrants, for gross proceeds of approximately $91.0 million, which was led by Frazier Life Sciences Public Fund with participation from Decheng Capital, BVF Partners, TCG X, Avidity Partners, OrbiMed, Omega Fund, and Logos Capital, among others.
Third Quarter 2021 Financial Results

As of September 30, 2021, we had cash, cash equivalents, restricted cash, and investments totaling $219.9 million. We recorded net losses of $13.5 million and $6.1 million for the quarters ended September 30, 2021 and 2020, respectively.

Collaboration revenue for the quarter ended September 30, 2021 was $8.5 million compared to $1.9 million for the quarter ended September 30, 2020. The increase was primarily attributable to the revenue recognized under our AbbVie Agreement.

Research and development expenses for the quarter ended September 30, 2021 were $18.3 million compared to $6.2 million for the quarter ended September 30, 2020. The increase was primarily attributable to clinical trial activities for the acazicolcept and ALPN-202 studies, direct research activities, contract manufacturing and process development of our product candidates, and personnel-related expenses.

General and administrative expenses for the quarter ended September 30, 2021 were $3.5 million compared to $2.7 million for the quarter ended September 30, 2020. The increase was primarily attributable to personnel-related expenses to support the growth and expansion of our business.

Alpine expects that its current cash resources are sufficient to fund Alpine’s planned operations through 2023.

On November 10, 2021 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, reported third quarter 2021 financial results (Press release, Relay Therapeutics, NOV 10, 2021, View Source [SID1234595104]).

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"It’s been a very productive year at Relay Therapeutics. We have delivered on all of our key goals set out at our IPO in July 2020 and have proven our ability to effectively advance our clinical trials, having recently disclosed interim clinical data for RLY-4008. Not only do the clinical data validate our Dynamo platform and approach, but they also suggest RLY-4008 is a highly selective FGFR2 inhibitor that has the potential to address a significant unmet medical need," said Sanjiv Patel, M.D., president and chief executive officer. "Our other programs continue to progress, with RLY-2608, the first of our PI3Kα franchise, on path to begin a first-in-human study in the first half of 2022. We will continue to focus on execution for the remainder of 2021 and into 2022, and are confident our recent financing will provide the capital needed to push multiple programs through the clinic while maintaining a robust preclinical pipeline."

Recent Corporate Highlights

Presented interim clinical data for RLY-4008 in a first-in-human trial in patients with FGFR2-altered cholangiocarcinoma and other solid tumors at the AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets Conference on October 8, 2021 that suggest RLY-4008 is a highly selective FGFR2 inhibitor demonstrating robust inhibition of FGFR2 regardless of alteration or tumor type while not being limited by off-target toxicities
Announced the Company anticipates selecting a once daily recommended Phase 2 dose and initiating expansion cohorts prior to the end of 2021
Shared preclinical data at the AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets Conference on October 7, 2021 that support RLY-2608 as the first known allosteric pan-mutant selective inhibitor of PI3Kα
Additional preclinical data for RLY-2608 in combination with standard of care medicines, fulvestrant (estrogen receptor inhibitor) and/or abemaciclib (CDK 4/6 inhibitor), will be presented at the San Antonio Breast Cancer Symposium
Presentation Title: RLY-2608: the first allosteric mutant- and isoform-selective inhibitor of PI3Kα, is efficacious as a single agent and drives regressions in combination with standard of care therapies in PIK3CA mutant breast cancer models
Presentation Time: Poster Session 5, December 10, 2021, 7:00 a.m. – 8:30 a.m. CT
Successfully raised $402 million of gross proceeds in an underwritten follow-on public offering
Third Quarter 2021 Financial Results

Cash, Cash Equivalents and Investments: As of September 30, 2021, cash, cash equivalents and investments totaled approximately $616.5 million, which excludes the gross proceeds of $402 million from the Company’s recent public offering, compared to $678.1 million as of December 31, 2020. The Company expects its current cash and cash equivalents, together with the net proceeds from its recent public offering, will be sufficient to fund its current operating plan at least into 2025.

R&D Expenses: Research and development expenses were $45.0 million for the third quarter of 2021, as compared to $24.4 million for the third quarter of 2020. The increase of $20.6 million was primarily due to $8.9 million related to pre-clinical development candidates and $9.6 million of additional employee related costs and expenses attributable to clinical development activities.

G&A Expenses: General and administrative expenses were $14.7 million for the third quarter of 2021, as compared to $12.2 million for the third quarter of 2020. The increase of $2.5 million was primarily due to $1.3 million of increased personnel costs and $0.7 million of other general and administrative expenses.

Net Loss: Net loss was $60.8 million for the third quarter of 2021, or a net loss per share of $0.66, as compared to a net loss of $36.1 million for the third quarter of 2020, or a net loss per share of $3.00.

On November 10, 2021 Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company primarily focused on discovering, developing and commercializing a broad portfolio of wholly-owned assets with different modes of action to provide a cure for people with chronic hepatitis B virus (HBV) infection and to treat coronaviruses (including COVID-19), reported that the Company will participate in a virtual fireside chat at the Jefferies London Healthcare Conference (Press release, Arbutus Biopharma, NOV 10, 2021, View Source [SID1234595119]).

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Presenters:
William Collier, President and Chief Executive Officer; Dr. Michael Sofia, Chief Scientific Officer; Dr. Gaston Picchio, Chief Development Officer; and David Hastings, Chief Financial Officer

A webcast of the virtual fireside chat will be available beginning on Thursday, November 18, 2021 at 8:00 am GMT / 3:00 am ET, and can be accessed through the Investors section of Arbutus’ website at www.arbutusbio.com. An archived replay of the webcast will be available on the Company’s website after the conference.

On November 10, 2021 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, reported Gaurav Shah, M.D., Chief Executive Officer, will participate in a fireside chat at the Stifel 2021 Virtual Healthcare Conference on Tuesday, November 16, 2021 at 2:40 p.m. ET (Press release, Rocket Pharmaceuticals, NOV 10, 2021, View Source [SID1234595136]).

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A live audio webcast of the presentation will be available under "Events" in the Investors section of the Company’s website at View Source The webcast replay will be available on the Rocket website following the conference.

On November 10, 2021 Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported that the company will present at the Piper Sandler 33rd Annual Healthcare Conference, taking place virtually on November 29, 2021 (Press release, Sapience Therapeutics, NOV 10, 2021, View Source [SID1234595152]).

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Members of Sapience’s management team will present a company overview and will also participate in one-on-one meetings with life science investors during the event.