On August 7, 2024 Assertio Holdings, Inc. ("Assertio" or the "Company") (Nasdaq: ASRT), a pharmaceutical company with comprehensive commercial capabilities oering dierentiated products to patients, today reported nancial results for the second quarter ended June 30, 2024 (Press release, Assertio Holdings, AUG 7, 2024, View Source [SID1234647065]).

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"In my rst two months at Assertio, I have been excited to work closely with the team, meet our growing list of oncology clinic customers and focus on how best to maximize our results going forward. The second quarter’s performance illustrates how we continue to diligently execute the three pillars of Assertio’s business plan: driving the nancial performance of Assertio’s key assets, including our lead asset Rolvedon, generating cash ow and identifying new assets to create further value for our stockholders," said Brendan O’Grady, who was appointed Chief Executive Ocer on May 29, 2024.

"Rolvedon has been well received by physicians and continues to increase its share of the oncology G-CSF market,
generating its sixth consecutive quarter of demand growth since launch. As a potential opportunity for further
dierentiation, we have also completed enrollment of Rolvedon’s same-day dosing trial and expect to present the
initial data at a medical conference later this year. Combined with the rest of our platform and pipeline of
prospective business development opportunities, I am excited about the potential for Assertio."

On August 7, 2024 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial results for the second quarter ended June 30, 2024, and provided recent business accomplishments (Press release, Personalis, AUG 7, 2024, View Source [SID1234645500]).

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Recent Business Accomplishments

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Highlighted clinical performance of NeXT Personal at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting in May
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Compelling breast cancer detection results were presented by Dr. Isaac Garcia-Murillas (Institute of Cancer Research, London) and Prof. Nicolas Turner (Royal Marsden NHS Foundation Trust UK). In this study, they found:
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NeXT Personal detected cancer recurrence approximately 15 months before imaging
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100% of patients that recurred were detected with NeXT Personal and 100% of patients that were ctDNA negative were cancer-free at follow up time points
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A presentation by Dr. Rodrigo Toledo of the Vall d’Hebron Institute of Oncology highlighted the importance of NeXT Personal’s use for immunotherapy monitoring. This data showed:
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Baseline levels of ctDNA and the changes detected by NeXT Personal predict therapy response and clinical outcomes for late-stage cancer patients receiving immunotherapy
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NeXT Personal detected cancer progression 81 days before imaging on average
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Delivered 561 total molecular tests in the second quarter of 2024, a 66% increase compared with the prior quarter, and commenced NeXT Personal Dx commercialization efforts with Tempus AI, Inc. (Tempus)
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Announced a cross-license agreement with Myriad Genetics, Inc. covering patent estates for tumor-informed approaches to detect minimal residual disease (MRD)
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Successfully settled the IP lawsuit with Foresight Diagnostics, Inc. (Foresight) with Foresight agreeing to license Personalis’ MRD patents

Second Quarter 2024 Results Compared to Second Quarter 2023

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Reported total company revenue of $22.6 million in the second quarter of 2024, an increase of 35% compared with $16.7 million
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Revenue from pharma testing and services of $13.2 million in the second quarter of 2024, an increase of 117% compared with $6.1 million

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Revenue from Enterprise customers of $8.0 million in the second quarter of 2024, an increase of 8% compared with $7.4 million
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Revenue from population sequencing for the U.S. Department of Veterans Affairs Million Veterans Program of $1.3 million in the second quarter of 2024, a decrease of 57% compared with $3.0 million
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Other Income of $3.0 million in the second quarter of 2024, which consists of a non-cash gain of $3.0 million related to fair-value accounting for the outstanding warrants issued to Tempus
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Net loss of $12.8 million in the second quarter of 2024, a decrease of 47% compared with $24.0 million
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Cash, cash equivalents, and short-term investments of $87.0 million as of June 30, 2024

"The revenue growth depicts growing customer confidence in both our technology and platform. Importantly, the growth in our clinical testing volume means that we can see the impact on patient lives. Now that our collaborators have presented compelling NeXT Personal clinical evidence, we expect to leverage that towards obtaining Medicare coverage and materially increasing the number of patients we can help," said Chris Hall, Chief Executive Officer. "As we continue to execute on our Win-in-MRD strategy, we are more confident than ever in our ability to drive broad adoption for patient testing."

Third Quarter and Revised Full Year 2024 Outlook

Personalis expects the following for the third quarter of 2024:

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Total company revenue in the range of $21.0 to $22.0 million
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Revenue from pharma tests, enterprise sales, and other customers in the range of $17.0 to $18.0 million
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Revenue from population sequencing of approximately $4.0 million

Personalis expects the following for the full year of 2024:

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Total company revenue in the range of $79.0 to $81.0 million, an increase from $76.0 to $78.0 million
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Revenue from pharma tests, enterprise sales, and all other customers in the range of $71.0 to $73.0 million, an increase from prior guidance of $68.0 to $70.0 million
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Revenue from population sequencing of approximately $8.0 million
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Non-GAAP net loss of approximately $75.0 million, a decrease from our prior guidance of $77.0 million and excludes any non-cash gain or loss from the outstanding warrants issued to Tempus
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Cash usage of approximately $60.0 million, a decrease from our prior guidance of $62.0 million

Webcast and Conference Call Information

Personalis will host a conference call to discuss the second quarter of 2024 financial results, as well as plans for 2024, after market close on Wednesday, August 7, 2024, at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live by dialing 800-717-1738 for domestic callers or 646-307-1865 for international callers. The live webinar can be accessed at View Source A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

On August 7, 2024 IDRx, Inc., a clinical-stage biopharmaceutical company dedicated to transforming cancer treatment with purpose-built precision therapies, reported the completion of an oversubscribed $120 million Series B Preferred Stock financing (Press release, IDRx, AUG 7, 2024, View Source [SID1234645522]). The financing was led by RA Capital Management, Commodore Capital, and Blackstone Multi-Asset Investing with additional new investors, including Rock Springs Capital and a U.S.-based healthcare-focused fund. Existing investors, including Andreessen Horowitz (a16z) Bio + Health, Casdin Capital, Nextech Invest Ltd. (on behalf of one or more funds managed by it), Forge Life Science Partners, co-founder Nick Lydon, Ph.D., and strategic partner Merck KGaA, Darmstadt, Germany also participated in the financing. Derek DiRocco, Ph.D., Partner at RA Capital Management, has joined the IDRx Board of Directors.

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IDRx plans to use the proceeds from the financing to support the ongoing Phase 1/1b StrateGIST 1 study of its lead product candidate IDRX-42, a potent, oral, highly selective KIT inhibitor targeting all major categories of activating and resistance mutations in patients with KIT-mutant GIST. Additionally, proceeds will be used to fund the expected initiation of the first pivotal study for IDRX-42 in patients with second-line GIST.

At the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, IDRx presented preliminary Phase 1 data from the ongoing Phase 1/1b StrateGIST 1 trial. The data support the best-in-class potential of IDRX-42 in patients with GIST. This included a 23% objective response rate (ORR) across all patients (median four prior lines of therapy) and a 43% ORR in second-line patients, including those with either or both ATP binding site and activation loop mutations, with a favorable tolerability profile consistent with use in front-line and second-line settings. IDRx is now enrolling patients in the Phase 1b portion of the trial. In addition, the U.S. Food and Drug Administration (FDA) has recently granted Fast Track designation to IDRX-42 for the treatment of GIST after disease progression on or intolerance to imatinib.

"We are thrilled to announce this financing, which includes support from a top-tier syndicate of investors and positions us to accelerate the development of IDRX-42 for a broad population of patients with GIST, including in the second-line and front-line settings, where patients haven’t seen a new treatment option in over 15 years," said Tim Clackson, Ph.D., Chief Executive Officer of IDRx. "IDRX-42 was designed to overcome the twin challenges of on-target treatment resistance and off-target driven adverse events, which limit the clinical benefit of currently available TKIs. We are extremely encouraged by the clinical data generated with IDRX-42 to date and are focused on rapidly advancing this potential new treatment option that could elevate the standard of care for GIST patients."

"RA Capital Management is excited to co-lead this round to support the advancement of IDRX-42 as a differentiated new treatment for GIST," said Derek DiRocco, Ph.D., Partner of RA Capital Management and board member of IDRx. "We have been extremely impressed by what the IDRx team has accomplished in a short time, and I look forward to contributing to IDRx’s future growth and success as the company prepares to execute on its late-stage clinical development activities for IDRX-42."

About GIST

GIST is the most common subtype of soft tissue sarcoma. Approximately 80% of cases arise from gain of function mutations in the KIT receptor tyrosine kinase, driving the malignancy through constitutive activation of aberrant signaling. Resistance mutations in KIT emerge in ~90% of patients treated with imatinib, the current standard of care for GIST. In unresectable or metastatic GIST, clinical benefits from existing treatments can vary by mutation type.

About the StrateGIST 1 Study

StrateGIST 1 is an ongoing, open-label, first-in-human Phase 1/1b study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of IDRX-42 in patients with metastatic and/or surgically unresectable GIST after failure of imatinib and other approved drugs. The study is currently enrolling patients with documented pathogenic mutation in KIT or any platelet-derived growth factor receptor alpha (PDGFRA) mutation (other than PDGFRA exon 18) at sites in the U.S., United Kingdom, Belgium, The Netherlands, France, Germany, Italy, Spain, and South Korea. The Phase 1b portion has been initiated and includes four expanded exploratory cohorts based on defined lines of prior TKI therapy, including front line, second line, third line + (with standard approved TKIs only), and third line + (including investigational TKIs).

About IDRX-42

IDRX-42 is a potent, oral, highly selective KIT inhibitor targeting all major categories of activating and resistance mutations in patients with KIT-mutant GIST (including variants in exons 9, 11, 13 and 17). In preclinical studies, IDRX-42 demonstrated superior antitumor activity compared to imatinib, the current first-line of therapy, in GIST human xenograft models expressing mutations in KIT exons 9 and 11. In xenograft models expressing secondary resistance mutations in KIT exon 13 or 17, IDRX-42 treatment resulted in potent and dose-dependent antitumor activity superior to the second-line standard of care agent, sunitinib. IDRX-42 is currently being evaluated in StrateGIST 1, a first-in-human Phase 1/1b study. IDRX-42 was granted Orphan Drug designation by the FDA for the treatment of GIST.

On August 7, 2024, Precigen, Inc. ("Precigen") reported to have entered into an underwriting agreement (the "Underwriting Agreement") with Stifel, Nicolaus & Company, Incorporated, as the representative of the several underwriters named therein (the "Underwriters"), in connection with the underwritten public offering (the "Offering") of 35,294,118 shares (the "Firm Shares") of Precigen common stock, no par value ("Common Stock"), at a price to the public of $0.85 per share (Filing, 8-K, Precigen, AUG 7, 2024, View Source [SID1234645682]). Pursuant to the Underwriting Agreement, Precigen granted to the Underwriters the option to purchase up to an additional 5,294,117 shares of Common Stock (together with the Firm Shares, the "Shares") for a period of 30 days from the date of the Underwriting Agreement.

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Net proceeds to Precigen from the offering will be approximately $31.4 million after deducting the underwriting discount and other estimated offering expenses payable by Precigen, such proceeds including the sale of 4,584,821 shares of Common Stock exercised pursuant to the Underwriters’ option to purchase additional shares.

The Offering was made pursuant to Precigen’s shelf registration statement declared effective on January 17, 2024 (Registration No. 333-276337), as supplemented by the final prospectus supplement dated August 7, 2024.

The Underwriting Agreement includes certain customary representations, warranties, and covenants by Precigen, and it provides that Precigen will indemnify the Underwriters against certain liabilities, including liabilities under the Securities Act of 1933, as amended, or contribute to payments the Underwriters may be required to make because of any of those liabilities. The representations, warranties, and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties. The foregoing description of the Underwriting Agreement does not purport to be complete and is qualified in its entirety by reference to the Underwriting Agreement, which is filed as Exhibit 1.1 hereto and incorporated herein by reference.

On August 7, 2024 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported second quarter 2024 financial results and recent portfolio and business updates (Press release, Alector, AUG 7, 2024, View Source [SID1234645485]). As of June 30, 2024, Alector’s cash, cash equivalents and investments totaled $503.3 million.

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"Alector’s significant progress in recent months has set the stage for a transformative period ahead, as we approach key clinical catalysts for our maturing, potential first-in-class immuno-neurology programs," said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. "We remain on track to report data from INVOKE-2, our Phase 2 clinical trial in early Alzheimer’s disease for AL002, in the fourth quarter, and we are encouraged that the recently reported patient baseline characteristics reflect a study population appropriate for the clinical evaluation of a TREM2 agonist in this indication."

Dr. Rosenthal continued, "In addition, the recent Breakthrough Therapy Designation for latozinemab in frontotemporal dementia with a progranulin gene mutation has provided the opportunity for increased interactions with the FDA about this program, and we now have additional clarity on how key biomarkers may support our path to a potential regulatory submission. In parallel, we are continuing to enroll patients in the PROGRESS-AD Phase 2 trial of AL101/GSK4527226. With a cash runway that extends through 2026, we are in a strong financial position as we approach these key milestones."

Sara Kenkare-Mitra, Ph.D., President and Head of Research and Development at Alector added, "In June, Alector hosted a virtual research and development event focused on the Alector Brain Carrier (ABC), our proprietary, versatile blood-brain barrier technology. We believe our ABC technology platform has the potential to deliver novel drugs safely into the CNS, enabling potential best-in-class therapeutics for patients suffering from neurological disorders. We look forward to providing updates on our progress in the future."

Recent Clinical Updates

Immuno-Neurology Portfolio
Progranulin Programs (latozinemab (AL001) and AL101/GSK4527226) Being Developed in Collaboration with GSK

In a recent Type B interaction with the U.S. Food and Drug Administration (FDA), Alector and GSK received feedback on the potential future Biologics License Application (BLA) for latozinemab targeting frontotemporal dementia with a progranulin gene mutation (FTD-GRN). The FDA has indicated that it would consider the effects of latozinemab on plasma and cerebrospinal fluid concentrations of progranulin (PGRN) as confirmatory evidence, supplementing the potential clinical effects of latozinemab in FTD-GRN, pending BLA review. The companies also aligned with the agency on disease-relevant fluid and imaging biomarkers that may be considered as supportive evidence of clinical efficacy, subject to BLA review. These include biomarkers of astrocyte function, neurodegeneration, and brain atrophy. Based on the FDA feedback, Alector and GSK remain confident that the totality of evidence, including the primary clinical endpoint and biomarkers, could provide a path to potential approval for latozinemab. The Type B interaction occurred after the FDA granted Breakthrough Therapy Designation to latozinemab for the potential treatment of FTD-GRN earlier this year.
The pivotal, randomized, double-blind, placebo-controlled INFRONT-3 Phase 3 clinical trial of latozinemab in FTD-GRN is ongoing. Enrollment was completed in October 2023, and the treatment duration is 96 weeks. INFRONT-3 is evaluating the safety and efficacy of latozinemab in slowing disease progression in individuals with FTD-GRN. The primary endpoint in INFRONT-3 is disease progression as measured by the Clinical Dementia Rating scale plus National Alzheimer’s Disease Coordinating Center Frontotemporal Lobar Degeneration Sum of Boxes (CDR plus NACC FTLD-SB). The trial also employs other clinical and functional outcome assessments.
Alector plans to present the poster "Baseline characteristics for INFRONT-3: A Phase 3, double-blind, placebo-controlled 96-week study evaluating latozinemab in FTD-GRN" at the International Society for Frontotemporal Dementias (ISFTD) in Amsterdam from September 19-22, 2024.
Enrollment is ongoing in the PROGRESS-AD global Phase 2 clinical trial of AL101/GSK4527226 in early Alzheimer’s disease (AD). Alector and GSK are co-developing AL101 for the potential treatment of more prevalent neurodegenerative diseases, including AD and Parkinson’s disease.
In July 2024, Alector and GSK presented posters highlighting PGRN and AL101 at the Alzheimer’s Association International Conference 2024 (AAIC). The presentations included data supporting the therapeutic hypothesis of increasing PGRN levels for the potential treatment of AD and the design of the ongoing PROGRESS-AD Phase 2 clinical trial.
TREM2 Program (AL002) Being Developed in Collaboration with AbbVie

The INVOKE-2 Phase 2 clinical trial of AL002 is fully enrolled, and data from the trial are anticipated in the fourth quarter of 2024. INVOKE-2, a randomized, double-blind, placebo-controlled, dose-ranging study, is designed to evaluate the efficacy and safety of AL002 in slowing disease progression in individuals with early AD. AL002 is a novel investigational humanized monoclonal antibody that binds to TREM2 to increase TREM2 signaling and, thereby, is hypothesized to improve the functionality of microglia. It is the most advanced TREM2-activating product candidate in clinical development worldwide.
At AAIC in July 2024, Alector presented data highlighting the patient baseline characteristics for the INVOKE-2 study. The data confirm the intended study population for testing the effects of AL002, a novel TREM2 agonist, in early AD. Of note, for those participants with amyloid PET assessed at baseline, the mean (standard deviation) in centiloids was 100.1 (38.9), consistent with expectations for an early AD population in INVOKE-2. In a separate poster, Alector also presented data supporting the use of a blood-based amyloid test for screening AD patients eligible for participation in the INVOKE-2 trial.
AbbVie has an exclusive option to globally develop and commercialize AL002, upon receipt and evaluation of the INVOKE-2 data. AbbVie’s exercise of that option would prompt a $250 million payment to Alector.
Early Research Pipeline

Alector is actively progressing its Alector Brain Carrier (ABC), a proprietary, versatile blood-brain barrier (BBB) technology platform, which is being applied selectively to the company’s next-generation product candidates and research pipeline. Initial work has focused on transferrin receptor (TfR) and CD98hc targets, which have distinct expression profiles and cellular trafficking pathways but have both been shown to be highly expressed at the BBB and able to drive brain uptake when utilized as transcytosis receptors.
In June 2024, Alector hosted a virtual research and development event discussing the company’s ABC technology platform in detail. The event included a presentation from Dr. Zhiqiang An, Ph.D., Professor & Robert A. Welch Distinguished University Chair in Chemistry and Director of the Texas Therapeutics Institute at UTHealth Houston, who provided insights into emerging technologies for BBB modulation and discussed future directions and opportunities in the field.
Second Quarter 2024 Financial Results

Revenue. Collaboration revenue for the quarter ended June 30, 2024, was $15.1 million, compared to $56.2 million for the same period in 2023. The decrease was mainly due to a $35.7 million decrease in revenue recognized for the AL101 programs, including a cumulative non-cash revenue adjustment due to a contract modification in the second quarter of 2023 to have GSK operationalize the AL101 Phase 2 study. The decrease is partially due to a $15.2 million decrease in revenue recognized for the AL002 program due to the addition of AL002 LTE and patient replacement revenue in 2023. This was offset by a $9.8 million increase in revenue recognized for the latozinemab programs.

R&D Expenses. Total research and development expenses for the quarter ended June 30, 2024, were $46.3 million, compared to $46.2 million for the quarter ended June 30, 2023. The increase was mainly driven by the Company’s prioritization on selected late-stage programs.

G&A Expenses. Total general and administrative expenses for the quarter ended June 30, 2024, were $14.4 million, compared to $13.6 million for the quarter ended June 30, 2023.

Net Income (Loss). For the quarter ended June 30, 2024, Alector reported a net loss of $38.7 million, or $0.40 per share, compared to a net income of $1.4 million, or $0.02 net income per share, for the same period in 2023.

Cash Position. Cash, cash equivalents, and investments were $503.3 million as of June 30, 2024. Management expects that this will be sufficient to fund current operations through 2026.

2024 Guidance. The Company continues to anticipate collaboration revenue to be between $60 million and $70 million. Management has updated its total research and development expenses to be between $210 million and $220 million and reiterated total general and administrative expenses to be between $60 million and $70 million.

Second Quarter 2024 Conference Call

Alector’s management team will host a conference call discussing Alector’s results for the second quarter of 2024 and provide a business update. The conference call will be webcast and accessible via the investor relations section of Alector’s website at www.alector.com.

To access the call, please use the following information:

Date: Wednesday, August 7, 2024
Time: 4:30 p.m. ET, 1:30 p.m. PT

The event will be webcast live under the investor relations section of Alector’s website at View Source, and following the event, a replay will be archived there for 30 days. Interested parties participating by phone will need to register using this online form. After registering for dial-in details, all phone participants will receive an auto-generated e-mail containing a link to the dial-in number along with a personal PIN number to use to access the event by phone.