On August 10, 2022 BiomX Inc. (NYSE American: PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, reported financial results, and provided a business update for the second quarter ended June 30, 2022 (Press release, BiomX, AUG 10, 2022, View Source [SID1234618064]).

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"It has been an eventful quarter for the Company. We enrolled our first patients in our BX004 cystic fibrosis program, expanded our partnering activities, published important research, and successfully restructured our operations to further extend our cash runway," said Jonathan Solomon, Chief Executive Officer of BiomX. "With the ongoing enrollment of patients in our CF study, we are one step closer towards reaching an important milestone in the BX004 program. Sites have been opening according to plan and, provided that the pace of enrollment for the study will continue as expected, we continue to anticipate a data readout from the first part of the study by the end of the third quarter of 2022. Our recent KOL event also highlighted the unmet medical need that exists today for so many CF patients who require innovative new therapeutic approaches to help combat these persistent and difficult-to-treat lung infections.

"As we enter the second half of 2022, BiomX also remains well positioned financially, with our cash runway now expected to take us through at least mid-2024. Over this period, we expect to reach potential milestones intended to help drive significant shareholder value, and I look forward to sharing additional updates later this year."

RECENT CORPORATE HIGHLIGHTS

In June, BiomX announced the dosing of the first two patients in the Company’s Phase 1b/2a study evaluating BX004 for the treatment of chronic respiratory infections in patients with cystic fibrosis.
Also in June, BiomX announced a second partnership with Boehringer Ingelheim to discover inflammatory bowel disease ("IBD") microbiome markers. BiomX will utilize its XMarker microbiome-based biomarker discovery platform with the goal of identifying biomarkers for a pathogenic bacterium thought to be associated with IBD. Such biomarkers could help identify IBD patients that would benefit from potential therapies targeted at the microbiome. In September 2020, Boehringer Ingelheim and BiomX entered into their first collaboration, which focused on identifying biomarkers associated with patient phenotypes in IBD.
In August, the Company announced the publication of a scientific paper titled "Targeted suppression of human IBD-associated gut microbiota commensals by phage consortia for treatment of intestinal inflammation" in the journal, Cell. The research was conducted across several organizations, including BiomX and the Weizmann Institute of Science (Rehovot, Israel), and presents positive results from a proof-of-concept assessment in a preclinical model of inflammatory bowel disease. The paper is available online at View Source(22)00850-9.
On May 12th, the Company hosted a Key Opinion Leader Event on BX004 for Treatment of Pseudomonas Aeruginosa ("PsA") Infections in CF patients. The live webinar featured presentations from Key Opinion Leaders, Dave Nichols, M.D. and Saima Aslam, M.D., who discussed phage therapy, the current treatment landscape, and the unmet medical need in CF patients with chronic PsA pulmonary infections. The webinar is now available on the Company’s website at View Source
Also in May, BiomX announced a corporate restructuring plan intended to extend the Company’s capital resources at least until the middle of 2024. With this plan, the Company reduced its operating costs, which included a reduction in personnel, while prioritizing the ongoing CF program.
Also in May, BiomX announced the publication of a scientific paper titled "Exodus: Sequencing-based Pipeline for Quantification of Pooled Variants" in the journal, Bioinformatics. The research was conducted by scientists at BiomX and is available online at View Source
Clinical Program Updates

Cystic Fibrosis (BX004)

In June, BiomX announced the dosing of the first two patients in the Company’s Phase 1b/2a study evaluating BX004 for the treatment of chronic respiratory infections in patients with CF.
BX004 is being developed for the treatment of chronic respiratory infections caused by Pseudomonas aeruginosa, a main contributor to morbidity and mortality in patients with CF.
The Phase 1b/2a trial is composed of two parts. Part 1 of the study will evaluate the safety, pharmacokinetics, and microbiologic/clinical activity of BX004 in eight CF patients in a single ascending dose and multiple dose design, with results expected by the end of the third quarter of 2022. Part 2 of the study will evaluate the safety and efficacy of BX004 in 24 CF patients randomized to a treatment or placebo cohort in a 2:1 ratio. Results from Part 2 are expected in the first quarter of 2023.
BiomX has received a Therapeutics Development Award of up to $5 million from the Cystic Fibrosis Foundation ("CF Foundation"). The award is structured as an equity investment in which the CF Foundation has agreed to purchase up to $5M million of BiomX common stock across two separate tranches. The first tranche was received on December 21, 2021, with the CF Foundation making an initial equity investment of $3 million. Upon completion of all patient dosing in Part 1 of the Company’s Phase 1b/2a study of BX004, BiomX would have the right to receive the second tranche of $2 million, also as an equity investment.
Atopic Dermatitis (BX005)

In April, the United States Food and Drug Administration ("FDA") approved the Company’s IND application for BX005, which is being developed for the treatment of moderate to severe atopic dermatitis ("AD").
While the recently announced restructuring is expected to result in a delay to the AD program, the Company plans to support a range of activities that will continue to move this program forward and will provide a more detailed update later in the year.
The Company and Maruho Co. Ltd., a leading dermatology-focused pharmaceutical company in Japan, entered into an agreement in the second half of 2021 granting Maruho a right of first offer to license BX005 in Japan.
The Company is collaborating with Maruho and working on evaluating timelines for a clinical trial.
Second Quarter 2022 Financial Results

Cash balance, short-term deposits and restricted cash as of June 30, 2022, were $46.7 million, compared to $63.1 million as of December 31, 2021. The decrease was primarily due to net cash used in operating activities. Based upon the Company’s strategic focus on the CF program, the existing cash and cash equivalents are expected to be sufficient to fund the current operating plan through middle of 2024.
Research and development ("R&D") expenses, net were $4.6 million for the three months ended June 30, 2022, compared to $3.8 million for the same period in 2021. R&D expenses, net were $9.5 million for six months ended June 30, 2022, as well as for the six months ended June 30, 2021. A decrease in Israel Innovation Authority grants resulted in higher R&D expenses, net, offset by a decrease in salaries and related expenses and stock-based compensation expenses due to a reduction in workforce. An additional offset is due to pauses in the development of BX003, the product candidate for the treatment of IBD and primary sclerosing cholangitis, and the colorectal cancer product candidate, as well as due to the discontinuation of the product candidate, BX001, for the treatment of acne.
General and administrative expenses were $2.4 million for the three months ended June 30, 2022, compared to $3.1 million for the same period in 2021. General and administrative expenses were $4.8 million for the six months ended June 30, 2022, compared to $5.6 million for the prior year. The decrease for the six months ended June 30, 2022 was primarily due to a decrease in salaries and related expenses and stock-based compensation expenses due to a reduction in workforce. In addition, the decrease is due to additional expenses incurred in 2021 that resulted from moving into new premises.
Net loss for the second quarter of 2022 was $7.5 million, compared to $7.3 million for the same period in 2021.
Net cash used in operating activities for the six months ended June 30, 2022 was $16.4 million, compared to $12.8 million for the same period in 2021.
Conference Call and Webcast Information

BiomX management will host a conference call and webcast today at 8:00 am ET to report financial results and business updates for the second quarter 2022. To participate in the conference, please dial 1-877-407-0724 (U.S.), 1-809-406-247 (Israel), or 1-201-389-0898 (International). A live and archived webcast of the call will be available on the Investors section of the Company’s website at www.biomx.com.

On August 10, 2022 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, reported that financial results for the quarter ended June 30, 2022 (Press release, DiaMedica, AUG 10, 2022, View Source [SID1234618062]). DiaMedica will host a conference call on Thursday, August 11, 2022, at 8:00AM Eastern Time / 7:00AM Central Time, to discuss its business update and second quarter financial results.

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Clinical Developments

DM199 for the Treatment of Acute Ischemic Stroke

As previously announced, the U.S. Food and Drug Administration (FDA) placed a clinical hold on the Company’s Phase 2/3 ReMEDy2 trial for the treatment of acute ischemic stroke (AIS). The clinical hold was issued following the Company voluntarily pausing patient enrollment in the trial to investigate three unexpected instances of clinically significant hypotension (low blood pressure) occurring shortly after initiation of the intravenous (IV) dose of DM199. The hypotension was transient and blood pressure levels of all three patients recovered back to baseline within minutes of stopping the infusion and the patients suffered no ongoing adverse effects.

After pausing enrollment, the Company immediately initiated an investigation and conducted a comprehensive analysis to determine the likely cause of the hypotensive events. The Company learned that these adverse events likely resulted from changing to a new formulation of IV bag in the ReMEDy2 trial, as compared to the IV bag used in the prior, Australian ReMEDy1 trial, which was not readily available at many U.S. study sites. Recent testing of the prior IV bag has shown that as much as half of the DM199 protein bound to the IV bag used in the prior trial. Whereas, the DM199 protein does not bind to the current IV bag. This effectively increased the dose of DM199 delivered to patients in the current trial as compared to the prior trial. DiaMedica notes that hypotension is a known response to KLK1 therapy and that DiaMedica’s prior safety studies revealed orthostatic hypotension as the dose limiting tolerability for DM199.

DiaMedica plans to submit this data and its proposed modifications to the study protocol to the FDA in September requesting a removal of the clinical hold. The Company’s proposal will include utilizing a reduced IV dose level that will be comparable to the delivered dose that was well tolerated in the 46 patients in the previous ReMEDy1 trial. Although DiaMedica is confident that this change will sufficiently mitigate the risk of clinically significant hypotension in future ReMEDy2 trial patients, no assurance can be provided that it will or that the FDA will release the clinical hold in response to the Company’s submission. The FDA will have up to 30 days to respond to DiaMedica’s request to lift the clinical hold.

DM199 for the Treatment of Chronic Kidney Disease

DiaMedica continues to work toward completing the study close-out and the final data analysis for its completed REDUX trial studying the use of DM199 for the treatment of chronic kidney disease (CKD) and preparation of plans for next steps while maintaining Company focus on the ReMEDy2 AIS clinical program.

Balance Sheet and Cash Flow

DiaMedica reported total cash and investments of $38.4 million, current liabilities of $1.5 million and working capital of $37.6 million as of June 30, 2022, compared to total cash and investments of $45.1 million, $1.5 million in current liabilities and $43.9 million in working capital as of December 31, 2021. The decreases in cash and investments and in working capital were due primarily to cash used to fund operating activities during the six months ended June 30, 2022.

Net cash used in operating activities was $6.4 million for each of the six months ended June 30, 2022 and June 30, 2021. Cash used in operating activities is driven primarily by the Company’s net loss, partially offset by non-cash share-based compensation and the effects of the changes in operating assets and liabilities.

Financial Results

Research and development (R&D) expenses were $2.0 million for the three months ended June 30, 2022, down $0.2 million from $2.2 million for the three months ended June 30, 2021. R&D expenses decreased to $3.9 million for the six months ended June 30, 2022, compared to $4.6 million for the six months ended June 30, 2021, a decrease of $0.7 million. This decrease for the six-month comparison was due to a number of factors including reduced costs incurred in the current year for wrap-up related activities for the REDUX Phase 2 CKD trial, decreased non-clinical testing costs which were incurred at greater levels in 2021 in preparation for the Phase 2/3 ReMEDy2 trial which initiated during 2021 and decreased manufacturing process development costs. These decreases were partially offset by current year ramp-up of costs incurred in performing the ReMEDy2 trial and increased personnel costs associated with R&D operations.

General and administrative (G&A) expenses were $1.4 million for the three months ended June 30, 2022, up from $1.2 million for the three months ended June 30, 2021. G&A expenses increased to $3.0 million for the six months ended June 30, 2022, compared to $2.4 million for the six months ended June 30, 2021, an increase of $0.6 million. The increase for the six-month comparison was primarily due to increased directors’ and officers’ liability insurance and personnel and professional services costs to support the Company’s expanding clinical programs. These increases were partially offset by a reduction in non-cash share-based compensation.

Conference Call and Webcast Information

DiaMedica Management will host a conference call and webcast to discuss its business update and second quarter 2022 financial results on Thursday, August 11, 2022, at 8:00 AM Eastern Time / 7:00 AM Central Time:

Date:

Thursday, August 11, 2022

Time:

8:00 AM ET / 7:00 AM CT

Web access:

View Source

Dial In:

(888) 440-4368

Conference ID:

4814247

Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for play back on DiaMedica’s website, under investor relations – events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until August 18, 2022, by dialing (800) 770-2030 (US Toll Free) and entering the replay passcode: 4814247.

About ReMEDy2 Trial

The ReMEDy2 trial is an adaptive design, randomized, double-blind, placebo-controlled trial studying the use of the Company’s product candidate, DM199, to treat AIS patients. The trial is intended to enroll approximately 350 patients at 75 sites in the United States. Patients enrolled in the trial will be treated for three weeks with either DM199 or placebo, beginning within 24 hours of the onset of AIS symptoms, with the final follow-up at 90 days. The trial excludes patients treated with tissue plasminogen activator (tPA) and/or mechanical thrombectomy. The study population is representative of the approximately 80% of AIS patients who do not have treatment options today, primarily due to the limitations on treatment with tPA or mechanical thrombectomy. DiaMedica believes that the proposed trial has the potential to serve as a pivotal registration study of DM199 in this patient population.

The ReMEDy2 trial has two separate, independent, primary endpoints based upon both the results observed in the first ReMEDy1 phase 2 trial and published results from the urine-derived form of KLK1 used to successfully treat AIS in China. ReMEDy2 is powered for success with either endpoint: 1) physical recovery from stroke as measured by the well-established modified Rankin Scale (mRS) at day 90, and 2) the rate of ischemic stroke recurrence through day 90. Recurrent strokes represent 25% of all ischemic strokes, often occurring in the first few weeks after an initial stroke and are typically more disabling, costly, and fatal than initial strokes.

About DM199

DM199 is a recombinant (synthetic) form of human tissue kallikrein-1 (KLK1). KLK1 is a serine protease (protein) that plays an important role in the regulation of diverse physiological processes including blood flow, inflammation, fibrosis, oxidative stress and neurogenesis via a molecular mechanism that increases production of nitric oxide and prostaglandin. KLK1 deficiency may play a role in multiple vascular and fibrotic diseases such as stroke, chronic kidney disease, retinopathy, vascular dementia, and resistant hypertension where current treatment options are limited or ineffective. DiaMedica is the first company to have developed a recombinant form of the KLK1 protein. The KLK1 protein, produced from porcine pancreas and human urine, has been used to treat patients in Japan, China and South Korea for decades. DM199 is currently being studied in patients with acute ischemic stroke and patients with chronic kidney disease. In September 2021, the FDA granted Fast Track Designation to DM199 for the treatment of AIS.

On August 10, 2022 TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported that the Independent Data Monitoring Committee for the ENVASARC pivotal trial has recommended that the trial proceed as planned following the review of three week safety data from more than 20 patients enrolled into the trial as of June 30, 2022 (Press release, Tracon Pharmaceuticals, AUG 10, 2022, View Source [SID1234618061]). The safety data reviewed included data from more than 10 patients enrolled into cohort A of treatment with single agent envafolimab at 600 mg administered subcutaneously every three weeks and more than 10 patients enrolled into cohort B of treatment with envafolimab at 600 mg administered subcutaneously every three weeks with Yervoy (ipilimumab) given intravenously.

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"Envafolimab at the 600 mg dose has been well tolerated as a single agent and when combined with Yervoy in refractory sarcoma patients who are enrolled in the ENVASARC trial. We remain on track for the Independent Data Monitoring Committee to review interim efficacy data in the fourth quarter of this year," said James Freddo, M.D., TRACON’s Chief Medical Officer.

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON expects the trial to enroll more than 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into a cohort of treatment with single agent envafolimab at 600 mg every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.

On August 10, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, reported that it has signed a supply agreement with 3D Imaging LLC. (3DI), a Contract Development and Manufacturing Organisation (CDMO), covering Clarity’s diagnostic 64Cu SAR-bisPSMA product (Press release, Clarity Pharmaceuticals, AUG 10, 2022, View Source [SID1234618060]).

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The new agreement, effective on August 11th, 2022, enables increased production and will create excess capacity in the supply of Clarity’s differentiated PSMA product in advance of two potential diagnostic Phase III trials in the US, ensuring reliable and seamless supply. 3DI will centrally manufacture and distribute the 64Cu SAR-bisPSMA products from its facility in Little Rock, Arkansas, USA, located close to the Global FedEx hub.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are excited to continue strengthening Clarity’s supply and manufacturing efforts and distinguishing ourselves from the current generation of radiopharmaceuticals that have many logistical limitations due to very short half-lives. In a field with all too many unforeseen product supply limitations and outages, we are building a reliable supply network with excess capacity."

Clarity’s 64Cu-based products can be centrally manufactured on existing cyclotrons and distributed broadly with a widespread geographical reach due to a significantly longer shelf-life of Clarity’s Targeted Copper Theranostics (TCT) products. A single cyclotron can supply 64Cu for the entire Phase III diagnostic clinical program.

"Clarity is overlaying several cyclotrons and manufacturers to enable TCTs’ future expansion into the larger commercial setting. By building a reliable and accessible supply chain that is consistent with that of the "big pharma" oncology model, Clarity aims to create a significant competitive advantage as we continue to pursue our ultimate goal of improving treatment outcomes for children and adults with cancer," said Dr Taylor.

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two prostate-specific membrane antigen (PSMA) binding motifs to Clarity’s proprietary sarcophagene (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide1. The National Cancer Institute estimates in 2022 there will be 268,490 new cases of prostate cancer in the US and around 34,500 deaths from the disease2.

On August 10, 2022 Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing a diversified pipeline of targeted therapeutic candidates across multiple modalities for patients with cancer, reported on recent and upcoming business highlights and announced its financial results for the second quarter ended June 30, 2022 (Press release, Cullinan Oncology, AUG 10, 2022, View Source [SID1234618059]).

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"In the second quarter of 2022, Cullinan Oncology demonstrated significant portfolio advancement, including the closing of our agreement with Taiho Pharmaceutical for CLN-081, an oral presentation for CLN-081 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting, and continued progression of our pipeline of potential first-in-class and best-in-class oncology assets. These achievements demonstrate our commitment to creating new standards of care for patients with unmet need," said Nadim Ahmed, Chief Executive Officer of Cullinan Oncology.

"We are pleased with the continued strengthening of CLN-081’s clinical profile," Ahmed continued. "Updated data released at ASCO (Free ASCO Whitepaper) highlighted a high response rate, favorable safety and tolerability, and improving durability of response from the ongoing Phase 1/2a study for patients with EGFR exon 20 insertion mutation non-small-cell lung cancer. Financially, the closing of the Taiho transaction for CLN-081 has extended our cash runway through 2026, giving us the financial flexibility to accelerate and expand the development of our diverse pipeline as well as obtain promising new oncology assets. Looking ahead, we continue to advance our earlier-stage programs, including CLN-619 and CLN-049, with initial Phase 1 data readouts expected by mid-2023, as well as CLN-617 and CLN-978, for which we anticipate IND filings in the first half of next year."

Portfolio Highlights

CLN-081: In June, Cullinan Oncology completed its strategic agreement with Taiho Pharmaceutical Co., Ltd. (Taiho Pharmaceutical) pursuant to which Cullinan Oncology received a $275 million upfront payment and is eligible to receive an additional $130 million tied to EGFR exon 20 non-small-cell lung cancer regulatory milestones in exchange for selling its equity interest in Cullinan Pearl, which holds worldwide rights to CLN-081 outside of Japan and Greater China. Additionally, Cullinan Oncology entered into an agreement with Taiho Oncology, Inc. (Taiho Oncology), a subsidiary of Taiho Pharmaceutical, to jointly develop and commercialize CLN-081 in the U.S. Pursuant to the co-development agreement, Cullinan Oncology and Taiho Oncology will share equally in the development expenses and future potential U.S. profits and losses for CLN-081.
Also in June, Cullinan Oncology presented updated data from its ongoing Phase 1/2a clinical study of CLN-081 in an oral presentation at the ASCO (Free ASCO Whitepaper) 2022 Annual Meeting. The updated data showed a median duration of response greater than 21 months, median progression free survival of 12 months and a confirmed overall response rate of 41% among 39 patients treated at the 100 mg BID dose, along with a continued favorable safety and tolerability profile. In collaboration with its partner, Taiho Oncology, Cullinan Oncology intends to initiate a pivotal study for CLN-081 in the second half of 2022 under the co-development agreement.
CLN-049: Cullinan Oncology continued dosing patients in its first-in-human clinical trial evaluating CLN-049 in patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Initial clinical data are expected by mid-2023. CLN-049 is a FLT3/CD3-bispecific T cell-engaging antibody in an IgG format for the treatment of AML and MDS. CLN-049 targets the extracellular domain of FLT3, regardless of mutant or wild type FLT3 status.
CLN-619: Cullinan Oncology continued dosing subjects in its first-in-human clinical trial evaluating CLN-619 alone and in combination with pembrolizumab in patients with advanced tumors. Initial clinical data are expected by mid-2023. CLN-619 is a first-in-class monoclonal antibody with broad therapeutic potential across multiple cancer indications. CLN-619 stabilizes expression of MICA/MICB on the tumor cell surface to promote an antitumor response via activation of both natural killer (NK) cells and certain T cells.
Preclinical Portfolio:
Cullinan Oncology remains on track for Investigational New Drug (IND) submissions in the first half of 2023 for its two most advanced preclinical programs:
CLN-617, a cytokine fusion protein uniquely combining IL-12 and IL-2 with a collagen binding domain designed for retention in the tumor microenvironment (TME) following intratumoral injection, and
CLN-978, a novel CD19/CD3-bispecific construct with extended serum half-life and high potency against target cells expressing low levels of CD19.
Cullinan Oncology continues to progress its additional 3 preclinical programs, including Jade, Opal, and the HPK1 degrader collaboration with Icahn Mount Sinai.

Second Quarter 2022 Financial Results

Cash Position: Cash and investments were $656 million as of June 30, 2022. During the second quarter of 2022, we received cash proceeds of $270 million from the sale of Cullinan Pearl. The remaining $5 million of the $275 million upfront payment was held in escrow as of June 30 and is expected to be released in the third quarter of 2022. Based on current operating plans, the Company expects that its cash and investments will be sufficient to fund operations through 2026.
R&D Expenses: Research and development (R&D) expenses were $26.4 million for the second quarter of 2022, compared to $24.5 million for the first quarter of 2022. R&D expenses for the second and first quarters of 2022 included $4.4 million and $2.6 million of equity-based compensation expenses, respectively. The increase in R&D expenses is primarily related to expanded clinical activities for CLN-049 and CLN-619 and IND-enabling activities for CLN-617, which were partially offset by a decrease in chemistry, manufacturing, and control activities for CLN-081.
G&A Expenses: General and administrative (G&A) expenses were $10.7 million for the second quarter of 2022, compared to $8.1 million for the first quarter of 2022. G&A expenses in the second and first quarters of 2022 included $4.2 million and $3.8 million of equity-based compensation expenses, respectively. Nonrecurring expenses related to the Cullinan Pearl transaction were $1.7 million in the second quarter and $0.3 million in the first quarter.
Gain on sale of Cullinan Pearl: The Company recognized a gain on the sale of Cullinan Pearl of $276.8 million, which includes the upfront payment of $275 million, as well as the impact of net liabilities transferred to Taiho. As of June 30, 2022, the Company also recognized an income tax liability related to this gain of $46.5 million. The Company estimates the net income tax liability will be reduced to approximately $41 million based on our utilization of net operating losses we anticipate incurring during the remainder of 2022. We expect to make estimated tax payments in an amount equal to 75% of our tax liability in the third quarter of 2022 and the remainder in the fourth quarter of 2022.
Net Income: The Company generated net income (before items attributable to noncontrolling interest) of $174.1 million for the second quarter of 2022 compared to a net loss of $12.9 million for the first quarter of 2022.